National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 1) (PB 5 of 2019)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 1) was introduced to address the allocation of specific drugs within the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This legislation, enacted by the Parliament of Australia, amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the formularies F1 and F2, which cater to single brand and multiple brand drugs respectively. The primary objective of this amendment is to ensure that listed drugs are appropriately assigned to their respective formularies based on their therapeutic characteristics and brand availability, thereby facilitating better management and regulation of pharmaceutical benefits. The determination process involves detailed consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, which comprises experts from various health-related fields. The 2019 amendment specifically adds four new drugs to F1 and moves one drug from F1 to F2, reflecting the dynamic nature of pharmaceutical advancements and market adjustments. This legislative instrument aims to maintain the integrity and efficiency of the PBS by ensuring that drugs are categorised in a manner that aligns with their therapeutic and market profiles.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 1) applies to the allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS), affecting pharmaceutical companies with medicines listed on the PBS. This instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding four new drugs to F1 and moving one drug from F1 to F2, while also removing one drug from F1 due to it no longer being listed on the PBS. The Act applies to Commonwealth entities and any person or entity involved in the supply or provision of drugs listed on the PBS, including pharmaceutical companies, healthcare providers, and consumers. The determination extends to all listed drugs that meet the specified criteria for allocation to F1 or F2. The Act does not specify any exclusions, exemptions, or thresholds beyond the criteria for drug allocation to the formularies. The application of the Act can be extended or restricted through subordinate instruments made under the authority of the National Health Act 1953.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 1) 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) (sections 1, 2). The F1 formulary is designated for single brand drugs, while the F2 formulary is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands (section 2). Drugs on F2 are subject to specific provisions, including statutory price reductions, price disclosure, and a guarantee of supply (section 2). A drug can only be assigned to F1 if it meets certain criteria, such as the absence of bioequivalent or biosimilar drugs in the same therapeutic group (subsection 85AB(4)). Conversely, a drug can be assigned to F2 if it does not meet the criteria for F1 (subsection 85AB(3)). However, if a drug has a single brand combination item on the PBS, it is placed on the administrative combination drug list instead of F1 or F2 (subsection 85AB(5)). The Amending Determination adds four new drugs to F1 – ferric derisomaltose, guselkumab, osimertinib, and tildrakizumab – and moves rasagiline from F1 to F2, while also removing gelatin-succinylated from F1 because it is no longer PBS listed (section 3). The obligations imposed by this Act primarily concern pharmaceutical companies with medicines listed on the PBS. These companies must comply with the allocation of their drugs to the appropriate formulary as determined by the Minister or their delegate under section 85AB of the Act (section 85AB). The process involves detailed consultations with the intended responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC consists of members from various relevant fields, such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists (section 2). Affected pharmaceutical companies are expected to provide submissions to the PBAC, which in turn makes recommendations based on these submissions. Although further consultation on the Amending Determination was deemed unnecessary, the companies must still adhere to the updated formulary allocations. Failure to comply with the provisions of the National Health Act 1953 and the Amending Determination may result in various consequences. The Act does not explicitly outline specific offences or penalties within the Explanatory Statement; however, non-compliance with PBS regulations could potentially lead to civil or criminal consequences under other relevant legislation. The Pharmaceutical Benefits Scheme Act 1990, for example, contains provisions for offences and penalties related to the PBS, which may apply to non-compliance with the Act and the Amending Determination. The maximum penalties for offences under the Pharmaceutical Benefits Scheme Act 1990 can vary depending on the specific offence, but may include fines of up to AUD 22,200 for individuals and AUD 111,000 for bodies corporate, as well as potential imprisonment terms.