EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 59 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 September 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 September 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
Item 1 amends section 3 of the Principal Instrument to change ‘Chief Executive Officer of Medicare Australia’ to ‘Chief Executive Medicare’.
Item 2 amends section 9 of the Principal Instrument to change ‘Chief Executive Officer of Medicare Australia’ to ‘Chief Executive Medicare’.
SCHEDULE 1
Addition of Listed Drug
Fluconazole with Water ─ Purified BP | Powder for oral suspension 50 mg in 5 mL, 35 mL |
SCHEDULE 3
Addition of Forms
Fentanyl | Transdermal patch 1.28 mg Transdermal patch 2.063 mg Transdermal patch 4.125 mg Transdermal patch 8.25 mg Transdermal patch 12.375 mg Transdermal patch 16.5 mg |
SCHEDULE 4
Addition of Form
Calcipotriol with betamethasone | Gel containing calcipotriol 50 micrograms with betamethasone
500 micrograms (as dipropionate) per g, 30 g |
Overview
The National Health Act 1953, enacted by the Parliament of Australia, establishes the framework for the Pharmaceutical Benefits Scheme (PBS), which aims to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. The Act allows the Minister for Health to determine the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This role is performed under paragraph 98C(1)(b) of the Act. The legislation was introduced to address the need for a structured, government-funded system to ensure the affordability and availability of essential medications. This legislative instrument, F2011L01764, amends the previous determination made by legislative instrument number PB 119 of 2008 to reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and updates the conditions for Commonwealth payments regarding the supply of pharmaceutical benefits. The amendments are designed to align the PBS with current medical needs and technological advancements, ensuring the scheme remains effective and responsive to the health requirements of the Australian population.
Scope and Application
The National Health Act 1953 provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS), ensuring that Australians have reliable, timely, and affordable access to a wide range of medicines. Under this Act, the Minister has the authority to declare certain drugs and medicinal preparations as listed drugs and to determine their form, manner of administration, and specific brands. The Minister can also determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The legislative instrument in question amends the conditions for such payments, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. The amendments, effective from 1 September 2011, primarily update references to the Chief Executive Officer of Medicare Australia to the Chief Executive Medicare and include new additions to the list of listed drugs and their forms, such as fluconazole, fentanyl, and calcipotriol with betamethasone. These changes facilitate the ongoing administration of the PBS and ensure that the scheme continues to meet the healthcare needs of Australians.
Key Provisions
The primary operative sections of this legislation involve amendments to the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (paragraph 98C(1)(b) of the National Health Act 1953). The amendments, set out in Schedule 1 to the instrument, detail changes to the form of certain drugs, including the addition of Fluconazole with Water – Purified BP Powder for oral suspension, various forms of Fentanyl transdermal patches, and Calcipotriol with betamethasone gel. These changes are effective as of 1 September 2011.
The Act imposes several obligations on parties and entities it governs. Primarily, the Minister is responsible for determining the conditions under which payments will be made for pharmaceutical benefits, as outlined in paragraph 98C(1)(b). The Minister must also declare drugs and medicinal preparations that qualify for these benefits under subsection 85(2) and determine their form, manner of administration, and the brand of pharmaceutical items that constitute the benefit. Furthermore, the Minister can designate a responsible person for a brand of a pharmaceutical item under section 84AF. Approved pharmacists and approved medical practitioners must comply with these determinations to be eligible for Commonwealth payments for the supply of pharmaceutical benefits.
Failure to comply with the conditions set out in the Act can lead to significant legal consequences. Although the specific offences, penalties, or civil/criminal consequences are not detailed in the text provided, the legislation generally allows for enforcement actions against those who breach the conditions for payments. Such breaches could potentially result in fines or other penalties as prescribed by the Act or other relevant legislation. The seriousness of the breach would determine the severity of the penalty, which could include criminal sanctions depending on the context and nature of the violation. It is important to note that the exact penalties and enforcement mechanisms would need to be referred to in the full text of the Act or associated regulations.