EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 6)
PB 73 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 tiaprofenic acid 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 November 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. 6) was enacted to amend the National Health (Listed Drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This determination addresses the need to adjust the formulary allocation of specific drugs to ensure appropriate pricing and supply mechanisms are applied. The instrument was made by the Minister for Health under subsection 85AB(1) of the National Health Act 1953 and removes the listed drug tiaprofenic acid from F1. The policy objective is to ensure that the allocation of drugs to the F1 and F2 formularies aligns with the criteria set out in the Act, specifically regarding bioequivalence, biosimilarity, and therapeutic grouping. The instrument was subject to consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee before its enactment.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (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). The Act applies to the Minister for Health, who has the authority to determine by legislative instrument whether a listed drug should be placed on F1 or F2. This decision is based on criteria such as the presence or absence of bioequivalent or biosimilar drugs and the drug's previous placement on F2. Pharmaceutical companies with medicines listed on the PBS are directly affected by this legislation, and their input is considered through consultations and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This instrument revokes the Principal Determination in part by removing the listed drug tiaprofenic acid from F1 and is effective from 1 November 2013.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 6) (the Amending Determination) include the removal of the listed drug tiaprofenic acid from F1 (subsection 85AB(5)). This change is made under the authority of the National Health Act 1953 (the Act) and follows the criteria outlined in the Act for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Specifically, the drug tiaprofenic acid no longer meets the criteria for F1, hence its removal from this formulary.
The Act imposes certain obligations on the parties it governs. Pharmaceutical companies with medicines listed on the PBS must adhere to the criteria specified in the Act for drug allocation to F1 or F2. This includes ensuring that the drug does not have any listed brands that are bioequivalent or biosimilar to other brands in the same therapeutic group. Additionally, the Act mandates consultation with the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to the formularies. The PBAC, which comprises representatives from various healthcare interests, reviews submissions from pharmaceutical companies and provides recommendations.
The Amending Determination also includes provisions for offences, penalties, or civil and criminal consequences for breach. While the explanatory statement does not specify penalties, breaches of the Act's provisions could lead to various enforcement actions, such as fines or other sanctions. The Act's overarching framework, including the potential penalties, is detailed elsewhere in the legislation, which may include administrative or criminal penalties depending on the nature and severity of the breach.
In summary, the Amending Determination alters the placement of tiaprofenic acid within the PBS formularies, reflecting the criteria set out in the National Health Act 1953. Pharmaceutical companies must comply with these criteria and engage in consultations with the PBAC. Failure to comply with the Act’s requirements may result in enforcement actions, though specific penalties are not outlined in this explanatory statement.