EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SECTION 93
NO. PB 34 OF 2005
The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
“Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
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.
The determination made under section 93 of the Act on 16 September 2005 with effect from
1 October 2005 is repealed and substituted with this determination.
This determination is remade to give effect, as from 1 December 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Committee.
This determination is remade in order to change the name, and description of form and strength, for Benzylpenicillin Sodium powder for injection to remove references to the
10 mL ampoule of Water for Injections – sterilised, supplied as solvent. This change is a result of the deletion of Water for Injections – sterilised, injection 10 mL, from the list of ready-prepared medicinal preparations available on the Pharmaceutical Benefits Scheme due to discontinuation by the manufacturer.
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.
Details of the determination are set out in the Attachment.
This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The determination was made on 23 November 2005 and commenced on 1 December 2005.
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 December 2005.
Paragraph 2 provides that the determination under section 93 of the National Health Act 1953 (the Act) made on 16 September 2005 is repealed.
Paragraph 3 provides that the Schedule to the determination lists those pharmaceutical benefits to which section 93 applies (emergency supply drugs).
Paragraph 4 provides that where a medical practitioner has obtained drugs under section 93 of the Act, that medical practitioner, or a locum acting on that medical practitioner’s behalf, may supply those drugs.
Paragraph 5 provides that the medical practitioner may not obtain more than the maximum quantity or number of units of a drug in any one month, the maximum quantity or number of units being specified in the Schedule to this determination.
Paragraph 6 provides that, if the medical practitioner has obtained a quantity of drugs under section 93 of the Act, and is in possession of a quantity that is equal to or more than the maximum quantity of that drug (as specified in the Schedule), that medical practitioner may not obtain a further quantity of that drug.
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.