EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 11)
PB 61 of 2013
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 71 of 2012 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, numbers of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
Authority
This Instrument exercises various powers 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)). Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.
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) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the PBAC has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.
Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.
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).
Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.
Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.
Variation and revocation
Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.
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 71 of 2012 made by this instrument
Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status. These changes are summarised, by subject matter, in the Attachment.
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, guarantee of supply and agreement to final listing details.
General
A provision by provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 October 2013.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 11)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 11) and may also be cited as PB 61 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2013.
Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Brands Added
Candesartan | Tablet containing candesartan cilexetil 4 mg (Candesartan RBX) |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Candesartan HCTZ RBX 16/12.5) |
Gabapentin | Capsule 100 mg (Gabapentin Aspen 100) |
Isotretinoin | Capsule 10 mg (Isotretinoin SCP 10) |
Meloxicam | Capsule 7.5 mg (Meloxicam Sandoz) |
Montelukast | Tablet, chewable, 4 mg (as sodium) (Auro-Montelukast Tabs 4) |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) |
Roxithromycin | Tablet 150 mg (Roxithromycin SCP 150) |
Sumatriptan | Tablet 50 mg (as succinate) (Sumatriptan Sandoz) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine GH) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (Tramadol SCP) |
Venlafaxine | Capsule (modified release) 75 mg (as hydrochloride) (Venlafaxine SR SCP 75) |
Zolmitriptan | Tablet 2.5 mg (Zoltrip) |
Brands Deleted
Carbomer | Eye gel 2 mg per g, 10 g (GelTears) |
Cephazolin | Powder for injection 500 mg (as sodium) (Hospira Pty Limited) |
Doxycycline | Tablet 50 mg (as hydrochloride) (Vibra-Tabs) |
Gabapentin | Capsule 100 mg (DBL Gabapentin) |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (AS-Gemcitabine) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL (AS-Oxaliplatin) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (GN-Paclitaxel) |
Pamidronic Acid | Concentrated injection containing disodium pamidronate 30 mg in 10 mL (Pamidronate Strides) |
Quinapril | Tablet 5 mg (as hydrochloride) (Quinapril Sandoz) |
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) (Rabeprazole-GA) |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (AS-Vinorelbine) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Paraffin | Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | From: Lacri-Lube To: Refresh Night Time
|
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Timolol | Eye gel 1 mg (as maleate) per g, 5 g | Nyogel | From: Novartis Pharmaceuticals Australia Pty Limited (NV) To: Aspen Pharmacare Australia Pty Limited (AS) |
The following brands previously listed with the Responsible Person Ascent Pharma Pty Ltd (GM) are now listed with the Responsible Person Actavis Pty Ltd (GN):
Aciclovir | Tablet 200 mg (Lovir) |
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Alendronate-GA) |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol (Dronalen Plus) |
Alprazolam | Tablet 1 mg (Ralozam) |
Amoxycillin | Capsule 250 mg (as trihydrate) (Amoxycillin-GA) |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (GA-Amclav 500/125) |
Anastrozole | Tablet 1 mg (Anastrozole-GA) |
Atorvastatin | Tablet 10 mg (as calcium) (Atorvachol) |
Azathioprine | Tablet 50 mg (Azamun) |
Azithromycin | Tablet 500 mg (as dihydrate) (Zitrocin) |
Bicalutamide | Tablet 50 mg (Bicalutamide-GA) |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) (Prexaton) |
Cabergoline | Tablet 500 micrograms (Dostan) |
Candesartan | Tablet containing candesartan cilexetil 4 mg (Candesartan-GA) |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Candesartan HCTZ-GA 16/12.5) |
Carvedilol | Tablet 3.125 mg (GN-Carvedilol) |
Cephalexin | Capsule 250 mg (anhydrous) (Cilex) |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ciprofloxacin-GA) |
Clarithromycin | Tablet 250 mg (Clarac) |
Clopidogrel | Tablet 75 mg (as besilate) (Clopidogrel-GA) |
Coal tar – Prepared | Gel 10 mg per g, 100 mL (Exorex) |
Cromoglycic acid | Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic) (Intal Spincaps) |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Procur) |
Diazepam | Tablet 5 mg (Diazepam-GA) |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg (Diclofenac-GA) |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg (Dilzem 60 mg) |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (Donepezil-GA) |
Doxycycline | Tablet 50 mg (as hydrochloride) (Doxy-50) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Drulox) |
Electrolyte Replacement, Oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 (restore O.R.S.) |
Enalapril | Tablet containing enalapril maleate 5 mg (Enalapril-GA) |
Exemestane | Tablet 25 mg (Exemestane-GA) |
Famciclovir | Tablet 125 mg (Famciclovir-GA) |
Famotidine | Tablet 20 mg (Pepzan) |
Fentanyl | Transdermal patch 2.063 mg (Dutran 12) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine-GA) |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg (Fluvoxamine GA) |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCTZ-GA 10/12/5) |
Frusemide | Tablet 20 mg (Frusid) |
Glimepiride | Tablet 1 mg (Glimepiride GA 1) |
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg (Hydroxychloroquine Actavis) |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg (Indapamide-GA) |
Irbesartan | Tablet 75 mg (Irbesartan-GA) |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg (Irbesartan HCTZ-GA 150/12.5) |
Isosorbide mononitrate | Tablet 60 mg (sustained release) (Imtrate 60 mg) |
Isotretinoin | Capsule 10 mg (Oratane) |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL (Lac-Dol) |
Leflunomide | Tablet 10 mg (Leflunomide-GA) |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg (Lercadip) |
Letrozole | Tablet 2.5 mg (Letrozole-GA) |
Levetiracetam | Tablet 250 mg (Kepcet) |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 (LaxaCon) |
Meloxicam | Tablet 7.5 mg (Meloxicam-GA) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Metformin-GA) |
Mirtazapine | Tablet 45 mg (Mirtazapine-GA) |
Moclobemide | Tablet 150 mg (Clobemix) |
Montelukast | Tablet, chewable, 4 mg (as sodium) ((Montair 4) |
Norfloxacin | Tablet 400 mg (Norfloxacin-GA) |
Olanzapine | Tablet 2.5 mg (Olanzapine-GA) |
Omeprazole | Tablet 20 mg (Omeprazole-GA) |
Oxybutynin | Transdermal patches 36 mg, 8 (Oxytrol) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole-GA) |
Paracetamol | Tablet 500 mg (Febridol) |
Phenoxymethylpenicillin | Capsule 250 mg phenoxymethylpenicillin (as potassium) (Cilopen VK) |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone-GA) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin-GA 10) |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Prochlorperazine-GA) |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) (Rabeprazole-GA) |
Ramipril | Capsule 1.25 mg (Ramipril-GA) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranoxyl) |
Risedronic acid | Tablet containing risedronate sodium 35 mg (Risedronate-GA) |
Risperidone | Tablet 0.5 mg (Risperidone-GA) |
Roxithromycin | Tablet 150 mg (Roxithromycin-GA) |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol-GA) |
Sumatriptan | Tablet 50 mg (as succinate) (Sumitriptan-GA) |
Tamoxifen | Tablet 20 mg (as citrate) (Tamoxen 20 mg) |
Testosterone | Transdermal patches 12.2 mg, 60 (Androderm) |
Topiramate | Tablet 25 mg (Topiramate-GA) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (GA Tramadol 50mg) |
Venlafaxine | Capsule (modified release) 75 mg (as hydrochloride) (Venlexor XR) |
The following brands previously listed with the Responsible Person Ascent Pharma Pty Ltd (GM) are now listed with the Responsible Person Actavis Pty Ltd (UA):
Amlodipine | Tablet 5 mg (as besylate) (Amlodipine-GA) |
Calcitriol | Capsule 0.25 microgram (Calcitriol-GA) |
Citalopram | Tablet 20 mg (as hydrobromide) (Ciazil) |
Escitalopram | Tablet 10 mg (as oxalate) (Esipram) |
Frusemide | Tablet 40 mg (Frusid) |
Gabapentin | Capsule 300 mg (Gabapentin-GA) |
Gemfibrozil | Tablet 600 mg (Gemfibrozil-GA) |
Mirtazapine | Tablet 30 mg (Mirtazapine-DP) |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoprazole-GA) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Perindopril-GA) |
Quinapril | Tablet 20 mg (as hydrochloride) (Quinapril-GA) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertraline-GA) |
Simvastatin | Tablet 10 mg (Simvastatin-DP) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine-GA) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Zelitrex) |
The following brands previously listed with the Responsible Person Ascent Pharma Pty Ltd (GM) are now listed with the Responsible Person Actavis Pty Ltd (VN):
Quetiapine | Tablet 25 mg (as fumarate) (Quipine) |
The following brands previously listed with the Responsible Person Willow Pharmaceuticals Pty Ltd (WQ) are now listed with the Responsible Person Actavis Pty Ltd (GN):
Ampicillin | Powder for injection 500 mg (as sodium) (Ibimycin) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Biso 2.5) |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (Bleo 15K) |
Carboplatin | Solution for I.V. injection 50 mg in 5 mL (Carbaccord) |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial (Accord Doxorubicin) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL (Epiccord) |
Flucloxacillin | Powder for injection 500 mg (as sodium) (Flubiclox) |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg (Farine) |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (Gemaccord) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinoccord) |
Methotrexate | Injection 50 mg in 2 mL vial (Methaccord) |
Ondansetron | Tablet (orally disintegrating) 4 mg (Onsetron ODT 4) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL (Oxaliccord) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (Plaxel) |
Rosuvastatin | Tablet 5 mg (as calcium) (Rosuvastatin Actavis 5) |
Temozolomide | Capsule 5 mg (Astromide) |
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) (Vycin IV) |
The following brands previously listed with the Responsible Person Willow Pharmaceuticals Pty Ltd (WQ) are now listed with the Responsible Person Actavis Pty Ltd (UA):
Anastrozole | Tablet 1 mg (Anzole) |
Letrozole | Tablet 2.5 mg (Lezole) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiaccord) |
Alteration of Name of Responsible Person (entity name only)
From: Ascent Pharmaceuticals Limited [GN] To: Actavis Pty Ltd [GN]
Addition of Responsible Person Code
Actavis Pty Ltd [UA] |
Actavis Pty Ltd [VN] |
Deletion of Responsible Person Code
Ascent Pharma Pty Ltd [GM] |
Willow Pharmaceuticals Pty Ltd [WQ] |
Alteration of Circumstances
Listed Drug | Alteration |
Zolmitriptan | Circumstances amended, removing some restrictions previously applied for the prescribing of this drug |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 11)
(PB 61 of 2013)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 11) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (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, numbers of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing