EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 8)
PB 63 of 2018
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, number 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). Subsection 85(6) provides that 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, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements) and equivalent brands. 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 to Australians 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. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. 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.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 August 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 8)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 8) and may also be cited as PB 63 of 2018.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2018.
Section 3 Amendment of 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 drugs, forms, brands, responsible person codes, the circumstances for prescribing various pharmaceutical benefits (including authority requirements) and equivalent brands. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Follitropin delta |
Glecaprevir with pibrentasvir |
Insulin degludec with insulin aspart |
Forms Added
Periciazine | Tablet 2.5 mg, 84 |
| Tablet 10 mg, 84 |
Pirfenidone | Tablet 267 mg |
| Tablet 801mg |
Forms Deleted
Diphtheria and tetanus vaccine, adsorbed, diluted for adult use | Injection 0.5 mL |
Brands Added
Aciclovir | Tablet 200 mg (APO-Aciclovir) |
| Tablet 800 mg (APO-Aciclovir) |
Clozapine | Oral liquid 50 mg per mL, 100 mL (Versacloz) |
Ezetimibe | Tablet 10 mg (APO-Ezetimibe; Blooms The Chemist Ezetimibe; EZEMICHOL; Ezetimibe GH; and Ezetimibe Sandoz) |
Ezetimibe with simvastatin | Tablet 10 mg-10 mg (APO-Ezetimibe/Simvastatin 10/10; and EZETIMIBE/SIMVASTATIN SANDOZ) |
| Tablet 10 mg-20 mg (APO-Ezetimibe/Simvastatin 10/20; and EZETIMIBE/SIMVASTATIN SANDOZ) |
| Tablet 10 mg-40 mg (APO-Ezetimibe/Simvastatin 10/40; and EZETIMIBE/SIMVASTATIN SANDOZ) |
| Tablet 10 mg-80 mg (APO-Ezetimibe/Simvastatin 10/80; and EZETIMIBE/SIMVASTATIN SANDOZ) |
Fluconazole | Capsule 200 mg (Fluconazole APOTEX)] |
Gabapentin | Capsule 300 mg Gabapentin generichealth) |
| Capsule 400 mg (Gabapentin generichealth) |
Lamotrigine | Tablet 200 mg (Sandoz Lamotrigine) |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg (Zircol 10) |
| Tablet containing lercanidipine hydrochloride 20 mg (Zircol 20) |
Moclobemide | Tablet 150 mg (APO-Moclobemide) |
| Tablet 300 mg (APO-Moclobemide) |
Moxonidine | Tablet 200 micrograms (APO-Moxonidine) |
| Tablet 400 micrograms (APO-Moxonidine) |
Nebivolol | Tablet 1.25 mg (as hydrochloride) (APO-Nebivolol) |
| Tablet 5 mg (as hydrochloride) (APO-Nebivolol) |
| Tablet 10 mg (as hydrochloride) (APO-Nebivolol) |
Piroxicam | Capsule 10 mg (APO-Piroxicam) |
| Capsule 20 mg (APO-Piroxicam) |
Brands Deleted
Amlodipine with atorvastatin | Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 5/10) |
| Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 5/20) |
| Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 5/40) |
| Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 5/80) |
| Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 10/10) |
| Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 10/20) |
| Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 10/40) |
| Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) (APO-Amlodipine/Atorvastatin 10/80) |
Amoxicillin with clavulanic acid | Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (APO-Amoxycillin and Clavulanic Acid 125/31.25) |
| Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL (APO-Amoxycillin and Clavulanic Acid 400/57) |
Cefalexin | Capsule 500 mg (as monohydrate) (Rancef) |
Donepezil | Tablet containing donepezil hydrochloride 10 mg (Donepezil RBX) |
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 (Repalyte New Formulation) |
Gabapentin | Capsule 300 mg (Gabapentin GH) |
| Capsule 400 mg (Gabapentin GH) |
Levetiracetam | Tablet 1 g (Levitaccord) |
Meloxicam | Tablet 7.5 mg (Meloxicam Ranbaxy) |
Meloxicam | Tablet 15 mg (Meloxicam Ranbaxy) |
Metformin | Tablet containing metformin hydrochloride 1 g (Metformin Ranbaxy 1000) |
Pravastatin | Tablet containing pravastatin sodium 40 mg (Pravastatin generichealth) |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) (Rabeprazole generichealth) |
Ramipril | Capsule 2.5 mg (Ramipril generichealth) |
| Capsule 5 mg (Ramipril generichealth) |
| Capsule 10 mg (Ramipril generichealth) |
Vinblastine | Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL (Vinblastine Teva) |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Furosemide | Injection 20 mg in 2 mL | Frusemide-Claris | From: AFT Pharmaceuticals Pty Ltd (AE) To: Baxter Healthcare Pty Limited (BX) |
Leuprorelin | Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set | Eligard 1 month | From: Tolmar Australia Pty Ltd (TL) To: Mundipharma Pty Limited (MF) |
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set | Eligard 3 month |
|
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set | Eligard 4 month |
|
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set | Eligard 6 month |
|
Leuprorelin and bicalutamide | Pack containing 1 syringe containing leuprorelin 7.5 mg (as acetate) and 28 tablets bicalutamide 50 mg | Bi ELIGARD CP | From: Tolmar Australia Pty Ltd (TL) To: Mundipharma Pty Limited (MF) |
| Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 28 tablets bicalutamide 50 mg | ||
| Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 84 tablets bicalutamide 50 mg |
Alteration to Restriction Level
Listed drug | From | To |
Budesonide with formoterol | Restricted Benefit | Streamlined Authority |
Fluticasone furoate with vilanterol | Restricted Benefit | Streamlined Authority |
Fluticasone with formoterol | Restricted Benefit | Streamlined Authority |
Fluticasone with salmeterol | Restricted Benefit | Streamlined Authority |
Addition of Maximum Quantity
Listed Drug | Form | Maximum Quantity | Number of Repeats |
Ibrutinib | Capsule 140 mg | 120 | 5 |
Peginterferon alfa-2a | Injection 135 micrograms in 0.5 mL single use pre-filled syringe | 4 | 5 |
| Injection 180 micrograms in 0.5 mL single use pre-filled syringe | 4 | 5 |
Perampanel | Tablet 4 mg (as hemisesquihydrate) | 28 | 2 |
| Tablet 6 mg (as hemisesquihydrate) | 28 | 2 |
Alteration of Number of Repeats
Listed Drug | Form | Brand Name | Number of Repeats |
Golimumab | Injection 100 mg in 1 mL single use pre-filled pen | Simponi | From: 1 |
Addition of Pack Quantity
Listed Drug | Form | Brand | Pack Quantity |
Baclofen | Intrathecal injection 10 mg in 5 mL | Bacthecal | 5 |
Addition of Responsible Person Code
Medsurge Healthcare Pty Ltd (DZ) |
Tolmar Australia Pty Ltd (TL) |
Alteration of Circumstances
Aclidinium with formoterol | Nivolumab |
Clopidogrel | Pegfilgrastim |
Ezetimibe | Pembrolizumab |
Golimumab | Perampanel |
Ibrutinib | Pirfenidone |
Indacaterol with glycopyrronium | Tiotropium with olodaterol |
Montelukast | Umeclidinium with vilanterol |
Nintedanib |
|
International Harmonisation of Ingredient Names – form changes
Listed drug | From | To |
Apomorphine | Injection containing apomorphine hydrochloride 20 mg in 2 mL | Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL |
| Injection containing apomorphine hydrochloride 50 mg in 5 mL | Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL |
| Injection containing apomorphine hydrochloride 100 mg in 20 mL | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL |
| Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe | Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe |
Atropine | Eye drops containing atropine sulfate 10 mg per mL, 15 mL | Eye drops containing atropine sulfate monohydrate 10 mg per mL, 15 mL |
| Injection containing atropine sulfate 600 micrograms in 1 mL | Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL |
Codeine | Tablet containing codeine phosphate 30 mg | Tablet containing codeine phosphate hemihydrate 30 mg |
Codeine with paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg |
Cyclophosphamide | Tablet 50 mg | Tablet 50 mg (anhydrous) |
Dantrolene | Capsule containing dantrolene sodium 25 mg | Capsule containing dantrolene sodium hemiheptahydrate 25 mg |
| Capsule containing dantrolene sodium 50 mg | Capsule containing dantrolene sodium hemiheptahydrate 50 mg |
Diphenoxylate with atropine | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate monohydrate 25 micrograms |
Doxycycline | Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Capsule 50 mg (as hyclate) (containing enteric coated pellets) |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Capsule 100 mg (as hyclate) (containing enteric coated pellets) |
| Tablet 50 mg (as hydrochloride) | Tablet 50 mg (as hyclate) |
| Tablet 100 mg (as hydrochloride) | Tablet 100 mg (as hyclate) |
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 | Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 |
Ferrous sulfate | Oral liquid 30 mg per mL, 250 mL | Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL |
Flucloxacillin | Capsule 250 mg (as sodium) | Capsule 250 mg (as sodium monohydrate) |
| Capsule 500 mg (as sodium) | Capsule 500 mg (as sodium monohydrate) |
| Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL |
| Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL |
| Powder for injection 1 g (as sodium) | Powder for injection 1 g (as sodium monohydrate) |
Ipratropium | Pressurised inhalation containing ipratropium bromide 21 micrograms per dose, 200 doses (CFC-free formulation) | Pressurised inhalation containing ipratropium bromide monohydrate 21 micrograms per dose, 200 doses (CFC-free formulation) |
| Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 | Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30 |
| Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 | Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30 |
Levodopa with carbidopa | Intestinal gel 20 mg-5 mg per mL, 100 mL | Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL |
| Tablet 100 mg-25 mg (anhydrous) | Tablet 100 mg-25 mg (as monohydrate) |
| Tablet 200 mg-50 mg (anhydrous) (modified release) | Tablet (modified release) 200 mg-50 mg (as monohydrate) |
| Tablet 250 mg-25 mg (anhydrous) | Tablet 250 mg-25 mg (as monohydrate) |
Levodopa with carbidopa and entacapone | Tablet 50 mg-12.5 mg-200 mg | Tablet 50 mg-12.5 mg (as monohydrate)-200 mg |
| Tablet 75 mg-18.75 mg-200 mg | Tablet 75 mg-18.75 mg (as monohydrate)-200 mg |
| Tablet 100 mg-25 mg-200 mg | Tablet 100 mg-25 mg (as monohydrate)-200 mg |
| Tablet 125 mg-31.25 mg-200 mg | Tablet 125 mg-31.25 mg (as monohydrate)-200 mg |
| Tablet 150 mg-37.5 mg-200 mg | Tablet 150 mg-37.5 mg (as monohydrate)-200 mg |
| Tablet 200 mg-50 mg-200 mg | Tablet 200 mg-50 mg (as monohydrate)-200 mg |
Mercaptopurine | Oral suspension 20 mg per mL, 100 mL | Oral suspension containing mercaptopurine monohydrate 20 mg per mL, 100 mL |
| Tablet 50 mg | Tablet containing mercaptopurine monohydrate 50 mg |
Methyldopa | Tablet 250 mg | Tablet 250 mg (as sesquihydrate) |
Metoclopramide | Injection containing metoclopramide hydrochloride 10 mg in 2 mL | Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL |
| Tablet containing metoclopramide hydrochloride 10 mg | Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate) |
Morphine | Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets) |
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets) |
| Capsule containing morphine sulfate 30 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 30 mg (controlled release) |
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets) |
| Capsule containing morphine sulfate 60 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 60 mg (controlled release) |
| Capsule containing morphine sulfate 90 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 90 mg (controlled release) |
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets) |
| Capsule containing morphine sulfate 120 mg (controlled release) | Capsule containing morphine sulfate pentahydrate 120 mg (controlled release) |
| Injection containing morphine hydrochloride 10 mg in 1 mL | Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL |
| Injection containing morphine sulfate 10 mg in 1 mL | Injection containing morphine sulfate pentahydrate 10 mg in 1 mL |
| Injection containing morphine sulfate 15 mg in 1 mL | Injection containing morphine sulfate pentahydrate 15 mg in 1 mL |
| Injection containing morphine hydrochloride 20 mg in 1 mL | Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL |
| Injection containing morphine sulfate 30 mg in 1 mL | Injection containing morphine sulfate pentahydrate 30 mg in 1 mL |
| Injection containing morphine hydrochloride 50 mg in 5 mL | Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL |
| Injection containing morphine hydrochloride 100 mg in 5 mL | Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL |
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL |
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL |
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet | Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet |
| Tablet containing morphine sulfate 5 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 5 mg (controlled release) |
| Tablet containing morphine sulfate 10 mg | Tablet containing morphine sulfate pentahydrate 10 mg |
| Tablet containing morphine sulfate 10 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 10 mg (controlled release) |
| Tablet containing morphine sulfate 15 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 15 mg (controlled release) |
| Tablet containing morphine sulfate 20 mg | Tablet containing morphine sulfate pentahydrate 20 mg |
| Tablet containing morphine sulfate 30 mg | Tablet containing morphine sulfate pentahydrate 30 mg |
| Tablet containing morphine sulfate 30 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 30 mg (controlled release) |
| Tablet containing morphine sulfate 60 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 60 mg (controlled release) |
| Tablet containing morphine sulfate 100 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 100 mg (controlled release) |
| Tablet containing morphine sulfate 200 mg (controlled release) | Tablet containing morphine sulfate pentahydrate 200 mg (controlled release) |
Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms | Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms |
| Tablet containing pramipexole hydrochloride 250 micrograms | Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms |
| Tablet (extended release) containing pramipexole hydrochloride 375 micrograms | Tablet (extended release) containing pramipexole dihydrochloride monohydrate |
| Tablet (extended release) containing pramipexole hydrochloride 750 micrograms | Tablet (extended release) containing pramipexole dihydrochloride monohydrate |
| Tablet containing pramipexole hydrochloride 1 mg | Tablet containing pramipexole dihydrochloride monohydrate 1 mg |
| Tablet (extended release) containing pramipexole hydrochloride 1.5 mg | Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg |
| Tablet (extended release) containing pramipexole hydrochloride 2.25 mg | Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg |
| Tablet (extended release) containing pramipexole hydrochloride 3 mg | Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg |
| Tablet (extended release) containing pramipexole hydrochloride 3.75 mg | Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg |
| Tablet (extended release) containing pramipexole hydrochloride 4.5 mg | Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg |
Quinine | Tablet containing quinine sulfate 300 mg | Tablet containing quinine sulfate dihydrate 300 mg |
Schedule 4, Part 3—General statement for drugs for the treatment of hepatitis C has been amended to include the listed drug Glecaprevir with pibrentasvir
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 2018 (No. 8)
(PB 63 of 2018)
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 2018 (No. 8) 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, schedule equivalence, maximum quantities, number 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, schedule equivalence, 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. The pharmaceutical industry now has a nominee on the PBAC membership.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Lisa La Rance
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health