National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 3) (No. PB 32 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 3) 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) under the National Health Act 1953. This legislation was introduced to address the need for updating the list of drugs on F1 and F2, ensuring that the most appropriate drugs are allocated to the correct formularies based on their therapeutic groups and brand equivalency. The determination was made under the authority of the Minister for Health, pursuant to subsection 85AB(1) of the Act. The policy objective is to maintain an efficient and effective pharmaceutical benefits system that provides access to affordable and necessary medications for Australians. The Amending Determination introduces two new drugs, plerixafor and sapropterin, to F1 and removes three drugs, anakinra, methysergide, and pergolide, from F1. This adjustment reflects the latest recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) following detailed consultations with stakeholders, including pharmaceutical companies and healthcare professionals. The Amending Determination aims to ensure that the PBS remains responsive to the evolving needs of the Australian population by accurately categorising drugs based on their therapeutic value and market availability. The changes are set to take effect on 1 May 2014, and the determination constitutes a legislative instrument under the Legislative Instruments Act 2003.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies with medicines listed on the PBS, and to consumers who are eligible for PBS-subsidised medications. The amendment adds two new drugs, plerixafor and sapropterin, to the F1 formulary and removes three drugs, anakinra, methysergide, and pergolide, from the F1 formulary. The F1 formulary is intended 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. The National Health Act 1953, which the Amendment Determination is made under, applies throughout the Commonwealth of Australia and governs the allocation of drugs to formularies on the PBS. The Act provides that listed drugs may be assigned to formularies identified as F1 and F2, with the criteria for inclusion in each formulary set out in the Principal Determination. The determination may be revoked or varied by subordinate instrument, and the Amending Determination constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Key Provisions

The key operative sections of this legislation are sections 85AB(1) and 85AB(5) of the National Health Act 1953, which empower the Minister to determine by legislative instrument the allocation of listed drugs to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Section 85AB(4) sets out the criteria for a drug to be placed on F1, while section 85AB(3) outlines the criteria for a drug to be placed on F2. If a listed drug has a single brand combination item on the PBS, section 85AB(5) applies, and the drug is placed on the administrative combination drug list instead of F1 or F2. Under this Act, pharmaceutical companies must ensure that their listed drugs comply with the criteria set out in the legislation for placement on either F1 or F2. The Minister has the authority to amend the Principal Determination, which allocates drugs to the formularies, by adding or removing drugs based on these criteria. This process involves consultation with the intended responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various healthcare-related interests and professions. The legislation imposes several obligations on parties and entities governed by it. Pharmaceutical companies must submit their drugs for evaluation and recommendation by the PBAC before they can be listed and allocated to a formulary. The Minister must also consult with the PBAC and consider their recommendations when making determinations about drug allocations. Additionally, the Minister must ensure that the criteria for placement on F1 or F2 are adhered to, and any amendments to the Principal Determination must be made in accordance with the provisions of the Act. Breaches of the Act or the Principal Determination may result in civil or criminal consequences. While the legislation does not explicitly state the maximum penalties for breaches, it is likely that penalties would be in line with those applicable under the National Health Act 1953 or the Acts Interpretation Act 1901. Civil penalties could include fines or other monetary penalties, while criminal penalties could include imprisonment or both fines and imprisonment, depending on the severity of the breach and any relevant case law or statutory provisions.