EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 62 OF 2007
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 tradename, 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 in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 49 of 2007 which came into effect on 1 August 2007. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 September 2007, was made on 14 August 2007.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.
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 1 September 2007.
Paragraph 2: provides that Schedule 1 amends PB 49 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1 – PART 1
Item Added
Cetuximab Solution for I.V. infusion 100 mg in 50 mL
Forms Added
Adalimumab Injection 40 mg in 0.8 mL pre-filled pen
Fluconazole Solution for I.V. infusion 400 mg in 200 mL
Lumiracoxib Tablet 100 mg
Phenoxybenzamine Capsules containing phenoxybenzamine
hydrochloride 10 mg, 30
Ramipril Tablet 10 mg
Brands Added
Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with
paracetamol 500 mg (Comfarol Forte)
Fosinopril with Tablet containing fosinopril sodium 10 mg with
Hydrochlorothiazide hydrochlorothiazide 12.5 mg (Hyforil)
Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Hyforil)
Meloxicam Tablet 7.5 mg (Meloxicam-GA)
Tablet 15 mg (Meloxicam-GA)
Omeprazole Tablet 20 mg (Omeprazole-GA)
Ondansetron I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
(Onsetron)
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
(Onsetron)
Valproic Acid Tablet (enteric coated) containing sodium valproate 200 mg
(Sodium Valproate Sandoz)
Tablet (enteric coated) containing sodium valproate 500 mg
(Sodium Valproate Sandoz)
Item Deleted
“Phenex-1” Oral powder 350 g
Forms Deleted
Ampicillin Capsule 250 mg (as trihydrate)
Capsule 500 mg (as trihydrate)
Lumiracoxib Tablet 200 mg
Brand Deleted
Levonorgestrel Tablets 30 micrograms, 28 (Microval 28)
Form Alteration
Fluconazole | From: |
| Solution for I.V. infusion 100 mg in 50 mL vial |
| To: |
| Solution for I.V. infusion 100 mg in 50 mL |
| From: |
| Solution for I.V. infusion 200 mg in 100 mL vial |
| To: |
| Solution for I.V. infusion 200 mg in 100 mL |
SCHEDULE 1 – PART 2
Item Added
Cetuximab Solution for I.V. infusion 100 mg in 50 mL
Form Added
Adalimumab Injection 40 mg in 0.8 mL pre-filled pen
Brands Added
Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with
paracetamol 500 mg (Comfarol Forte)
Omeprazole Tablet 20 mg (Omeprazole-GA)
Ondansetron I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
(Onsetron)
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
(Onsetron)
SCHEDULE 3 – PART 1
Brand Added
Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with
paracetamol 500 mg (Comfarol Forte)
Forms Deleted
Ampicillin Capsule 250 mg (as trihydrate)
Capsule 500 mg (as trihydrate)