EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 7)
PB 81 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 three new listed drugs carbomer with triglyceride lipids, human menopausal gonadotrophin and pazopanib to F1. It also moves one drug, risedronic acid and calcium with colecalciferol, from the combination drug list to 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 October 2012.
This instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, establishes the framework for the provision of health services and the regulation of pharmaceuticals in Australia. To address the need for a systematic approach to the allocation of drugs on the Pharmaceutical Benefits Scheme (PBS), the Act allows for the classification of listed drugs into formularies, specifically F1 and F2. The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 7) was introduced to amend the National Health (Listed drugs on F1 or F2) Determination 2010, refining the allocation of specific drugs across these formularies. This legislative instrument, made under subsection 85AB(1) of the Act, aims to ensure that drugs are appropriately categorised based on their therapeutic groups and brand availability, facilitating effective price management and supply guarantees as outlined in the Act. The policy objective is to maintain a streamlined and efficient PBS while ensuring that patients have access to necessary medications.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 7) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by incorporating three new drugs into the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, it allocates the drugs carbomer with triglyceride lipids, human menopausal gonadotrophin, and pazopanib to F1, and reclassifies risedronic acid and calcium with colecalciferol from the combination drug list to F2. The National Health Act 1953, under which this instrument is made, governs the administration of the PBS and the allocation of listed drugs to formularies, with F1 intended for single-brand drugs and F2 for drugs with multiple brands or in therapeutic groups with other multi-brand drugs. The Act applies to all listed drugs within the PBS, overseen by the Minister for Health, and this legislative instrument extends its reach by modifying the Principal Determination. The determination does not specify any exclusions, exemptions, or thresholds beyond those outlined in the Act. The Amending Determination is applicable nationally, consistent with the Commonwealth jurisdiction of the Act.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 7) are sections 2 and 3. Section 2 amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new drugs, carbomer with triglyceride lipids, human menopausal gonadotrophin, and pazopanib, to the F1 formulary. Section 3, on the other hand, removes risedronic acid and calcium with colecalciferol from the combination drug list and places it on the F2 formulary. These sections detail the changes made to the existing list of drugs and their allocation to the relevant formularies, ensuring clarity and consistency in the classification of drugs within the Pharmaceutical Benefits Scheme (PBS).
The obligations and requirements imposed by the Amending Determination primarily concern pharmaceutical companies with medicines listed on the PBS. These companies must comply with the criteria for drug allocation to the F1 and F2 formularies as outlined in the National Health Act 1953. Pharmaceutical companies must engage in consultations with the intended responsible person and await recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC, composed of experts from various relevant fields, reviews submissions from affected pharmaceutical companies and makes recommendations based on detailed consultations and expert opinions.
The Amending Determination does not explicitly state offences or penalties for breach. However, any failure to comply with the requirements and obligations of the National Health Act 1953 or the Pharmaceutical Benefits Scheme could result in civil or criminal consequences. The Act itself provides for penalties, including fines and imprisonment, for breaches of its provisions. The Pharmaceutical Benefits Regulations 2009 also detail specific penalties for non-compliance with the PBS, which may include fines and other civil penalties. It is essential for pharmaceutical companies to adhere to the requirements and obligations set out in the Act and the Amending Determination to avoid any potential consequences.