National Health Act 1953 - Amendment determination under subsections 85A(1) and (2) and 88(1C) - Prescription of pharmaceutical benefits by authorised optometrists (No. PB 71 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L02064 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 71 OF 2010

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATION UNDER
SUBSECTIONS 85A(1) AND (2) AND 88(1C)

 

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under subsections 85A(1) and (2) and 88(1C) made by legislative instrument number PB 11 of 2009 which came into effect on 1 March 2009. The amendments provide for changes to the listed drugs which may be prescribed by an approved optometrist. 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 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).

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 85A(1) authorises the Minister to determine the form or forms of pharmaceutical benefits or pharmaceutical item that may be prescribed under Part VII of the Act by specified classes of persons.

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(1C) authorises the Minister to determine the pharmaceutical benefits for the supply of which an optometrist is authorised to write a prescription on or after 1 January 2008.

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determination under subsections 85A(1) and (2), and 88(1C) made by legislative instrument number PB 11 of 2009 which came into effect on 1 March 2009.  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 August 2010, was made on 5 July 2010.


Consultations

The involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (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 making  recommendations relevant to 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.

 

The medicine determined under subsection 88(1C) reflects the recommendations of the PBAC and the outcome of the consultation process.

 

 

 

 

 

 

 

 

 

 

 


ATTACHMENT

Paragraph 1: provides that this instrument commences on 1 August 2010.

Paragraph 2: provides that Schedule 1 amends PB 11 of 2009.

Schedule 1: provides for the following amendments:

 

 

SCHEDULE 1

 

Addition of Listed Drug

Brinzolamide with Timolol

 

Overview

The National Health Act 1953, amended by the legislative instrument F2010L02064, addresses the need to update the list of drugs that may be prescribed by approved optometrists under the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, the Act provides the legislative basis for the PBS, ensuring Australians have access to affordable and timely medicines. The 2010 amendment was introduced in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body tasked with advising on the availability of pharmaceutical benefits. The primary policy objective behind this amendment was to enhance the scope of medications that optometrists could prescribe, thereby improving patient care and streamlining access to necessary treatments. The changes, effective from 1 August 2010, reflect the PBAC's recommendations and the broader consultation process involving various stakeholders in the health sector.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument F2010L02064, governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth ensures accessible, reliable, and affordable medication for all Australians. The Act applies to listed drugs and pharmaceutical items, which are declared by the Minister through legislative instruments. The amendments outlined in the instrument pertain specifically to the determination of pharmaceutical benefits that may be prescribed by approved optometrists. These amendments are effective from 1 August 2010 and are designed to align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The Act’s scope extends nationally, and its application is subject to the criteria set by the Minister, including the form, manner of administration, and brand of the pharmaceutical item. The instrument further refines the authority of the Minister to determine the types of pharmaceutical benefits that can be prescribed by optometrists and the parameters for such prescriptions, such as maximum quantities, repetitions, and administration methods. This instrument ensures that the amendments reflect the PBAC's recommendations, taking into account the clinical effectiveness, safety, and cost-effectiveness of the medicines.

Key Provisions

The main operative sections of this instrument, PB 71 of 2010, amend the determination under subsections 85A(1) and (2) and 88(1C) of the National Health Act 1953 (the Act), made by legislative instrument number PB 11 of 2009. These amendments, effective from 1 August 2010, update the list of drugs that may be prescribed by an approved optometrist under the Pharmaceutical Benefits Scheme (PBS). Specifically, the addition of brinzolamide with timolol to the list of listed drugs is detailed in Schedule 1 of this instrument. The Act, under Part VII, governs the PBS, which ensures Australians have access to affordable medicines. Subsection 85(1) mandates that the Commonwealth provides benefits under the PBS, while subsection 85(2) allows the Minister to declare drugs and medicinal preparations as listed drugs through legislative instruments. These declarations, along with determinations under subsections 85A(1) and (2) and 88(1C), govern what constitutes a pharmaceutical benefit and the conditions under which prescriptions can be written. The Minister's authority to determine these aspects ensures that the PBS operates efficiently and effectively, aligning with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The obligations imposed by this Act on the parties involved, particularly optometrists, include adhering to the updated list of drugs that can be prescribed. Optometrists must ensure that their prescriptions comply with the maximum quantities, repetitions, and administration methods specified in the determinations. Additionally, the Act requires that prescriptions align with the PBAC's recommendations and the consultation process, ensuring that the medicines prescribed are clinically effective, safe, and cost-effective. Failure to comply with the provisions of this Act can lead to various consequences. While the specific penalties are not detailed in the instrument, breaches of the PBS regulations generally result in civil or criminal penalties. Civil penalties may include fines, while criminal penalties can result in imprisonment, reflecting the seriousness of non-compliance with the PBS regulations. The exact penalties would depend on the nature and severity of the breach, as outlined in the broader framework of the National Health Act 1953 and associated regulations.

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