EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 131 OF 2008
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 2009, was made on 3 December 2008.
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 January 2009.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Addition of Listed Drug
Posaconazole Oral suspension 40 mg per mL, 105 mL
Overview
The National Health Act 1953, as amended by the National Health Amendment (No. 14) Determination 2008, aims to ensure the Pharmaceutical Benefits Scheme (PBS) continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. This legislation, enacted by the Commonwealth Government, was introduced to address the need for updated conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments outlined in this Act are intended to refine the operational framework of the PBS, ensuring that the scheme remains effective in delivering high-quality healthcare solutions. The determination under paragraph 98C(1)(b) of the Act specifies the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits, thereby supporting the overarching policy objective of maintaining an accessible and efficient healthcare system for the nation.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) specifies the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, thereby regulating the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical benefits as defined in the Act, with drugs and medicinal preparations being declared by the Minister through legislative instruments under subsection 85(2). The Act primarily concerns the Commonwealth's role in ensuring Australians have access to reliable, timely, and affordable medicines, with the Pharmaceutical Benefits Advisory Committee (PBAC) providing expert recommendations on which drugs should be included on the PBS. The amendments detailed in Schedule 1 of this instrument, which came into effect on 1 January 2009, modify the previous determination made by legislative instrument number PB 119 of 2008. These amendments, including the addition of Posaconazole Oral Suspension 40 mg per mL, 105 mL as a listed drug, are set out in the items of Schedule 1 to the instrument. The Act applies nationally, with the Minister for Health and Ageing having the authority to make these determinations under the authority conferred by the Act.
Key Provisions
The primary operative sections of the National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) revolve around the conditions and procedures for the supply of pharmaceutical benefits. Section 85(1) stipulates that the Commonwealth will provide pharmaceutical benefits in accordance with Part VII, which is the legislative basis for the Pharmaceutical Benefits Scheme (PBS). Section 85(2) outlines that drugs and medicinal preparations to which Part VII applies are declared by the Minister through a legislative instrument, which are then listed as defined drugs in subsection 84(1). Subsections 85(3), 85(5), and 85(6) further specify the form, administration manner, and brand of the pharmaceutical item, respectively. Section 84AF allows the Minister to determine a responsible person for a brand of a pharmaceutical item. Paragraph 98C(1)(b) empowers the Minister to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The obligations and requirements imposed by the Act include the declaration of drugs and medicinal preparations that are subject to the PBS by the Minister. This process must be preceded by a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) as per subsection 101(4). The PBAC's recommendations are based on factors such as the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness. Additionally, the Minister must determine the form, manner of administration, and brand of pharmaceutical items as per subsections 85(3), 85(5), and 85(6). The Minister also has the authority to determine a responsible person for a brand of a pharmaceutical item under section 84AF. Moreover, the conditions for payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners must be clearly outlined by the Minister as per paragraph 98C(1)(b).
Any breaches of the provisions outlined in the National Health Act 1953 may lead to civil or criminal consequences. The Act does not specify maximum penalties for breaches in this particular amendment determination. However, in general, violations of the Act may result in fines or imprisonment depending on the severity and nature of the breach. It is important to note that the Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in ensuring that the recommendations align with the requirements set forth in the Act. Failure to comply with the conditions set by the Minister or to follow the procedures for declaring drugs and medicinal preparations may lead to enforcement actions, including legal proceedings and penalties.