EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 77 OF 2007
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 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 52 of 2007 which came into effect on 1 August 2007. The amendments are set out in the items of Schedule 1 to the instrument.
This instrument contains changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 October 2007, was made on 6 Septemeber 2007.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed 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 October 2007.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Alteration of Listed Drug Name and Form
From:
“Metabolic Mineral Mixture” Powder 250 g
To
Mineral mixture Oral powder 250 g (Metabolic Mineral Mixture)
Alteration of Form
From:
Prochlorperazine Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5
To:
Prochlorperazine Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5
From:
Prochlorperazine Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5
To:
Prochlorperazine Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5
Overview
The National Health Act 1953, as amended by the F2007L03626 instrument, governs the Pharmaceutical Benefits Scheme (PBS) through which the Commonwealth ensures accessible, timely, and affordable medications for all Australians. The instrument updates the legislative instrument (PB 52 of 2007) that set out the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. The amendments, effective from 1 October 2007, include terminology changes to align with the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 and other adjustments to the listing of drugs and their forms under the PBS. The objective is to ensure the PBS operates smoothly and efficiently, providing Australians with reliable access to necessary medications.
Scope and Application
The F2007L03626 instrument pertains to the National Health Act 1953, specifically focusing on amendments to the Pharmaceutical Benefits Scheme (PBS) as administered by the Commonwealth of Australia. This Act applies to all Australians by providing them with access to a range of affordable medicines through the PBS. The Act governs the pharmaceutical benefits provided under Part VII, which includes the listing of drugs and medicinal preparations by the Minister. The instrument also determines the form, manner of administration, and brands of listed drugs, thereby governing what constitutes a pharmaceutical benefit under the Act. The Minister has the authority to determine conditions for payments made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This instrument, effective from 1 October 2007, amends the earlier determination made by legislative instrument PB 52 of 2007, with changes primarily aimed at aligning terminology with the amendments introduced by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs and medicinal preparations for inclusion on the PBS based on clinical effectiveness, safety, and cost-effectiveness.
Key Provisions
The primary operative sections of this legislation pertain to the conditions under which pharmaceutical benefits are provided under the National Health Act 1953 (the Act) (sections 85 and 98C(1)(b)). Section 85 sets out the requirements for benefits to be provided by the Commonwealth in respect of pharmaceutical benefits, while section 98C(1)(b) allows the Minister to determine the conditions under which payments will be made for the supply of these benefits by approved pharmacists and approved medical practitioners. Specifically, the Minister can declare drugs and medicinal preparations, determine their form and manner of administration, and establish the pharmaceutical benefit that constitutes the payment under Part VII of the Act. This Act also allows for the designation of a responsible person for a brand of a pharmaceutical item (section 84AF). The legislative instrument amends the determination under section 98C(1)(b), which was made by legislative instrument number PB 52 of 2007, and incorporates changes in terminology to align with the amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007.
The obligations and requirements imposed by the Act on the parties it governs include the necessity for the Pharmaceutical Benefits Advisory Committee (PBAC) to recommend drugs and medicinal preparations for inclusion on the Pharmaceutical Benefits Scheme (PBS) before they can be declared under the Act (subsection 101(4)). The PBAC must consider factors such as 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 when making recommendations. Additionally, the Minister, in accordance with section 85, has the responsibility to declare drugs and medicinal preparations, determine their form and manner of administration, and establish the pharmaceutical benefit that constitutes the payment under Part VII of the Act. Approved pharmacists and approved medical practitioners must adhere to the conditions set out in the determination under section 98C(1)(b) to be eligible for payments for the supply of pharmaceutical benefits.
Any breaches of the conditions set out in the determination under section 98C(1)(b) may result in penalties or other civil or criminal consequences. The Act does not specify the exact penalties for breaches, but it is likely that non-compliance with the conditions could lead to fines or other sanctions as determined by the relevant authorities. Furthermore, any misrepresentation or fraudulent claims in relation to the supply of pharmaceutical benefits could result in more severe penalties, including imprisonment, as provided under other sections of the Act or related legislation. The exact penalties for such offences would depend on the nature and severity of the breach.