EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
NO. PB 1 OF 2007
Purpose and operation
- 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.
2. 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.
3. “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.
4. Subsection 85(2) of the Act empowers the Minister to declare the drugs and medicinal preparations to which Part VII of the Act applies, and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits.
5. Subsection 85(2A) provides that the Minister may, in a declaration under subsection 85(2), declare that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A, and specify the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.
6. Subsection 85(3) provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a drug or medicinal preparation referred to in subsection 85(2). Drugs or medicinal preparations in any other form are not pharmaceutical benefits.
7. Subsection 85(4) provides that a form of a drug or medicinal preparation as determined by the Minister under subsection 85(3) may be such as to require the addition of a substance or substances to the drug or medicinal preparation so that it will be suitable for administration in a particular manner or at a particular strength.
8. Subsection 85(6) provides that the Minister may determine, in respect of a drug or medicinal preparation to which Part VII of the Act applies, a brand or brands under which the drug or medicinal preparation may be supplied under that Part VII of the Act, and where such a determination is in force in relation to a drug or medicinal preparation, Part VII of the Act does not apply in relation to the drug or medicinal preparation as marketed under any other brand.
9. Subsection 85A(1) of the Act provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a pharmaceutical benefit that is or are allowable for the purposes of this Part for prescription by persons included in a class of persons specified in the determination.
10. Subsection 85A(2) of the Act provides that the Minister may, with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit:
a) determine the maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion, either for all purposes or for particular purposes;
b) determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes; and
c) determine the manner of administration that may, in a prescription, be directed to be used in relation to the pharmaceutical benefit.
11. Section 88A of the Act provides that, where a pharmaceutical benefit is declared in a declaration made under subsection 85(2) of the Act to be a relevant pharmaceutical benefit for the purposes of that section, the writing of a prescription for the supply of the benefit is authorised under Part VII of the Act only in the circumstances specified in the declaration pursuant to subsection 85(2A) of the Act.
12. These determinations amend Paragraph 14, the First Schedule – Part 1 and the Third Schedule – Part 1 to the Principal Determinations made on 7 November 2006 with effect from 1 December 2006 (No. PB 47 of 2006), in order to make the following amendments with effect from 1 January 2007:
a) add a new manufacturer, MedWatchDog Pty Limited;
b) make the following new forms of Glucose Indicator–Blood available as pharmaceutical benefits:
- electrode strips, 50 (MWD Pen Sensor Strips), manufactured by MedWatchDog Pty Limited
- electrode strips, 50 (Omnitest Plus), manufactured by B. Braun Australia Pty Ltd;
c) make available the HX brand of the following Fluconazole capsules currently listed as pharmaceutical benefits:
- capsule 50 mg
- capsule 100 mg
- capsule 200 mg;
d) remove the details in respect of Moxifloxacin Hydrochloride;
e) make available the MX brand of the following Oxaliplatin powders for I.V. infusion currently listed as pharmaceutical benefits:
- powder for I.V. infusion 50 mg
- powder for I.V. infusion 100 mg; and
f) change the drug and form description for the following pharmaceutical benefits, due to the relisting of Sodium Chloride injection 10 mL as an approved solvent for supply when the injectable forms are prescribed with a solvent:
- Bleomycin Sulfate
- Cefepime Hydrochloride
- Cyclophosphamide (injectable forms only)
- Ticarcillin Sodium with Potassium Clavulanate.
Consultations
13. 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.
14. The determinations give 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.
15. Details of the determinations are set out in the Attachment.
16. The determinations are legislative instruments for the purposes of the Legislative Instruments Act 2003.
17. These determinations were made on 1 December 2006 and commenced on 1 January 2007.
ATTACHMENT
Paragraph 1 provides that these determinations commence on 1 January 2007.
Paragraph 2 provides that the determinations (No. PB 47 of 2006) under sections 85, 85A and 88 of the National Health Act 1953 made on 7 November 2006 with effect from 1 December 2006 are, in these Determinations, referred to as the Principal Determinations.
Paragraph 3 provides for the addition of a new manufacturer, MedWatchDog Pty Limited, to Paragraph 14. Paragraph 14 lists the names of the manufacturers of those brands of pharmaceutical benefits, listed under “Brand” in the First, Second or Third Schedule, to which this determination applies.
Paragraph 4 provides for the following amendments to the First Schedule – Part 1:
a) for Bleomyin Sulfate, change the name of the pharmaceutical benefit to “Bleomycin Sulfate with any determined brand of Sodium Chloride Injection” and the form (strength, type, size, etc.) from “Powder for injection 15,000 I.U.” to “Powder for injection 15,000 I.U. (with required solvent)”;
b) for Cefepime Hydrochloride, change the name of the pharmaceutical benefit to “Cefepime Hydrochloride with any determined brand of Sodium Chloride Injection” and the forms (strength, type, size, etc.) from “Powder for injection equivalent to 1 g cefepime” to “Powder for injection equivalent to 1 g cefepime (with required solvent)” and from “Powder for injection equivalent to 2 g cefepime” to “Powder for injection equivalent to 2 g cefepime (with required solvent)”;
c) for Cyclophosphamide, change the name of the pharmaceutical benefit to “Cyclophosphamide with any determined brand of Sodium Chloride Injection” and the forms (strength, type, size, etc.) from “Powder for injection 500 mg (anhydrous)” to “Powder for injection 500 mg (anhydrous) (with required solvent)”, from “Powder for injection 1 g (anhydrous)” to “Powder for injection 1 g (anhydrous) (with required solvent)” and from “Powder for injection 2 g (anhydrous)” to “Powder for injection
2 g (anhydrous) (with required solvent)”;
d) make available the HX brand of the following Fluconazole capsules currently listed as pharmaceutical benefits:
- capsule 50 mg
- capsule 200 mg;
e) make available the HX brand of the Fluconazole capsule 100 mg, currently listed as a pharmaceutical benefit;
f) make the Glucose Indicator–Blood electrode strips, 50 (MWD Pen Sensor Strips), manufactured by MedWatchDog Pty Limited , available as a pharmaceutical benefit;
g) make the Glucose Indicator–Blood electrode strips, 50 (Omnitest Plus), manufactured by B. Braun Australia Pty Ltd, available as a pharmaceutical benefit;
h) remove the details in respect of Moxifloxacin Hydrochloride;
i) make available the MX brand of the following Oxaliplatin powders for I.V. infusion currently listed as pharmaceutical benefits:
- powder for I.V. infusion 50 mg
- powder for I.V. infusion 100 mg; and
j) for Ticarcillin Sodium with Potassium Clavulanate, change the name of the pharmaceutical benefit to “Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection” and the form (strength, type, size, etc.) from “Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid” to “Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)”.
The First Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner.
Paragraph 5 provides for the following amendment to the Third Schedule – Part 1:
a) for Ticarcillin Sodium with Potassium Clavulanate, change the name of the pharmaceutical benefit to “Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection” and the form (strength, type, size, etc.) from “Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid” to “Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)”.
The Third Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a participating dental practitioner.