EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER PARAGRAPH 98B (1) (a)
Paragraph 98B (1) (a) of the National Health Act 1953 (“the Act”) provides that a function of the Pharmaceutical Benefits Remuneration Tribunal (“the PBRT”) is to determine the manner in which the Commonwealth price 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, 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 to the terms of the Fourth Agreement that set out the fees that are to be paid to pharmacists for the supply of pharmaceutical benefits. The Principal Determination has been previously amended on 26 July 2006 (with effect from 1 August 2006), 4 October 2006 (with effect from 1 October 2006), 24 November 2006 (with effect from 1 December 2006), 28 February 2007 (with effect from 1 March 2007), 13 March 2007 (with effect from 1 April 2007), 12 April 2007 (with effect 1 May 2007), 20 June 2007 (with effect from 1 July 2007) and 20 June (with effect from 1 August).
Effective from 1 August 2007, 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.
Further details of the Determination are set out in the Attachment.
Consultation
The Principal Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003. Amendments to the Principal 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.
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. 9.
Clause 2 – Commencement
Clause 2 provided that the Determination commences on 1 August 2007.
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 ‘determination under subsection 85(6) of the Act as set out in PB 45 of 2007’ are amended to ‘determination under subsection 85(6) of the Act as set out in PB 49 of 2007’.
Item 2 – provides that all references in the Principal Determination to ‘determination under paragraph 85A(2)(a) of the Act as set out in PB 45 of 2007’ are amended to ‘determination under paragraph 85A(2)(a) of the Act as set out in PB 49 of 2007’.
Item 3 – provides that all references in the Principal Determination to ‘determination under paragraph 98C(1)(b) of the Act as set out in PB 46 of 2007’ are amended to ‘determination under paragraph 98C(1)(b) of the Act as set out in PB 52 of 2007’.
Item 4 – Paragraph 37 – provides that the reference in paragraph 37 to ‘determinations under sections 85, 85A and 88 of the Act as set out in PB 45 of 2007’ is amended to ‘determinations under sections 85, 85A and 88 of the Act as set out in PB 49 of 2007’.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, addresses the provision and regulation of health services, including the administration of the Pharmaceutical Benefits Scheme (PBS). The Act, through the Pharmaceutical Benefits Remuneration Tribunal (PBRT), ensures the calculation and payment of pharmaceutical benefits to pharmacists. The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 9, made on 1 August 2007, amends the Principal Determination to update references to legislative instruments incorporated by reference, ensuring compliance with the Legislative Instruments Act 2003. This amendment was made in consultation with the Pharmacy Guild of Australia, which supports the changes and is a party to the Fourth Community Pharmacy Agreement. The policy objective is to maintain the integrity and functionality of the PBS by ensuring accurate and up-to-date references within the legislative framework.
Scope and Application
The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 9 applies to the Commonwealth price for pharmaceutical benefits, specifically addressing how these prices are to be calculated for payments to approved pharmacists for the supply of pharmaceutical benefits. This determination is integral to the administrative framework established by the National Health Act 1953, focusing on ensuring that the remuneration for pharmacists is correctly aligned with the terms of the Fourth Community Pharmacy Agreement between the Commonwealth and the Pharmacy Guild of Australia. This Agreement, signed on 16 November 2005 and commenced on 1 December 2005, dictates the fees to be paid to pharmacists and is given effect by the Pharmaceutical Benefits Remuneration Tribunal in its determinations. The Amendment Determination, which commenced on 1 August 2007, is designed to update references to legislative instruments incorporated by the Principal Determination to comply with the Legislative Instruments Act 2003, ensuring the continued relevance and legality of these references. The scope of this legislation is primarily Commonwealth-wide, reflecting the national framework for pharmaceutical benefits and remuneration set by the National Health Act 1953.
Key Provisions
The main sections of the legislation under consideration pertain to the manner in which the Commonwealth price for pharmaceutical benefits is calculated, as determined by the Pharmaceutical Benefits Remuneration Tribunal (PBRT) under the National Health Act 1953. According to section 98B(1)(a), the PBRT is tasked with determining how the Commonwealth price for all or any pharmaceutical benefits is to be worked out for the purpose of payments to approved pharmacists. When the Commonwealth and the Pharmacy Guild of Australia, or another pharmacists’ organisation representing a majority of approved pharmacists, enter into an agreement concerning the calculation of the Commonwealth price for pharmaceutical benefits, the PBRT is required under section 98BAA(1) to give effect to the terms of that agreement in its determinations.
This legislation imposes several obligations and requirements on the parties it governs. The PBRT must ensure that its determinations reflect the terms of any relevant agreements between the Commonwealth and pharmacists’ organisations. In this context, the Fourth Community Pharmacy Agreement, signed on 16 November 2005, serves as the current agreement that sets out the fees to be paid to pharmacists. The PBRT's determinations, as reflected in the Principal Determination made on 23 June 2006, must therefore give effect to the terms of this agreement. Additionally, the legislative instruments incorporated by reference into the Principal Determination must be updated to ensure compliance with the Legislative Instruments Act 2003. The amendments to the Principal Determination, as outlined in the Schedule, are designed to reflect these necessary changes.
The legislation also outlines potential consequences for non-compliance. While the specific offences, penalties, or civil and criminal consequences are not explicitly stated in the text, the importance of adhering to the PBRT's determinations and the amendments to the Principal Determination is evident. Failure to comply with the terms of the agreement or the PBRT's determinations could potentially lead to legal repercussions, although the exact nature of these consequences is not detailed in the provided text. Given the regulatory nature of the Act, it is likely that non-compliance could result in enforcement actions by the relevant authorities, including potential penalties or other sanctions as prescribed by law.