National Health (Listed drugs on F1 or F2) Amendment Determination 2018 (No. 6) (PB 70 of 2018)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2018, enacted by the Australian government, amends the National Health (Listed drugs on F1 or F2) Determination 2010 under the National Health Act 1953. The purpose of this legislation is to update the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), where F1 is designated for single brand drugs and F2 for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. This amendment responds to the need to ensure that the allocation of drugs to these formularies remains current and appropriate, considering the evolving landscape of pharmaceutical products. The policy objective is to ensure effective and efficient management of the PBS, providing access to necessary medications while managing costs. The Minister for Health or their delegate has the authority to make such determinations, and this specific amendment adds two new drugs to F1 and moves one drug from F1 to F2, effective from 1 August 2018.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2018 applies to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Specifically, this legislation pertains to pharmaceutical companies and their products that are listed on the PBS, affecting the availability and pricing of drugs for consumers. The Act applies nationally as it is a Commonwealth legislation. Drugs on F1 are designated for those with a single brand, while F2 is for drugs that have multiple brands or are in a therapeutic group with other multiple brand drugs, subject to statutory price reductions, price disclosure, and supply guarantees. The Amendment Determination introduces two new drugs to F1 and moves one drug from F1 to F2, thereby altering the formulary allocations of these specific pharmaceutical products. The Amendment Determination commences on 1 August 2018, and its provisions are subject to variation or revocation under the Acts Interpretation Act 1901, unless otherwise specified.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2018 (No. 6) amends the National Health (Listed Drugs on F1 or F2) Determination 2010, introducing changes to the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS). Specifically, it adds two new drugs, follitropin delta and glecaprevir with pibrentasvir, to the F1 formulary, which is intended for single brand drugs (subsection 85AB(4) of the Act). Additionally, it moves nebivolol from F1 to F2, the formulary for drugs with multiple brands or within a therapeutic group with other drugs having multiple brands (subsection 85AB(3)). This amendment comes into effect on 1 August 2018. The Act imposes certain obligations on the parties involved, primarily the Minister or their delegate, who is responsible for determining which drugs are placed on F1 or F2 under section 85AB(1) of the Act. To be placed on F1, a drug must satisfy specific criteria, including the absence of bioequivalent or biosimilar listed brands of pharmaceutical items in the same therapeutic group. Conversely, a drug may only be placed on F2 if it does not meet the criteria for F1 (subsection 85AB(3)). Pharmaceutical companies with drugs listed on the PBS are required to engage in detailed consultations with the relevant authorities and the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representation from consumers, health economists, and medical professionals. The PBAC provides recommendations based on submissions from affected parties, ensuring a balanced consideration of the drug's allocation. Failure to comply with the requirements and obligations stipulated by the Act may result in civil or criminal penalties. While specific penalties are not detailed in the Explanatory Statement, breaches of the Act can lead to enforcement actions by the relevant authorities. The Pharmaceutical Benefits Scheme is governed by a comprehensive set of rules and regulations, and non-compliance can attract penalties that are commensurate with the severity of the breach. The precise nature and extent of penalties would be determined based on the specific provisions of the Act and any applicable subsidiary legislation. The National Health Act 1953 provides a framework for the regulation of listed drugs within the PBS, ensuring that they are appropriately allocated to the F1 or F2 formularies. The 2018 Amendment Determination reflects ongoing assessments and consultations with relevant stakeholders, aiming to maintain the integrity and effectiveness of the scheme. The legislative process, including the required consultations and recommendations from the PBAC, ensures that the allocation of drugs is based on thorough evaluation and stakeholder input. This systematic approach helps to uphold the standards and objectives of the Pharmaceutical Benefits Scheme.