EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2016 (No. 2)
PB 11 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 March 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. 2)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) and may also be cited as PB 11 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 March 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), determined quantities, pack quantities and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drug Added
Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine |
Daclatasvir |
Empagliflozin with metformin |
Ledipasvir with sofosbuvir |
Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid |
Ribavirin |
Sofosbuvir |
Forms Added
Glycomacropeptide and essential amino acids with vitamins and minerals | Sachets containing oral powder 49 g, 30 (Camino Pro Bettermilk)
|
Leuprorelin | I.M. injection (modified release), powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe |
Brands Added
Cabergoline | Tablet 500 micrograms (APO-Cabergoline) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine Sandoz) |
Leflunomide | Tablet 10 mg (Leflunomide APOTEX) |
Olanzapine | Tablet 2.5 mg (Olanzacor 2.5) |
Pramipexole | Tablet (extended release) containing pramipexole hydrochloride 375 micrograms (APO-Pramipexole ER) |
| Tablet (extended release) containing pramipexole hydrochloride 750 micrograms (APO-Pramipexole ER) |
| Tablet (extended release) containing pramipexole hydrochloride 1.5 mg |
| Tablet (extended release) containing pramipexole hydrochloride 2.25 mg (APO-Pramipexole ER) |
| Tablet (extended release) containing pramipexole hydrochloride 3 mg |
| Tablet (extended release) containing pramipexole hydrochloride 3.75 mg (APO-Pramipexole ER) |
| Tablet (extended release) containing pramipexole hydrochloride 4.5 mg |
Rosuvastatin | Tablet 5 mg (as calcium) (Rosuvastatin AMNEAL) |
Ursodeoxycholic Acid | Capsule 250 mg (Ursodox GH) |
Voriconazole | Tablet 50 mg (Vttack) |
Brands Deleted
Amlodipine | Tablet 5 mg (as besylate) (Amlodipine-DRLA) |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (Clamoxyl Duo) |
Anastrozole | Tablet 1 mg (Anastrozole-DRLA; Pharmacy Choice Anastrozole) |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) (Ciprofloxacin-DRLA) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine-DRLA) |
Irbesartan | Tablet 75 mg (Irbesartan-DRLA) |
Lamotrigine | Tablet 5 mg (Lamogine) |
Letrozole | Tablet 2.5 mg (Letrozole-DRLA; Pharmacy Choice Letrozole) |
Lisinopril | Tablet 5 mg (Lisinopril-DRLA) |
Metoprolol | Tablet containing metoprolol tartrate 50 mg (Metatar) |
Olanzapine | Tablet 2.5 mg (Pharmacor Olanzapine 2.5; Pharmacy Choice Olanzapine) |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin MYX) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Indopril 2) |
Quetiapine | Tablet 25 mg (as fumarate) (Pharmacy Choice Quetiapine) |
Risperidone | Tablet 0.5 mg (Risperidone-DRLA) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertraline-DRLA) |
Simvastatin | Tablet 10 mg (Simvastatin-DRLA) |
Sumatriptan | Tablet 50 mg (as succinate) (Sumatab) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Pharmacy Choice Terbinafine) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Levetiracetam | Tablet 500 mg | From: Levetiracetam generichealth |
Phenoxybenzamine | Capsules containing phenoxybenzamine hydrochloride 10 mg, 30 | From: Dibenyline |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person |
Carmustine | Implants 7.7 mg, 8 | Gliadel | From: Orphan Australia Pty Ltd (OA) To: Eisai Australia Pty Ltd (EI) |
Doxorubicin – Pegylated Liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Liposomal Doxorubicin SUN | From: Sun Pharmaceutical Industries (Australia) Pty Ltd (ZF) To: Ranbaxy Australia Pty Limited (RA) |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) Powder for I.V. infusion 1 g (as hydrochloride) | Gemcitabine Sun | From: Sun Pharmaceutical Industries (Australia) Pty Ltd (ZF) To: Ranbaxy Australia Pty Limited (RA) |
Octreotide | Injection 50 micrograms (as acetate) in 1 mL | Octreotide (SUN) | From: Sun Pharmaceutical Industries (Australia) Pty Ltd (ZF) To: Ranbaxy Australia Pty Limited (RA) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL | Oxaliplatin SUN | From: Sun Pharmaceutical Industries (Australia) Pty Ltd (ZF) To: Ranbaxy Australia Pty Limited (RA) |
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 |
Metformin | Tablet containing metformin hydrochloride 500 mg | Formet Aspen 500 |
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 |
Clopidogrel | Tablet 75 mg (as besilate) | Plidogrel |
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 |
Levetiracetam | Tablet 250 mg | Levi 250 |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Chemists’ Own Macrogol with Electrolytes |
Quetiapine | Tablet 25 mg (as fumarate) | Quetia 25 |
The Responsible Person for the following brand has changed from Aspen Pharma Pty Ltd (QA) to Arrow Pharma Pty Ltd (RF)
Listed Drug | Form | Brand Name |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Macrovic |
Quetiapine | Tablet 25 mg (as fumarate) | Seronia 25 |
The Responsible Person for the following brands has changed from Aspen Pharma Pty Ltd (QA) to Arrow Pharma Pty Ltd (OW)
Listed Drug | Form | Brand Name |
Sumatriptan | Tablet 50 mg (as succinate) | Sumatran |
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 |
Amiodarone | Tablet containing amiodarone hydrochloride 200 mg | Rithmik 200 |
Amisulpride | Tablet 400 mg | Amipride 400 |
Atenolol | Tablet 50 mg | Tensig |
Atorvastatin | Tablet 10 mg (as calcium) | Torvastat 10 |
Azathioprine | Tablet 50 mg | Azapin |
Calcitriol | Capsule 0.25 microgram | Kosteo |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Candesartan Aspen 4 |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg | Candesartan Combi Aspen 16/12.5 |
Carvedilol | Tablet 3.125 mg | Vedilol 3.125 |
Celecoxib | Capsule 100 mg | Celexi |
Citalopram | Tablet 10 mg (as hydrobromide) | Talam |
Clindamycin | Capsule 150 mg (as hydrochloride) | Calindamin |
Clopidogrel | Tablet 75 mg (as besilate) | Clovix 75 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium | Clonac 25 |
Dipyridamole with Aspirin | Capsule 200 mg (sustained release)-25 mg | Diasp SR |
Doxycycline | Tablet 50 mg (as monohydrate) | Frakas |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Faverin 50 Faverin 100 |
Galantamine | Capsule (prolonged release) 8 mg (as hydrobromide) | Gamine XR |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg | KSART HCT 150/12.5 |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Lercan |
Memantine | Tablet containing memantine hydrochloride 10 mg | Memanxa |
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Metrol 50 |
Metoprolol succinate | Tablet 23.75 mg (controlled release) | Metrol-XL 23.75 |
Mirtazapine | Tablet 30 mg | Mirtazon |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Respikast 4 |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) | Momex SR 10 |
Nifedipine | Tablet 30 mg (controlled release) | Addos XR 30 |
Omeprazole | Capsule 20 mg | Pemzo |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) | Parbezol |
Ramipril | Tablet 2.5 mg | Prilace 2.5 |
Zolmitriptan | Tablet 2.5 mg | Zoltrip |
Addition of Responsible Person Code
Orpharma Pty Ltd (OH) |
Deletion of Responsible Person Code
Sun Pharmaceutical Industries (Australia) Pty Ltd (ZF) |
Alteration of Circumstances
Listed Drug | Alteration |
Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain tryglycerides |
|
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides |
|
Calcipotriol with betamethasone |
|
Empagliflozin |
|
Ribavirin and Peginterferon Alfa-2a | Circumstances amended following the listing of additional drugs for the treatment of hepatitis C |
Simeprevir | Authority changed from “streamlined” to “authority required” |
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.
Aciclovir |
Famciclovir |
Folinic acid |
Nitrazepam |
Temazepam |
Valaciclovir |
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. 2)
(PB 11 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. 2) 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, 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.
Penny Shakespeare
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health