National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 6) (No. PB 67 of 2012)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (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). This legislation, enacted by the Parliament of Australia, aims to address issues related to the classification and pricing of drugs on the PBS. F1 is designated for single brand drugs, while F2 is for drugs with multiple brands or those in therapeutic groups with other multi-brand drugs. Drugs on F2 are subject to statutory price reductions, price disclosure, and supply guarantees. The policy objective of this amendment is to ensure the appropriate allocation of drugs to the correct formulary based on their therapeutic characteristics and market presence. The Amending Determination removes two specific drugs, dihydroergotamine and etidronic acid, from F1. This decision was made following detailed consultations with pharmaceutical companies, the intended responsible parties, and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, comprising members from various healthcare-related fields, ensures that recommendations are comprehensive and consider multiple stakeholder interests. The Amending Determination, which commenced on 1 September 2012, represents a legislative instrument under the Legislative Instruments Act 2003.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 applies to pharmaceutical companies and their listed drugs that are included in the Pharmaceutical Benefits Scheme (PBS). Specifically, it pertains to the allocation of drugs to the F1 and F2 formularies of the PBS, which is a critical aspect of the National Health Act 1953. The F1 formulary is designated for single brand drugs, while the F2 formulary accommodates drugs that have multiple brands or are in a therapeutic group with other drugs having multiple brands. The Amending Determination alters the Principal Determination by removing two drugs, dihydroergotamine and etidronic acid, from the F1 formulary. This amendment is geographically applicable across the Commonwealth of Australia and involves the national health system, ensuring consistency in drug allocation and pricing across the country. The Act and its amendments are designed to facilitate statutory price reductions, price disclosure, and guarantee of supply for drugs on the F2 formulary. The Minister has the authority to make such determinations through subordinate legislative instruments, thus extending or restricting the application of the Act as necessary.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 6) are section 2, which amends the Principal Determination by removing two listed drugs, dihydroergotamine and etidronic acid, from F1. This determination is made under subsection 85AB(1) of the National Health Act 1953, which allows the Minister to decide by legislative instrument which listed drugs are assigned to F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The criteria for assigning drugs to F1 or F2 are outlined in subsections 85AB(3) and 85AB(4) of the Act, which require that there are no bioequivalent or biosimilar brands of the drug or any drug in the same therapeutic group, and that the drug was not on F2 the day before the determination comes into effect. The Act imposes obligations on the Minister to determine which listed drugs are assigned to F1 or F2, based on the criteria set out in the Act. It also requires that there be detailed consultations about the drug with the intended responsible person, and a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC is made up of two-thirds members from interests or professions such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. There are no explicit offences, penalties, or consequences for breach stated in the determination. However, any breach of the Act or the determination may have legal consequences, such as a challenge to the decision in court, or other consequences such as loss of reputation or damage to business interests. The maximum penalties for breaches of the Act may vary depending on the specific provision that is breached, and could include fines or imprisonment. In summary, the National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 6) amends the Principal Determination by removing two listed drugs from F1, and imposes obligations on the Minister and PBAC to consult and recommend on the allocation of drugs to formularies. There are no explicit penalties stated in the determination, but breaches of the Act or determination may have legal and other consequences.