Explanatory Statement

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.

1 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.

2 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 25 mg GN-Carvedilol Genepharm Pty Ltd

Insulin Glulisine Injection (human analogue) Apidra sanofi-aventis Australia Pty Ltd 100 units per mL, 10 mL

Irinotecan I.V. injection containing Irinotecan-GA Genepharm Pty Ltd irinotecan hydrochloride trihydrate 100 mg in 5 mL

Lamotrigine Tablet 25 mg Lamotrigine-GA Ascent Pharmahealth Ltd

Mesalazine Sachet containing granules, Salofalk Orphan Australia Pty Ltd 1.5 g per sachet

Paroxetine Tablet 20 mg (as mesilate) Paroxetine generichealth Generic Health Pty Ltd

Quetiapine Tablet (modified release) Seroquel XR AstraZeneca Pty Ltd 50 mg (as fumarate)

3 Quetiapine Tablet (modified release) Seroquel XR AstraZeneca Pty Ltd 400 mg (as fumarate)

Tramadol Tablet (extended release) Durotram XR iNova Pharmaceuticals (Australia) containing tramadol Pty Limited hydrochloride 100 mg

Deletions

Cabergoline Tablet 4 mg Cabaser Pfizer Australia Pty Ltd

Epirubicin Powder for injection Hospira Pty Limited Hospira Pty Limited containing epirubicin hydrochloride 50 mg

Lisinopril Tablet 5 mg Lisinotrust 5 Meditech Int. Pty Ltd

Sertraline Tablet 50 mg (as Sertratrust 50 Meditech Int. Pty Ltd hydrochloride)

Sertraline Tablet 100 mg (as Sertratrust 100 Meditech Int. Pty Ltd hydrochloride)

Simvastatin Tablet 10 mg Simvatrust 10 Meditech Int. Pty Ltd

4 Alteration of Form

Form Listed Drug (strength, type,size, etc.) Brand Responsible Person From: Tramadol Tramahexal SR Sandoz Pty Ltd Tablet containing tramadol hydrochloride 100 mg Tramal SR 100 CSL Biotherapies Pty Ltd (sustained release) To: Tramedo SR 100 Alphapharm Pty Ltd Tablet (sustained release) containing tramadol Zydol SR 100 Arrow Pharmaceuticals Pty Ltd hydrochloride 100 mg From: Tramadol Tramahexal SR Sandoz Pty Ltd Tablet containing tramadol hydrochloride 150 mg Tramal SR 150 CSL Biotherapies Pty Ltd (sustained release) To: Tramedo SR 150 Alphapharm Pty Ltd Tablet (sustained release) containing tramadol Zydol SR 150 Arrow Pharmaceuticals Pty Ltd hydrochloride 150 mg From: Tramadol Tramahexal SR Sandoz Pty Ltd Tablet containing tramadol hydrochloride 200 mg Tramal SR 200 CSL Biotherapies Pty Ltd (sustained release) To: Tramedo SR 200 Alphapharm Pty Ltd Tablet (sustained release) containing tramadol Zydol SR 200 Arrow Pharmaceuticals Pty Ltd hydrochloride 200 mg From: Tramadol Tramal SR 50 CSL Biotherapies Pty Ltd Tablet containing tramadol hydrochloride 50 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 50 mg

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

5 Alteration of Responsible Person

Alendronic acid Tablet 70 mg (as alendronate Alendro Once Weekly From: Arrow Pharmaceuticals Pty Ltd sodium) To: Sigma Pharmaceuticals (Australia) Pty Ltd

Alprazolam Tablet 250 micrograms Alprax 0.25 From: Arrow Pharmaceuticals Pty Ltd Tablet 500 micrograms Alprax 0.5 To: Sigma Pharmaceuticals Tablet 1 mg Alprax 1 (Australia) Pty Ltd Tablet 2 mg Alprax 2 Amiodarone Tablet containing Rithmik 100 From: Arrow Pharmaceuticals Pty Ltd amiodarone hydrochloride Rithmik 200 To: Sigma Pharmaceuticals 100 mg (Australia) Pty Ltd Tablet containing amiodarone hydrochloride 200 mg Azathioprine Tablet 50 mg Azapin From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd Baclofen Tablet 10 mg Stelax 10 From: Arrow Pharmaceuticals Pty Ltd Tablet 25 mg Stelax 25 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 Ciprol 250 From: Arrow Pharmaceuticals Pty Ltd hydrochloride) To: Sigma Pharmaceuticals Tablet 500 mg (as Ciprol 500 (Australia) Pty Ltd hydrochloride) Tablet 750 mg (as Ciprol 750 hydrochloride) Citalopram Tablet 20 mg (as Talam From: Arrow Pharmaceuticals Pty Ltd hydrobromide) 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 Fermil From: Arrow Pharmaceuticals Pty Ltd citrate 50 mg To: Sigma Pharmaceuticals (Australia) Pty Ltd Diazepam Tablet 2 mg Valpam 2 From: Arrow Pharmaceuticals Pty Ltd Tablet 5 mg Valpam 5 To: Sigma Pharmaceuticals (Australia) Pty Ltd Doxycycline Tablet 50 mg (as Frakas From: Arrow Pharmaceuticals Pty Ltd monohydrate) To: Sigma Pharmaceuticals (Australia) Pty Ltd Famotidine Tablet 20 mg Ausfam 20 From: Arrow Pharmaceuticals Pty Ltd Tablet 40 mg Ausfam 40 To: Sigma Pharmaceuticals (Australia) Pty Ltd Felodipine Tablet 5 mg (extended Felodil XR 5 From: Arrow Pharmaceuticals Pty Ltd release) To: Sigma Pharmaceuticals Tablet 10 mg (extended Felodil XR 10 (Australia) Pty Ltd release)

6 Fluconazole Capsule 50 mg Fluzole 50 From: Arrow Pharmaceuticals Pty Ltd Capsule 200 mg Fluzole 200 To: Sigma Pharmaceuticals (Australia) Pty Ltd Fluvoxamine Tablet containing Faverin 50 From: Arrow Pharmaceuticals Pty Ltd fluvoxamine maleate 50 mg To: Sigma Pharmaceuticals Tablet containing Faverin 100 (Australia) Pty Ltd fluvoxamine maleate 100 mg Fosinopril Tablet containing fosinopril Fosipril 10 From: Arrow Pharmaceuticals Pty Ltd sodium 10 mg To: Sigma Pharmaceuticals Tablet containing fosinopril Fosipril 20 (Australia) Pty Ltd sodium 20 mg Gabapentin Capsule 100 mg Gantin From: Arrow Pharmaceuticals Pty Ltd Capsule 300 mg Gantin To: Sigma Pharmaceuticals Capsule 400 mg Gantin (Australia) Pty Ltd Tablet 800 mg Gantin Gliclazide Tablet 80 mg Nidem From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd Glimepiride Tablet 1 mg Diapride 1 From: Arrow Pharmaceuticals Pty Ltd Tablet 2 mg Diapride 2 To: Sigma Pharmaceuticals Tablet 3 mg Diapride 3 (Australia) Pty Ltd Tablet 4 mg Diapride 4 Ipratropium Nebuliser solution containing Aeron 250 From: Arrow Pharmaceuticals Pty Ltd ipratropium bromide To: Sigma Pharmaceuticals 250 micrograms (anhydrous) (Australia) Pty Ltd in 1 mL single dose units, 30 Nebuliser solution containing Aeron 500 ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 Lamotrigine Tablet 5 mg Seaze 5 From: Arrow Pharmaceuticals Pty Ltd Tablet 25 mg Seaze 25 To: Sigma Pharmaceuticals Tablet 50 mg Seaze 50 (Australia) Pty Ltd Tablet 100 mg Seaze 100 Tablet 200 mg Seaze 200 Lisinopril Tablet 5 mg Fibsol 5 From: Arrow Pharmaceuticals Pty Ltd Tablet 10 mg Fibsol 10 To: Sigma Pharmaceuticals Tablet 20 mg Fibsol 20 (Australia) Pty Ltd Meloxicam Tablet 7.5 mg Movalis 7.5 From: Arrow Pharmaceuticals Pty Ltd Tablet 15 mg Movalis 15 To: Sigma Pharmaceuticals (Australia) Pty Ltd Metformin Tablet containing metformin Formet 500 From: Arrow Pharmaceuticals Pty Ltd hydrochloride 500 mg To: Sigma Pharmaceuticals Tablet containing metformin Formet 850 (Australia) Pty Ltd hydrochloride 850 mg Tablet containing metformin Formet 1000 hydrochloride 1 g Metoprolol Tablet containing metoprolol Metrol 50 From: Arrow Pharmaceuticals Pty Ltd tartrate 50 mg To: Sigma Pharmaceuticals Tablet containing metoprolol Metrol 100 (Australia) Pty Ltd tartrate 100 mg

7 Mirtazapine Tablet 30 mg Mirtazon From: Arrow Pharmaceuticals Pty Ltd Tablet 45 mg Mirtazon To: Sigma Pharmaceuticals (Australia) Pty Ltd Nifedipine Tablet 30 mg (controlled Addos XR 30 From: Arrow Pharmaceuticals Pty Ltd release) To: Sigma Pharmaceuticals Tablet 60 mg (controlled Addos XR 60 (Australia) Pty Ltd release) Norfloxacin Tablet 400 mg Roxin From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd Ondansetron Tablet 4 mg (as Onsetron 4 From: Arrow Pharmaceuticals Pty Ltd hydrochloride dihydrate) To: Sigma Pharmaceuticals Tablet 8 mg (as Onsetron 8 (Australia) Pty Ltd hydrochloride dihydrate) I.V. injection 4 mg (as Onsetron hydrochloride dihydrate) in 2 mL I.V. injection 8 mg (as Onsetron hydrochloride dihydrate) in 4 mL Paracetamol Tablet 500 mg Parmol From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd Paroxetine Tablet 20 mg (as Extine 20 From: Arrow Pharmaceuticals Pty Ltd hydrochloride) To: Sigma Pharmaceuticals (Australia) Pty Ltd Pravastatin Tablet containing pravastatin Lipostat 10 From: Arrow Pharmaceuticals Pty Ltd sodium 10 mg To: Sigma Pharmaceuticals Tablet containing pravastatin Lipostat 20 (Australia) Pty Ltd sodium 20 mg Tablet containing pravastatin Lipostat 40 sodium 40 mg Tablet containing pravastatin Lipostat 80 sodium 80 mg Quinapril Tablet 5 mg (as Acquin 5 From: Arrow Pharmaceuticals Pty Ltd hydrochloride) To: Sigma Pharmaceuticals Tablet 10 mg (as Acquin 10 (Australia) Pty Ltd hydrochloride) Tablet 20 mg (as Acquin 20 hydrochloride) Ramipril Tablet 1.25 mg Prilace 1.25 From: Arrow Pharmaceuticals Pty Ltd Tablet 2.5 mg Prilace 2.5 To: Sigma Pharmaceuticals Tablet 5 mg Prilace 5 (Australia) Pty Ltd Capsule 10 mg Prilace 10

Roxithromycin Tablet 150 mg Roxar 150 From: Arrow Pharmaceuticals Pty Ltd Tablet 300 mg Roxar 300 To: Sigma Pharmaceuticals (Australia) Pty Ltd Salbutamol Nebuliser solution 2.5 mg (as Butamol 2.5 From: Arrow Pharmaceuticals Pty Ltd sulfate) in 2.5 mL single dose To: Sigma Pharmaceuticals units, 30 (Australia) Pty Ltd Nebuliser solution 5 mg (as Butamol 5 sulfate) in 2.5 mL single dose units, 30

8 Sertraline Tablet 50 mg (as Xydep 50 From: Arrow Pharmaceuticals Pty Ltd hydrochloride) To: Sigma Pharmaceuticals Tablet 100 mg (as Xydep 100 (Australia) Pty Ltd hydrochloride) Sotalol Tablet containing sotalol Solavert From: Arrow Pharmaceuticals Pty Ltd hydrochloride 80 mg To: Sigma Pharmaceuticals Tablet containing sotalol Solavert (Australia) Pty Ltd hydrochloride 160 mg Sumatriptan Tablet 50 mg (as succinate) Sumagran 50 From: Arrow Pharmaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd Terbinafine Tablet 250 mg (as Tamsil From: Arrow Pharmaceuticals Pty Ltd hydrochloride) To: Sigma Pharmaceuticals (Australia) Pty Ltd Trandolapril Capsule 500 micrograms Dolapril 0.5 From: Arrow Pharmaceuticals Pty Ltd Capsule 1 mg Dolapril 1 To: Sigma Pharmaceuticals Capsule 2 mg Dolapril 2 (Australia) Pty Ltd Capsule 4 mg Dolapril 4