EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
No. PB 38 OF 2007
Purpose and operation
1. 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. The determinations made under sections 85, 85A and 88 of the Act on 30 March 2007 with effect from 1 May 2007 (No. PB 31 of 2007) are amended by these determinations.
13. These determinations give effect, as from 1 June 2007, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as detailed in the attached summary of amendments.
Consultations
14. 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 for listing 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.
15. 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.
16. Details of the determinations are set out in the Attachment.
17. These determinations are legislative instruments for the purposes of the Legislative Instruments Act 2003.
18. The determinations were made on 26 April 2007 and commenced on 1 June 2007
SUMMARY OF AMENDMENTS
LIST OF MANUFACTURERS
Manufacturers Added
CR | Pharmacor Limited |
DB | Diabetes Association of Australia |
Manufacturers Deleted
SL | SBPA A Division of Sandoz Pty Ltd |
FIRST SCHEDULE - PART 1
Items Added
Olmesartan Medoxomil | Tablet 20 mg |
| Tablet 40 mg |
Olmesartan Medoxomil with | Tablet 20 mg-12.5 mg |
Hydrochlorothiazide | Tablet 40 mg-12.5 mg |
| Tablet 40 mg-25 mg |
Forms Added
Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 |
Glucose Indicator - Blood | Electrode strips, 50 (Glucoboy) |
Brands Added
Aciclovir | Tablet 800 mg (CR) |
Bupropion Hydrochloride | Tablet 150 mg (sustained release) (AF) |
Gabapentin | Capsule 400 mg (CR) |
Gliclazide | Tablet 30 mg (modified release) (RA) |
Paroxetine Hydrochloride | Tablet equivalent to 20 mg paroxetine (CR) |
Pravastatin Sodium | Tablet 10 mg (CR, WA) |
| Tablet 20 mg (CR, WA) |
| Tablet 40 mg (CR, WA) |
Ramipril | Tablet 1.25 mg (AW) |
| Tablet 2.5 mg (AW) |
| Tablet 5 mg (AW) |
| Capsule 10 mg (AW) |
Simvastatin | Tablet 5 mg (CR) |
| Tablet 10 mg (CR) |
| Tablet 20 mg (CR) |
| Tablet 40 mg (CR) |
| Tablet 80 mg (CR) |
Terbinafine Hydrochloride | Tablet equivalent to 250 mg terbinafine (CR) |
Forms Deleted
Cholestyramine | Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50 |
Brands Deleted
Carbamazepine | Tablet 100 mg (BG) |
| Tablet 200 mg (BG) |
Alteration of Manufacturer's Codes
|
| From | To | ||||
Citalopram Hydrobromide | Tablet equivalent to 20 mg citalopram | SL | WA | ||||
Enalapril Maleate | Tablet 5 mg | SL | WA | ||||
| Tablet 10 mg | SL | WA | ||||
| Tablet 20 mg | SL | WA | ||||
Famotidine | Tablet 20 mg | HX | SZ | ||||
| Tablet 40 mg | HX | SZ | ||||
Moclobemide | Tablet 150 mg | HX | SZ | ||||
| Tablet 300 mg | HX | SZ | ||||
Roxithromycin | Tablet 150 mg | HX | SZ | ||||
| Tablet 300 mg | HX | SZ | ||||
Sertraline Hydrochloride | Tablet equivalent to 50 mg sertraline | SL | WA | ||||
| Tablet equivalent to 100 mg sertraline | SL | WA | ||||
Simvastatin | Tablet 5 mg | SL | WA | ||||
| Tablet 10 mg | SL | WA | ||||
| Tablet 20 mg | SL | WA | ||||
| Tablet 40 mg | SL | WA | ||||
| Tablet 80 mg | SL | WA | ||||
FIRST SCHEDULE - PART 2
Forms Added
Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 |
Brands Added
Aciclovir | Tablet 200 mg (CR) |
Bupropion Hydrochloride | Tablet 150 mg (sustained release) (AF) |
THIRD SCHEDULE - PART 1
Brands Deleted
Carbamazepine | Tablet 100 mg (BG) |
| Tablet 200 mg (BG) |
ATTACHMENT
Paragraph 1 provides that these determinations commence on 1 June 2007.
Paragraph 2 provides that the determinations (No. PB 31 of 2007) under sections 85, 85A and 88 of the National Health Act 1953 made on 30 March 2007 with effect from 1 May 2007 are, in these Determinations, referred to as the Principal Determinations.
Paragraph 3 provides for the amendment of Paragraph 14 of the Principal Determinations.
Paragraph 4 provides for amendments to the First Schedule — Part 1 to the Principal Determinations.
Paragraph 5 provides for amendments to the First Schedule — Part 2 to the Principal Determinations.
Paragraph 6 provides for amendments to the Third Schedule — Part 1 to the Principal Determinations.
The Schedules
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.
The First Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, 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.
The Second 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 for patients receiving palliative care.
The Second Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, 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 for patients receiving palliative care.
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.
The Third Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, 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.
The Fourth Schedule lists the forms, maximum quantity and maximum number or repeats of extemporaneously-prepared pharmaceutical benefits, the ingredients of which are declared in Schedule 4 of the declaration under subsection 85(2) of the Act.