National Health Act 1953 - Pharmaceutical Benefits - Amendment Determination under paragraph 98B(1)(a) No. 7 (20/06/2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L01888 Not in force Legislative Instrument

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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) and 20 June 2007 (with effect from 1 July 2007).

The purpose of this Determination is to amend the Principal Determination to reflect the necessary changes to the references to the legislative instruments which are incorporated by reference into the Principal Determination and changes to the pharmacists’ dispensing fees.  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.

Part 2 of the Fourth Agreement sets out the manner in which the Commonwealth price for pharmaceutical benefits is to be calculated.  A component of the Commonwealth price is the pharmacists’ dispensing fees.  The method by which the pharmacists’ dispensing fees are to be adjusted, with effect from 1 July of each year (from the 2006-07 financial year to the 2009-10 financial year) is also set out in the Fourth Agreement.  As part of the Fourth Agreement, the Minister for Health and Ageing (on behalf of the Commonwealth) and the Pharmacy Guild of Australia have agreed to the amount of the pharmacists dispensing fees to have effect from 1 July 2007.  This Determination is made pursuant to paragraph 98B (1) (a) of the Act and gives effect to the terms of the Fourth Agreement concerning the Commonwealth price for pharmaceutical benefits.  The dispensing fee for ready-prepared pharmaceutical benefits will increase by 17 cents to $5.32, and the dispensing fee for extemporaneously-prepared pharmaceutical benefits will increase by 17 cents to $7.36.

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. 7.

Clause 2 – Commencement

Clause 2 provided that the Determination commences on 1 July 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 1Paragraph 6 provides that the amount of the prepared dispensing fee referred to in the definition of “extemporaneously-prepared dispensing fee” in paragraph 6 of the Principal Determination is increased by 17 cents to $7.36.

 

Item 2 Paragraph 6 provides that the amount of the dispensing fee referred to in the definition of “ready-prepared dispensing fee” in paragraph 6 of the Principal Determination is increased by 17 cents to $5.32.

Item 3 provides that all references in the Principal Determination to ‘determination under subsection 85(6) of the Act as set out in PB 20 of 2007’ are amended to ‘determination under subsection 85(6) of the Act as set out in PB 45 of 2007’. 

Item 4 – provides that all references in the Principal Determination to ‘determination under paragraph 85A(2)(a) of the Act as set out in PB 31 of 2007’ are amended to ‘determination under paragraph 85A(2)(a) of the Act as set out in PB 45 of 2007’.

Item 5 – provides that all references in the Principal Determination to ‘determination under paragraph 98C(1)(b) of the Act as set out in PB 34 of 2007’ are amended to ‘determination under paragraph 98C(1)(b) of the Act as set out in PB 46 of 2007’.

Item 6 – 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 31 of 2007’ is amended to ‘determinations under sections 85, 85A and 88 of the Act as set out in PB 45 of 2007’.

 

 

 

 

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, addresses the need for a structured and systematic approach to the provision and regulation of health services, including pharmaceutical benefits. This Act establishes the framework for the Pharmaceutical Benefits Scheme (PBS), ensuring that eligible Australians have access to affordable and necessary medications. One of the critical functions of the Pharmaceutical Benefits Remuneration Tribunal (PBRT) under the Act is to determine the Commonwealth price for pharmaceutical benefits, which in turn affects the payments to approved pharmacists. The National Health Act 1953 Pharmaceutical Benefits Amendment Determination under paragraph 98B(1)(a) No. 7, made on 20 June 2007, aims to amend the principal determination to incorporate necessary changes to legislative instruments and update pharmacists' dispensing fees. This determination ensures that the legislative instruments are correctly referenced and that the fees paid to pharmacists are adjusted in line with the agreed terms of the Fourth Community Pharmacy Agreement. The amendments are intended to maintain the integrity and effectiveness of the PBS, ensuring continued access to affordable medications for the Australian public.

Scope and Application

The National Health Act 1953, through the Pharmaceutical Benefits Remuneration Tribunal, applies to the calculation and remuneration of Commonwealth prices for pharmaceutical benefits supplied by approved pharmacists. This legislation specifically governs the manner in which fees are determined for pharmacists supplying ready-prepared and extemporaneously-prepared pharmaceutical benefits, ensuring that the remuneration aligns with agreements between the Commonwealth and pharmacists' organisations such as the Pharmacy Guild of Australia. The scope of this Act is national, impacting all approved pharmacists across Australia. The determinations made under this Act are subject to amendments, particularly in the context of updating legislative references and adjusting dispensing fees as agreed upon in the Fourth Community Pharmacy Agreement. The Act does not explicitly provide for exclusions or exemptions, but its application is confined to the terms of agreements and the legislative framework governing pharmaceutical benefits. The application and interpretation of the Act may be further refined through subordinate instruments, which allow for detailed specifications and adjustments in line with evolving agreements and legislative changes.

Key Provisions

The primary operative sections of this legislation are paragraphs 98B(1)(a) and 98BAA(1) of the National Health Act 1953. Section 98B(1)(a) mandates the Pharmaceutical Benefits Remuneration Tribunal (PBRT) to determine the method for calculating the Commonwealth price for pharmaceutical benefits, while section 98BAA(1) requires the PBRT to implement the terms of any agreement between the Commonwealth and the Pharmacy Guild of Australia (or another pharmacists’ organisation) when making such a determination. The current framework for determining these fees is governed by the Fourth Community Pharmacy Agreement (Fourth Agreement), which was signed on 16 November 2005 and came into effect on 1 December 2005. The PBRT's determination, known as the Principal Determination, which was made on 23 June 2006 and commenced on 1 July 2006, reflects the terms of the Fourth Agreement. This determination has been amended multiple times to incorporate necessary changes in the legislative instruments and pharmacists’ dispensing fees. The obligations and requirements imposed by this legislation on the parties involved are primarily focused on adherence to the Fourth Agreement and the Principal Determination. The PBRT is obligated to give effect to the terms of the Fourth Agreement when making determinations under section 98B(1)(a). The Commonwealth and the Pharmacy Guild of Australia, as signatories to the Fourth Agreement, must ensure that the agreed terms concerning the Commonwealth price and pharmacists’ dispensing fees are accurately implemented in the Principal Determination. The legislative instruments referenced in the Principal Determination must be updated to reflect the latest legal requirements, as stipulated under section 14 of the Legislative Instruments Act 2003. The amendments to the Principal Determination, as outlined in this legislation, must be carried out to maintain the integrity and accuracy of the pharmacists’ dispensing fees and the incorporated legislative instruments. The legislation also addresses potential breaches and the associated penalties. While specific penalties are not detailed in the provided text, breaches of the National Health Act 1953 and its associated determinations could result in civil or criminal consequences depending on the nature and severity of the breach. The penalties could include fines or other sanctions as prescribed by the relevant laws. It is important for all parties involved, including the PBRT, the Commonwealth, and the Pharmacy Guild of Australia, to comply with the terms of the Fourth Agreement and the amendments made through this legislation to avoid any potential legal repercussions. Ensuring adherence to these requirements helps maintain the proper functioning of the pharmaceutical benefits system and protects the interests of all stakeholders involved.

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