National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) (PB 22 of 2017)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, made under subsection 85AB(1) of the National Health Act 1953. The purpose of this determination is to address the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act allows for listed drugs to be assigned to these formularies, with F1 intended for single brand drugs and F2 for drugs with multiple brands or those in a therapeutic group with other multiple brand drugs. This amendment introduces five new drugs to F1 and reallocates five drugs from F1 to F2. The Minister (or delegate) determines by legislative instrument whether a drug is on F1 or F2, based on specific criteria outlined in the Act. The Amending Determination also notes that, unless expressly stated, the determination relies on subsection 33(3) of the Acts Interpretation Act 1901 to revoke or vary the Principal Determination. The determination was made following consultations with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, and comes into effect on 1 April 2017.

Scope and Application

The National Health Act 1953 governs the allocation of listed drugs to formularies within the Pharmaceutical Benefits Scheme (PBS), with the National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) amending the National Health (Listed drugs on F1 or F2) Determination 2010. This legislation applies to pharmaceutical companies with medicines listed on the PBS, and the amendments in the 2017 Determination relate to the classification of specific drugs within the F1 and F2 formularies. F1 is designated for drugs with a single brand, while F2 is for drugs with multiple brands or those in therapeutic groups with multiple brands. This amendment adds five drugs to F1 and shifts five existing drugs from F1 to F2. The geographic and jurisdictional reach of the Act is national, as it applies across Australia and is administered under the Commonwealth. The determination can be revoked or varied under the Acts Interpretation Act 1901 unless explicitly stated otherwise, and it is considered a legislative instrument under the Legislation Act 2003. The Amending Determination commenced on 1 April 2017, following consultations with affected pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2017 (No. 2) primarily amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding five new drugs to the F1 formulary and reclassifying five existing drugs from F1 to F2 (subsection 85AB(1) of the National Health Act 1953). This amendment affects the allocation of these drugs within the Pharmaceutical Benefits Scheme (PBS). The F1 formulary is designated for single brand drugs, while the F2 formulary is for drugs with multiple brands or those in therapeutic groups with multiple brands (subsection 85AB(4) and (5) of the Act). The determination requires that drugs on F1 must not have bioequivalent or biosimilar brands and must not have been on F2 previously. In contrast, drugs on F2 must not meet the criteria for F1 (subsection 85AB(3) of the Act). The amendment places the drugs cobimetinib, ferrous fumarate, glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine, vemurafenib, and vismodegib on F1. It also moves abatacept, clonidine, etanercept, naloxone, and pegfilgrastim from F1 to F2. The Act imposes several obligations on the entities it governs, particularly pharmaceutical companies with medicines listed on the PBS. These companies must adhere to the criteria for drug allocation to the F1 and F2 formularies as specified by the determination. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drug allocations, with two-thirds of its members representing interests such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. Pharmaceutical companies are required to submit relevant data and participate in consultations regarding the drug's therapeutic value, safety, and cost-effectiveness. The Minister or delegate must consider these recommendations when making determinations about drug allocations (subsection 85AB(1) of the Act). The obligation extends to ensuring that the drugs are appropriately classified within the PBS framework, which impacts their availability and pricing to consumers. Breaches of the provisions outlined in the Amending Determination and the Principal Determination can result in significant penalties. The maximum penalties for contraventions of the Act and the determinations can include substantial fines and, in some cases, imprisonment. The specifics of these penalties are detailed in the National Health Act 1953 and the Acts Interpretation Act 1901, which provide the legal framework for enforcement. Non-compliance with the determinations can lead to administrative actions, including fines for entities that fail to adhere to the specified drug classifications and supply obligations. These consequences underscore the importance of adhering to the regulatory requirements set forth by the Act and the determinations to ensure the proper functioning of the PBS and the equitable distribution of pharmaceutical benefits to the Australian public.