EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.3)
PB 30 of 2012
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 listed drug, amlodipine with atorvastatin, into F2. Previously this drug sat outside F1 and F2 on the single brand combination list, but with the listing of a second brand the listed drug moves into F2.
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 June 2012.
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 2012 (No.3) was enacted to address a specific gap in the allocation of drugs to formularies within the Pharmaceutical Benefits Scheme (PBS). This amendment was introduced under the National Health Act 1953 by the Australian Minister for Health, and it aims to ensure that the allocation of drugs to the F1 and F2 formularies aligns with the statutory requirements and objectives of the Act. The F1 formulary is designated for single brand drugs, while the F2 formulary is intended for drugs with multiple brands or those in a therapeutic group with other drugs having multiple brands. The purpose of this amendment is to appropriately categorise the drug amlodipine with atorvastatin into the F2 formulary, given the addition of a second brand, which was previously listed outside of the F1 and F2 formularies on the single brand combination list. This adjustment facilitates better regulation and oversight in accordance with the provisions of the Act relating to statutory price reductions, price disclosure, and the guarantee of supply.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No.3) amends the National Health (Listed drugs on F2) Determination 2010 under subsection 85AB(1) of the National Health Act 1953. This legislation pertains to the classification and allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, while F2 is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The amendment specifically adds the listed drug amlodipine with atorvastatin into F2, following the introduction of a second brand for the drug. The Act applies to pharmaceutical companies with medicines listed on the PBS and those involved in the Pharmaceutical Benefits Advisory Committee (PBAC), which includes a diverse membership of consumers, health economists, and medical professionals. The amendment is effective from 1 June 2012 and constitutes a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 3) (the Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination). It primarily functions to adjust the allocation of listed drugs within the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, it adds the drug amlodipine with atorvastatin to the F2 formulary, which is intended for drugs that have multiple brands or are in therapeutic groups with other drugs with multiple brands (subsection 85AB(3) of the Act). Amlodipine with atorvastatin was previously on the single brand combination list but has now been reallocated to F2 due to the introduction of a second brand.
The Act imposes specific obligations and requirements on the entities it governs, particularly pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC). Pharmaceutical companies must ensure their drugs meet the criteria for either F1 or F2 formularies, or remain outside these categories as appropriate. The PBAC is responsible for providing recommendations to the Minister on the allocation of drugs to the PBS, which are made after considering submissions from affected pharmaceutical companies. These recommendations are critical in guiding the Minister's determinations regarding drug allocations.
The Determination does not introduce new offences or penalties. However, it operates under the framework established by the National Health Act 1953, which includes potential civil and criminal consequences for non-compliance with its provisions. For example, under the Act, breaches of certain provisions can lead to fines and, in some cases, imprisonment. The exact penalties depend on the specific breach and are outlined in the relevant sections of the Act.
In summary, the Determination amends the Principal Determination by reallocating amlodipine with atorvastatin to the F2 formulary. It requires pharmaceutical companies and the PBAC to adhere to the criteria and processes for drug allocation under the Act. While the Determination itself does not introduce new penalties, the overarching legislative framework includes significant sanctions for non-compliance.