National Health Act 1953 - Amendment determination under subsection 85AB(1) - drugs on F1 (No. PB 38 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00940 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 38 OF 2010

 

NATIONAL HEALTH ACT 1953

 

AMENDMENT DETERMINATION UNDER SUBSECTION 85AB(1)

 

This instrument amends the principal instrument, PB 87 of 2007, which determines drugs on F1 for the purposes of the Pharmaceutical Benefits Scheme (PBS). It adds two drugs which meet the criteria 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)), for example a 70 milligram tablet;
  • the manner of administration of the form of the listed drug so determined (subsection 85(5)) for example, oral; 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 a pharmaceutical benefit (defined in subsection 84(1)) under 

Part VII of the Act.

 

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 in a therapeutic group with other drugs with multiple brands.  F2 is in turn divided into Part A and Part T. 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 section 99AEJ 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 the PBS as at 1 August 2007 were prescribed in the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) to be on F1 and F2 (in Parts A and T) with effect from 1 August 2007.

 

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.

 

A provision-by-provision description of the instrument is contained in the Attachment.  It is expressed to commence on 1 May 2010.

 

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 (PBAC) for a drug to be listed on the PBS.  Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.  When drugs are listed on the PBS each drug is allocated into a formulary, F1, F2A or FT from the recommendation of the PBAC, which is made following receipt of submissions by affected pharmaceutical companies.

     
Attachment

 

 

Paragraph 1:  Provides that this instrument commences on 1 May 2010.

Paragraph 2:  Determines that Schedule 1 amends PB 87 of 2007, which determines drugs on F1.

Schedule 1:     Adds the listed drugs Lacosamide and Methoxyflurane to those determined to                                   be on F1.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Act 1953, amended by the National Health Amendment (Pharmaceutical Benefits Scheme) Determination 2010 (PB 38 of 2010), addresses the need for timely and efficient updates to the Pharmaceutical Benefits Scheme (PBS) to ensure Australians have access to necessary medicines. This determination empowers the Minister for Health to add specific drugs to the PBS, ensuring that the scheme can adapt to new medical needs and technologies. Enacted by the Parliament of Australia, the policy objective is to maintain the integrity and effectiveness of the PBS by incorporating new drugs that meet the required criteria, ensuring that the scheme remains a reliable and affordable source of essential medications. The determination specifically adds Lacosamide and Methoxyflurane to the list of drugs on F1, ensuring these medications are available under the PBS with the appropriate conditions and pricing structures in place.

Scope and Application

This instrument amends the National Health Act 1953 by adding two drugs, Lacosamide and Methoxyflurane, to the list of drugs on Formulary F1 of the Pharmaceutical Benefits Scheme (PBS). The Act provides the legislative basis for the PBS, which ensures reliable, timely, and affordable access to a wide range of medicines for all Australians. The Minister determines which drugs are eligible for PBS coverage by legislative instrument, and these drugs are listed under the Act as defined in subsection 84(1). The Act applies to the Commonwealth, and the changes effected by this instrument are subject to the criteria outlined in subsection 85AB(4) for inclusion in Formulary F1, which requires the absence of bioequivalent or biosimilar listed brands of pharmaceutical items that have the drug or another drug in the same therapeutic group. The instrument is effective from 1 May 2010 and affects pharmaceutical companies with medicines listed on the PBS. Consultations for these amendments occurred through submissions to the Therapeutic Goods Administration and the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various interests and professions such as consumers, health economists, community pharmacists, general practitioners, clinical pharmacologists, and medical specialists.

Key Provisions

The key operative sections of this instrument include subsections 85AB(1) and 85AB(4) of the National Health Act 1953, which empower the Minister to determine by legislative instrument whether a listed drug is on F1 or F2. This determination is crucial as it governs what constitutes a pharmaceutical benefit under Part VII of the Act. Specifically, subsection 85AB(1) allows the Minister to add drugs to F1 if they meet the criteria outlined in subsection 85AB(4), which 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, and that the drug was not previously on F2. If these criteria are not met, the drug may only be determined to be on F2. This legislative instrument adds two drugs, Lacosamide and Methoxyflurane, to those determined to be on F1, effective from 1 May 2010. The obligations and requirements imposed by the Act on the parties or entities it governs primarily revolve around the classification of drugs into F1 or F2 formularies. Pharmaceutical companies must ensure that their drugs comply with the criteria for listing on the Pharmaceutical Benefits Scheme (PBS). The Minister's role includes determining the form, manner of administration, and brand of pharmaceutical items listed on the PBS. This determination is based on consultations with the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various healthcare interests and professions. The PBAC recommends the allocation of drugs into F1, F2A, or FT formularies following submissions from pharmaceutical companies. There are no explicit offences, penalties, or civil/criminal consequences for breach mentioned in the text. However, non-compliance with the determinations could potentially lead to exclusion from the PBS, which would impact the availability and affordability of the drugs for Australian patients. The legislative instrument itself does not specify penalties for non-compliance but implies that adherence to the Minister's determinations is essential for the drugs to be included in the PBS and thus accessible to the public under the scheme. The regulations and the broader legislative framework likely provide further details on potential consequences for non-compliance.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Listing & Classification of Drugs
Formulary Management

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.