EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 63 OF 2008
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SECTION 93
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).
Section 93 of the Act provides for the supply of certain pharmaceutical benefit items to medical practitioners as an emergency drug supply. These drugs are supplied free of charge to patients.
Subsection 93(1) of the Act provides that, except as prescribed, a medical practitioner is authorised to supply such pharmaceutical benefits as the Minister determines to persons who are entitled under Part VII of the Act to receive those pharmaceutical benefits.
Subsection 93(2) of the Act provides that the Minister may determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by a medical practitioner during a specified period and that the medical practitioner shall obtain the pharmaceutical benefit as prescribed.
The determination under section 93 of the Act sets out the conditions under which a medical practitioner is authorised to supply emergency drugs as pharmaceutical benefits.
The Schedule to the determination lists the names of the pharmaceutical benefits to which section 93 applies, together with the form (strength type, size etc.) and maximum quantity of those pharmaceutical benefits.
This legislative instrument amends the determination under section 93 (PB 57 of 2007) which came into effect on
1 August 2007. The amendments are set out in the items of Schedule 1 to the instrument.
This instrument contains a change in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 July 2008, was made on 3 June 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 determination gives effect to recommendations made by the PBAC. PBAC members are selected 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.
ATTACHMENT
Paragraph 1: provides that this determination commences on 1 July 2008.
Paragraph 2: provides that Schedule 1 amends PB 57 of 2007.
Schedule 1: provides for the following amendments:
THE SCHEDULE
Addition of listed drugs
Clonazepam [Oral liquid 2.5 mg per mL, 10 mL]
Hyoscine [Injection containing hyoscine butylbromide 20 mg in 1 mL]
Alteration of Form
Diazepam From:
Injection 10 mg in 2 mL ampoule
To:
Injection 10 mg in 2 mL
Haloperidol From:
Injection 5 mg in 1 mL ampoule
To:
Injection 5 mg in 1 mL