EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
COMMONWEALTH PRICE (PHARMACEUTICAL BENEFITS SUPPLIED BY APPROVED PHARMACISTS) AMENDMENT DETERMINATION 2010 (No. 1)
Purpose
This determination amends the determination made under paragraph 98B(1)(a) of the National Health Act 1953 (“the Act”) consequential to amendments in the Act and legislative instruments related to 2010 Pharmaceutical Benefits Scheme reforms and to new provisions for midwife and nurse practitioner prescribing.
Background
Paragraph 98B(1)(a) of 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 Fifth Community Pharmacy Agreement (“the Fifth Agreement”) between the Commonwealth and the Pharmacy Guild of Australia, signed on 3 May 2010 and due to expire on 30 June 2015, is an agreement for the purposes of subsection 98BAA(1) of the Act. The Fifth Agreement sets out an agreement about the manner in which it is intended the Commonwealth price for pharmaceutical benefits is to be calculated.
The Commonwealth Price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010 (the Determination) commenced on 1 July 2010 and gives effect to the terms of the Fifth Community Pharmacy Agreement with respect to calculations for Commonwealth price.
This Determination
The Commonwealth Price (Pharmaceutical benefits supplied by approved pharmacists) Amendment Determination 2010 (No. 1) (the Amending Determination) amends the Determination to ensure that references to statutory provisions in the Act and references to other legislative instruments made under the Act remain current. The Amendment Determination makes minor changes to the Determination to ensure that the Determination continues to give effect to the terms of the Fifth Community Pharmacy Agreement.
The Amending Determination contains consequential changes arising from implementation of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010 which amended the Act and commenced on 1 December 2010. The Amending Determination replaces references to a previous PBS listing instrument (the Determinations under sections 85, 85A and 88 of the National Health Act 1953), which was replaced by the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 on 1 December 2010, with equivalent cross-references to determinations under paragraph 85A(2) of the Act to ensure that the Determination continues to work as intended.
The Amending Determination also contains a consequential change to subsection 9(1) of the Determination arising from implementation of the Health Legislation Amendment (Midwives and Nurse Practitioners) Act 2010, which enabled authorised midwives and authorised nurse practitioners to prescribe certain pharmaceutical benefits under the Act. From 1 November 2010, under new subsection 88(6A) of the Act and regulation 24 of the National Health (Pharmaceutical Benefits) Regulations 1960, an authorised midwife or authorised nurse practitioner may, instead of directing a repeated supply of a pharmaceutical benefit, direct the supply of a quantity or number of units of the benefit on one occasion. The Amending Determination ensures that subsection 9(1), which previously only referred to subsection 88(6) and medical practitioners, also applies when an authorised midwife or authorised nurse practitioner directs supply on one occasion.
The Amending Determination also replaces an incorrect reference to ‘paragraph 31(a)’ in paragraph 30(4)(b) of the Determination with the correct reference to ‘subsection 31(1)’.
Consultation
This Amending Determination has 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 Fifth Agreement and supports this Amending Determination. The changes are machinery in nature, being consequential on amendments to other instruments.
The Amending Determination commences the day after it is registered on the Federal Register of Legislative Instruments.
The Amending Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The Commonwealth Price (Pharmaceutical Benefits Supplied by Approved Pharmacists) Amendment Determination 2010 (No. 1) was enacted to address the need for minor adjustments to the Commonwealth Price (Pharmaceutical Benefits Supplied by Approved Pharmacists) Determination 2010, consequential to legislative changes and new provisions for midwife and nurse practitioner prescribing. This amendment was introduced by the Parliament of Australia to ensure that the pricing mechanism for pharmaceutical benefits supplied by approved pharmacists aligns with recent reforms in the Pharmaceutical Benefits Scheme (PBS) and the updated role of midwives and nurse practitioners in prescribing. The amendment was made in consultation with the Pharmacy Guild of Australia, reflecting the need to maintain the integrity of the Fifth Community Pharmacy Agreement. By correcting references and updating statutory provisions, the determination ensures that the Commonwealth price for pharmaceutical benefits remains consistent with the legislative framework and continues to function as intended.
Scope and Application
The Commonwealth Price (Pharmaceutical benefits supplied by approved pharmacists) Amendment Determination 2010 (No. 1) amends the Commonwealth Price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010 to ensure that references to statutory provisions in the National Health Act 1953 and references to other legislative instruments made under the Act remain current. This is consequential to amendments in the Act and legislative instruments related to 2010 Pharmaceutical Benefits Scheme reforms and to new provisions for midwife and nurse practitioner prescribing. The determination applies to approved pharmacists, the Pharmaceutical Benefits Remuneration Tribunal, and any parties to agreements relating to the manner in which the Commonwealth price for pharmaceutical benefits is to be calculated. The jurisdiction of the Act is national, as it is Commonwealth legislation. The determination includes minor changes to ensure the Determination continues to give effect to the terms of the Fifth Community Pharmacy Agreement and makes consequential changes arising from the implementation of the National Health Amendment (Pharmaceuticeutical Benefits Scheme) Act 2010 and the Health Legislation Amendment (Midwives and Nurse Practitioners) Act 2010. The Amending Determination commenced the day after it was registered on the Federal Register of Legislative Instruments.
Key Provisions
The main operative sections of the Commonwealth Price (Pharmaceutical Benefits Supplied by Approved Pharmacists) Amendment Determination 2010 (No. 1) involve amending the Commonwealth Price (Pharmaceutical Benefits Supplied by Approved Pharmacists) Determination 2010. Section 1 of the Amending Determination provides for the replacement of references to outdated statutory provisions and legislative instruments with updated equivalents to ensure that the Determination continues to reflect the terms of the Fifth Community Pharmacy Agreement. Section 2 makes changes to subsection 9(1) of the Determination to include authorised midwives and authorised nurse practitioners, who can now prescribe pharmaceutical benefits on one occasion under the National Health Act 1953, as amended by the Health Legislation Amendment (Midwives and Nurse Practitioners) Act 2010. Finally, Section 3 corrects an error by replacing an incorrect reference in paragraph 30(4)(b) of the Determination with the correct reference to subsection 31(1).
The obligations imposed by the Act on parties or entities it governs include ensuring that the Commonwealth price for pharmaceutical benefits supplied by approved pharmacists is calculated in accordance with the terms of the Fifth Community Pharmacy Agreement. This is achieved through the Pharmaceutical Benefits Remuneration Tribunal, which must give effect to any agreements made between the Commonwealth and the Pharmacy Guild of Australia or another pharmacists' organisation representing a majority of approved pharmacists. The Amending Determination ensures that the Determination continues to reflect the Fifth Agreement and any relevant legislative changes, thereby maintaining compliance with the requirements of the National Health Act 1953.
The Amending Determination does not explicitly outline offences or penalties for breach; however, non-compliance with the terms of the Determination or the Fifth Agreement could lead to disputes or legal actions under the National Health Act 1953. The National Health Act 1953 itself includes provisions for penalties for non-compliance with the Pharmaceutical Benefits Scheme, which could apply in cases where the Amending Determination is not adhered to. The maximum penalties for breaches under the National Health Act 1953 can include substantial fines and, in some cases, imprisonment, depending on the nature and severity of the breach. These penalties serve as a deterrent to non-compliance and ensure that the provisions of the Act and its related determinations are properly implemented and enforced.