EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 103 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88
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 declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no trade name, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.
This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).
This legislative instrument amends the determinations under sections 85, 85A and 88 made by legislative instrument number PB 75 of 2008 which came into effect on 1 August 2008. This legislative instrument amends PB 75 of 2008 by enabling the determination of Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ with a manner of administration by oral delivery in the brand ‘Dibenzyline’ to be made available as a pharmaceutical benefit. Phenoxybenzamine is an essential medicine used in the treatment of patients with a condition for which there is no other treatment. Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ is being made available as an alternative to the other forms of the listed drug phenoxybenzamine which 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 involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.
The responsible person that supplies Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ in the brand ‘Dibenzyline’ was consulted before the delegate of the Minister decided to make the amendments set out in this instrument.
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When recommending the listing of a medicine 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 on 14 October 2008.
Paragraph 2: provides that Schedule 1 amends PB 75 of 2008.
Schedule 1: provides for the following amendments:
Item 1 of Schedule 1:
Enables the addition of Phenoxybenzamine in the form ‘Capsules containing phenoxybenzamine hydrochloride 10 mg, 100’ with a manner of administration by oral delivery in the brand ‘Dibenzyline’ to be made available as a pharmaceutical benefit in Schedule 1, Part 1.