EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 11 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 January 2008, was made on 14 December 2007.
Another legislative instrument expressed to commence on 1 January 2008 and made by the Minister on 19 November 2007 also amends determinations under paragraph 98C(1)(b) made by legislative instrument number PB 52 of 2007. It is intended that both this legislative instrument and the legislative instrument made by the Minister on 19 November 2007 amend the legislative instrument number
PB 52 of 2007 with effect on 1 January 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 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Forms Deleted
Oestradiol Transdermal patches 3.28 mg, 8
Transdermal patches 4.33 mg, 8
Transdermal patches 6.57 mg, 8
Transdermal patches 8.66 mg, 8
Pilocarpine Eye drops containing pilocarpine hydrochloride 5 mg per mL, 15 mL
Overview
The National Health Act 1953, as amended by the legislative instrument F2007L04908, addresses the gap in ensuring reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). This legislation, enacted by the Australian Parliament, provides the legal foundation for the PBS, which enables the Commonwealth to provide pharmaceutical benefits to the public. The Act specifically empowers the Minister for Health to declare drugs and medicinal preparations eligible for inclusion in the PBS and to determine the conditions under which payments will be made for these pharmaceutical benefits. This legislative instrument, coming into effect on 1 January 2008, amends the determinations under section 98C(1)(b) of the Act, modifying the conditions for payments related to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2007L04908, applies to the Pharmaceutical Benefits Scheme (PBS), which is the legislative basis for the Commonwealth providing reliable, timely, and affordable access to a wide range of medicines for all Australians. This Act applies to pharmaceutical benefits, which are primarily declared by the Minister for Health, and encompasses drugs and medicinal preparations listed under the Act, except for some with additives. The Act also applies to the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The geographic reach of this Act is national, as it applies across the Commonwealth of Australia. The Minister has the authority to determine the form, manner of administration, and brand of pharmaceutical items, governing what constitutes a pharmaceutical benefit under the Act. The instrument, which commenced on 1 January 2008, amends the determination under paragraph 98C(1)(b) made by legislative instrument number PB 52 of 2007, with effect from the same date. Additionally, there are no stated exclusions, exemptions, or thresholds in the text, and the application of the Act extends through subordinate instruments as necessary.
Key Provisions
The primary operative sections of this legislation, as stated in the Explanatory Statement, focus on the amendments to the determinations under paragraph 98C(1)(b) of the National Health Act 1953, which governs the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, this instrument (subsection 85(1)) amends the determinations made by legislative instrument number PB 52 of 2007 to reflect changes effective from 1 January 2008. The key changes are detailed in Schedule 1 of the instrument, which includes the deletion of specific forms of certain drugs, such as oestradiol transdermal patches in various strengths and pilocarpine eye drops, from the list of drugs covered under the Pharmaceutical Benefits Scheme (PBS).
The obligations and requirements imposed by this Act on the parties it governs include ensuring compliance with the amended conditions for pharmaceutical benefits payments. For approved pharmacists and approved medical practitioners, this means adhering to the new terms set forth in the amended determinations, particularly regarding the forms of drugs that can be prescribed and reimbursed under the PBS. The Minister for Health and Ageing is tasked with updating the legislative instruments to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which provides independent expert advice on which drugs should be included on the PBS. These amendments ensure that only recommended and approved drugs are covered under the scheme, maintaining the integrity and cost-effectiveness of the PBS.
The legislation also outlines consequences for breaches, although the specific offences, penalties, or civil/criminal consequences are not detailed in the Explanatory Statement. Generally, under the National Health Act 1953, non-compliance with the provisions of the Act can result in a range of penalties, including fines and potential criminal charges, depending on the severity and intent of the breach. Approved pharmacists and approved medical practitioners who fail to adhere to the amended conditions could face disciplinary action, including fines and other administrative penalties, which may impact their ability to practice. The specific maximum penalties would depend on the nature of the offence and are likely detailed in other sections of the Act or related legislation.