EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SECTION 93
NO. PB 72 OF 2007
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).
Section 93 of the Act provides for the supply of certain pharmaceutical benefit items to medical practitioners as an emergency drug supply. These drugs are supplied free of charge to patients.
Subsection 93(1) of the Act provides that, except as prescribed, a medical practitioner is authorised to supply such pharmaceutical benefits as the Minister determines to persons who are entitled under Part VII of the Act to receive those pharmaceutical benefits.
Subsection 93(2) of the Act provides that the Minister may determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by a medical practitioner during a specified period and that the medical practitioner shall obtain the pharmaceutical benefit as prescribed.
The determination under section 93 of the Act sets out the conditions under which a medical practitioner is authorised to supply emergency drugs as pharmaceutical benefits.
The Schedule to the determination lists the names of the pharmaceutical benefits to which section 93 applies, together with the form (strength type, size etc.) and maximum quantity of those pharmaceutical benefits.
This legislative instrument amends the determination under section 93 (PB 57 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 a change 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 September 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.
The determination gives effect to recommendations made by the PBAC. PBAC members are selected 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.
ATTACHMENT
Paragraph 1: provides that this determination commences on 1 October 2007.
Paragraph 2: provides that Schedule 1 amends PB 57 of 2007.
Schedule 1: provides for the following amendments:
THE SCHEDULE
Alteration of listed drug name
From: | To: |
Diphtheria and Tetanus Vaccine – Adsorbed (diluted) | Diphtheria and tetanus vaccine, adsorbed, diluted for adult use |
Overview
The National Health Act 1953, as amended, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which aims to ensure reliable, timely, and affordable access to a broad range of medicines for all Australians. Enacted by the Parliament of Australia, the Act establishes the framework through which the Commonwealth delivers pharmaceutical benefits. The Act’s Part VII specifically governs the PBS, with the Minister for Health authorised to declare by legislative instrument which drugs and medicinal preparations are included in the scheme. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending which drugs should be added to the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. This determination under section 93 of the Act outlines the conditions under which medical practitioners can supply certain pharmaceutical benefits as emergency drugs, free of charge to patients, and amends previous provisions to reflect updates in terminology and recommendations from the PBAC. This legislative instrument, which commenced on 1 October 2007, reflects the ongoing commitment to improving access to essential medicines within the Australian healthcare system.
Scope and Application
The determination under Section 93 of the National Health Act 1953, as amended by the Determination under Section 93 No. PB 72 of 2007, applies to medical practitioners who are authorised to supply certain pharmaceutical benefits as emergency drugs to patients entitled to receive these benefits under Part VII of the Act. This authorisation is provided under subsection 93(1) of the Act, with specific conditions set out in the Schedule to the determination. These conditions include the list of pharmaceutical benefits, their form, and the maximum quantity that can be supplied. The Minister may also determine the maximum quantity or number of units of a pharmaceutical benefit that a medical practitioner can obtain during a specified period, as per subsection 93(2). This legislative instrument commences on 1 October 2007 and amends the previous determination under section 93 (PB 57 of 2007) that came into effect on 1 August 2007. The amendments reflect changes in terminology to align with the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007, which also came into effect on 1 August 2007. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits, ensuring that these recommendations consider the medical conditions for which the medicines have been approved, their clinical effectiveness, safety, and cost-effectiveness compared to other treatments.
Key Provisions
The main operative sections of the determination under section 93 of the National Health Act 1953 (the Act) focus on the supply of certain pharmaceutical benefit items to medical practitioners as an emergency drug supply. Specifically, subsection 93(1) of the Act provides that, except as prescribed, a medical practitioner is authorised to supply certain pharmaceutical benefits to persons who are entitled under Part VII of the Act to receive those pharmaceutical benefits. Subsection 93(2) further allows the Minister to determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by a medical practitioner during a specified period and that the medical practitioner shall obtain the pharmaceutical benefit as prescribed. The Schedule to the determination lists the names of the pharmaceutical benefits to which section 93 applies, together with the form (strength type, size etc.) and maximum quantity of those pharmaceutical benefits.
The Act imposes obligations on medical practitioners and the Minister for Health and Ageing. Medical practitioners must adhere to the conditions set by the Minister for the supply of emergency pharmaceutical benefits, including any limits on the quantity or number of units that can be supplied within a specified period. The Minister, on the other hand, must determine the pharmaceutical benefits that can be supplied as emergency drugs and set the maximum quantities or units allowed. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs and medicinal preparations to be available as pharmaceutical benefits, which the Minister must consider before making any declarations under the Act.
Breaches of the provisions of this determination could result in various consequences. While the Act does not explicitly state the penalties for non-compliance, unauthorised supply of pharmaceutical benefits could be subject to general criminal and civil penalties under other sections of the Act or relevant state or territory laws. For example, unauthorised supply of pharmaceutical benefits could potentially be considered as contravening regulations under the Therapeutic Goods Act 1989, which could result in criminal penalties such as fines or imprisonment, or civil penalties such as fines or compensation orders. It is essential for medical practitioners and the Minister to comply with the requirements of this determination to avoid any potential legal consequences.