EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 54 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 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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 June 2008, was made on 1 May 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 June 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Deletion of Form
Flucloxacillin Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL
with Water —
Purified BP
SCHEDULE 4
Addition of Form
Glucose Indicator Electrode strips, 100 (FreeStyle Lite)
— Blood
Deletion of Form
Flucloxacillin Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL
Overview
The National Health Act 1953 was enacted to provide a legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures reliable, timely, and affordable access to medicines for all Australians. The Act allows the Minister to declare drugs and medicinal preparations as listed drugs under subsection 85(2), determine the forms of these listed drugs by legislative instrument, and specify the conditions for Commonwealth payments for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners under section 98C(1)(b). The explanatory statement details amendments to the determination under this section, made on 1 May 2008, which came into effect on 1 June 2008. These amendments include the deletion of certain forms of flucloxacillin and the addition of glucose indicator electrode strips to the PBS, reflecting decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) based on clinical effectiveness, safety, and cost-effectiveness. The PBAC, established under section 100A of the Act, makes recommendations to the Minister regarding which drugs and preparations should be listed on the PBS, ensuring that only recommended medicines are added to the scheme.
Scope and Application
The National Health Act 1953, through its Part VII, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS) which ensures that all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act applies to the Commonwealth and encompasses a broad range of conduct and transactions related to the provision and supply of pharmaceutical benefits. The Minister for Health, acting under the authority of the Act, has the power to declare specific drugs and medicinal preparations as listed drugs, determine their forms and manner of administration, and designate brands eligible for inclusion in the PBS. The Minister can also determine the conditions under which payments will be made for the supply of these pharmaceutical benefits by approved pharmacists and medical practitioners. The amendments to the determination under paragraph 98C(1)(b) of the Act, as set out in the instrument, include specific changes such as the addition and deletion of certain drug forms from the PBS, and these amendments reflect recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body established under the Act, assesses and recommends drugs for inclusion on the PBS based on clinical effectiveness, safety, cost-effectiveness, and the medical conditions for which the drugs have been approved. This instrument, commencing on 1 June 2008, amends the previous determination made in 2007 to reflect current recommendations and conditions for the supply of pharmaceutical benefits.
Key Provisions
The main operative sections of this legislation (F2008L01386) amend the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Section 98C(1)(b) of the National Health Act 1953 provides that the Minister may, from time to time, determine these conditions. The instrument amends the previous determination (PB 52 of 2007) and comes into effect on 1 June 2008. It includes changes to the listed drugs under Part VII of the Act, specifically by deleting a form of Flucloxacillin Powder for oral suspension and adding Glucose Indicator Electrode strips (FreeStyle Lite) to Schedule 4.
The obligations and requirements imposed by this Act on the parties or entities it governs include the declaration of drugs and medicinal preparations by the Minister, which must be based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC evaluates medicines for their clinical effectiveness, safety, and cost-effectiveness, among other factors, before making its recommendations. The Minister, in turn, must follow the PBAC's recommendations when declaring drugs and medicinal preparations that will be available as pharmaceutical benefits under the Act. Additionally, approved pharmacists and medical practitioners must comply with the conditions set forth in the determination regarding the supply of pharmaceutical benefits to ensure that they receive appropriate payments from the Commonwealth.
The Act also outlines specific offences, penalties, or consequences for breaches. While the Act does not explicitly state the penalties for non-compliance with the conditions for pharmaceutical benefit payments, it is implied that any breach of the conditions could result in civil or criminal consequences. This is because the Act is designed to ensure reliable, timely, and affordable access to medicines for all Australians, and any failure to comply with the legislative requirements could potentially undermine this objective. It is also worth noting that the Pharmaceutical Benefits Scheme (PBS) itself has specific rules and regulations that govern the supply and reimbursement of medicines, which may also carry penalties for non-compliance.
In summary, this legislation amends the conditions for payments in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners under the National Health Act 1953. It imposes obligations on the Minister to follow PBAC recommendations when declaring drugs and medicinal preparations and on approved pharmacists and medical practitioners to comply with the conditions for pharmaceutical benefit payments. While specific penalties for non-compliance are not explicitly stated in the Act, any breach of the conditions could result in civil or criminal consequences.