EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 122 OF 2009
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
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 (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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 what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
This legislative instrument amends the determination under section 98C(1)(b) made by legislative instrument number PB 119 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 January 2010, was made on 4 December 2009.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 January 2010.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Deletion of Listed Drugs
Addition of Form
Glucose Indicator―Blood Test strips, 100 (Accu-Chek Performa)
Alteration of Form Description
Glucose Indicator―Blood [forms previously described as “Electrode strips” are now described as “Test strips”]
Overview
The National Health Act 1953, enacted by the Parliament of Australia, serves as the foundational legislation for the Pharmaceutical Benefits Scheme (PBS). The PBS is designed to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. As part of this scheme, the Minister for Health is tasked with determining the conditions under which pharmaceutical benefits are provided, including the specific drugs that qualify for subsidy and the forms in which they can be supplied. The Act, through its various provisions, aims to facilitate the equitable distribution of essential medications across the country. The legislative instrument F2009L04556, introduced to amend the conditions under which payments are made for the supply of pharmaceutical benefits, reflects ongoing efforts to update and refine the scheme in response to evolving healthcare needs and feedback from relevant stakeholders. This amendment, effective from 1 January 2010, includes changes to the list of listed drugs and their forms, ensuring that the PBS continues to meet the health requirements of the Australian population.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) (PB 122 of 2009) amends the conditions under which the Commonwealth provides payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment applies to the Pharmaceutical Benefits Scheme (PBS) which is governed by Part VII of the National Health Act 1953 and involves the listing and categorisation of drugs and medicinal preparations. The Minister for Health is empowered to declare and amend the listing of drugs and their forms, including the determination of the manner of administration and the responsible person for a brand of a pharmaceutical item. This legislative instrument, which commenced on 1 January 2010, amends the previous determination (PB 119 of 2008) and includes specific changes such as the deletion of listed drugs like Posaconazole and Voriconazole, the addition of a new form for Glucose Indicator―Blood Test strips, and an alteration in the form description from "Electrode strips" to "Test strips." These changes are detailed in Schedule 1 of the instrument. The Minister’s decisions are informed by consultations with the Pharmaceutical Benefits Advisory Committee, an independent body comprising representatives from various healthcare and consumer sectors.
Key Provisions
The primary operative sections of this legislative instrument (F2009L04556) involve amendments to the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits. Specifically, section 98C(1)(b) of the National Health Act 1953 is amended by this instrument to adjust the payment conditions for approved pharmacists and approved medical practitioners. These changes are detailed in Schedule 1 of the instrument, which includes the deletion of certain listed drugs, such as Posaconazole and Voriconazole, and the addition of new forms of pharmaceutical benefits like Glucose Indicator—Blood Test strips, 100 (Accu-Chek Performa). Additionally, the form descriptions are altered to reflect changes in terminology, for instance, updating "Electrode strips" to "Test strips" for Glucose Indicator—Blood.
The obligations imposed by this Act primarily concern the Minister’s authority to determine the conditions under which pharmaceutical benefits will be provided. The Minister must ensure that the determinations made comply with the legislative framework and reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This includes consulting with the PBAC, which comprises representatives from various healthcare and consumer interests, and considering their advice on which medicines should be subsidised under the Pharmaceutical Benefits Scheme (PBS). The Minister must also ensure that the determinations align with the overarching objectives of the PBS, which is to provide reliable, timely, and affordable access to a wide range of medicines for all Australians.
In terms of offences, penalties, and consequences for breach, the Act does not explicitly detail penalties for non-compliance with the payment conditions set out in this instrument. However, breaches of the National Health Act 1953 can lead to civil and criminal penalties. For instance, individuals or entities that provide pharmaceutical benefits without adhering to the conditions set forth by the Minister may face civil penalties, such as fines. Furthermore, if the breach involves fraudulent activities, it could result in criminal charges, leading to more severe penalties, including imprisonment. The exact penalties would depend on the nature and severity of the breach, as outlined in other relevant sections of the National Health Act 1953.