EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 77 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 September 2009, was made on 31 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 September 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 |
Cephalexin | Capsule 500 mg (anhydrous) | Cephalexin generichealth | Generic Health Pty Ltd |
Clotrimazole | Cream 10 mg per g, 20 g | Clonea | Alphapharm Pty Ltd |
Escitalopram | Tablet 10 mg (as oxalate) | LoxaLate | Alphapharm Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | LoxaLate | Alphapharm Pty Ltd |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg | Fludarabine Actavis | Generic Health Pty Ltd |
Gliclazide | Tablet 30 mg (modified release) | APO-Gliclazide MR | Apotex Pty Ltd |
Gliclazide | Tablet 30 mg (modified release) | Chem mart Gliclazide MR | Apotex Pty Ltd |
Gliclazide | Tablet 30 mg (modified release) | Terry White Chemists Gliclazide MR | Apotex Pty Ltd |
Glimepiride | Tablet 1 mg | APO-Glimepiride | Apotex Pty Ltd |
Glimepiride | Tablet 2 mg | APO-Glimepiride | Apotex Pty Ltd |
Glimepiride | Tablet 3 mg | APO-Glimepiride | Apotex Pty Ltd |
Glimepiride | Tablet 4 mg | APO-Glimepiride | Apotex Pty Ltd |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Lansoprazole | Tablet 30 mg (orally disintegrating) | Zoton FasTabs | Wyeth Australia Pty Limited |
Metformin | Tablets (extended release) containing metformin hydrochloride 500 mg, 120 | Diaformin XR | Alphapharm Pty Ltd |
Metformin | Tablets (extended release) containing metformin hydrochloride 500 mg, 120 | Metex XR | Sigma Pharmaceuticals (Australia) Pty Ltd |
Poly-l-lactic acid | Powder for injection 150 mg | Sculptra | sanofi-aventis Australia Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium 10 mg | APO-Pravastatin | Apotex Pty Ltd |
Roxithromycin | Tablet 150 mg | Roxithromycin-GA | Genepharm Pty Ltd |
Roxithromycin | Tablet 300 mg | Roxithromycin-GA | Genepharm Pty Ltd |
Silver sulfadiazine | Cream 10 mg per g, 50 g | Flamazine | Smith & Nephew Pty Limited |
Sodium bicarbonate | Capsule 840 mg | Sodibic | Aspen Pharmacare Australia Pty Limited |
Sodium Chloride | I.V. infusion 154 mmol per L, 1 L | 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 | Pharmatel Fresenius Kabi Pty Limited | Pharmatel Fresenius Kabi Pty Limited |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Lodam 50 | Spirit Pharmaceuticals Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | Lodam SR 100 | Spirit Pharmaceuticals Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 150 mg | Lodam SR 150 | Spirit Pharmaceuticals Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 200 mg | Lodam SR 200 | Spirit Pharmaceuticals Pty Ltd |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Amoxycillin | Capsule 250 mg (as trihydrate) | Amohexal | Sandoz Pty Ltd |
Carboplatin | Solution for I.V. injection | Baxter Carboplatin | Baxter Healthcare Pty Ltd |
Etanercept | Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent | Enbrel | Wyeth Australia Pty Limited |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Baxter Paclitaxel | Baxter Healthcare Pty Ltd |
Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Baxter Paclitaxel | Baxter Healthcare Pty Ltd |
Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Baxter Paclitaxel | Baxter Healthcare Pty Ltd |
Simvastatin | Tablet 10 mg | Genepharm Pty Ltd | Genepharm Pty Ltd |
Simvastatin | Tablet 20 mg | Genepharm Pty Ltd | Genepharm Pty Ltd |
Simvastatin | Tablet 40 mg | Genepharm Pty Ltd | Genepharm Pty Ltd |
Simvastatin | Tablet 80 mg | Genepharm Pty Ltd | Genepharm Pty Ltd |
Alteration of Brand
Listed Drug | Form | Brand | Responsible Person |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | From: Curam 500/125 To: Curam Duo 500/125 | Sandoz Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | From: Curam 875/125 To: Curam Duo Forte 875/125 | Sandoz Pty Ltd |
Alteration of Brand and Responsible Person
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited |
Ciprofloxacin | Tablet 750 mg (as hydrochloride) | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited |
Metformin | Tablet containing metformin hydrochloride 500 mg | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited |
Metformin | Tablet containing metformin hydrochloride 850 mg | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Anakinra | Injection 100 mg in 0.67 mL single use pre-filled syringe | Kineret | From: Amgen Australia Pty Limited To: PharmaLink Pty Ltd |
Atenolol | Tablet 50 mg | Atenolol-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Cefaclor-GA | From: Genepharm Pty Ltd To: Genepharm (Australia) Limited |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Diclofenac-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Escitalopram | Tablet 10 mg (as oxalate) | Esipram | From: CNS Pharma Pty Ltd To: Genepharm Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | Esipram | From: CNS Pharma Pty Ltd To: Genepharm Pty Ltd |
Lamotrigine | Tablet 25 mg | Lamotrigine-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Lamotrigine | Tablet 50 mg | Lamotrigine-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Lamotrigine | Tablet 100 mg | Lamotrigine-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Lamotrigine | Tablet 200 mg | Lamotrigine-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Lisinopril | Tablet 20 mg | Lisinopril-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Metformin | Tablet containing metformin hydrochloride 1 g | Metformin-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine-GA | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Pravastatin | Tablet containing pravastatin sodium 10 mg | Pravastatin-GA 10 | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Pravastatin | Tablet containing pravastatin sodium 20 mg | Pravastatin-GA 20 | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Pravastatin | Tablet containing pravastatin sodium 40 mg | Pravastatin-GA 40 | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |
Pravastatin | Tablet containing pravastatin sodium 80 mg | Pravastatin-GA 80 | From: Ascent Pharmahealth Ltd To: Genepharm (Australia) Limited |