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 20 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L01071 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 20 OF 2009

NATIONAL HEALTH ACT 1953

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

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

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 Pharmaceutical Benefits Advisory Committee (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.

This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 113 of 2008 which came into effect on 1 December 2008.  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 April 2009, was made on 3 March 2009.

 


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 April 2009.

Paragraph 2:  provides that Schedule 1 amends PB 113 of 2008.

Schedule 1: provides for the following amendments:

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

SCHEDULE 1

Addition of Listed Drugs

Zonisamide

 

Alteration of Listed Drug

From:

Carbomer 980

To:

Carbomer

 

Alteration of Circumstances

Adalimumab [initial treatment of adult patients with severe active psoriatic arthritis]

Carbomer [amendment of description of “ocular lubricating gel” to “eye gel” and of “eye drops” to “eye gel”]

Desmopressin [addition of wafer 120 micrograms (as acetate)]

Escitalopram [in respect of the oral solution 10 mg (as oxalate) per mL, 28 mL ― additional availability for treatment of anxiety disorder and removal of the indications for exemption from the Special Patient Contribution payment]

Etanercept [initial treatment of adult patients with severe active psoriatic arthritis]

Oxycodone [addition of tablet containing oxycodone hydrochloride 15 mg (controlled release) and tablet containing oxycodone hydrochloride 30 mg (controlled release)]

Pramipexole [addition of circumstances for the treatment of Restless Legs Syndrome for the 125 micrograms and 250 micrograms tablets]

Risedronic acid and calcium with colecalciferol [additional availability for the treatment of corticosteroid-induced osteoporosis in certain patients]

Sitagliptin [streamlined authority code 3097 added and circumstances amended]

Ziprasidone [addition of streamlined authority code 3084 and corresponding circumstances]

Zoledronic acid [additional availability for the treatment of osteoporosis in women aged 70 or older with a low bone mineral density (BMD T-score of –3.0 or less), and minor amendment to existing indications]

 

Deletion of Listed Drug

Amino acid formula without phenylalanine, and vitamins with minerals [a reformulation of the item has meant the name is no longer appropriate and the item is now listed under Amino acid formula with vitamins and minerals without phenylalanine]


SCHEDULE 2

Alteration of Circumstances

Oxycodone [addition of tablet containing oxycodone hydrochloride 15 mg (controlled release) and tablet containing oxycodone hydrochloride 30 mg (controlled release)]

 

SCHEDULE 2A

Alteration of Listed Drug

From:

Carbomer 980

To:

Carbomer

 

Alteration of Circumstances

Carbomer [amendment of description of “ocular lubricating gel” to “eye gel” and of “eye drops” to “eye gel”]

 

 

Overview

The National Health Act 1953 was amended in 2009 to address the ongoing need to update the Pharmaceutical Benefits Scheme (PBS) by incorporating recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This legislative instrument was enacted to facilitate the timely and efficient incorporation of PBAC recommendations into the PBS, ensuring that Australians have reliable, timely, and affordable access to a wide range of medicines. The amendments were made under the authority of subsections 85(2), 85(2AA), and 85(2A) of the Act, allowing the Minister for Health to declare, revoke, or vary the listing of drugs and medicinal preparations, with mandatory consultation with the PBAC where a revocation or variation would result in the cessation of a drug or medicinal preparation being listed. The amendments, which came into effect on 1 April 2009, were made in response to the PBAC's recommendations and involved both the addition and modification of certain pharmaceutical items on the PBS.

Scope and Application

The National Health Act 1953 Amendment Instrument applies to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth of Australia, which ensures that Australians have reliable, timely, and affordable access to a wide range of medicines. This legislation specifically governs the declaration and determination of listed drugs and medicinal preparations by the Minister for Health, subject to the advice and recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The Act applies to pharmaceutical items, including drugs and medicinal preparations, that are listed under the PBS, which are declared by the Minister through legislative instruments. The Act also extends to certain extemporaneously-prepared medicinal preparations as declared under the provisions of the Act. The amendments and determinations governed by this legislation directly affect the pharmaceutical industry, healthcare providers, and consumers who rely on the PBS for access to medicines. This instrument, which amends previous declarations and determinations, was made on 3 March 2009 and commenced on 1 April 2009, reflecting the recommendations of the PBAC regarding the listing of specific drugs and medicinal preparations on the PBS.

Key Provisions

The main operative sections of this legislation, namely subsections 85(2), 85(2AA), and 85(2A) of the National Health Act 1953, establish the framework through which the Pharmaceutical Benefits Scheme (PBS) operates. Section 85(1) mandates that the Commonwealth provide benefits in accordance with Part VII, concerning pharmaceutical benefits. Subsection 85(2) allows the Minister to declare, by legislative instrument, which drugs and medicinal preparations are subject to Part VII, listing them as such. Subsection 85(2AA) further empowers the Minister to revoke or vary these declarations, also through legislative instrument. Additionally, subsection 85(2A) allows the Minister to determine the form, administration, and brand of listed drugs, which govern what constitutes a pharmaceutical benefit under Part VII. The Act imposes several obligations and requirements on the parties it governs. The Minister must obtain written advice from the Pharmaceutical Benefits Advisory Committee (PBAC) before revoking or varying a declaration if it would result in a drug or medicinal preparation ceasing to be a listed drug, as mandated by subsection 85(2AB). This advice must then be tabled in Parliament as per subsection 85(2AC). Moreover, a drug or medicinal preparation cannot be declared under subsection 85(2)(a) unless the PBAC has recommended it to the Minister, as stipulated in subsection 101(4). The PBAC, an independent expert body, must consider the medical conditions for which a medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness when making recommendations. The Act also delineates the consequences for non-compliance. Although the explanatory statement does not specify penalties for breaches, the National Health Act 1953 may contain provisions that impose penalties for non-compliance with its requirements. Generally, breaches of legislative instruments in Australia can result in fines, imprisonment, or both, depending on the severity of the breach and the specific provisions of the Act. The exact penalties would be outlined in the relevant sections of the National Health Act 1953. In summary, this legislative instrument amends the Pharmaceutical Benefits Scheme by updating the list of drugs and medicinal preparations subject to the scheme, their forms, administration, and circumstances of use, as recommended by the PBAC. These changes, which come into effect on 1 April 2009, ensure that the PBS remains aligned with current medical needs and recommendations, thereby continuing to provide reliable and affordable access to essential medicines for Australians.

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