EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 60 OF 2008
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 trade name, 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 89 of 2007 which came into effect on 1 December 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 July 2008, was made on 3 June 2008.
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 July 2008.
Paragraph 2: provides that Schedule 1 amends PB 89 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1 – PART 1
Listed Drugs Added
Cinacalcet | Tablet 30 mg (as hydrochloride) Tablet 60 mg (as hydrochloride) Tablet 90 mg (as hydrochloride)
|
Cystine with carbohydrate | Sachets of oral powder 4 g containing 500 mg cystine, 30 |
Memantine | Tablet containing memantine hydrochloride 10 mg Oral drops containing memantine hydrochloride 10 mg per g, 50 g
|
Tyrosine with carbohydrate | Sachets of oral powder 4 g containing 1 g tyrosine, 30 |
Forms Added
Calcipotriol | Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL |
Rivastigmine | Transdermal patch 9 mg Transdermal patch 18 mg |
Terbinafine | Cream containing terbinafine hydrochloride 10 mg per g, 15 g |
Alteration of Form
Oestradiol and Oestradiol with Norethisterone | From: Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate |
| To: Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate |
| From: Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate |
| To: Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate |
Brands Added
Amlodipine | Tablet 5 mg (as besylate) (Amlodipine generichealth) Tablet 10 mg (as besylate) (Amlodipine generichealth) |
Influenza Vaccine | Injection containing inactivated, split virion influenza vaccine, |
Metronidazole | I.V. infusion 500 mg in 100 mL
|
Perindopril | Tablet containing perindopril erbumine 2 mg (Indopril 2) Tablet containing perindopril erbumine 4 mg (Indopril 4) Tablet containing perindopril erbumine 8 mg (Indopril 8) |
Alteration of Maximum Quantity
Mesalazine | Tablet 500 mg (enteric coated) From: 100 To: 200 |
| Sachet containing granules, 500 mg per sachet From: 100 To: 200 |
Alteration of Brand
In all instances the brand “Hospira Australia Pty Ltd” is changed to the brand “Hospira Pty Limited”
Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid, injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL and injection containing calcium folinate equivalent to |
| From: Leucovorin Calcium (Hospira Australia Pty Ltd) |
| To: Leucovorin Calcium (Hospira Pty Limited) |
Forms Deleted
Dexamethasone | Injection containing dexamethasone sodium phosphate equivalent to 120 mg dexamethasone phosphate in 5 mL |
Hydroxocobalamin | Injection 1 mg (as acetate) in 1 mL |
Phenoxymethylpenicillin | Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL |
Brands Deleted
Oestradiol | Transdermal patches 2 mg, 4 (Femtran 25) Transdermal patches 3.8 mg, 4 (Femtran 50) Transdermal patches 7.6 mg, 4 (Femtran 100) |
SCHEDULE 1 – PART 2
Alteration of Purposes
Adalimumab | Injection 40 mg in 0.8 mL pre-filled syringe [for the treatment of severe active psoriatic arthritis] Injection 40 mg in 0.8 mL pre-filled pen [for the treatment of severe active psoriatic arthritis] |
Etanercept | Injection set containing 4 vials powder for injection 25 mg and Injection set containing 4 vials powder for injection 50 mg and Injections 50 mg in 1 mL single use pre-filled syringes, 4 [for the treatment of severe active psoriatic arthritis] |
Alteration of Brand
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) From: Hospira Australia Pty Ltd To: Hospira Pty Limited |
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) From: Hospira Australia Pty Ltd To: Hospira Pty Limited |
SCHEDULE 3 – PART 1
Brand Added
Metronidazole | I.V. infusion 500 mg in 100 mL |
Forms Deleted
Phenoxymethylpenicillin | Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL |
Alteration of Brand
In all instances the brand “Hospira Australia Pty Ltd” is changed to the brand “Hospira Pty Limited”