EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98B (1) (a) No. 4
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. 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) and 24 November 2006 (with effect from 1 December 2006).
Effective from 1 March 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.
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.
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. 4
Clause 2 – Commencement
Clause 2 provides that the Determination commences on 1 March 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 ‘the determination under paragraph 98C(1)(b) of the Act as set out in PB 50 of 2006’ are amended to ‘the determination under paragraph 98C(1)(b) of the Act as set out in PB 14 of 2007.
Item 1 – provides that all references in the Principal Determination to ‘the determination under paragraph 85A(2)(a) of the Act as set out in PB 47 of 2006’ are amended to ‘the determination under paragraph 85A(2)(a) of the Act as set out in PB 12 of 2007.
Item 2 – provides that all references in the Principal Determination to ‘the determination under subsection 85(6) of the Act as set out in PB 47 of 2006’ are amended to ‘the determination under subsection 85(6) of the Act as set out in PB 12 of 2007’.
Item 3 – 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 47 of 2006’ is amended to ‘the determinations under sections 85, 85A and 88 of the Act as set out in PB 12 of 2007.
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative foundation for the country's healthcare system, addressing gaps in the provision, financing, and administration of health services. This Act was introduced to establish a framework for the administration of health benefits and services in Australia, aiming to ensure the provision of accessible and affordable health care. The Pharmaceutical Benefits Remuneration Tribunal, established under the Act, plays a crucial role in determining the remuneration for pharmaceutical benefits. This Amendment Determination, issued in 2007 under paragraph 98B(1)(a) No. 4 of the Act, seeks to refine the methodology for calculating the Commonwealth price for pharmaceutical benefits by updating references to legislative instruments incorporated into the Principal Determination. This amendment ensures that the remade legislative instruments are properly referenced, thereby maintaining the integrity and applicability of the remuneration framework established under the Act. The determination was made in consultation with relevant stakeholders, including the Pharmacy Guild of Australia, which supports the amendment.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98B(1)(a) No. 4 applies to the Pharmaceutical Benefits Remuneration Tribunal (PBRT), which is established under section 98A of the Act. The PBRT's function, as outlined in paragraph 98B(1)(a) of the Act, is to determine the manner in which the Commonwealth price for pharmaceutical benefits is to be calculated for payments to approved pharmacists supplying pharmaceutical benefits. This determination is made in accordance with any existing agreements between the Commonwealth and pharmacists' organisations, such as the Pharmacy Guild of Australia, and specifically gives effect to the terms of the Fourth Community Pharmacy Agreement, which was signed on 16 November 2005 and commenced on 1 December 2005. The Amendment Determination amends the Principal Determination made by the PBRT on 23 June 2006, which commenced on 1 July 2006, to reflect necessary changes to the references to legislative instruments incorporated by reference into the Principal Determination. This ensures that the remade legislative instruments are incorporated by reference under section 14 of the Legislative Instruments Act 2003. The amendments have been made in consultation with the Pharmacy Guild of Australia, a party to the Fourth Agreement, and the Guild supports this Determination.
Key Provisions
The main operative sections of the National Health Act 1953 Amendment Determination under Paragraph 98B(1)(a) No. 4 (the "Determination") relate to the amendment of the National Health Act 1953 Pharmaceutical Benefits Determination (the "Principal Determination") to reflect changes to the legislative instruments incorporated by reference. The Determination itself is named in Clause 1, and it commences on 1 March 2007 as per Clause 2. Clause 3 specifies that the Principal Determination is amended as detailed in the attached Schedule. The Schedule, in turn, details the specific amendments to the references within the Principal Determination to legislative instruments, ensuring compliance with the Legislative Instruments Act 2003.
The obligations imposed by the Act on the parties involved, primarily the Commonwealth, the Pharmacy Guild of Australia, and approved pharmacists, include adherence to the terms set out in the Fourth Community Pharmacy Agreement and the Principal Determination. The Pharmaceutical Benefits Remuneration Tribunal (PBRT) is tasked with ensuring that these agreements are given effect in its determinations. The PBRT must also consult with relevant parties, such as the Pharmacy Guild of Australia, in making amendments to the Principal Determination. The Pharmacy Guild of Australia, as a party to the Fourth Agreement and a representative of the majority of approved pharmacists, has a vested interest in supporting the terms of the Determination and ensuring that its provisions are implemented correctly.
Under the Act, breaches of the requirements set out in the Determination could lead to various civil and criminal consequences. While the specific offences and penalties are not detailed in the provided text, it is reasonable to infer that any non-compliance with the legislative instruments incorporated by reference could result in legal action. The penalties for such breaches could range from fines to more severe criminal sanctions, depending on the nature and severity of the violation. The exact penalties would be determined in accordance with the broader legal framework governing the Act and related legislation.
In summary, the Determination amends the Principal Determination to align with updated legislative instruments, ensuring ongoing compliance with the Act. It imposes specific obligations on the PBRT, the Commonwealth, the Pharmacy Guild of Australia, and approved pharmacists to adhere to the terms of the Fourth Agreement and the Principal Determination. Failure to comply with these provisions could result in civil or criminal penalties, although the exact nature of these penalties is not specified in the provided text.