EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 32 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
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).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
This instrument determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument. These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN). The names of the responsible persons were notified before the commencement of section 84AF as permitted by subsection 84AF(2).
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 84AF made by legislative instrument number
PB 90 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 April 2008, was made on 3 March 2008.
Consultations
This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases. This has occurred through meetings with both peak body organisations and individual companies. Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item. Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.
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 April 2008.
Paragraph 2: provides that Schedule 1 amends PB 90 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Alendronic acid Tablet 70 mg (as alendronate sodium) (Adronat)
Tablet 70 mg (as alendronate sodium) (APO-Alendronate)
Tablet 70 mg (as alendronate sodium) (Chem mart Alendronate70 mg)
Tablet 70 mg (as alendronate sodium) (Terry White Chemists Alendronate70 mg)
Amlodipine Tablet 5 mg (as besylate) (APO-Amlodipine)
Tablet 5 mg (as besylate) (Chem mart Amlodipine)
Tablet 5 mg (as besylate) (Terry White Chemists Amlodipine)
Tablet 10 mg (as besylate) (APO-Amlodipine)
Tablet 10 mg (as besylate) (Chem mart Amlodipine)
Tablet 10 mg (as besylate) (Terry White Chemists Amlodipine)
Benzathine benzylpenicillin Injection 900 mg in 2.3 mL single use pre-filled syringe (Bicillin L-A)
Carvedilol Tablet 3.125 mg (Dilasig 3.125)
Tablet 6.25 mg (Dilasig 6.25)
Tablet 12.5 mg (Dilasig 12.5)
Tablet 25 mg (Dilasig 25)
Cefaclor Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Cefaclor Sandoz)
Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Cefaclor Sandoz)
Cephalexin Granules for oral suspension 125 mg per 5 mL, 100 mL (Cefalexin Sandoz)
Granules for oral suspension 250 mg per 5 mL, 100 mL (Cefalexin Sandoz)
Cetuximab Solution for I.V. infusion 100 mg in 20 mL (Erbitux)
Solution for I.V. infusion 500 mg in 100 mL (Erbitux)
Enalapril with Tablet containing enalapril maleate 20 mg with hydrochlorothiazide
hydrochlorothiazide 6 mg (Enalapril/HCT Sandoz)
Felodipine Tablet 5 mg (extended release) (Felodipine XR 5)
Tablet 10 mg (extended release) (Felodipine XR 10)
Fentanyl Lozenges 200 micrograms (as citrate), 3 (Actiq)
Lozenges 400 micrograms (as citrate), 3 (Actiq)
Lozenges 600 micrograms (as citrate), 3 (Actiq)
Lozenges 800 micrograms (as citrate), 3 (Actiq)
Lozenges 1200 micrograms (as citrate), 3 (Actiq)
Lozenges 1600 micrograms (as citrate), 3 (Actiq)
Flucloxacillin Powder for injection 500 mg (as sodium) (Flucil)
Gemfibrozil Tablet 600 mg (Pharmacor Gemfibrozil 600)
Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in
2 mL (Irinotecan Sandoz)
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in
5 mL (Irinotecan Sandoz)
Methylphenidate Capsule containing methylphenidate hydrochloride 20 mg
(modified release) (Ritalin LA)
Capsule containing methylphenidate hydrochloride 30 mg
(modified release) (Ritalin LA)
Capsule containing methylphenidate hydrochloride 40 mg
(modified release) (Ritalin LA)
Metronidazole I.V. infusion 500 mg in 100 mL (Metronidazole Sandoz)
Paliperidone Tablet 3 mg (prolonged release) (Invega)
Tablet 6 mg (prolonged release) (Invega)
Tablet 9 mg (prolonged release) (Invega)
Phenoxymethylpenicillin Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL
(Abbocillin-V)
Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL
(Cilicaine V)
Salbutamol Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Pharmacor Salbutamol 2.5)
Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol Sandoz)
Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol-GA)
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Pharmacor Salbutamol 5)
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol Sandoz)
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol-GA)
Deletions
Benzathine penicillin Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) (Bicillin L-A Tubex)
Captopril Tablet 12.5 mg (Topace)
Tablet 25 mg (Topace)
Tablet 50 mg (Topace)
Drotrecogin alfa (activated) Powder for I.V. infusion 20 mg (Xigris)
Flucloxacillin Powder for injection 500 mg (as sodium) (Flopen)
Powder for injection 1 g (as sodium) (Flopen)
Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL (Floxapen)
Hypromellose Eye drops 5 mg per mL, 15 mL (Isopto Tears)
Oestradiol Nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL (Aerodiol)
Prochlorperazine Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 (Stemetil)
Alteration of Brand
Flucloxacillin [Powder for injection 1 g (as sodium)]
From: Aspen Flucil
To: Flucil
Alteration of Responsible Person
“Genepharm Limited” has been omitted and substituted with “Genepharm (Australia) Limited”.