National Health Act 1953 - Amendment determination under subsections 85A(1) and (2) and 88(1C) - Prescription of pharmaceutical benefits by authorised optometrists (No. PB 111 of 2009)

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Legislation au F2009L04285 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 111 OF 2009

NATIONAL HEALTH ACT 1953

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

 

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 December 2009, was made on 12 November 2009.

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 December 2009.

 

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

 

Schedule 1: provides for the following amendments:

 

 

SCHEDULE 1

 

Addition of Listed Drug

Polyethylene glycol 400

Deletion of Listed Drug

Tamarindus indica seed polysaccharide

Overview

The National Health Act 1953 was enacted to establish the legislative framework for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have reliable, timely, and affordable access to a wide range of medicines. This Act, overseen by the Parliament of Australia, was introduced to address the need for a comprehensive system to regulate and subsidise the cost of pharmaceutical products in Australia. The policy objective of the Act is to make essential medications accessible and affordable to the population. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which drugs should be included in the PBS, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument amends previous determinations under subsections 85A(1) and (2), and 88(1C) to update the list of pharmaceutical benefits in response to recommendations from the PBAC, reflecting the outcomes of their formal consultation process. The amendments, effective from 1 December 2009, include the addition of polyethylene glycol 400 and the removal of tamarindus indica seed polysaccharide from the list of listed drugs.

Scope and Application

The National Health Act 1953, through its Part VII, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a broad spectrum of medicines. This legislation applies to pharmaceutical benefits, which are declared by the Minister via legislative instruments, encompassing listed drugs and certain extemporaneously-prepared medicinal preparations. The Minister also has the authority to determine the form and manner of administration of these pharmaceutical items, as well as the brand of a pharmaceutical item that qualifies under the PBS. The Act extends its application across the Commonwealth and governs the prescription of pharmaceutical benefits by specified classes of persons, including optometrists, as determined by the Minister. The amendments under subsections 85A(1) and (2), and 88(1C) of the Act, which were made on 12 November 2009 and commenced on 1 December 2009, reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and involve the addition of polyethylene glycol 400 and the deletion of tamarindus indica seed polysaccharide from the list of declared drugs.

Key Provisions

The primary operative sections of the National Health Act 1953 Amendment Determination (PB 111 of 2009) pertain to the Pharmaceutical Benefits Scheme (PBS) and are designed to provide reliable, timely, and affordable access to medicines for all Australians. Under section 85(1), benefits are to be provided by the Commonwealth in accordance with Part VII of the Act. Section 85(2) authorises the Minister to declare by legislative instrument the drugs and medicinal preparations that are to be listed drugs under the PBS. These listed drugs are defined in section 84(1). Section 85A(1) and (2) further empower the Minister to determine the forms and conditions under which pharmaceutical benefits can be prescribed, including the maximum quantities, the number of occasions for repetition, and the manner of administration. Additionally, section 88(1C) allows the Minister to specify the pharmaceutical benefits for which an optometrist is authorised to write a prescription. The obligations imposed by the Act on parties and entities governed by it include ensuring compliance with the declared forms and conditions of listed drugs as well as the prescribed conditions for writing prescriptions. Specifically, practitioners must adhere to the maximum quantities and repetitions specified in section 85A(2) when prescribing pharmaceutical benefits. This means that the prescriptions must not exceed the authorised limits unless there are exceptional circumstances. Furthermore, the Act requires that any changes to the listed drugs or prescription conditions must be made by the Minister through a legislative instrument, ensuring that these amendments are subject to review and consultation processes. Failure to comply with the provisions of the Act may result in various civil or criminal consequences. Although the Act itself does not specify maximum penalties, breaches of the PBS regulations or related legislative instruments could lead to fines or other penalties as stipulated in the regulations. Additionally, practitioners who issue prescriptions that contravene the conditions set out in the Act may face disciplinary actions from their respective professional boards, potentially leading to suspension or revocation of their licenses to practice. The specific penalties and consequences would be determined in accordance with the applicable regulations and professional standards.

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