EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2011 (No. 10)
PB 67 of 2011
Purpose
The purpose of this legislative instrument, made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 108 of 2010 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities and numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Authority
PB 108 of 2010 exercises numerous provisions in Part VII of the Act, as set out below:
Pharmaceutical benefits listed on the PBS
Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies. A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)). Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug. A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB). The Minister may also determine a brand of a pharmaceutical item (subsection 85(6)). The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).
Prescribing pharmaceutical benefits
Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.
Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.
Supplying pharmaceutical benefits
Subsection 85(2A) and paragraph 85(8)(a), respectively, provide that the Minister may declare that a particular listed drug or a particular pharmaceutical benefit may only be supplied under special arrangements under section 100. Similarly, paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).
Variation and revocation of subsection 85(2) declaration
Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation. Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).
Changes to PB 108 of 2010 made by this instrument
This instrument provides for additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing and to the maximum quantities and number of repeats that may be prescribed for various pharmaceutical benefits. These changes are summarised, by subject matter, in Attachment 2.
Consultation
The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation. PBAC is an independent expert body established by section 100A of the Act 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the PBS, 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.
Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, and agreement to final listing details.
General
A provision by provision description of this Instrument is contained in Attachment 1.
The Instrument commences on 1 October 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT 1
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2011 (NO.10)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 10) and may also be cited as PB 67 of 2011.
Section 2 Commencement
This section provides that the Instrument commences on 1 October 2011.
Section 3 Amendment of PB 108 of 2010
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing and to the maximum quantities and number of repeats that may be prescribed. These changes are summarised in Attachment 2.
ATTACHMENT 2
SUMMARY OF CHANGES
Forms Added
Docetaxel | Powder for I.V. infusion 20 mg with solvent Powder for I.V. infusion 80 mg with solvent |
Tobramycin | Solution for inhalation 300 mg in 5 mL |
Forms Deleted
Ribavirin and Peginterferon Alfa-2b (s.100) | Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent |
Alteration of Form Description
Degarelix | From: Powder for injection 80 mg (as acetate) with solvent, syringe and needles To: Powder for injection 80 mg (as acetate), injection set |
| From: Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2 To: Powder for injection 120 mg (as acetate), 2, injection set |
Brands Added
Clopidogrel with aspirin | Tablet 75 mg (as hydrogen sulphate)-100 mg (Clopidogrel Winthrop plus aspirin) |
Docetaxel | Solution concentrate for I.V. infusion 20 mg in 2 mL (Docetaxel Sandoz) Solution concentrate for I.V. infusion 80 mg in 8 mL (Docetaxel Sandoz) |
Glimepiride | Tablet 1 mg (Glimepiride GA 1) Tablet 2 mg (Glimepiride GA 2) Tablet 3 mg (Glimepiride GA 3) Tablet 4 mg (Glimepiride GA 4) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan Kabi) I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Kabi) |
Macrogol 3350 | Powder for oral solution 510 g (your pharmacy Clear Laxative) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL (Oxaliplatin SUN) Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin SUN) Solution concentrate for I.V. infusion 200 mg in 40 mL (Oxaliplatin SUN) |
Risedronic Acid | Tablet containing risedronate sodium 35 mg (Risedronate-GA) |
Brands Deleted
Amiodarone | Tablet containing amiodarone hydrochloride 100 mg (Cardinorm) Tablet containing amiodarone hydrochloride 200 mg (Cardinorm) |
Cimetidine | Tablet 400 mg (GenRx Cimetidine) Tablet 800 mg (GenRx Cimetidine) |
Metronidazole | I.V. infusion 500 mg in 100 mL (Metronidazole Sandoz) |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (Vinorelbine Kabi; Vinorelbine Link) Solution for I.V. infusion 50 mg (as tartrate) in 5 mL (Vinorelbine Link) |
Alteration of Brand
Pravastatin | Tablet containing pravastatin sodium 20 mg
Tablet containing pravastatin sodium 40 mg | From: Vastoran To: Cholvastin From: Vastoran To: Cholvastin |
Alteration of Responsible Person Code (no change to Responsible Person)
Listed Drug | Form | Brand | Responsible Person Code |
Clodronic Acid | Capsule containing 400 mg sodium clodronate (as tetrahydrate) Tablet containing 800 mg sodium clodronate (as tetrahydrate) | Bonefos Bonefos 800 mg | From: SC To: BN |
Cyproterone | Tablet containing cyproterone acetate 50 mg Tablet containing cyproterone acetate 100 mg | Androcur Androcur-100 | From: SC To: BN |
Iloprost | Solution for inhalation 20 micrograms (as trometamol) in 2 mL | Ventavis | From: SC To: BN |
Interferon Beta-1b | Injection set including 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent | Betaferon | From: SC To: BN |
Levonorgestrel | Tablets 30 micrograms, 28 Intrauterine drug delivery system 52 mg | Microlut 28 Mirena | From: SC To: BN |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets | Microgynon Microgynon Triquilar ED | From: SC To: BN |
Norethisterone | Tablet 5 mg | Primolut N | From: SC To: BN |
Oestradiol | Tablet containing oestradiol valerate 1 mg Tablet containing oestradiol valerate 2 mg Transdermal patches 2 mg, 4 Transdermal patches 3.8 mg, 4 Transdermal patches 5.7 mg, 4 Transdermal patches 7.6 mg, 4 | Progynova Progynova Climara 25 Climara 50 Climara 75 Climara 100 | From: SC To: BN |
Testosterone | Injection containing testosterone enanthate 250 mg in 1 mL I.M injection containing testosterone undecanoate 1,000 mg in 4 mL Transdermal gel 50 mg in 5 g sachet, 30 | Primoteston Depot Reandron 1000 Testogel | From: SC To: BN |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg | Fludarabine Actavis | From: Generic Health Pty Ltd (GQ) To: Actavis Australia Pty Ltd (TA) |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) Powder for I.V. infusion 1 g (as hydrochloride) | Gemcitabine Actavis | From: Generic Health Pty Ltd (GQ) To: Actavis Australia Pty Ltd (TA) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Irinotecan Actavis | From: Generic Health Pty Ltd (GQ) To: Actavis Australia Pty Ltd (TA) |
Oxaliplatin | Powder for I.V. infusion 50 mg Powder for I.V. infusion 100 mg | Oxaliplatin Actavis | From: Generic Health Pty Ltd (GQ) To: Actavis Australia Pty Ltd (TA) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL Solution concentrate for I.V. infusion 100 mg in 16.7 mL Solution concentrate for I.V. infusion 150 mg in 25 mL Solution concentrate for I.V. infusion 300 mg in 50 mL | Paclitaxel Actavis | From: Generic Health Pty Ltd (GQ) To: Actavis Australia Pty Ltd (TA) |
Alteration of Circumstances Code (no change to circumstances)
Ranibizumab |
Verteporfin |
Deletion of Responsible Person Code
FU [Fresenius Kabi Australia Pty Limited] |
SC [Bayer Australia Ltd] |