National Health Act 1953 - Amendment Determination under subsections 85A(1) and (2) and 88(1C) - Prescription of pharmaceutical benefits by authorized Optometrists (No. PB 17 of 2008)

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Legislation au F2008L00038 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 17 OF 2008

 

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 10 of 2008 which came into effect on 1 January 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 February 2008, was made on 4 January 2008.

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

Section 1: provides that this instrument commences on 1 February 2008.

Section 2: provides that Schedule 1 amends PB 10 of 2008.

Schedule 1: provides for the addition of tamarindus indica seed polysaccharide to the list of the pharmaceutical benefits which may be prescribed by authorised optometrists.

 

Overview

The National Health Act 1953, enacted by the Commonwealth Parliament, establishes the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have reliable, timely, and affordable access to a wide range of medicines. The Act was introduced to address the need for a structured and comprehensive system to provide access to essential medications. The 2008 amendment, F2008L00038, made under subsections 85A(1) and (2) and 88(1C), further refines the scheme by amending the determinations regarding the form and prescription of pharmaceutical benefits, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, provides recommendations to the Minister about which drugs should be available as pharmaceutical benefits, considering factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument, effective from 1 February 2008, adds tamarindus indica seed polysaccharide to the list of pharmaceutical benefits that may be prescribed by authorised optometrists, aligning with the PBAC's recommendations and consultation outcomes.

Scope and Application

The National Health Act 1953, as amended by the National Health Act 1953 Amendment Determination under subsections 85A(1) and (2), and 88(1C), applies to the Pharmaceutical Benefits Scheme (PBS), which is the legislative basis for the Commonwealth's provision of reliable, timely, and affordable access to a wide range of medicines for all Australians. This Act applies to persons authorised to prescribe pharmaceutical benefits, such as doctors and optometrists, and to pharmaceutical items listed under the Act, which are declared by the Minister and include drugs and medicinal preparations. The Act operates across the Commonwealth, ensuring uniform regulation and access to these benefits nationwide. The amendments through this legislative instrument, effective from 1 February 2008, specifically incorporate recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) to adjust the list of pharmaceutical benefits that optometrists are authorised to prescribe. This amendment adds tamarindus indica seed polysaccharide to the list, reflecting the PBAC's recommendations and the outcomes of the consultation process involving stakeholders from various healthcare fields. The Act's application is governed by the Minister's determinations, which can be extended or restricted through subordinate instruments, ensuring that the PBS remains responsive to evolving healthcare needs and evidence-based recommendations.

Key Provisions

The main operative sections of the National Health Act 1953 Amendment Determination (PB 17 of 2008) under subsections 85A(1), (2) and 88(1C) pertain to the Pharmaceutical Benefits Scheme (PBS), specifically focusing on the addition of pharmaceutical benefits and the regulation of their prescription. Section 85(1) establishes the basis for providing pharmaceutical benefits, while section 85A(1) and (2) enable the Minister to determine various aspects of these benefits, including the form, quantity, and manner of administration. Section 88(1C) specifically addresses the prescription of pharmaceutical benefits by optometrists. This amendment determination updates the list of benefits that can be prescribed by authorised optometrists, aligning with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The Act imposes obligations on the Minister to ensure that the PBS operates efficiently, providing reliable, timely, and affordable access to a range of medicines. The Minister is tasked with determining the form, quantity, and administration of pharmaceutical benefits and has the authority to specify these aspects through legislative instruments. Additionally, the Minister must consult with the PBAC, an independent body comprising experts from various health-related fields, to make informed decisions on which drugs and medicinal preparations should be included in the PBS. These obligations ensure that the PBS remains effective in meeting the health needs of Australians while maintaining cost-effectiveness and safety. Failure to comply with the provisions of the National Health Act 1953 and its amendments can result in various civil and criminal consequences. While specific penalties are not detailed in the text, breaches of regulations related to the PBS could potentially lead to fines, imprisonment, or other penalties as prescribed by relevant laws. The Act’s focus on ensuring the availability of affordable and effective medicines underscores the seriousness with which it treats compliance, reflecting the critical role of the PBS in public health. The legislative framework thus aims to protect both the public and the integrity of the healthcare system by imposing stringent requirements and consequences for non-compliance.

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