EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 5)
PB 68 of 2013
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 removing the listed drug zolmitriptan from F1 and placing it on 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 October 2013.
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 2013 (No. 5) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, which is part of the National Health Act 1953. The primary purpose of this amendment is to adjust the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) by removing the listed drug zolmitriptan from the F1 formulary and placing it on the F2 formulary. This change is intended to ensure that the drug allocation aligns with the criteria set out in the Act for F1 and F2 formularies, where F1 is designated for single brand drugs and F2 for drugs with multiple brands or those in a therapeutic group with other drugs with multiple brands. The enacting body for this amendment is the Minister for Health under the authority provided by subsection 85AB(1) of the National Health Act 1953. The policy objective is to maintain an effective and efficient PBS by ensuring drugs are appropriately categorised within the scheme, which in turn supports equitable access to affordable medications for the Australian public.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 5) applies to the allocation of drugs within the Pharmaceutical Benefits Scheme (PBS) in Australia. It amends the National Health (Listed drugs on F1 or F2) Determination 2010 by removing zolmitriptan from the F1 formulary and placing it on the F2 formulary. This determination is made under the authority of the National Health Act 1953, which provides for the assignment of listed drugs to the F1 and F2 formularies. The F1 formulary is designated for single brand drugs, whereas F2 is for drugs with multiple brands or those in therapeutic groups with multiple brands. The amendment is aimed at ensuring that drugs are appropriately categorised to comply with statutory requirements such as price reductions, price disclosure, and the guarantee of supply. The determination affects pharmaceutical companies with medicines listed on the PBS and is implemented following consultations with stakeholders, including the Pharmaceutical Benefits Advisory Committee, which considers submissions from affected parties before making recommendations.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (section 85AB(1) of the National Health Act 1953). This amendment specifically removes the drug zolmitriptan from the F1 formulary and places it on the F2 formulary (subsection 85AB(5)). The F1 formulary is designated for single-brand drugs, while the F2 formulary is for drugs with multiple brands or those in a therapeutic group with other drugs having multiple brands. Drugs on F2 are subject to statutory price reductions, price disclosure, and a guarantee of supply under the Act. The criteria for F1 include the absence of bioequivalent or biosimilar listed brands of the drug or any drug in the same therapeutic group, and the drug must not have been on F2 the day before the determination takes effect.
The Amending Determination imposes several obligations on the parties it governs. Pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) must comply with the new formulary allocation for zolmitriptan. The Pharmaceutical Benefits Advisory Committee (PBAC) must have recommended this change, following consultations with affected pharmaceutical companies and considering submissions from a broad spectrum of stakeholders, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. Any changes to the formulary allocation must be communicated to these stakeholders and implemented accordingly.
Breaches of the provisions outlined in the Amending Determination may result in civil or criminal penalties. While the explanatory statement does not specify the exact penalties, the National Health Act 1953 generally provides for enforcement actions against non-compliance. These may include fines, corrective actions, or other measures to ensure adherence to the Act's requirements. The penalties for non-compliance can be severe, reflecting the importance of ensuring the proper allocation of drugs to the appropriate formularies within the PBS.