EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 45 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 May 2008, was made on 2 April 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 May 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Form:
Flucloxacillin Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL
with Water – Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL
Purified BP
SCHEDULE 4
Addition of Listed Drug:
Risedronic acid and calcium with colecalciferol | Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms |
Addition of Form:
Flucloxacillin Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL
Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL
Macrogol 3350 Sachets containing powder for oral solution 6.563 g with electrolytes, 30
Deletion of Form:
Salmeterol Pressurised inhalation 25 micrograms (as xinafoate) per dose, 120 doses
Overview
The National Health Act 1953, as amended by the determination under paragraph 98C(1)(b), addresses the issue of regulating the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Enacted by the Australian Parliament, this legislation aims to ensure reliable, timely, and affordable access to a broad range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). The policy objective behind the Act is to provide an efficient and equitable system for listing drugs and medicinal preparations that are available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness. The determination under paragraph 98C(1)(b) specifically governs the conditions for making payments for the supply of pharmaceutical benefits, with amendments such as the addition of new forms of listed drugs and the deletion of certain forms, reflecting ongoing adjustments to the scheme to better serve the needs of the Australian population.
Scope and Application
The National Health Act 1953, as amended by the determination under paragraph 98C(1)(b), establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS) that ensures Australians have access to affordable and reliable medicines. This Act applies to the Commonwealth government, approved pharmacists and medical practitioners, and the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister for Health and Ageing, under this Act, has the authority to determine the conditions under which payments for pharmaceutical benefits are made, and to declare which drugs and medicinal preparations are eligible for the PBS. The determination also outlines the specific forms and brands of pharmaceutical items that are covered by the PBS. The amendments to the determination, effective from 1 May 2008, include adding new forms of certain drugs to the PBS, such as Flucloxacillin and Macrogol 3350, and removing others like Salmeterol, as well as adding a new drug combination of Risedronic acid and calcium with colecalciferol. The Act's provisions extend nationally, covering all states and territories of Australia, and it is supported by subordinate instruments that specify the details of listed drugs and their forms.
Key Provisions
The key provisions of the National Health Act 1953 Amendment Determination, as outlined in the explanatory statement, centre around the amendments to the Pharmaceutical Benefits Scheme (PBS). Section 98C(1)(b) allows 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 determination, which is expressed to commence on 1 May 2008, amends the previous determination (PB 52 of 2007) and includes several specific changes. One of the primary changes involves the addition of new forms of listed drugs and pharmaceutical items (subsection 85(3) and (5)), such as Flucloxacillin Powder for oral liquid 125 mg and 250 mg, and the deletion of some forms like Salmeterol Pressurised inhalation 25 micrograms. Additionally, the Act lists new pharmaceutical items, such as Risedronic acid and calcium with colecalciferol.
The obligations and requirements imposed by the Act on the parties it governs include compliance with the declared forms and pharmaceutical items listed in the Schedule. For example, approved pharmacists and approved medical practitioners must adhere to the new forms of listed drugs as determined by the Minister. Furthermore, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in recommending which drugs and medicinal preparations should be available under the PBS. Any drug or medicinal preparation to be declared under Part VII of the Act must have a recommendation from the PBAC, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness (subsection 101(4)).
The Act also outlines the consequences for non-compliance. While the explanatory statement does not specify detailed penalties or consequences, breaches of the conditions set out under section 98C(1)(b) could potentially lead to civil or criminal liabilities, depending on the severity and nature of the breach. For instance, providing pharmaceutical benefits without adhering to the stipulated conditions or misrepresenting pharmaceutical items could result in penalties. However, the specific penalties are not detailed in the explanatory statement and would need to be referred to within the full text of the Act or related regulations.