EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 52 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 June 2008, was made on 1 May 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 June 2008.
Paragraph 2: provides that Schedule 1 amends PB 90 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Citalopram Tablet 20 mg (as hydrobromide) (Celica)
Duloxetine Capsule 30 mg (as hydrochloride) (Cymbalta)
Capsule 60 mg (as hydrochloride) (Cymbalta)
Glucose Indicator—Blood Electrode strips, 100 (FreeStyle Lite)
Meloxicam Tablet 7.5 mg (Meloxicam Winthrop)
Tablet 15 mg (Meloxicam Winthrop)
Pramipexole Tablet containing pramipexole hydrochloride 125 micrograms (Sifrol)
Tablet containing pramipexole hydrochloride 250 micrograms (Sifrol)
Tablet containing pramipexole hydrochloride 1 mg (Sifrol)
Quinapril Tablet 20 mg (as hydrochloride) (Quinapril Sandoz)
Deletions
Citalopram Tablet 20 mg (as hydrobromide) (Citalopram-RL)
Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with paracetamol 500 mg (Dymadon Forte)
Flucloxacillin Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL (Floxapen)
Gabapentin Tablet 600 mg (Pharmacor Gabapentin 600)
Tablet 800 mg (Pharmacor Gabapentin 800)
Hydrochlorothiazide with Tablet containing hydrochlorothiazide 50 mg with amiloride
Amiloride hydrochloride 5 mg (Amizide)
Oxaliplatin Powder for I.V. infusion 50 mg (Oxaliplan 50)
Powder for I.V. infusion 100 mg (Oxaliplan 100)
Pravastatin Tablet containing pravastatin sodium 10 mg (Pravastatin-RL)
Tablet containing pravastatin sodium 20 mg (Pravastatin-RL)
Tablet containing pravastatin sodium 40 mg (Pravastatin-RL)
Roxithromycin Tablet 150 mg (Roxithromycin-RL)
Tablet 300 mg (Roxithromycin-RL)
Simvastatin Tablet 5 mg (Simvastatin-RL)
Tablet 10 mg (Simvastatin-RL)
Tablet 20 mg (Simvastatin-RL)
Tablet 40 mg (Simvastatin-RL)
Tablet 80 mg (Simvastatin-RL)
Brand Amended
Felodipine Tablet 5 mg (extended release)
From: Felodipine XR 5
To: Felodil XR 5
Felodipine Tablet 10 mg (extended release)
From: Felodipine XR 10
To: Felodil XR 10
Alteration of Brand
Captopril [Tablet 12.5 mg, tablet 25 mg and tablet 50 mg]
From: Genepharm Limited
To: Genepharm Pty Ltd
Ciprofloxacin [Tablet 500 mg (as hydrochloride) and tablet 750 mg (as hydrochloride)]
From: Genepharm Australasia Limited
To: Genepharm Pty Ltd
Folinic acid [Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL (Leucovorin Calcium (ABN 50 008 422 348)]
From: Leucovorin Calcium
To: Leucovorin Calcium (Pfizer Australia Pty Ltd)
Folinic acid [Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL (Leucovorin Calcium (ABN 58 097 064 330)]
From: Leucovorin Calcium
To: Leucovorin Calcium (Hospira Australia Pty Ltd)
Folinic acid [Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL (Leucovorin Calcium (ABN 58 097 064 330)]
From: Leucovorin Calcium
To: Leucovorin Calcium (Hospira Australia Pty Ltd)
Folinic acid [Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL (Leucovorin Calcium (ABN 50 008 422 348)]
From: Leucovorin Calcium
To: Leucovorin Calcium (Pfizer Australia Pty Ltd)
Folinic acid [Tablet containing calcium folinate equivalent to 15 mg folinic acid (Leucovorin Calcium (ABN 58 097 064 330)]
From: Leucovorin Calcium
To: Leucovorin Calcium (Hospira Australia Pty Ltd)
Metformin [Tablet containing metformin hydrochloride 500 mg and tablet containing metformin hydrochloride 850 mg]
From: Genepharm Australasia Limited
To: Genepharm Pty Ltd
Norfloxacin [Tablet 400 mg]
From: Genepharm Limited
To: Genepharm Pty Ltd
Simvastatin [Tablet 10 mg, tablet 20 mg, tablet 40 mg and tablet 80 mg]
From: Genepharm Australasia Limited
To: Genepharm Pty Ltd
Alteration of Responsible Person
The Responsible Person for all items previously listed under “Genepharm Australasia Limited,
ABN 52 107 340 367” or “Genepharm Limited, ABN 17 003 854 626” is now
“Genepharm Pty Ltd, ABN 68 118 734 795”
Acitretin [Capsule 10 mg (Neotigason) and capsule 25 mg (Neotigason)]
From: Roche Products Pty Ltd (ABN 70 000 132 865)
To: Actavis Australia Pty Ltd (ABN 43 122 896 468)
Calcium [Tablet 250 mg (as citrate) (Citracal)]
From: Key Pharmaceuticals Pty Ltd (ABN 21 001 215 130)
To: Bayer Australia Ltd (ABN 22 000 138 714)
Raltitrexed [Powder for I.V. infusion 2 mg in single use vial (Tomudex)]
From: AstraZeneca Pty Ltd (ABN 54 009 682 311)
To: Hospira Pty Ltd (ABN 13 107 058 328)
Responsible Person Amended
The Responsible Person for all items previously listed under “Medical Specialities Australia Unit Trust” is now “Medical Specialties Australia Unit Trust”