EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 126 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 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 January 2009, was made on 3 December 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 January 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 | Capsule 500 mg (as trihydrate) | Amoxycillin Sandoz | Sandoz Pty Ltd |
Carboplatin | Solution for I.V. injection | Baxter Carboplatin | Baxter Healthcare Pty Ltd |
Clarithromycin | Tablet 250 mg | APO-Clarithromycin | Apotex Pty Ltd |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg | APO-Fosinopril HCTZ 10/12.5 | Apotex Pty Ltd |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg | APO-Fosinopril HCTZ 20/12.5 | Apotex Pty Ltd |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg | Fosetic 20/12.5 | Spirit Pharmaceuticals Pty Ltd |
Glucose Indicator─Blood | Electrode strips, 50 (FreeStyle) | FreeStyle | Abbott Australasia Pty Ltd |
Ibandronic acid | Tablet 50 mg (as ibandronate sodium monohydrate) | Bondronat | Hospira Pty Limited |
Ipratropium | Nebuliser solution containing ipratropium bromide | APO-Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | APO-Ipratropium | Apotex Pty Ltd |
Metformin | Tablet (extended release) containing metformin hydrochloride 500 mg | Metex XR | Sigma Pharmaceuticals (Australia) Pty Ltd |
Mirtazapine | Tablet 45 mg | APO-Mirtazapine | Apotex Pty Ltd |
Mirtazapine | Tablet 45 mg | Chem mart Mirtazapine | Apotex Pty Ltd |
Mirtazapine | Tablet 45 mg | Terry White Chemists Mirtazapine | Apotex 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 30 mg in 5 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 |
Posaconazole | Oral suspension 40 mg per mL, 105 mL | Noxafil | Schering-Plough Pty Limited |
Pravastatin | Tablet containing pravastatin sodium 80 mg | APO-Pravastatin | Apotex Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium 80 mg | Chem mart Pravastatin | Apotex Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium 80 mg | Terry White Chemists Pravastatin | Apotex Pty Ltd |
Temozolomide | Capsule 140 mg | Temodal | Schering-Plough Pty Limited |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Aminoglutethimide | Tablet 250 mg | Cytadren 250 | Novartis Pharmaceuticals Australia Pty Limited |
Amiodarone | Tablet containing amiodarone hydrochloride 100 mg | GenRx Amiodarone | Apotex Pty Ltd |
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 | Clavulin | GlaxoSmithKline Australia 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 5 mL, 60 mL | Clavulin Duo 400 | GlaxoSmithKline Australia Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Clavulin Duo | GlaxoSmithKline Australia Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Clavulin Duo Forte | GlaxoSmithKline Australia Pty Ltd |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) | Bupropion-RL | GlaxoSmithKline Australia Pty Ltd |
Captopril | Tablet 12.5 mg | Chem mart Captopril | Apotex Pty Ltd |
Captopril | Tablet 12.5 mg | Terry White Chemists Captopril | Apotex Pty Ltd |
Captopril | Tablet 25 mg | Chem mart Captopril | Apotex Pty Ltd |
Captopril | Tablet 25 mg | Terry White Chemists Captopril | Apotex Pty Ltd |
Captopril | Tablet 50 mg | Chem mart Captopril | Apotex Pty Ltd |
Captopril | Tablet 50 mg | Terry White Chemists Captopril | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | Chem mart Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | GenRx Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | Terry White Chemists Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | Chem mart Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | GenRx Ipratropium | Apotex Pty Ltd |
Ipratropium | Nebuliser solution containing ipratropium bromide | Terry White Chemists Ipratropium | Apotex Pty Ltd |
Isotretinoin | Capsule 10 mg | GenRx Isotretinoin | Apotex Pty Ltd |
Lamotrigine | Tablet 100 mg | Elmendos | GlaxoSmithKline Australia Pty Ltd |
Lamotrigine | Tablet 100 mg | Lamitrin | Sandoz Pty Ltd |
Lamotrigine | Tablet 200 mg | Elmendos | GlaxoSmithKline Australia Pty Ltd |
Lamotrigine | Tablet 200 mg | Lamitrin | Sandoz Pty Ltd |
Lamotrigine | Tablet 25 mg | Elmendos | GlaxoSmithKline Australia Pty Ltd |
Lamotrigine | Tablet 25 mg | Lamitrin | Sandoz Pty Ltd |
Lamotrigine | Tablet 5 mg | Elmendos | GlaxoSmithKline Australia Pty Ltd |
Lamotrigine | Tablet 5 mg | Lamitrin | Sandoz Pty Ltd |
Lamotrigine | Tablet 50 mg | Elmendos | GlaxoSmithKline Australia Pty Ltd |
Lamotrigine | Tablet 50 mg | Lamitrin | Sandoz Pty Ltd |
Nifedipine | Tablet 20 mg | Chem mart Nifedipine | Apotex Pty Ltd |
Nifedipine | Tablet 20 mg | Terry White Chemists Nifedipine | Apotex Pty Ltd |
Paracetamol | Tablet 500 mg | Tylenol | Johnson & Johnson Pacific Pty Limited |
Piperazine Oestrone | Tablet 1.46 mg (as sulfate) | Genoral 1.25 | Pfizer Australia Pty Ltd |
Piperazine Oestrone | Tablet 1.46 mg (as sulfate) | Ogen 1.25 | Pfizer Australia Pty Ltd |
Piperazine Oestrone | Tablet 730 micrograms (as sulfate) | Genoral 0.625 | Pfizer Australia Pty Ltd |
Piperazine Oestrone | Tablet 730 micrograms (as sulfate) | Ogen .625 | Pfizer Australia Pty Ltd |
Piroxicam | Dispersible tablet 10 mg | GenRx Piroxicam Dispersible | Apotex Pty Ltd |
Piroxicam | Dispersible tablet 20 mg | Chem mart Piroxicam Dispersible | Apotex Pty Ltd |
Piroxicam | Dispersible tablet 20 mg | GenRx Piroxicam Dispersible | Apotex Pty Ltd |
Piroxicam | Dispersible tablet 20 mg | Terry White Chemists Piroxicam Dispersible | Apotex Pty Ltd |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Chem mart Salbutamol | Apotex Pty Ltd |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Terry White Chemists Salbutamol | Apotex Pty Ltd |
Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Chem mart Salbutamol | Apotex Pty Ltd |
Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Terry White Chemists Salbutamol | Apotex Pty Ltd |
Sumatriptan | Tablet 50 mg (as succinate) | Suvalan 50 | GlaxoSmithKline Australia Pty Ltd |
Tamoxifen | Tablet 10 mg (as citrate) | Nolvadex | AstraZeneca Pty Ltd |
Trimethoprim with Sulfamethoxazole | Tablet 160 mg-800 mg | Chem mart Trimethoprim with Sulfamethoxazole DS | Apotex Pty Ltd |
Trimethoprim with Sulfamethoxazole | Tablet 160 mg-800 mg | GenRx Trimethoprim with Sulfamethoxazole DS | Apotex Pty Ltd |
Trimethoprim with Sulfamethoxazole | Tablet 160 mg-800 mg | Terry White Chemists Trimethoprim with Sulfamethoxazole DS | Apotex Pty Ltd |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Cyproheptadine | Tablet containing cyproheptadine hydrochloride 4 mg (anhydrous) | Periactin | From: Merck Sharp & Dohme (Australia) Pty Ltd To: Aspen Pharmacare Australia Pty Limited |
Indomethacin | Capsule 25 mg | Indocid | From: Merck Sharp & Dohme (Australia) Pty Ltd To: Aspen Pharmacare Australia Pty Limited |
Indomethacin | Suppository 100 mg | Indocid | From: Merck Sharp & Dohme (Australia) Pty Ltd To: Aspen Pharmacare Australia Pty Limited |
Methyldopa | Tablet 250 mg | Aldomet | From: Merck Sharp & Dohme (Australia) Pty Ltd To: Aspen Pharmacare Australia Pty Limited |