EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
AMENDMENT 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) and 25 July (with effect from 1 August 2007).
Effective from 1 December 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 AMENDMENT 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.10.
Clause 2 – Commencement
Clause 2 provided that the Amendment Determination commences on 1 December 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 49 of 2007’ are amended to ‘determination under subsection 85(6) of the Act as set out in PB 89 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 49 of 2007’ are amended to ‘determination under paragraph 85A(2)(a) of the Act as set out in PB 89 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 49 of 2007’ is amended to ‘determinations under sections 85, 85A and 88 of the Act as set out in PB 89 of 2007’.
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves as a fundamental piece of legislation governing health-related matters across Australia. This Act was introduced to establish a framework for ensuring accessible and affordable health services, particularly focusing on the regulation and funding of pharmaceutical benefits. One of the Act's key provisions involves the Pharmaceutical Benefits Remuneration Tribunal (PBRT), which is tasked with determining the Commonwealth price for pharmaceutical benefits to be paid to approved pharmacists. The purpose of the 2007 Amendment Determination under paragraph 98B(1)(a) of the Act is to update and reflect necessary changes to the legislative instruments incorporated by reference into the Principal Determination. This ensures the continued relevance and effectiveness of the Pharmaceutical Benefits Determination, thereby maintaining the integrity of the pricing and supply mechanisms for pharmaceuticals. The amendments were made in consultation with the Pharmacy Guild of Australia, ensuring that the changes align with the terms of the Fourth Community Pharmacy Agreement.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98B(1)(a) No. 10 applies to the Pharmaceutical Benefits Remuneration Tribunal (PBRT) and the manner in which the Commonwealth price for pharmaceutical benefits is calculated and paid to approved pharmacists. This determination is necessary to reflect the changes in references to the legislative instruments that are incorporated by reference into the Principal Determination. Effective from 1 December 2007, the Amendment Determination amends the Principal Determination made on 23 June 2006 to ensure that the remade legislative instruments are incorporated by reference under section 14 of the Legislative Instruments Act 2003. The changes are aimed at maintaining the integrity and effectiveness of the remuneration system for pharmacists supplying pharmaceutical benefits. This Amendment Determination is applicable nationally, and it is made in consultation with the Pharmacy Guild of Australia, which represents a majority of approved pharmacists and is a party to the Fourth Community Pharmacy Agreement.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Determination under paragraph 98B(1)(a) (F2007L04427) concern the amendment of the Principal Determination, which was established on 23 June 2006 and provides the fees to be paid to pharmacists for the supply of pharmaceutical benefits. Section 1 of the Amendment Determination specifies its name, while Section 2 outlines its commencement date, 1 December 2007. The core of the Amendment Determination is found in Section 3, which details the specific amendments to the Principal Determination. These amendments primarily involve updating references to legislative instruments incorporated by reference into the Principal Determination, ensuring alignment with the Legislative Instruments Act 2003. The Schedule of the Amendment Determination lists the precise changes, such as updating references from PB 49 of 2007 to PB 89 of 2007.
The obligations and requirements imposed by the Amendment Determination on the parties involved are primarily administrative and compliance-based. The Pharmaceutical Benefits Remuneration Tribunal (PBRT) must ensure that the amendments to the Principal Determination are correctly implemented and that all references to legislative instruments are updated as specified. This includes verifying that the remade legislative instruments are accurately incorporated by reference under the Legislative Instruments Act 2003. The Pharmacy Guild of Australia, which is party to the Fourth Community Pharmacy Agreement and supports this Amendment Determination, must ensure that its members are informed of and comply with the updated fees and conditions set forth in the amended Principal Determination.
The Amendment Determination does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, any failure to comply with the updated provisions of the Principal Determination could potentially lead to disputes or legal challenges regarding the fees paid to pharmacists for pharmaceutical benefits. While the Amendment Determination itself does not specify penalties, non-compliance with the National Health Act 1953 or related agreements could result in legal actions, which may include seeking declarations, injunctions, or other remedies in the courts. The penalties for such breaches would be determined based on the specific nature of the non-compliance and the applicable laws at the time.