National Health Act 1953 - Amendment Determination under subsection 85AB(1) - drugs on F1 (No. PB 37 of 2009)

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Legislation au F2009L01445 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 

INSTRUMENT NUMBER PB 37 OF 2009

 

 

NATIONAL HEALTH ACT 1953

 

 

AMENDMENT DETERMINATION UNDER SUBSECTION 85AB(1)

 

 

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

 

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

 

Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

 

The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)).  These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.

 

Provisions of the Act relating to brands of pharmaceutical items, including in relation to statutory price reductions, price disclosure, and guarantee of supply, are the result of amendments in relation to PBS reform by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 (the amending Act), which commenced on 1 August 2007. 

 

The Act provides for listed drugs to be assigned to formularies, identified as F1 and F2.  F1 is intended for single brand drugs, F2 for drugs that have multiple brands, or are interchangeable at the patient level with other drugs with multiple brands.  F2 is in turn divided into Part A and Part T, intended for drugs where price competition between brands is high.  Drugs on F2 are subject to the provisions of the Act relating to statutory price reductions (with different outcomes for Part A and Part T); price disclosure; and guarantee of supply.

 

Section 84AC relevantly provides that a drug is on F1 if determined to be so under section 85AB, or if prescribed to be so by regulations. A drug may also be determined to be on F1 under s99AEJ of the Act. A drug is on F2 if determined to be so under section 85AB, or prescribed to be so by the regulations.  Section 84AD provides that a drug is in Part A or Part T of F2 if determined to be so under section 85AC or if prescribed to be so in the regulations under subsection 85AD(5).  Subsections 84AC(5) and 84AD(5) provide that the regulations may, on the day on which section 84AC commenced, prescribe the matters referred.

 

Drugs on F1 and F2 (in Parts A and T) were prescribed with effect from 1 August 2007 in the National Health (Pharmaceutical Benefits) Regulations.

 

Subsection 85AB empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2.  For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that there are no listed brands of pharmaceutical items that have the drug, or another drug in the same therapeutic group, that are bioequivalent or biosimilar.  It also requires that the drug was not on the day before, on F2.  A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1.

 

This instrument amends instrument number PB 87 of 2007 by adding the listed drugs “Lanthanum”, “Paclitaxel, nanoparticle albumin-bound”, “Sunitinib” and “Teriparatide” to F1.

 

A provision-by-provision description of the instrument is contained in the Attachment.

 

The instrument is expressed to commence on 1 May 2009.

 

Consultations

This instrument affects pharmaceutical companies with medicines listed on the PBS.  Consultation has occurred through a company submission to the Therapeutic Goods Administration and the Pharmaceutical Benefits Advisory Committee for a drug to be listed on the PBS.  When drugs are listed on the PBS each drug is allocated into a formulary, F1, F2A or F2T from the recommendation of the PBAC. 

     
Attachment

 

 

Paragraph 1:  Provides that this instrument commences on 1 May 2009.

Paragraph 2:  Determines that Schedule 1 amends PB 87 of 2007.

Schedule 1:     Adds the listed drugs “Lanthanum”, “Paclitaxel, nanoparticle albumin-bound”, “Sunitinib” and “Teriparatide” to F1.              

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Amendment Determination under Subsection 85AB(1) (Instrument Number PB 37 of 2009) amends the National Health Act 1953, which provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) and ensures reliable, timely, and affordable access to a wide range of medicines for all Australians. The determination was enacted by the Parliament of Australia to address specific issues related to the classification and pricing of listed drugs within the PBS. This legislative instrument, which commenced on 1 May 2009, aims to refine the categorisation of certain drugs, specifically "Lanthanum," "Paclitaxel, nanoparticle albumin-bound," "Sunitinib," and "Teriparatide," into formulary F1. This classification is critical as it determines the extent of price competition and other regulatory provisions applicable to these drugs, thereby impacting their availability and cost to consumers. The objective is to ensure that the PBS operates efficiently and effectively, providing appropriate access to necessary medications while maintaining fiscal responsibility.

Scope and Application

The National Health Act 1953, as amended, establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures accessible, timely, and affordable medicines for all Australians. This Act applies to pharmaceutical benefits provided by the Commonwealth in accordance with Part VII, which includes the declaration of listed drugs by the Minister under subsection 85(2). These listed drugs are designated into formularies F1 and F2, with F1 intended for single-brand drugs and F2 for drugs with multiple brands or interchangeable drugs. The Act also provides for statutory price reductions, price disclosure, and a guarantee of supply for drugs in formulary F2, which is further divided into Part A and Part T based on the level of price competition. The Minister has the authority to determine the form and manner of administration of a listed drug through legislative instruments, which govern what constitutes a pharmaceutical benefit under Part VII of the Act. This instrument, commencing on 1 May 2009, amends the Pharmaceutical Benefits Regulations by adding four specific drugs—"Lanthanum", "Paclitaxel, nanoparticle albumin-bound", "Sunitinib", and "Teriparatide"—to formulary F1, reflecting consultations with pharmaceutical companies and the Therapeutic Goods Administration. This amendment ensures these drugs meet the criteria for single-brand designation under the Act.

Key Provisions

This legislative instrument, PB 37 of 2009, amends the National Health Act 1953 to update the Pharmaceutical Benefits Scheme (PBS). The primary sections involved are subsections 85(1) to 85(6) and section 85AB, which together govern the PBS and the listing of drugs. Under these sections, the Minister can determine the forms of listed drugs, their administration, and the brands that qualify for the PBS. The instrument specifies that certain drugs, namely “Lanthanum”, “Paclitaxel, nanoparticle albumin-bound”, “Sunitinib”, and “Teriparatide”, are to be added to the F1 formulary. The Act imposes specific obligations on pharmaceutical companies and the Minister regarding the PBS. Pharmaceutical companies must ensure their drugs meet the criteria set by the Minister for inclusion in the PBS and be aware of the formulary (F1 or F2) to which their drugs are allocated. The Minister, on the other hand, is responsible for determining the forms and brands of listed drugs and ensuring they comply with the Act’s provisions. The regulations and determinations made under the Act must follow the criteria outlined in sections 85AB and 84AC to 84AD. There are no explicit offences, penalties, or consequences for breach mentioned in the text of the instrument. However, failure to comply with the Minister’s determinations or regulations could potentially lead to legal challenges or disputes. Non-compliance with the Act or the regulations could also result in the drugs not being eligible for PBS listing, which would impact their availability and affordability for patients. The instrument's provisions are designed to ensure that drugs are appropriately categorised within the PBS framework to maintain the scheme’s objectives of reliability, timeliness, and affordability.

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