EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 111 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
This legislative instrument amends the determination under section 98C(1)(b) made by legislative instrument number PB 79 of 2008 which came into effect on 1 August 2008. This legislative instrument amends PB 79 of 2008 to enable the deletion of Risperidone in the form ‘Oral solution 1 mg per mL, 30 mL’ from Schedule 4. At the same time, the determinations relevant to this pharmaceutical item will be revoked by the amendment to the instrument that makes determinations under sections 85, 85(A) and 88 of the Act.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument is expressed to commence at 11.59 pm on 30 November 2008, and was made on
3 November 2008. It commences at 11.59 pm on 30 November 2008 because revoking the determinations relevant to this pharmaceutical item will commence at the same time.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
ATTACHMENT
Paragraph 1: provides that this instrument commences at 11:59 pm on 30 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 79 of 2008.
Schedule 1: provides for the following amendment:
Item 1: Deletes the ‘Oral solution 1 mg per mL, 30 mL’ form of the listed drug Risperidone from Schedule 4.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, is the foundational legislation underpinning the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have affordable and timely access to a broad range of medications. This Act addresses the gap by providing a legislative framework for the Commonwealth to offer financial assistance for pharmaceutical benefits, thereby enabling the regulation and declaration of drugs and medicinal preparations listed for subsidy. The 2008 amendment to the Act, specifically the legislative instrument numbered PB 111 of 2008, aims to refine the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. The policy objective behind this amendment is to adjust the terms governing the PBS, ensuring that the scheme remains efficient and responsive to changes in medical needs and market conditions. This amendment, effective from 30 November 2008, includes the removal of the 'Oral solution 1 mg per mL, 30 mL' form of Risperidone from Schedule 4, alongside the revocation of related determinations.
Scope and Application
The National Health Act 1953 Amendment Determination under paragraph 98C(1)(b) amends the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination is made under the authority granted by the Act to the Minister for Health and Ageing and affects the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medicines. The amendment involves deleting the 'Oral solution 1 mg per mL, 30 mL' form of the listed drug Risperidone from Schedule 4, which lists the drugs and forms of drugs for which the Commonwealth provides benefits. The instrument, which commenced on 30 November 2008, also revokes the relevant determinations regarding this pharmaceutical item. The Act applies to all persons and entities involved in the supply of pharmaceutical benefits in Australia, as well as the drugs and preparations listed under the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) recommends which drugs should be available under the PBS, ensuring that only those meeting clinical effectiveness, safety, and cost-effectiveness criteria are listed.
Key Provisions
The primary sections of this legislative instrument involve the amendment of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. Specifically, section 85(1) outlines the provision of pharmaceutical benefits, while subsection 85(2) details the declaration of listed drugs by the Minister. Subsection 85(3) allows the Minister to determine the form of a listed drug, and subsection 85(5) governs the manner of administration. Furthermore, section 84AF enables the Minister to designate a responsible person for a brand of a pharmaceutical item. The amendment under paragraph 98C(1)(b) specifies the conditions for payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument modifies the previous determination made under PB 79 of 2008, effective from 1 August 2008, by removing the 'Oral solution 1 mg per mL, 30 mL' form of the drug Risperidone from Schedule 4.
The Act imposes several obligations on the parties it governs. Firstly, the Minister must ensure that any drug or medicinal preparation declared under Part VII is recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) as per subsection 101(4) of the Act. Additionally, the Minister is responsible for determining the forms, administration, and brands of listed drugs as per subsections 85(2), 85(3), and 85(5) respectively. Approved pharmacists and medical practitioners must adhere to the conditions set forth in the determination under paragraph 98C(1)(b) to receive payments for supplying pharmaceutical benefits. These conditions include compliance with the declared forms and administration methods of listed drugs.
Breaches of the conditions set by the Minister for the supply of pharmaceutical benefits can result in various consequences. While the specific offences and penalties are not detailed in the instrument, the National Health Act 1953 likely encompasses provisions for both civil and criminal penalties. These could include fines, imprisonment, or other sanctions depending on the severity and nature of the breach. The exact penalties would be determined based on the specific breach and the relevant sections of the Act.
This legislative instrument, which includes amendments to the determination under section 98C(1)(b) and the revocation of relevant determinations, is scheduled to commence at 11:59 pm on 30 November 2008. The commencement time is chosen to align with the effective date of the revocation of the determinations relevant to the pharmaceutical item in question. This timing ensures that all changes are implemented simultaneously and comprehensively, thereby maintaining the integrity and functionality of the PBS under the National Health Act 1953.