EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 68 OF 2009
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 119 of 2008 which came into effect on 1 December 2008. 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 August 2009, was made on 6 July 2009.
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 August 2009.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drug
Voriconazole with Water – Purified BP |
SCHEDULE 4
Addition of Listed Drugs
Bimatoprost with timolol |
Oxybutynin |
Rivaroxaban |
Voriconazole |
Addition of Form
Hypromellose | Oral gel 20 mg per g, 100 g |
Deletion of Form
Glucose Indicator—Blood | Electrode strips, 100 (TrueSense) |
Overview
The National Health Act 1953, enacted by the Australian Parliament, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), aiming to ensure Australians have reliable, timely, and affordable access to a wide range of medicines. The Act allows the Minister to determine the conditions under which payments for pharmaceutical benefits will be made to approved pharmacists and medical practitioners. This legislative instrument, F2009L02717, amends the conditions set by the Minister for payments under section 98C(1)(b) of the Act, reflecting the changes made by the Pharmaceutical Benefits Advisory Committee and approved by the Minister. The determination, effective from 1 August 2009, updates the list of listed drugs and forms, including the addition of Voriconazole with Water – Purified BP, Bimatoprost with timolol, Oxybutynin, and Rivaroxaban, among others, and the deletion of certain forms like Glucose Indicator—Blood Electrode strips. This amendment aims to align the PBS with the current therapeutic needs and medical advancements.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) pertains to the Pharmaceutical Benefits Scheme (PBS), which is the legislative foundation governing the Commonwealth's provision of accessible, timely, and affordable medicines to all Australians. This instrument specifically modifies the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The determination applies to drugs and medicinal preparations declared by the Minister as listed drugs under the Act, which are subject to the Act's provisions unless specifically exempted. The amendments outlined in this instrument affect the forms and brands of listed drugs eligible for PBS subsidies and are applicable across the Commonwealth, extending to all states and territories. The Minister's authority to amend the conditions under which payments are made is exercised through subordinate legislation, which allows for the inclusion of new drugs and forms or the exclusion of certain items based on recommendations from the Pharmaceutical Benefits Advisory Committee. The instrument commenced on 1 August 2009 and amends the previous determination made in 2008, reflecting updated recommendations for pharmaceutical subsidies.
Key Provisions
The National Health Act 1953, specifically as amended by the legislative instrument F2009L02717, outlines the conditions under which payments are made for pharmaceutical benefits provided through the Pharmaceutical Benefits Scheme (PBS) (section 98C(1)(b)). This instrument, which came into effect on 1 August 2009, amends the previous determination made in 2008. It sets the conditions for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, ensuring that these services are compensated appropriately by the Commonwealth. The determination includes new additions to the listed drugs and forms, such as Voriconazole with Water – Purified BP and Hypromellose Oral gel 20 mg per g, 100 g, and removes certain forms such as Glucose Indicator—Blood Electrode strips, 100 (TrueSense).
Under the Act, the Minister is responsible for determining which drugs and forms are eligible for inclusion in the PBS, as well as the manner of their administration and the brands that qualify (subsections 85(2) to 85(6)). This legislation requires the Minister to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) to consider applications and recommend which medicines should be subsidised. The PBAC, an independent body comprising members from various health-related professions and consumer interests, plays a crucial role in advising the Minister on these matters. The Minister then makes the final determination on the conditions of payments, as detailed in the legislative instrument.
Entities and individuals involved in the supply of pharmaceutical benefits, such as approved pharmacists and approved medical practitioners, must adhere to the conditions set forth in the amended determination. This includes ensuring that the drugs they supply meet the listed criteria and forms specified in the Act. Failure to comply with these conditions may result in non-payment for the services rendered. The Act imposes a responsibility on these parties to stay updated with the latest legislative changes and ensure their practices align with the requirements set out in the determination.
Breaches of the provisions outlined in this Act can result in significant consequences. While the specific offences and penalties are not detailed in the legislative instrument, under the National Health Act 1953, non-compliance with the provisions governing the PBS can lead to civil or criminal penalties. These may include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any additional provisions outlined in related legislation. It is essential for all parties involved to understand and comply with these requirements to avoid any potential legal repercussions.