EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 37 OF 2011
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) 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 provide for changes to 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 amendments are set out in the items of Schedule 1 to the instrument.
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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This instrument commences on 1 June 2011.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 June 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drug
Phenoxymethylpenicillin with Water – Purified BP |
SCHEDULE 4
Deletion of Listed Drug
Addition of Form
Risedronic Acid and Calcium | Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate) |
Risedronic acid and calcium with colecalciferol | Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms |
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures that Australians have reliable, timely, and affordable access to a broad range of medicines. The Act was introduced to address the need for a national scheme that could provide equitable access to essential medications. One of the key provisions of the Act, section 98C(1)(b), allows the Minister for Health to determine the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This ensures that the scheme can be adapted and updated in response to medical, economic, and other relevant considerations. The 2011 amendment to the Act, detailed in the legislative instrument F2011L00867, reflects recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and includes updates to the conditions governing payments for certain pharmaceutical benefits. This amendment aims to refine the administration and oversight of the PBS to better meet the evolving healthcare needs of the Australian population.
Scope and Application
The National Health Act 1953, as amended by the legislative instrument F2011L00867, pertains to the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to a range of medicines for all Australians. The Act applies to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, who are required to meet certain conditions to receive payments from the Commonwealth. These conditions are detailed in the instrument and are determined by the Minister based on recommendations from the Pharmaceutical Benefits Advisory Committee. The Act applies nationally across Australia, with the Commonwealth overseeing the scheme. The instrument amends the conditions set out in previous legislation, specifically PB 119 of 2008, and introduces changes such as the addition of certain listed drugs and forms, and the removal of others. The changes are effective from 1 June 2011 and are subject to further adjustments through subordinate instruments as needed. The instrument ensures that the scheme remains responsive to the needs of the Australian public and the pharmaceutical industry.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Determination (F2011L00867) are outlined in the instrument and include changes to the conditions under which payments are made for pharmaceutical benefits. Specifically, the amendments relate to the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in paragraph 98C(1)(b) of the Act (paragraph 1). The amendments provide for the addition of new listed drugs and forms, as well as the deletion of certain drugs from the list (paragraph 2 and Schedule 1). These changes are made to ensure the Pharmaceutical Benefits Scheme (PBS) remains effective and up-to-date in providing affordable access to a wide range of medicines for Australians.
The obligations and requirements imposed by this Act on the parties it governs include adherence to the updated conditions for payments as set out in the amendment determination. Approved pharmacists and approved medical practitioners must ensure their practices comply with these changes, which may affect how certain pharmaceutical benefits are supplied and reimbursed. The Minister, in determining the conditions under which payments will be made, must consider the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and other relevant factors. The Act also mandates that the Minister, through the determination, sets out the conditions governing the supply of pharmaceutical benefits, ensuring that these conditions are clearly defined and accessible to all parties involved.
There are potential civil and criminal consequences for breach of the conditions set out in the Act. While the specific penalties are not detailed in the instrument, breaches of the National Health Act 1953 can result in significant fines and other penalties. For instance, fraudulent claims under the PBS can lead to civil penalties of up to $22,200 per offence and criminal penalties, including imprisonment, under certain circumstances. Additionally, non-compliance with the conditions set by the Minister may result in the withholding of payments for pharmaceutical benefits, impacting the financial viability of approved pharmacists and approved medical practitioners. It is essential for all parties to understand and comply with the updated conditions to avoid any adverse legal consequences.