National Health Act 1953 - Amendment Determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 62 of 2007)

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Legislation au F2007L02628 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 62 OF 2007

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88

 

Purpose and operation

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 to be so 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).

Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.

Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).

Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item.  A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item,  or if there is no tradename, the name of the responsible person.  The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.

Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit.  Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose.  Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose.  Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used. 

Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits.  Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.

This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).    

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 49 of 2007 which came into effect on 1 August 2007.  The amendments are set out in the items of Schedule 1 to the instrument.

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

This instrument, expressed to commence on 1 September 2007, was made on 14 August 2007.

Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.

The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.


ATTACHMENT

Paragraph 1: provides that this instrument commences on 1 September 2007.

Paragraph 2: provides that Schedule 1 amends PB 49 of 2007.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1 – PART 1

 

Item Added

Cetuximab    Solution for I.V. infusion 100 mg in 50 mL

 

Forms Added

Adalimumab    Injection 40 mg in 0.8 mL pre-filled pen

Fluconazole    Solution for I.V. infusion 400 mg in 200 mL

Lumiracoxib     Tablet 100 mg

Phenoxybenzamine Capsules containing phenoxybenzamine

hydrochloride 10 mg, 30

Ramipril  Tablet 10 mg

 

Brands Added

Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with

paracetamol 500 mg (Comfarol Forte)

Fosinopril with   Tablet containing fosinopril sodium 10 mg with

Hydrochlorothiazide   hydrochlorothiazide 12.5 mg (Hyforil)

Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Hyforil)

Meloxicam    Tablet 7.5 mg (Meloxicam-GA)

Tablet 15 mg (Meloxicam-GA)

Omeprazole    Tablet 20 mg (Omeprazole-GA)

Ondansetron  I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

(Onsetron)

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

(Onsetron)

Valproic Acid  Tablet (enteric coated) containing sodium valproate 200 mg

(Sodium Valproate Sandoz)

Tablet (enteric coated) containing sodium valproate 500 mg

(Sodium Valproate Sandoz)

 

 

 

 

Item Deleted

 “Phenex-1”    Oral powder 350 g

 

Forms Deleted

Ampicillin    Capsule 250 mg (as trihydrate)

     Capsule 500 mg (as trihydrate)

Lumiracoxib    Tablet 200 mg

 

Brand Deleted

Levonorgestrel   Tablets 30 micrograms, 28 (Microval 28)

 

Form Alteration

Fluconazole

From:

 

Solution for I.V. infusion 100 mg in 50 mL vial

 

To:

 

Solution for I.V. infusion 100 mg in 50 mL

 

From:

 

Solution for I.V. infusion 200 mg in 100 mL vial

 

To:

 

Solution for I.V. infusion 200 mg in 100 mL

 

SCHEDULE 1 – PART 2

 

Item Added

Cetuximab    Solution for I.V. infusion 100 mg in 50 mL

 

Form Added

Adalimumab    Injection 40 mg in 0.8 mL pre-filled pen

 

Brands Added

Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with

paracetamol 500 mg (Comfarol Forte)

Omeprazole    Tablet 20 mg (Omeprazole-GA)

Ondansetron  I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

(Onsetron)

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

(Onsetron)


SCHEDULE 3 – PART 1

 

Brand Added

Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with

paracetamol 500 mg (Comfarol Forte)

 

Forms Deleted

Ampicillin    Capsule 250 mg (as trihydrate)

     Capsule 500 mg (as trihydrate)

 

 

Overview

The National Health Act 1953 Amendment Determinations under sections 85, 85A, and 88, enacted in 2007, address the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth ensures reliable, timely, and affordable access to a wide range of medicines for all Australians. This legislative instrument was enacted by the Australian Government and is intended to give effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). It amends previous determinations to update the list of pharmaceutical items covered under the PBS, including the addition of new drugs, forms, and brands, as well as the deletion of certain items and forms. The policy objective is to ensure that the PBS remains current with the latest medical advancements and cost-effective treatments available to Australians.

Scope and Application

This legislative instrument amends determinations under sections 85, 85A and 88 of the National Health Act 1953 (the Act) and is made pursuant to the authority conferred by those subsections. The Act, which establishes the Pharmaceutical Benefits Scheme (PBS), applies to the whole of Australia and governs the provision of reliable, timely, and affordable access to a range of medicines for all Australians. The Act applies to drugs and medicinal preparations declared by the Minister to be pharmaceutical benefits and to certain extemporaneously-prepared medicinal preparations. The instrument, which commenced on 1 September 2007, amends determinations made by legislative instrument number PB 49 of 2007 which came into effect on 1 August 2007. The amendments include the addition of new drugs and forms of drugs, the alteration of existing forms, and the deletion of certain drugs and forms. The Pharmaceutical Benefits Advisory Committee (PBAC) was consulted in the development of these amendments, with its recommendations being central to the changes made by this instrument.

Key Provisions

The main operative sections of this instrument focus on the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Section 85 allows the Minister to declare drugs and medicinal preparations to be listed drugs, which means they are eligible for benefits under the PBS. This includes determining the form of a listed drug (subsection 85(3)), the manner of administration (subsection 85(5)), and the brand of a pharmaceutical item (subsection 85(6)). Section 85A enables the Minister to set limits on the writing of prescriptions by specified classes of persons, such as the maximum quantity or number of units that can be supplied in one prescription (paragraph 85A(2)(a)), the maximum number of occasions a supply can be repeated (paragraph 85A(2)(b)), and the manner of administration (paragraph 85A(2)(c)). Section 88 allows the Minister to determine which pharmaceutical benefits a dental practitioner is authorised to prescribe. The obligations imposed by this Act on parties and entities include adherence to the declared forms, brands, and prescription limits set by the Minister. Pharmaceutical companies must ensure that the drugs they produce meet the specified forms and brands. Healthcare professionals, such as doctors and pharmacists, must comply with the prescription limits and conditions set forth in the Act. The Minister's determinations under sections 85, 85A, and 88 must be followed to ensure the proper administration and supply of pharmaceutical benefits under the PBS. The instrument also outlines the consequences for non-compliance. While specific offences and penalties are not detailed in the provided text, breaches of the PBS regulations could result in civil or criminal penalties. These might include fines or other sanctions imposed by relevant authorities, depending on the nature and severity of the breach. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending changes to the PBS, ensuring that the scheme remains effective and cost-efficient. Consultations with the PBAC ensure that various stakeholder interests are considered in decision-making processes.

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