EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 99 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 76 of 2008 which came into effect on 1 August 2008. 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 November 2008, was made on 2 October 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 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 76 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Listed Drug | Form | Brand | Responsible Person |
Amisulpride | Tablet 400 mg | Amipride 400 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Amlodipine | Tablet 5 mg (as besylate) | Amlotrust 5 | Meditech Int. Pty Ltd |
Amlodipine | Tablet 10 mg (as besylate) | Amlotrust 10 | Meditech Int. Pty Ltd |
Carvedilol | Tablet 3.125 mg | GN-Carvedilol | Genepharm Pty Ltd |
Carvedilol | Tablet 6.25 mg | GN-Carvedilol | Genepharm Pty Ltd |
Carvedilol | Tablet 12.5 mg | GN-Carvedilol | Genepharm Pty Ltd |
Carvedilol | Tablet 25 mg | GN-Carvedilol | Genepharm Pty Ltd |
Insulin Glulisine | Injection (human analogue) 100 units per mL, 10 mL | Apidra | sanofi-aventis Australia Pty Ltd |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate | Irinotecan-GA | Genepharm Pty Ltd |
Lamotrigine | Tablet 25 mg | Lamotrigine-GA | Ascent Pharmahealth Ltd |
Lamotrigine | Tablet 50 mg | Lamotrigine-GA | Ascent Pharmahealth Ltd |
Lamotrigine | Tablet 100 mg | Lamotrigine-GA | Ascent Pharmahealth Ltd |
Lamotrigine | Tablet 200 mg | Lamotrigine-GA | Ascent Pharmahealth Ltd |
Mesalazine | Sachet containing granules, 1.5 g per sachet | Salofalk | Orphan Australia Pty Ltd |
Paroxetine | Tablet 20 mg (as mesilate) | Paroxetine generichealth | Generic Health Pty Ltd |
Quetiapine | Tablet (modified release) | Seroquel XR | AstraZeneca Pty Ltd |
Quetiapine | Tablet (modified release) | Seroquel XR | AstraZeneca Pty Ltd |
Quetiapine | Tablet (modified release) | Seroquel XR | AstraZeneca Pty Ltd |
Quetiapine | Tablet (modified release) | Seroquel XR | AstraZeneca Pty Ltd |
Tramadol | Tablet (extended release) containing tramadol hydrochloride 100 mg | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited |
Tramadol | Tablet (extended release) containing tramadol hydrochloride 200 mg | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited |
Tramadol | Tablet (extended release) containing tramadol hydrochloride 300 mg | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Cabergoline | Tablet 4 mg | Cabaser | Pfizer Australia Pty Ltd |
Epirubicin | Powder for injection containing epirubicin hydrochloride 50 mg | Hospira Pty Limited | Hospira Pty Limited |
Lisinopril | Tablet 5 mg | Lisinotrust 5 | Meditech Int. Pty Ltd |
Lisinopril | Tablet 10 mg | Lisinotrust 10 | Meditech Int. Pty Ltd |
Lisinopril | Tablet 20 mg | Lisinotrust 20 | Meditech Int. Pty Ltd |
Sertraline | Tablet 50 mg (as hydrochloride) | Sertratrust 50 | Meditech Int. Pty Ltd |
Sertraline | Tablet 100 mg (as hydrochloride) | Sertratrust 100 | Meditech Int. Pty Ltd |
Simvastatin | Tablet 10 mg | Simvatrust 10 | Meditech Int. Pty Ltd |
Simvastatin | Tablet 20 mg | Simvatrust 20 | Meditech Int. Pty Ltd |
Simvastatin | Tablet 40 mg | Simvatrust 40 | Meditech Int. Pty Ltd |
Simvastatin | Tablet 80 mg | Simvatrust 80 | Meditech Int. Pty Ltd |
Alteration of Form
Listed Drug | Form (strength, type,size, etc.) | Brand | Responsible Person |
Tramadol | From: Tablet containing tramadol hydrochloride 100 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramahexal SR Tramal SR 100 Tramedo SR 100 Zydol SR 100 | Sandoz Pty Ltd CSL Biotherapies Pty Ltd Alphapharm Pty Ltd Arrow Pharmaceuticals Pty Ltd |
Tramadol | From: Tablet containing tramadol hydrochloride 150 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramahexal SR Tramal SR 150 Tramedo SR 150 Zydol SR 150 | Sandoz Pty Ltd CSL Biotherapies Pty Ltd Alphapharm Pty Ltd Arrow Pharmaceuticals Pty Ltd |
Tramadol | From: Tablet containing tramadol hydrochloride 200 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramahexal SR Tramal SR 200 Tramedo SR 200 Zydol SR 200 | Sandoz Pty Ltd CSL Biotherapies Pty Ltd Alphapharm Pty Ltd Arrow Pharmaceuticals Pty Ltd |
Tramadol | From: Tablet containing tramadol hydrochloride 50 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 50 mg | Tramal SR 50 | CSL Biotherapies Pty Ltd
|
Alteration of Brand
Pancreatic Extract [Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity]
From: Creon
To: Creon 10,000
Pancreatic Extract [Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity]
From: Creon Forte
To: Creon 25,000
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Alendronic acid | Tablet 70 mg (as alendronate sodium) | Alendro Once Weekly | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Alprazolam | Tablet 250 micrograms Tablet 500 micrograms Tablet 1 mg Tablet 2 mg | Alprax 0.25 Alprax 0.5 Alprax 1 Alprax 2 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Amiodarone | Tablet containing amiodarone hydrochloride 100 mg Tablet containing amiodarone hydrochloride 200 mg | Rithmik 100 Rithmik 200 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Azathioprine | Tablet 50 mg | Azapin | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Baclofen | Tablet 10 mg Tablet 25 mg | Stelax 10 Stelax 25 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Calcitriol | Capsule 0.25 microgram | Kosteo | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) Tablet 500 mg (as hydrochloride) Tablet 750 mg (as hydrochloride) | Ciprol 250 Ciprol 500 Ciprol 750 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Citalopram | Tablet 20 mg (as hydrobromide) | Talam | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Clarithromycin | Tablet 250 mg | Clarithro 250 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Clomiphene | Tablet containing clomiphene citrate 50 mg | Fermil | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Diazepam | Tablet 2 mg Tablet 5 mg | Valpam 2 Valpam 5 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Doxycycline | Tablet 50 mg (as monohydrate) | Frakas | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Famotidine | Tablet 20 mg Tablet 40 mg | Ausfam 20 Ausfam 40 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Felodipine | Tablet 5 mg (extended release) Tablet 10 mg (extended release) | Felodil XR 5 Felodil XR 10 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Fluconazole | Capsule 50 mg Capsule 200 mg | Fluzole 50 Fluzole 200 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg Tablet containing fluvoxamine maleate 100 mg | Faverin 50 Faverin 100 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Fosinopril | Tablet containing fosinopril sodium 10 mg Tablet containing fosinopril sodium 20 mg | Fosipril 10 Fosipril 20 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Gabapentin | Capsule 100 mg Capsule 300 mg Capsule 400 mg Tablet 800 mg | Gantin Gantin Gantin Gantin | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Gliclazide | Tablet 80 mg | Nidem | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Glimepiride | Tablet 1 mg Tablet 2 mg Tablet 3 mg Tablet 4 mg | Diapride 1 Diapride 2 Diapride 3 Diapride 4 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide Nebuliser solution containing ipratropium bromide | Aeron 250
Aeron 500 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Lamotrigine | Tablet 5 mg Tablet 25 mg Tablet 50 mg Tablet 100 mg Tablet 200 mg | Seaze 5 Seaze 25 Seaze 50 Seaze 100 Seaze 200 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Lisinopril | Tablet 5 mg Tablet 10 mg Tablet 20 mg | Fibsol 5 Fibsol 10 Fibsol 20 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Meloxicam | Tablet 7.5 mg Tablet 15 mg | Movalis 7.5 Movalis 15 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Metformin | Tablet containing metformin hydrochloride 500 mg Tablet containing metformin hydrochloride 850 mg Tablet containing metformin hydrochloride 1 g | Formet 500 Formet 850 Formet 1000 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Metoprolol | Tablet containing metoprolol tartrate 50 mg Tablet containing metoprolol tartrate 100 mg | Metrol 50 Metrol 100 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Mirtazapine | Tablet 30 mg Tablet 45 mg | Mirtazon Mirtazon | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Nifedipine | Tablet 30 mg (controlled release) Tablet 60 mg (controlled release) | Addos XR 30 Addos XR 60 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Norfloxacin | Tablet 400 mg | Roxin | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) Tablet 8 mg (as hydrochloride dihydrate) I.V. injection 4 mg (as hydrochloride dihydrate) in I.V. injection 8 mg (as hydrochloride dihydrate) in | Onsetron 4 Onsetron 8 Onsetron Onsetron | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Paracetamol | Tablet 500 mg | Parmol | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Paroxetine | Tablet 20 mg (as hydrochloride) | Extine 20 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium 10 mg Tablet containing pravastatin sodium 20 mg Tablet containing pravastatin sodium 40 mg Tablet containing pravastatin sodium 80 mg | Lipostat 10 Lipostat 20 Lipostat 40 Lipostat 80 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Quinapril | Tablet 5 mg (as hydrochloride) Tablet 10 mg (as hydrochloride) Tablet 20 mg (as hydrochloride) | Acquin 5 Acquin 10 Acquin 20 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Ramipril | Tablet 1.25 mg Tablet 2.5 mg Tablet 5 mg Capsule 10 mg | Prilace 1.25 Prilace 2.5 Prilace 5 Prilace 10 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Roxithromycin | Tablet 150 mg Tablet 300 mg | Roxar 150 Roxar 300 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Butamol 2.5 Butamol 5 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Sertraline | Tablet 50 mg (as hydrochloride) Tablet 100 mg (as hydrochloride) | Xydep 50 Xydep 100 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Sotalol | Tablet containing sotalol hydrochloride 80 mg Tablet containing sotalol hydrochloride 160 mg | Solavert Solavert | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Sumatriptan | Tablet 50 mg (as succinate) | Sumagran 50 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Terbinafine | Tablet 250 mg (as hydrochloride) | Tamsil | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Trandolapril | Capsule 500 micrograms Capsule 1 mg Capsule 2 mg Capsule 4 mg | Dolapril 0.5 Dolapril 1 Dolapril 2 Dolapril 4 | From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |