EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 8)
PB 98 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 one new drug tofacitinib to 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 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 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. This legislative instrument, enacted by the Minister for Health, is designed to address the allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The purpose of this amendment is to place a new drug, tofacitinib, on the F1 formulary, which is designated for single brand drugs. This amendment aims to ensure that the drug is subject to the provisions of the Act relating to statutory price reductions, price disclosure, and the guarantee of supply, thereby facilitating equitable access to the drug for Australian patients. The amendment process involved extensive consultation with relevant pharmaceutical companies and a recommendation from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of various stakeholder interests.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 pertains to the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This amendment applies to pharmaceutical companies whose drugs are listed on the PBS and are subject to the criteria for placement on the F1 or F2 formularies. F1 is designated for single-brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The amendment specifically adds the drug tofacitinib to the F1 formulary. The geographic reach of this determination is national, as it applies across Australia under the Commonwealth’s legislative framework. The Amending Determination is subject to consultation processes involving the Pharmaceutical Benefits Advisory Committee (PBAC) and submissions from affected pharmaceutical companies, ensuring that recommendations are informed by a broad range of stakeholders. This legislative instrument also extends or restricts application through subordinate instruments, relying on the authority granted by the Acts Interpretation Act 1901 unless explicitly stated otherwise.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 8) (the Amending Determination) amend the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) by adding the drug tofacitinib to F1 (subsection 85AB(1)). This is consistent with section 84AC of the National Health Act 1953 (the Act), which requires a determination to be in force under section 85AB to assign a listed drug to F1 or F2. For a drug to be placed on F1, it must satisfy certain criteria (subsection 85AB(4)), which includes 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 that are bioequivalent or biosimilar. The drug must also not have been on F2 the day before the determination comes into effect.
The Amending Determination imposes obligations on pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS). These companies must adhere to the criteria set out in the Principal Determination and the Amending Determination for drugs to be allocated to F1 or F2. Pharmaceutical companies must also engage in consultations with the intended responsible person and the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC recommendation process involves receiving submissions from affected pharmaceutical companies, and two-thirds of the PBAC membership must be from specified interests or professions, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists.
There are no explicit offences, penalties, or civil/criminal consequences outlined for breach of the Amending Determination. However, the Amending Determination affects pharmaceutical companies with medicines listed on the PBS, and they must comply with the criteria and processes set out in the Principal Determination and the Amending Determination. Failure to comply with these requirements may result in the drug not being allocated to F1 or F2, which could impact the availability and affordability of the drug for patients. Additionally, the Act and the Principal Determination provide for statutory price reductions, price disclosure, and guarantee of supply for drugs on F2, which may be impacted by non-compliance with the requirements of the Amending Determination.