EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 105 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 addition to Schedule 4 of Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ to be supplied as a complete pack, as described in the size of unit specified in the form of the listed drug, regardless of any lesser quantity prescribed. Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ is being made available as a pharmaceutical benefit to provide an alternative to the forms of Phenoxybenzamine currently available as benefits as these are temporarily unable to be supplied.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 14 October 2008, was made on 13 October 2008.
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.
The responsible person that supplies Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ was consulted before the delegate of the Minister decided to make the amendments set out in this instrument.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 14 October 2008.
Paragraph 2: provides that Schedule 1 amends PB 79 of 2008.
Schedule 1: provides for the following amendments:
Item 1, of Schedule 1: Enables the addition to Schedule 4 of Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ to be supplied as a complete pack as described in the size of unit specified in the form of the listed drug, regardless of any lesser quantity prescribed.
Overview
The National Health Act 1953 was enacted by the Australian Parliament to provide the legislative basis for the Pharmaceutical Benefits Scheme (PBS), ensuring that all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act was introduced to address the need for a structured, government-supported system that would manage the costs and availability of essential pharmaceuticals. Under the Act, the Minister for Health is authorised to determine which drugs and medicinal preparations are covered by the PBS and to set the conditions for the supply of these pharmaceutical benefits. This includes the ability to amend the forms and quantities of listed drugs, as demonstrated by the recent amendments to the PBS concerning the supply of Phenoxybenzamine in a specific form and quantity. The policy objective of these amendments is to provide an alternative supply option for Phenoxybenzamine due to temporary unavailability of other forms, ensuring continuity of care for patients.
Scope and Application
The National Health Act 1953 Amendment Determination under Paragraph 98C(1)(b) pertains to the Pharmaceutical Benefits Scheme (PBS) managed by the Commonwealth to ensure affordable access to a range of medicines for all Australians. This legislative instrument specifically amends the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as outlined in the determination under section 98C(1)(b) of the Act. The amendments address the supply of Phenoxybenzamine in the form of capsules containing phenoxybenzamine hydrochloride 10 mg, 100, allowing it to be supplied as a complete pack regardless of any lesser quantity prescribed. This change is a response to the temporary unavailability of other forms of Phenoxybenzamine that are currently available as benefits. The Act applies to the Minister for Health and Ageing, approved pharmacists, approved medical practitioners, and the responsible persons supplying listed drugs, with the Pharmaceutical Benefits Advisory Committee providing expert recommendations on the inclusion of drugs and medicinal preparations in the PBS. The instrument's amendments came into effect on 14 October 2008, following consultations with the relevant stakeholders.
Key Provisions
The operative sections of this legislation amend the conditions under which payments will be made for pharmaceutical benefits under the National Health Act 1953 (the Act). Specifically, section 98C(1)(b) is amended to allow the addition of Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ to Schedule 4 of the Act (section 1). This amendment enables this form of Phenoxybenzamine to be supplied as a complete pack, regardless of any lesser quantity prescribed (section 2). The amendments commence on 14 October 2008, following the date of the instrument, 13 October 2008.
Under the amended Act, there are several obligations placed on parties involved in the supply of pharmaceutical benefits. The Minister for Health and Ageing must ensure that the conditions under which payments are made are updated to reflect any changes in the availability of pharmaceutical items. Approved pharmacists and approved medical practitioners must comply with the amended conditions when supplying pharmaceutical benefits. The responsible person for Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ must also ensure compliance with the new conditions.
The Act does not specify any offences, penalties, or consequences for breaches of the amended conditions. However, non-compliance with the conditions could potentially lead to administrative actions or disputes over the payment of benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in ensuring that the recommendations for listing pharmaceutical items on the PBS are based on clinical effectiveness, safety, and cost-effectiveness. The responsible person for the pharmaceutical item in question was consulted before the Minister's delegate made the amendments.
In summary, the legislation amends the conditions for the supply of pharmaceutical benefits under the Act, specifically enabling the supply of Phenoxybenzamine in a new form. The Minister, approved pharmacists, approved medical practitioners, and the responsible person for the pharmaceutical item must all comply with these amended conditions. While there are no specific penalties outlined for breaches, non-compliance could result in administrative or legal consequences. The PBAC's recommendations are integral to the process of adding new pharmaceutical items to the PBS.