EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98B (1) (a) No. 1
The Pharmaceutical Benefits Remuneration Tribunal (“the PBRT”) is established under section 98A of the National Health Act 1953 (“the Act”). Paragraph 98B(1)(a) of the Act provides that a function of the PBRT is to determine the manner in which the Commonwealth price (as defined in section 84 of the Act) for all or any pharmaceutical benefits is to be worked out for the purpose of payments to approved pharmacists for the supply of pharmaceutical benefits.
Subsection 98BAA(1) of the Act requires that, where the Commonwealth and the Pharmacy Guild of Australia (or another pharmacists’ organisation representing a majority of approved pharmacists) enter into an agreement relating to the manner in which the Commonwealth price for pharmaceutical benefits is to be calculated, the PBRT, when making a determination pursuant to paragraph 98B(1)(a) of the Act, is to give effect to the terms of that agreement. The current agreement is the Fourth Community Pharmacy Agreement (“the Fourth Agreement”) between the Commonwealth and the Pharmacy Guild of Australia, which was signed on 16 November 2005 and commenced on 1 December 2005. On 23 June 2006 the PBRT made the National Health Act 1953 Pharmaceutical Benefits Determination under paragraph 98B(1)(a) which commenced on 1 July 2006 (“the Principal Determination”). The Principal Determination gives effect the terms of the Fourth Agreement that set out the fees that are to be paid to pharmacists for the supply of pharmaceutical benefits.
Effective from 1 August 2006, various legislative instruments which are incorporated by reference into the Principal Determination are revoked and remade. The purpose of this determination is to amend the Principal Determination to reflect necessary changes to the references to the legislative instruments which are incorporated by reference into the Principal Determination. The amendments to the Principal Determination are necessary to ensure that the remade legislative instruments are incorporated by reference under section 14 of the Legislative Instruments Act 2003.
Consultation
The Principle Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003. Amendments to the Principle Determination have been made in consultation with the Pharmacy Guild of Australia, an organisation representing a majority of approved pharmacists. The Pharmacy Guild of Australia is a party to the Fourth Agreement and supports this Determination.
Further details of the Determination are set out in the Attachment.
ATTACHMENT
NOTES ON CLAUSES TO THE DETERMINATION
Clause 1 – Name of Determination
Clause 1 provides that the name of the Determination is the National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 1
Clause 2 – Commencement
Clause 2 provides that the Determination commences on 1 August 2006.
Clause 3 – Amendment of the Determination under paragraph 98B(1)(a)
Clause 3 provides that the National Health Act 1953 Pharmaceutical Benefits Determination under paragraph 98B(1)(a) made on 23 June 2006 (“the Principal Determination”) is amended as set out in the Schedule.
Schedule – Amendments
Item 1 – provides that all references in the Principal Determination to ‘the determination under paragraph 98C(1)(b) of the Act as set out in PB 26 of 2006’ are amended to ‘the determination under paragraph 98C(1)(b) of the Act as set out in PB 32 of 2006.
Item 2 – provides that all references in the Principal Determination to ‘the determination under paragraph 85A(2)(a) of the Act as set out in PB 24 of 2006’ are amended to ‘the determination under paragraph 85A(2)(a) of the Act as set out in PB 33 of 2006.
Item 3 – provides that all references in the Principal Determination to ‘the determination under subsection 85(6) of the Act as set out in PB 24 of 2006’ are amended to ‘the determination under subsection 85(6) of the Act as set out in PB 33 of 2006’.
Item 4 – Paragraph 37 – provides that the reference in paragraph 37 to ‘the determinations under sections 85, 85A and 88 of the Act as set out in PB 24 of 2006’ is amended to ‘the determinations under sections 85, 85A and 88 of the Act as set out in PB 33 of 2006.
Overview
The National Health Act 1953 was enacted to provide for the development and implementation of policies and programs that promote health and wellbeing, and to establish a framework for the delivery of health services across Australia. The Pharmaceutical Benefits Remuneration Tribunal was established under the Act to determine the Commonwealth price for pharmaceutical benefits, ensuring that these benefits are supplied to the public at a reasonable cost. The problem this legislation aimed to address was the need for a structured and fair system for calculating and remunerating pharmacists for the supply of pharmaceutical benefits. The Parliament of Australia enacted this legislation to provide a robust framework for health service delivery and to ensure that pharmaceutical services are accessible and affordable for all Australians. The policy objective of this amendment was to update and align the Principal Determination with the remade legislative instruments, ensuring that the fees paid to pharmacists for the supply of pharmaceutical benefits are accurately reflected and updated as necessary.
Scope and Application
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 1 amends the existing Pharmaceutical Benefits Determination under the National Health Act 1953, which was established to work out the Commonwealth price for pharmaceutical benefits to be paid to approved pharmacists for the supply of these benefits. The amendment is necessary to update the references to the legislative instruments incorporated by reference into the Principal Determination, ensuring compliance with the Legislative Instruments Act 2003. This amendment applies to the Commonwealth and the Pharmacy Guild of Australia, an organisation representing a majority of approved pharmacists, and affects the manner in which the Commonwealth price for pharmaceutical benefits is calculated and subsequently paid to pharmacists. The Determination has a national jurisdictional reach, affecting all approved pharmacists across Australia. There are no stated exclusions or exemptions in this Amendment Determination; however, the application may be further extended or restricted through subordinate instruments. The Amendment Determination was made in consultation with the Pharmacy Guild of Australia, which supports the changes.
Key Provisions
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 1, which came into effect on 1 August 2006, amends the Principal Determination made by the Pharmaceutical Benefits Remuneration Tribunal (PBRT) on 23 June 2006. This amendment ensures that certain references within the Principal Determination are updated to reflect remade legislative instruments. Specifically, references to outdated legislative instruments (PB 26, PB 24) are updated to reflect new instruments (PB 32, PB 33), ensuring that the Principal Determination continues to operate correctly within the legislative framework. The purpose of this amendment is to maintain the accuracy and relevance of the references within the Principal Determination, thereby ensuring the ongoing effectiveness of the legislative instruments that support the calculation and payment of pharmaceutical benefits.
The obligations imposed by this Determination primarily concern the PBRT and the entities it governs. The PBRT is required to ensure that the Principal Determination reflects the terms of the Fourth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild of Australia. Additionally, the PBRT must ensure that references within the Principal Determination are updated to reflect the remade legislative instruments, as specified in the Amendment Determination. The Pharmacy Guild of Australia, as a party to the Fourth Agreement and a representative of approved pharmacists, is also involved in these processes, having been consulted during the amendment process and supporting the Determination.
Failure to comply with the requirements of this Determination could lead to various consequences. While the specific civil or criminal penalties for non-compliance are not explicitly stated in the text, breaches of the National Health Act 1953 or related legislative instruments could result in penalties under the relevant sections of the Act or other applicable laws. These penalties could include fines or other sanctions, depending on the nature and severity of the breach. The precise penalties would be determined by the courts or relevant authorities based on the specific circumstances of the non-compliance. It is essential for the PBRT and other relevant entities to adhere to the requirements set out in the Amendment Determination to avoid any potential legal repercussions.