National Health Act 1953 - Amendment determination under subsections 85AB(1) and 85AC(1) - drugs on F1 and drugs in Part A of F2 (No. PB 66 of 2009)

Overview

The National Health Act 1953, as amended by the F2009L02715 instrument, serves as the legislative framework for the Pharmaceutical Benefits Scheme (PBS) by which the Australian government ensures reliable, timely, and affordable access to a wide range of medicines. Enacted by the Parliament of Australia, this legislation addresses the problem of providing equitable access to essential medications while managing costs. The policy objective is to ensure that Australians have access to necessary medications at reasonable prices through a structured formulary system, which includes F1 and F2 categories. The F2009L02715 instrument, commencing on 1 August 2009, amends the previous instrument (PB 95 of 2007) by determining that certain listed drugs are to be placed in either the F1 or F2 categories of the PBS, ensuring that these medications fit within the appropriate regulatory and pricing frameworks.

Scope and Application

The National Health Act 1953 governs the Pharmaceutical Benefits Scheme (PBS) in Australia, ensuring reliable, timely, and affordable access to a range of medicines for all Australians. Part VII of the Act, as amended by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007, provides the legal framework for the PBS, including provisions for the listing of drugs and their categorisation into formularies. This Act applies to all persons and entities involved in the provision, administration, and regulation of pharmaceutical benefits in Australia, including pharmaceutical companies, healthcare providers, and patients. The Act's jurisdiction is national, extending to the entire Commonwealth of Australia. The Act includes provisions for the Minister to determine the form, manner of administration, and brand of pharmaceutical items listed under the PBS. Additionally, the Act mandates the categorisation of listed drugs into formularies F1 and F2, with further subdivisions into Part A and Part T of F2, based on the level of price competition between brands. The Act also includes provisions for statutory price reductions, price disclosure, and the guarantee of supply for drugs in these categories. This instrument amends a previous instrument by determining specific listed drugs to be placed in formularies F1 and F2, and further into Part A or Part T of F2, in accordance with the statutory criteria set out in the Act. These determinations ensure compliance with the legislative provisions regarding the categorisation of drugs for the purposes of the PBS. The instrument is effective from 1 August 2009, and any exclusions or exemptions are governed by the statutory criteria outlined in the Act and the regulations.

Key Provisions

The main operative sections of this instrument, under the National Health Act 1953, are sections 85AB(1), 85AB(4), 85AC(1), and 85AC(4). Section 85AB(1) allows the Minister to determine by legislative instrument that a listed drug is on Formulary 1 (F1) or Formulary 2 (F2). Section 85AB(4) specifies the criteria for a drug to be on F1, which includes the absence of listed brands of pharmaceutical items that are bioequivalent or biosimilar, and the drug not being on F2 on the previous day. Section 85AC(1) allows the Minister to determine by legislative instrument that a drug on F2 is in either Part A or Part T of F2. Section 85AC(4) outlines the criteria for a drug to be in Part T, such as being in the same therapeutic group as a drug already in Part T or having been in Part T previously. This instrument amends instrument number PB 95 of 2007 by determining under section 85AB(1) that the listed drugs “Arsenic trioxide”, “High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate”, “Praziquantel”, “Rivaroxaban” and “Soy lecithin” are on F1, and that the listed drugs “Azithromycin”, “Bisoprolol”, “Cabergoline”, “Glucose”, “Morphine”, “Sodium chloride” and “Sodium lactate compound” are on F2. It also determines under subsection 85AC(1) that “Azithromycin”, “Bisoprolol”, “Cabergoline”, “Glucose”, “Morphine”, “Sodium chloride” and “Sodium lactate compound” are in Part A of F2. These determinations comply with the relevant statutory criteria. The obligations and requirements imposed by this Act on the parties or entities it governs include the allocation of listed drugs to the appropriate formulary, F1 or F2, based on the criteria set out in the Act. Pharmaceutical companies must ensure that their drugs meet the criteria for being on F1 or F2, and that they are aware of the provisions of the Act relating to brands of pharmaceutical items, including statutory price reductions, price disclosure, and guarantee of supply. The Minister is responsible for determining by legislative instrument the form or forms of a listed drug, the manner of administration of the form of the listed drug, and a brand of the pharmaceutical item that has the listed drug in that form with that manner of administration. The instrument also outlines the offences, penalties, or civil/criminal consequences for breach, including maximum penalties where stated. However, the specific penalties for breach of the provisions of the Act are not detailed in this instrument. Generally, under the National Health Act 1953, penalties for breaches may include fines and/or imprisonment, depending on the nature and severity of the breach. The maximum penalties for offences under the Act are set out in the Act itself and may vary depending on the specific offence. It is important for parties and entities governed by the Act to be aware of these potential penalties and to ensure compliance with the provisions of the Act to avoid any legal consequences. In summary, this instrument amends instrument number PB 95 of 2007 by determining under section 85AB(1) that the listed drugs “Arsenic trioxide”, “High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate”, “Praziquantel”, “Rivaroxaban” and “Soy lecithin” are on F1, and that the listed drugs “Azithromycin”, “Bisoprolol”, “Cabergoline”, “Glucose”, “Morphine”, “Sodium chloride” and “Sodium lactate compound” are on F2. It also determines under subsection 85AC(1) that “Azithromycin”, “Bisoprolol”, “Cabergoline”, “Glucose”, “Morphine”, “Sodium chloride” and “Sodium lactate compound” are in Part A of F2. These determinations comply with the relevant statutory criteria and impose obligations and requirements on pharmaceutical companies to ensure compliance with the provisions of the Act. Failure to comply with the Act may result in civil or criminal consequences, including fines and/or imprisonment, depending on the nature and severity of the breach.