National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 3) (PB 24 of 2019)

Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, provides the framework for the allocation of drugs to the Pharmaceutical Benefits Scheme (PBS) formularies. The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by assigning safinamide to F1 and reassigning atazanavir from F1 to F2. This amendment aims to ensure that drugs are appropriately categorised within the PBS, with F1 designated for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. The amendment process involves consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring a balanced consideration of various interests in the healthcare sector. The policy objective is to maintain a well-regulated and efficient PBS that appropriately allocates resources to ensure the availability and affordability of essential medications.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010, providing for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to listed drugs and the entities that manufacture, supply, or administer these drugs within the Commonwealth of Australia. Drugs are assigned to F1 if they have a single brand and meet specific criteria, such as the absence of bioequivalent or biosimilar listed brands and not having been on F2 previously. Drugs that do not meet the criteria for F1 may be assigned to F2, which includes provisions for price reductions, price disclosure, and guaranteed supply. This legislative instrument also includes a provision for a drug to be placed on an administrative combination drug list if it has a single brand combination item on the PBS. The Amending Determination adds safinamide to F1 and moves atazanavir from F1 to F2, reflecting decisions made after thorough consultation with the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies. This Instrument, made under the authority of the National Health Act 1953, comes into effect on 1 April 2019.

Key Provisions

The main operative sections of this determination are subsection 85AB(1) of the National Health Act 1953, which empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2, and subsection 85AB(5) which relates to listed drugs with a single brand combination item on the Pharmaceutical Benefits Scheme (PBS) and places such drugs on the administrative combination drug list. This determination also relies on subsection 33(3) of the Acts Interpretation Act 1901 for revoking or varying the Principal Determination. In plain terms, this legislation allows for the allocation of drugs to specific formularies within the PBS, with F1 reserved for single brand drugs and F2 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 guaranteed supply provisions. The obligations and requirements imposed by the Act on the parties and entities it governs include ensuring that listed drugs meet the criteria for allocation to F1 or F2 formularies. For a drug to be placed on F1, it must have no bioequivalent or biosimilar listed brands in the same therapeutic group as another drug, and it must not have been on F2 the day before the determination comes into effect. Conversely, a drug may only be placed on F2 if it fails to meet one or more of the criteria for F1. Additionally, the Act mandates that before drugs are listed and allocated to formularies, detailed consultations must occur with the intended responsible person, and a recommendation must be received from the Pharmaceutical Benefits Advisory Committee (PBAC). The determination outlines several potential consequences for breaches of its provisions. However, the explanatory statement does not specify particular offences or penalties. Generally, under the National Health Act 1953, non-compliance with the provisions related to the PBS could result in various penalties, both civil and criminal, depending on the nature and severity of the breach. Civil penalties can include fines up to $22,200 per offence for individuals and $111,000 for corporations, while criminal penalties can include fines up to $555,000 for individuals and $2,775,000 for corporations, along with potential imprisonment terms. The exact penalties would depend on the specific provisions of the Act that are breached and the circumstances of the breach.