National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 5) (PB 48 of 2016)

Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, serves as the foundation for the administration and regulation of the Pharmaceutical Benefits Scheme (PBS), aiming to ensure that Australians have access to affordable and necessary medications. The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 5) was introduced to address the need to update the allocation of certain drugs within the PBS formularies. This legislative instrument, authorised under section 85AB(1) of the National Health Act, seeks to amend the National Health (Listed drugs on F1 or F2) Determination 2010 by moving specific drugs from one formulary to another based on their therapeutic characteristics and brand availability. The policy objective is to ensure that drugs are appropriately categorised within the PBS to facilitate efficient pricing and supply mechanisms. The Amending Determination specifically shifts acarbose, azacitidine, and eplerenone from F1 to F2, thereby subjecting them to the provisions of the Act relating to statutory price reductions, price disclosure, and the guarantee of supply. This adjustment was made following consultations with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 5) 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). This amendment applies to specific pharmaceutical drugs, namely acarbose, azacitidine, and eplerenone, which are being moved from the F1 to the F2 formulary. This determination applies to the entities involved in the manufacture, supply, and prescribing of these drugs within the Australian jurisdiction. The Pharmaceutical Benefits Scheme is a national scheme, hence the determination applies across Australia. The Amending Determination is subject to consultation with affected pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which comprises members from various healthcare-related interests and professions. The Amending Determination does not include any specific exclusions or thresholds but relies on the criteria set out in the National Health Act 1953 for the allocation of drugs to F1 or F2.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 5) (F2016L00864) involve the amendment of the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) to adjust the formulary allocation of certain drugs on the Pharmaceutical Benefits Scheme (PBS). Specifically, the determination moves three drugs—acarbose, azacitidine, and eplerenone—from the F1 formulary to the F2 formulary (subsection 85AB(5)). This is done under the authority granted by subsection 85AB(1) of the National Health Act 1953 (the Act). For a drug to be allocated to F2, it must not meet the criteria for F1, which includes the absence of bioequivalent or biosimilar drugs in the same therapeutic group (subsection 85AB(3)). The Amending Determination also specifies that drugs on F2 are subject to certain provisions of the Act, such as first new brand statutory price reductions, price disclosure, and guarantee of supply (section 84AC). The obligations imposed by the Act on the parties it governs primarily involve ensuring compliance with the determination's allocation of drugs to the appropriate formularies. Pharmaceutical companies must adhere to the criteria for drug classification and ensure that their products are listed and allocated as specified by the Act and the Determination. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in providing recommendations based on detailed consultations and submissions from affected parties. The Minister, empowered by subsection 85AB(1) of the Act, has the authority to make determinations regarding the allocation of drugs to F1 or F2, subject to the criteria set out in subsections 85AB(3) and 85AB(4). The Act also mandates that drugs with a single brand combination item on the PBS are placed on the administrative combination drug list rather than F1 or F2 when subsection 85AB(5) applies. The determination does not explicitly outline specific offences or penalties for non-compliance with the drug allocation provisions. However, breaches of the National Health Act 1953 or any related regulations may result in civil or criminal penalties as stipulated elsewhere in the Act. For example, misleading or deceptive conduct in relation to PBS listings can lead to civil penalties under section 104C, while serious offences may attract criminal penalties. Pharmaceutical companies and other entities subject to the Act must ensure they comply with the requirements to avoid potential legal consequences. Overall, the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 5) seeks to ensure that drugs are appropriately classified and managed within the PBS framework, aligning with the Act's objectives for equitable access to pharmaceuticals.