EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 64 OF 2009
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 115 of 2008 which came into effect on 1 December 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 August 2009, was made on 6 July 2009.
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 August 2009.
Paragraph 2: provides that Schedule 1 amends PB 115 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Listed Drug | Form | Brand | Responsible Person |
Amoxycillin with Clavulanic Acid | Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Curam | Sandoz Pty Ltd |
Amoxycillin with Clavulanic Acid | Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per | Curam Duo | Sandoz Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | APO-Amoxycillin/Clavulanic Acid 500/125 | Apotex Pty Ltd |
Arsenic | Injection concentrate containing arsenic trioxide | Phenasen | Virgo Unit Trust |
Azithromycin | Tablet 500 mg (as dihydrate) | Azithromycin Sandoz | Sandoz Pty Ltd |
Bimatoprost with timolol | Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL | Ganfort 0.3/5 | Allergan Australia Pty Limited |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Bisoprolol Sandoz | Sandoz Pty Ltd |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Bispro 2.5 | Alphapharm Pty Ltd |
Bisoprolol | Tablet containing bisoprolol fumarate 5 mg | Bisoprolol Sandoz | Sandoz Pty Ltd |
Bisoprolol | Tablet containing bisoprolol fumarate 5 mg | Bispro 5 | Alphapharm Pty Ltd |
Bisoprolol | Tablet containing bisoprolol fumarate 10 mg | Bisoprolol Sandoz | Sandoz Pty Ltd |
Bisoprolol | Tablet containing bisoprolol fumarate 10 mg | Bispro 10 | Alphapharm Pty Ltd |
Cabergoline | Tablet 500 micrograms | Tinexa | Sigma Pharmaceuticals (Australia) Pty Ltd |
Cabergoline | Tablet 1 mg | Bergoline 1 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Cabergoline | Tablet 2 mg | Bergoline 2 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Citalopram | Tablet 20 mg (as hydrobromide) | APO-Citalopram | Apotex Pty Ltd |
Clarithromycin | Tablet 250 mg | APO-Clarithromycin | Apotex Pty Ltd |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | APO-Paracetamol/Codeine 500/30 | Apotex Pty Ltd |
Escitalopram | Tablet 10 mg (as oxalate) | Lexam 10 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | Lexam 20 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Etanercept | Injection 50 mg in 1 mL single use injection pen, 4 | Enbrel | Wyeth Australia Pty Limited |
Gemcitabine | Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL | Gemcitabine Ebewe | InterPharma Pty Ltd |
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Glucose | I.V. infusion 278 mmol (anhydrous) per 500 mL, | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Glucose Indicator—Blood | Electrode strips, 50 (MyGlucoHealth) | MyGlucoHealth | Entra Health Systems Pty Ltd |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal) | KetoCal | Nutricia Australia Pty Limited |
Hypromellose | Oral gel 20 mg per g, 100 g | Aquae Gel | Hamilton Pharmaceutical Pty Ltd |
Lisinopril | Tablet 20 mg | Lisinopril Sandoz | Sandoz Pty Ltd |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) | Momex SR 10 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Morphine | Tablet containing morphine sulfate 30 mg (controlled release) | Momex SR 30 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Morphine | Tablet containing morphine sulfate 60 mg (controlled release) | Momex SR 60 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Morphine | Tablet containing morphine sulfate 100 mg (controlled release) | Momex SR 100 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Nifedipine | Tablet 30 mg (controlled release) | APO-Nifedipine XR | Apotex Pty Ltd |
Nifedipine | Tablet 60 mg (controlled release) | APO-Nifedipine XR | Apotex Pty Ltd |
Oxybutynin | Transdermal patches 36 mg, 8 | Oxytrol | Hospira Pty Limited |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Paclitaxel Actavis | Generic Health Pty Ltd |
Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Paclitaxel Actavis | Generic Health Pty Ltd |
Paclitaxel | Solution concentrate for I.V. infusion 150 mg in 25 mL | Paclitaxel Actavis | Generic Health Pty Ltd |
Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Paclitaxel Actavis | Generic Health Pty Ltd |
Paracetamol | Tablet 500 mg | APO-Paracetamol | Apotex Pty Ltd |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine-GA | Ascent Pharmahealth Ltd |
Praziquantel | Tablet 600 mg | Biltricide | Bayer Australia Ltd |
Ramipril | Tablet 1.25 mg | APO-Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 1.25 mg | Chem mart Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 1.25 mg | Terry White Chemists Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 2.5 mg | APO-Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 2.5 mg | Chem mart Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 2.5 mg | Terry White Chemists Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 5 mg | APO-Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 5 mg | Chem mart Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 5 mg | Terry White Chemists Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 10 mg | APO-Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 10 mg | Chem mart Ramipril | Apotex Pty Ltd |
Ramipril | Tablet 10 mg | Terry White Chemists Ramipril | Apotex Pty Ltd |
Rivaroxaban | Tablet 10 mg | Xarelto | Bayer Australia Ltd |
Rivaroxaban | Tablet 10 mg, 15 | Xarelto | Bayer Australia Ltd |
Rivaroxaban | Tablet 10 mg, 30 | Xarelto | Bayer Australia Ltd |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride | Janumet | Merck Sharp & Dohme (Australia) Pty Ltd |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride | Janumet | Merck Sharp & Dohme (Australia) Pty Ltd |
Sitagliptin with metformin | Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride | Janumet | Merck Sharp & Dohme (Australia) Pty Ltd |
Sodium Chloride | I.V. infusion 38.5 mmol per 250 mL, 250 mL | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Sodium Chloride | I.V. infusion 77 mmol per | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Sodium Chloride | I.V. infusion 77 mmol per | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Sodium Chloride | I.V. infusion 154 mmol per L, 1 L | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Sodium Lactate Compound | I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Sodium Lactate Compound | I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L | B. Braun Australia Pty Ltd | B. Braun Australia Pty Ltd |
Soy lecithin | Eye spray 10 mg per mL, | tearsagain | Bio Revive Pty Ltd |
Temazepam | Tablet 10 mg | APO-Temazepam | Apotex Pty Ltd |
Voriconazole | Powder for oral suspension | Vfend | Pfizer Australia Pty Ltd |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Bisacodyl | Suppositories 10 mg, 12 | Fleet Laxative Suppositories | C.B. Fleet Co. (Aust.) Pty Ltd |
Chorionic Gonadotrophin | Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL | Pregnyl | Schering-Plough Pty Limited |
Glucose Indicator—Blood | Electrode strips, 100 (TrueSense) | TrueSense | Abbott Australasia Pty Ltd |
Paracetamol | Tablet 500 mg | Parmol | Sigma Pharmaceuticals (Australia) Pty Ltd |
Alteration of Brand
Listed Drug | Form | Brand | Responsible Person |
Insulin Lispro | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | From: Humalog Pen To: Humalog KwikPen
| Eli Lilly Australia Pty Ltd |
Insulin Lispro with Insulin Lispro Protamine Suspension | Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5 | From: Humalog Mix25 Pen To: Humalog Mix25 KwikPen
| Eli Lilly Australia Pty Ltd |
Insulin Lispro with Insulin Lispro Protamine Suspension | Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5 | From: Humalog Mix50 Pen To: Humalog Mix50 KwikPen
| Eli Lilly Australia Pty Ltd |
Alteration of Form
Listed Drug | Form | Brand | Responsible Person |
Teriparatide | From: Injection 250 micrograms per mL, 3 mL in multi-dose pre-filled pen To: Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen
| Forteo | Eli Lilly Australia Pty Ltd |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Ampicillin | Powder for injection 500 mg (as sodium) | Ibimicyn | From: Genepharm Pty Ltd To: Specialised Therapeutics Australia Pty Ltd |
Ampicillin | Powder for injection 1 g (as sodium) | Ibimicyn | From: Genepharm Pty Ltd To: Specialised Therapeutics Australia Pty Ltd |
Carvedilol | Tablet 3.125 mg | Dilasig 3.125 | From: Sigma Pharmaceuticals (Australia) Pty Ltd To: Fawns and McAllan Proprietary Limited |
Carvedilol | Tablet 3.125 mg | Vedilol 3.125 | From: Spirit Phamaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Carvedilol | Tablet 6.25 mg | Dilasig 6.25 | From: Sigma Pharmaceuticals (Australia) Pty Ltd To: Fawns and McAllan Proprietary Limited |
Carvedilol | Tablet 6.25 mg | Vedilol 6.25 | From: Spirit Phamaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Carvedilol | Tablet 12.5 mg | Dilasig 12.5 | From: Sigma Pharmaceuticals (Australia) Pty Ltd To: Fawns and McAllan Proprietary Limited |
Carvedilol | Tablet 12.5 mg | Vedilol 12.5 | From: Spirit Phamaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Carvedilol | Tablet 25 mg | Dilasig 25 | From: Sigma Pharmaceuticals (Australia) Pty Ltd To: Fawns and McAllan Proprietary Limited |
Carvedilol | Tablet 25 mg | Vedilol 25 | From: Spirit Phamaceuticals Pty Ltd To: Sigma Pharmaceuticals (Australia) Pty Ltd |
Flucloxacillin | Powder for injection 500 mg (as sodium) | Flubiclox | From: Genepharm Pty Ltd To: Specialised Therapeutics Australia Pty Ltd |
Flucloxacillin | Powder for injection 1 g (as sodium) | Flubiclox | From: Genepharm Pty Ltd To: Specialised Therapeutics Australia Pty Ltd |