EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 49 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 July 2009, was made on 4 June 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 July 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 |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Dronalen Plus | Genepharm Pty Ltd |
Amino acid formula with vitamins and minerals without lysine and low in tryptophan | Sachets containing oral powder 20 g, 30 (GA gel) | GA gel | Vitaflo Australia Pty Limited |
Arginine with carbohydrate | Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine Amino Acid Supplement) | Arginine Amino Acid Supplement | Vitaflo Australia Pty Limited |
Atovaquone with proguanil | Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg | Malarone | GlaxoSmithKline Australia Pty Ltd |
Bevacizumab | Solution for I.V. infusion | Avastin | Roche Products Pty Ltd |
Bevacizumab | Solution for I.V. infusion | Avastin | Roche Products Pty Ltd |
Escitalopram | Tablet 10 mg (as oxalate) | APO-Escitalopram | Apotex Pty Ltd |
Escitalopram | Tablet 10 mg (as oxalate) | Chem mart Escitalopram | Apotex Pty Ltd |
Escitalopram | Tablet 10 mg (as oxalate) | Terry White Chemists Escitalopram | Apotex Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | APO-Escitalopram | Apotex Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | Chem mart Escitalopram | Apotex Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | Terry White Chemists Escitalopram | Apotex Pty Ltd |
Fluoxetine | Capsule 20 mg (as hydrochloride) | Fluoxetine generichealth | Generic Health Pty Ltd |
Gemcitabine | Powder for I.V. infusion | Gemcite | Spirit Pharmaceuticals Pty Ltd |
Gemcitabine | Powder for I.V. infusion 1 g (as hydrochloride) | Gemcite | Spirit Pharmaceuticals Pty Ltd |
Insulin Lispro | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Humalog Pen | 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 | Humalog Mix25 Pen | 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 | Humalog Mix50 Pen | Eli Lilly Australia Pty Ltd |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Irinotecan Actavis | Generic Health Pty Ltd |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Irinotecan Actavis | Generic Health Pty Ltd |
Isoleucine with carbohydrate | Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000 Amino Acid Supplement) | Isoleucine 1000 Amino Acid Supplement | Vitaflo Australia Pty Limited |
Lisinopril | Tablet 20 mg | Lisinopril-GA | Ascent Pharmahealth Ltd |
Metformin | Tablets (extended release) containing metformin hydrochloride 500 mg, 120 | Diabex XR | Alphapharm Pty Ltd |
Mupirocin | Nasal ointment 20 mg (as calcium) per g, 3 g | Bactroban | GlaxoSmithKline Australia Pty Ltd |
Oxaliplatin | Powder for I.V. infusion | Oxaliplatin Actavis | Generic Health Pty Ltd |
Oxaliplatin | Powder for I.V. infusion | Oxaliplatin Actavis | Generic Health Pty Ltd |
Perindopril | Tablet containing perindopril erbumine 2 mg | Ozapace | Ranbaxy Australia Pty Limited |
Perindopril | Tablet containing perindopril erbumine 4 mg | Ozapace | Ranbaxy Australia Pty Limited |
Perindopril | Tablet containing perindopril erbumine 8 mg | Ozapace | Ranbaxy Australia Pty Limited |
Risedronic Acid | Tablet containing risedronate sodium 150 mg | Actonel Once-a-Month | sanofi-aventis Australia Pty Ltd |
Risperidone | Tablet 0.5 mg | Ozidal | Ranbaxy Australia Pty Limited |
Risperidone | Tablet 1 mg | Ozidal | Ranbaxy Australia Pty Limited |
Risperidone | Tablet 2 mg | Ozidal | Ranbaxy Australia Pty Limited |
Risperidone | Tablet 3 mg | Ozidal | Ranbaxy Australia Pty Limited |
Risperidone | Tablet 4 mg | Ozidal | Ranbaxy Australia Pty Limited |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | APO-Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | Chem mart Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | Terry White Chemists Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 150 mg | APO-Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 150 mg | Chem mart Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 150 mg | Terry White Chemists Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 200 mg | APO-Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 200 mg | Chem mart Tramadol SR | Apotex Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 200 mg | Terry White Chemists Tramadol SR | Apotex Pty Ltd |
Trandolapril | Capsule 500 micrograms | Trandolapril generichealth | Generic Health Pty Ltd |
Trandolapril | Capsule 1 mg | Trandolapril generichealth | Generic Health Pty Ltd |
Trandolapril | Capsule 2 mg | Trandolapril generichealth | Generic Health Pty Ltd |
Trandolapril | Capsule 4 mg | Trandolapril generichealth | Generic Health Pty Ltd |
Valine with carbohydrate | Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000 Amino Acid Supplement) | Valine 1000 Amino Acid Supplement | Vitaflo Australia Pty Limited |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Amoxycillin | Capsule 500 mg (as trihydrate) | Amohexal | Sandoz Pty Ltd |
Amoxycillin | Powder for oral suspension | Amohexal | Sandoz Pty Ltd |
Anecortave | Suspension for injection containing anecortave acetate 15 mg in 0.5 mL | Retaane | Alcon Laboratories (Australia) Pty Ltd |
Enalapril | Tablet containing enalapril maleate 10 mg | Amprace 10 | Merck Sharp & Dohme (Australia) Pty Ltd |
Enalapril | Tablet containing enalapril maleate 20 mg | Amprace 20 | Merck Sharp & Dohme (Australia) Pty Ltd |
Nifedipine | Tablet 10 mg | Nypine 10 | Arrow Pharmaceuticals Pty Ltd |
Nifedipine | Tablet 20 mg | Nypine 20 | Arrow Pharmaceuticals Pty Ltd |
Oestradiol and Oestradiol with Norethisterone | Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg | Trisequens | Novo Nordisk Pharmaceuticals Pty Limited |
Oestradiol with Norethisterone | Tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 | Kliovance | Novo Nordisk Pharmaceuticals Pty Limited |
Oestradiol with Norethisterone | Tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28 | Kliogest | Novo Nordisk Pharmaceuticals Pty Limited |
Oxaliplatin | Powder for I.V. infusion 50 mg | Winthrop Oxaliplatin | sanofi-aventis Australia Pty Ltd |
Paracetamol | Tablet 500 mg | Parahexal | Sandoz Pty Ltd |