National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 54 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L01623 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 54 OF 2010

NATIONAL HEALTH ACT 1953

AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 14 of 2010 which came into effect on 1 April 2010.  The amendments declare additions and changes to the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed.  The amendments are set out in the items of Schedule 1 to the instrument.

 

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 in relation 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.  

Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation. 

Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the PBAC.  Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA).  Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.

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

This instrument, expressed to commence on 1 July 2010, was made on 3 June 2010.

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 July 2010.

Paragraph 2:  provides that Schedule 1 amends PB 14 of 2010.

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

Alteration of Circumstances

Adrenaline

[addition of the names EpiPen Jr. and Epipen to the form descriptions of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and the I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector respectively; addition of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior) and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen); circumstances amended to specify treatment is for intitial and continuing “sole” PBS-subsidised supply]

Bevacizumab

[circumstances altered to specify the maximum dose approved for initial and continuing treatment of patients with metastatic colorectal cancer]

Bimatoprost with timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Bisoprolol

[circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code]

Brimonidine with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Carvedilol

[circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code]

Docetaxel

[circumstances altered in respect of the treatment of advanced breast cancer]

Dorzolamide with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Esomeprazole

[additional availability for the treatment of scleroderma oesophagus and pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion]

Lapatinib

[circumstances altered for the treatment of patients with HER2 positive metastatic breast cancer]

Latanoprost with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Medroxyprogesterone

[deletion of the injection containing medroxyprogesterone acetate 50 mg in 1 mL]

Mesalazine

[alteration of form description of the suppository 1 g]

Metoprolol succinate

[circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code]

Paclitaxel

[circumstances altered in respect of the treatment of advanced breast cancer]

Paclitaxel, nanoparticle albumin-bound

[circumstances altered in respect of the treatment of metastatic breast cancer]

Pioglitazone

[circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code]

Rosiglitazone

[circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code]

Rosiglitazone with Metformin

[circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code]

Rosuvastatin

[additional availability for the treatment of patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Sitagliptin

[circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code]

Sitagliptin with metformin

[circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code]

Travoprost with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

 

SCHEDULE 2

Addition of Listed Drug

Roxithromycin

 

SCHEDULE 2A

Alteration of Circumstances

Bimatoprost with timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Brimonidine with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Dorzolamide with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Latanoprost with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

Travoprost with Timolol

[circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension]

 

Overview

The National Health Act 1953, as amended by the instrument F2010L01623, aims to ensure Australians have reliable, timely, and affordable access to a wide range of medicines through the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the legislation allows the Minister for Health to declare and determine drugs and medicinal preparations available as pharmaceutical benefits and the circumstances under which they may be prescribed. The Pharmaceutical Benefits Advisory Committee (PBAC) provides expert advice on which drugs should be listed on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, which commenced on 1 July 2010, makes amendments to the list of drugs and the circumstances of their use, as recommended by the PBAC, ensuring the PBS remains up-to-date with the latest medical advancements and patient needs.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 54 of 2010, applies to the Minister for Health and Ageing in the Commonwealth of Australia. The Act facilitates the administration of the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures that Australians have reliable, timely, and affordable access to a broad range of medicines. The Act applies to the declaration of drugs and medicinal preparations as listed drugs under subsection 85(2), and to the determination of the form, manner of administration, and brand of pharmaceutical items under subsections 85(3), 85(5), and 85(6). The Minister must obtain advice from the Pharmaceutical Benefits Advisory Committee (PBAC) before revoking or varying a declaration under subsection 85(2AA), and this advice must be tabled in Parliament under subsection 85(2AC). The PBAC, an independent expert body, makes recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account medical conditions, clinical effectiveness, safety, and cost-effectiveness. The instrument, which commenced on 1 July 2010, amends the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed, as set out in Schedule 1 and Schedule 2 of the instrument.

Key Provisions

The National Health Act 1953 Amendment Instrument primarily focuses on the Pharmaceutical Benefits Scheme (PBS) and the drugs and medicinal preparations available under it. Section 85(1) mandates that the Commonwealth provides pharmaceutical benefits in accordance with Part VII of the Act. The Minister, under section 85(2), declares by legislative instrument the drugs and medicinal preparations that are subject to the PBS. This includes certain extemporaneously-prepared medicinal preparations, as per section 85(2)(b). The Minister can also determine the form or manner of administration of these listed drugs through further legislative instruments (subsections 85(3), 85(5), and 85(6)). Section 85(2AA) allows the Minister to revoke or vary these declarations, but if this would result in the cessation of a drug being a listed drug, the Minister must first obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which must then be tabled in Parliament (subsections 85(2AB) and 101(4)). The Act imposes several obligations on the Minister and PBAC. The Minister is responsible for declaring and determining the forms and administration of listed drugs and must follow PBAC recommendations for listing new drugs. The PBAC must provide advice to the Minister on which drugs should be included in the PBS, considering factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. This advice is a prerequisite for the Minister's decision on drug listings, ensuring a thorough evaluation process. Failure to comply with the provisions of the Act can lead to various consequences. While the Act does not explicitly list specific offences or penalties for breaches, it is reasonable to infer that non-compliance could potentially lead to legal actions under general statutory compliance provisions. For example, non-compliance with declarations or determinations could result in civil penalties or legal challenges to the validity of the Minister's actions. Additionally, failure to follow the required advisory process with the PBAC might render any subsequent Minister's decisions vulnerable to judicial review, which could have significant implications for the validity of the drug listings or changes. In summary, the Act outlines a structured process for the Minister and PBAC to manage the PBS, ensuring that pharmaceutical benefits are provided in a manner that is reliable, timely, and affordable. The amendments introduced by this instrument reflect ongoing adjustments to the PBS based on expert recommendations, aiming to optimise the availability of necessary medications for Australians.

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