National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1) (PB 1 of 2016)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2016 (No. 1)

PB 1 of 2016

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 (equivalent brands, 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 4(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). Subsection 85(6) provides that the the Minister may determine a brand of a pharmaceutical item.

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.

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.

Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

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.

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).

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), equivalent brands, 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 February 2016.

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 2016 (No. 1)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1) and may also be cited as PB 1 of 2016.

Section 2 Commencement

This section provides that this Instrument commences on 1 February 2016.

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), equivalent brands, determined quantities, pack quantities and section 100 only status. These changes are summarised below.

SUMMARY OF CHANGES

Listed Drug Added

Ruxolitinib

Forms Added

Fentanyl	Tablet (sublingual) 100 micrograms (as citrate) Tablet (sublingual) 200 micrograms (as citrate) Tablet (sublingual) 300 micrograms (as citrate) Tablet (sublingual) 400 micrograms (as citrate) Tablet (sublingual) 600 micrograms (as citrate) Tablet (sublingual) 800 micrograms (as citrate)
Flucloxacillin	Powder for injection 1 g (as sodium) [differential max. qty/rpts]
Insect Allergen Extract–Honey Bee Venom	Injection set containing 550 micrograms with diluent
Insect Allergen Extract–Paper Wasp Venom	Injection set containing 550 micrograms with diluent
Insect Allergen Extract–Yellow Jacket Venom	Injection set containing 550 micrograms with diluent
Leuprorelin	Powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe

Forms Deleted

Docetaxel	Solution concentrate for I.V. infusion 20 mg in 1 mL
Stavudine	Capsule 20 mg

Brands Added

Alendronic acid with colecalciferol	Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol (APO-Alendronate Plus D3 70 mg/70 mcg; Chem mart Alendronate Plus D3 70 mg/70 mcg; Terry White Chemists Alendronate Plus D3 70 mg/70 mcg) Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol (APO-Alendronate Plus D3 70 mg/140 mcg; Chem mart Alendronate Plus D3 70 mg/140 mcg; Terry White Chemists Alendronate Plus D3 70 mg/140 mcg)
Amitryptiline	Tablet containing amitriptyline hydrochloride 10 mg (Amitryptiline Alphapharm 10) Tablet containing amitriptyline hydrochloride 25 mg (Amitryptiline Alphapharm 25) Tablet containing amitriptyline hydrochloride 50 mg (Amitryptiline Alphapharm 50)
Apomorphine	Injection containing apomorphine hydrochloride 20 mg in 2 mL (Movapo) Injection containing apomorphine hydrochloride 50 mg in 5 mL (Movapo)
Esomeprazole	Capsule (enteric) 20 mg (as magnesium) (Esomeprazole ACTAVIS) Capsule (enteric) 40 mg (as magnesium) (Esomeprazole ACTAVIS)
Morphine	Tablet containing morphine sulfate 10 mg (Morphine MR AN) Tablet containing morphine sulfate 30 mg (Morphine MR AN) Tablet containing morphine sulfate 60 mg (Morphine MR AN) Tablet containing morphine sulfate 100 mg (Morphine MR AN)
Pemetrexed	Powder for I.V. infusion 100 mg (as disodium) (DBL Pemetrexed; Pemetrexed APOTEX; Pemetrexed Juno; Reladdin) [see also under heading “Alteration of Form Description] Powder for I.V. infusion 500 mg (as disodium) (DBL Pemetrexed; Pemetrexed APOTEX; Pemetrexed-DRLA; Pemetrexed Juno; Reladdin) [see also under heading “Alteration of Form Description]
Pioglitazone	Tablet 15 mg (as hydrochloride) (Actaze) Tablet 30 mg (as hydrochloride) (Actaze) Tablet 45 mg (as hydrochloride) (Actaze)
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate) (Rizatriptan ODT GH)
Tacrolimus	Capsule 0.5 mg (TACROLIMUS APOTEX) Capsule 1 mg (TACROLIMUS APOTEX) Capsule 5 mg (TACROLIMUS APOTEX)
Voriconazole	Tablet 50 mg (Voriconazole Sandoz) Tablet 200 mg (Voriconazole Sandoz)

Brands Deleted

Cephalexin	Capsule 250 mg (anhydrous) (GenRx Cephalexin) Capsule 500 mg (anhydrous) (GenRx Cephalexin)
Docetaxel	Solution concentrate for I.V. infusion 80 mg in 4 mL (Taxotere)
Enalapril	Tablet containing enalapril maleate 5 mg (Auspril) Tablet containing enalapril maleate 10 mg (Auspril) Tablet containing enalapril maleate 20 mg (Auspril)
Irbesartan	Tablet 75 mg (Karbesat 75) Tablet 150 mg (Karbesat 150) Tablet 300 mg (Karbesat 300)
Lamotrigine	Tablet 5 mg (Seaze 5) Tablet 25 mg (Seaze 25) Tablet 50 mg (Seaze 50) Tablet 100 mg (Seaze 100) Tablet 200 mg (Seaze 200)
Levetiracetam	Tablet 250 mg (Levitam 250) Tablet 500 mg (Levitam 500) Tablet 1 g (Levitam 1000)
Montelukast	Tablet, chewable, 4 mg (as sodium) (Montelukast RBX) Tablet, chewable, 5 mg (as sodium) (Montelukast RBX)
Oxaliplatin	Solution concentrate for I.V. infusion 50 mg in 10 mL (Eloxatin) Solution concentrate for I.V. infusion 100 mg in 20 mL (Eloxatin) Solution concentrate for I.V. infusion 200 mg in 40 mL (Eloxatin)
Quetiapine	Tablet 100 mg (as fumarate) (Seronia 100) Tablet 200 mg (as fumarate) (Seronia 200) Tablet 300 mg (as fumarate) (Seronia 300)

Alteration of Form Description

Listed Drug

Form

Pemetrexed

From: Powder for I.V. infusion 100 mg (as disodium heptahydrate)
To: Powder for I.V. infusion 100 mg (as disodium)

From: Powder for I.V. infusion 500 mg (as disodium heptahydrate)
To: Powder for I.V. infusion 500 mg (as disodium)

Alteration of Brand Name and Responsible Person

Listed Drug	Form	Brand Name	Responsible Person
Isoniazid	Tablet 100 mg	From: Fawns and McAllan Proprietary Limited To: Arrow Pharma Pty Ltd	From: Fawns and McAllan Proprietary Limited (FM) To: Arrow Pharma Pty Ltd (RW)
Phenobarbitone	Tablet 30 mg	From: Aspen Pharma Pty Ltd To: Phenobarbitone Aspen	From: Aspen Pharma Pty Ltd (QA) To: Arrow Pharma Pty Ltd (RW)

Alteration of Responsible Person

Listed Drug

Form

Brand Name

Responsible Person

Amoxycillin

Powder for oral suspension
125 mg (as trihydrate) per 5 mL, 100 mL
Powder for oral suspension
250 mg (as trihydrate) per 5 mL, 100 mL

Bgramin

Bgramin

From: Actavis Pty Ltd (GN)

To: Fawns and McAllan Proprietary Limited (FM)

Nicotine

Transdermal patch 17.5 mg
Transdermal patch 35 mg
Transdermal patch 52.5 mg

Nicotinell Step 3
Nicotinell Step 2
Nicotinell Step 1

From: Novartis Consumer Health Australasia Pty Ltd (NC)

To: Orion Laboratories Pty Ltd (ON)

The Responsible Person for the following brands has changed from Aspen Pharma Pty Ltd (QA) to Arrow Pharma Pty Ltd (RF)

Listed Drug	Form	Brand Name
Pioglitazone	Tablet 15 mg (as hydrochloride) Tablet 30 mg (as hydrochloride) Tablet 45 mg (as hydrochloride)	Acpio 15 Acpio 30 Acpio 45
Pravastatin	Tablet containing pravastatin sodium 10 mg Tablet containing pravastatin sodium 20 mg Tablet containing pravastatin sodium 40 mg Tablet containing pravastatin sodium 80 mg	Lipostat 10 Lipostat 20 Lipostat 40 Lipostat 80
Sotalol	Tablet containing sotalol hydrochloride 80 mg Tablet containing sotalol hydrochloride 160 mg	Solavert Solavert

The Responsible Person for the following brand has changed from Aspen Pharma Pty Ltd (QA) to Arrow Pharma Pty Ltd (OW)

Listed Drug	Form	Brand Name
Valaciclovir	Tablet 500 mg	Valnir

The Responsible Person for the following brands has changed from Aspen Pharma Pty Ltd (QA) to Arrow Pharma Pty Ltd (RW)

Listed Drug	Form	Brand Name
Acetazolamide	Tablet 250 mg	Diamox
Alendronic acid	Tablet 70 mg (as alendronate sodium)	Alendro Once Weekly
Allopurinol	Tablet 100 mg Tablet 300 mg	Zyloprim Zyloprim
Amlodipine	Tablet 5 mg (as besylate) Tablet 10 mg (as besylate)	Amlo 5 Amlo 10
Baclofen	Tablet 10 mg Tablet 25 mg	Stelax 10 Stelax 25
Benzhexol	Tablet containing benzhexol hydrochloride 2 mg Tablet containing benzhexol hydrochloride 5 mg	Artane Artane
Bisoprolol	Tablet containing bisoprolol fumarate 2.5 mg Tablet containing bisoprolol fumarate 5 mg Tablet containing bisoprolol fumarate 10 mg	Bicard 2.5 Bicard 5 Bicard 10
Captopril	Tablet 25 mg Tablet 50 mg Oral solution 5 mg per mL, 95 mL	Capoten Capoten Capoten
Ciprofloxacin	Tablet 250 mg (as hydrochloride) Tablet 500 mg (as hydrochloride) Tablet 750 mg (as hydrochloride)	Ciprol 250 Ciprol 500 Ciprol 750
Citalopram	Tablet 20 mg (as hydrobromide)	Talam
Clarithromycin	Tablet 250 mg	Clarithro 250
Diazepam	Tablet 2 mg Tablet 5 mg	Valpam 2 Valpam 5
Donepezil	Tablet containing donepezil hydrochloride 5 mg Tablet containing donepezil hydrochloride 10 mg	Aridon 5 Aridon 10
Doxycycline	Tablet 100 mg (as hydrochloride)	Doxsig
Escitalopram	Tablet 10 mg (as oxalate) Tablet 20 mg (as oxalate)	Lexam 10 Lexam 20
Famciclovir	Tablet 125 mg Tablet 250 mg Tablet 500 mg	Favic 125 Favic 250 Favic 500
Famotidine	Tablet 20 mg Tablet 40 mg	Ausfam 20 Ausfam 40
Felodipine	Tablet 5 mg (extended release) Tablet 10 mg (extended release)	Felodil XR 5 Felodil XR 10
Fluconazole	Capsule 200 mg	Fluzole 200
Fluoxetine	Capsule 20 mg (as hydrochloride)	Auscap Aspen
Fosinopril	Tablet containing fosinopril sodium 10 mg Tablet containing fosinopril sodium 20 mg	Fosipril 10 Fosipril 20
Gemfibrozil	Tablet 600 mg	Ausgem
Gliclazide	Tablet 80 mg	Nidem
Glimepiride	Tablet 1 mg Tablet 2 mg Tablet 3 mg Tablet 4 mg	Diapride 1 Diapride 2 Diapride 3 Diapride 4
Glyceryl Trinitrate	Tablets 600 micrograms, 100	Anginine Stabilised
Hydroxychloroquine	Tablet containing hydroxychloroquine sulfate 200 mg	Hequinel
Indapamide	Tablet containing indapamide hemihydrate 1.5 mg (sustained release) Tablet containing indapamide hemihydrate 2.5 mg	Tenaxil SR Insig
Isotretinoin	Capsule 10 mg Capsule 20 mg	Rocta 10 Rocta 20
Lisinopril	Tablet 5 mg Tablet 10 mg Tablet 20 mg	Fibsol 5 Fibsol 10 Fibsol 20
Meloxicam	Capsule 7.5 mg Capsule 15 mg Tablet 7.5 mg Tablet 15 mg	Movalis 7.5 Movalis 15 Movalis 7.5 Movalis 15
Metformin	Tablet (extended release) containing metformin hydrochloride 500 mg Tablet containing metformin hydrochloride 1 g	Metex XR Formet 1000
Norfloxacin	Tablet 400 mg	Roxin
Pantoprazole	Tablet (enteric coated) 20 mg (as sodium sesquihydrate) Tablet (enteric coated) 40 mg (as sodium sesquihydrate)	Sozol Sozol
Paroxetine	Tablet 20 mg (as hydrochloride)	Extine 20
Perindopril with Indapamide	Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg	Indosyl Combi 4/1.25
Phenobarbitone	See under “Alteration of Brand Name and Responsible Person”
Pramipexole	Tablet containing pramipexole hydrochloride 125 micrograms Tablet containing pramipexole hydrochloride 250 micrograms Tablet containing pramipexole hydrochloride 1 mg	Simipex 0.125 Simipex 0.25 Simipex 1
Prochlorperazine	Tablet containing prochlorperazine maleate 5 mg	ProCalm
Propantheline	Tablet containing propantheline bromide 15 mg	Pro-Banthine
Ranitidine	Tablet 150 mg (as hydrochloride) Tablet 300 mg (as hydrochloride)	Ausran Ausran
Risedronic Acid	Tablet containing risedronate sodium 35 mg	Risedro once a week
Risperidone	Tablet 0.5 mg Tablet 1 mg Tablet 2 mg Tablet 3 mg Tablet 4 mg	Rispa Rispa Rispa Rispa Rispa
Roxithromycin	Tablet 150 mg Tablet 300 mg	Roxar 150 Roxar 300
Sertraline	Tablet 50 mg (as hydrochloride) Tablet 100 mg (as hydrochloride)	Sertra 50 Sertra 100
Simvastatin	Tablet 10 mg Tablet 20 mg Tablet 40 mg Tablet 80 mg	Simvar 10 Simvar 20 Simvar 40 Simvar 80
Telmisartan	Tablet 40 mg Tablet 80 mg	Teltartan Teltartan
Telmisartan with Hydrochlorothiazide	Tablet 40 mg-12.5 mg Tablet 80 mg-12.5 mg Tablet 80 mg-25 mg	Teltartan HCT 40/12.5 Teltartan HCT 80/12.5 Teltartan HCT 80/25
Terbinafine	Tablet 250 mg (as hydrochloride)	Tamsil
Topiramate	Tablet 25 mg Tablet 50 mg Tablet 100 mg Tablet 200 mg	Epiramax 25 Epiramax 50 Epiramax 100 Epiramax 200
Trandolapril	Capsule 500 micrograms Capsule 1 mg Capsule 2 mg Capsule 4 mg	Dolapril 0.5 Dolapril 1 Dolapril 2 Dolapril 4
Trimethoprim	Tablet 300 mg	Triprim
Trimethoprim with Sulfamethoxazole	Tablet 160 mg-800 mg Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Septrin Forte Septrin
Valaciclovir	Tablet 500 mg	Valtrex
Valproic Acid	Tablet (enteric coated) containing sodium valproate 200 mg Tablet (enteric coated) containing sodium valproate 500 mg	Valprease 200 Valprease 500
Verapamil	Capsule containing verapamil hydrochloride 160 mg (sustained release) Capsule containing verapamil hydrochloride 240 mg (sustained release)	Veracaps SR Veracaps SR

The Responsible Person for the following brands has changed from Aspen Pharmacare Australia Pty Limited (AS) to Arrow Pharma Pty Ltd (RW)

Listed Drug	Form	Brand Name
Lamivudine	Tablet 100 mg Oral solution 5 mg per mL, 240 mL	Zeffix Zeffix
Nizatidine	Capsule 150 mg Capsule 300 mg	Tazac Tazac
Nortriptyline	Tablet 10 mg (as hydrochloride) Tablet 25 mg (as hydrochloride)	Allegron Allegron
Pyrimethamine	Tablet 25 mg	Daraprim
Quinapril	Tablet 5 mg (as hydrochloride) Tablet 10 mg (as hydrochloride) Tablet 20 mg (as hydrochloride)	Acquin Aspen 5 Acquin Aspen 10 Acquin Aspen 20
Quinine	Tablet containing quinine sulfate 300 mg	Quinate
Sumatriptan	Tablet 50 mg (as succinate)	Sumagran Aspen 50)

The Responsible Person for the following brands has changed from Aspen Pharmacare Australia Pty Limited (LN) to Arrow Pharma Pty Ltd (RF)

Listed Drug	Form	Brand Name
Nizatidine	Capsule 150 mg Capsule 300 mg	Nizac Nizac

The Responsible Person for the following brands has changed from Fawns and McAllan Proprietary Limited (FM) to Arrow Pharma Pty Ltd (RF)

Listed Drug	Form	Brand Name
Allopurinol	Tablet 100 mg Tablet 300 mg	Allosig Allosig
Glyceryl Trinitrate	Tablets 600 micrograms, 100	Lycinate
Valaciclovir	Tablet 500 mg	Zelitrex

The Responsible Person for the following brands has changed from Fawns and McAllan Proprietary Limited (FM) to Arrow Pharma Pty Ltd (RW)

Listed Drug	Form	Brand Name
Enalapril	Tablet containing enalapril maleate 5 mg Tablet containing enalapril maleate 10 mg Tablet containing enalapril maleate 20 mg	Malean Malean Malean
Frusemide	Tablet 20 mg Tablet 40 mg Tablet 500 mg	Urex-M Urex Urex-Forte

Gabapentin	Capsule 100 mg Capsule 300 mg Capsule 400 mg Tablet 600 mg Tablet 800 mg	Gabapentin Aspen 100 Gabapentin Aspen 300 Gabapentin Aspen 400 Gabapentin Aspen 600 Gabapentin Aspen 800
Isoniazid	See under “Alteration of Brand Name and Responsible Person”
Lamotrigine	Tablet 5 mg Tablet 25 mg Tablet 50 mg Tablet 100 mg Tablet 200 mg	Lamotrigine Aspen 5 Lamotrigine Aspen 25 Lamotrigine Aspen 50 Lamotrigine Aspen 100 Lamotrigine Aspen 200
Morphine	Tablet containing morphine sulfate 30 mg	Anamorph
Oxazepam	Tablet 30 mg	Murelax
Perindopril	Tablet containing perindopril erbumine 2 mg Tablet containing perindopril erbumine 4 mg Tablet containing perindopril erbumine 8 mg	Indosyl Mono 2 Indosyl Mono 4 Indosyl Mono 8
Pravastatin	Tablet containing pravastatin sodium 10 mg Tablet containing pravastatin sodium 20 mg Tablet containing pravastatin sodium 40 mg Tablet containing pravastatin sodium 80 mg	Pravachol Pravachol Pravachol Pravachol
Sotalol	Tablet containing sotalol hydrochloride 80 mg Tablet containing sotalol hydrochloride 160 mg	Sotacor Sotacor

Alteration of Maximum Quantity

Listed Drug

Form

Maximum Quantity

IncobotulinumtoxinA

Lyophilised powder for injection 100 units

From: 3

To: 4

Addition of Responsible Person Code

Arrow Pharma Pty Ltd (OW; RF; RW)

Stada Pharmaceuticals Australia Pty Limited (TD)

Alteration of Circumstances Code

The circumstance codes for the following drugs in Schedule 1 and the corresponding circumstance codes in Schedule 4 to the principal instrument have changed. Any other changes to these listings are detailed under the relevant headings in this summary.

Fentanyl

Risperidone

Thalidomide

Ticarcillin with clavulanic acid

Alteration of Circumstances

Listed Drug
Octreotide

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 2016 (No. 1)

(PB 1 of 2016)

This 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 Instrument

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) 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, equivalent 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 Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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 Instrument is compatible with human rights because it advances the protection of human rights.

Julianne Quaine
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health

Administered by Department of Health, Disability and Ageing

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