EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2014 (No. 9)
PB 61 of 2014
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 September 2014.
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 2014 (No. 9)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 9) and may also be cited as PB 61 of 2014.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 2014.
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
Macitentan |
Listed Drug Deleted
Omeprazole and Clarithromycin and Amoxycillin |
Form Added
Ranibizumab | Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe |
Forms Deleted
Darunavir | Tablet 400 mg (as ethanolate) |
Gemcitabine | Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL |
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL |
Glucose Indicator—Blood | Test strips, 50 (Glucocard 01 Sensor) |
Oxprenolol | Tablet containing oxprenolol hydrochloride 20 mg |
Sodium Chloride | I.V. infusion 38.5 mmol per 250 mL, 250 mL |
Sodium Lactate Compound | I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), |
Testosterone | Subcutaneous implant 100 mg |
Brands Added
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Alendronate AN) |
Amoxycillin | Capsule 250 mg (as trihydrate) (Amoxycillin AN) |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (Amoxiclav AN 500/125) |
Anastrozole | Tablet 1 mg (Anastrozole AN) |
Atenolol | Tablet 50 mg (Atenolol AN) |
Atorvastatin | Tablet 10 mg (as calcium) (Atorvastatin AN) |
Azathioprine | Tablet 50 mg (Azathioprine AN) |
Bicalutamide | Tablet 50 mg (Bicalutamide AN) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol AN) |
Calcitriol | Capsule 0.25 microgram (Calcitriol AN) |
Candesartan | Tablet containing candesartan cilexetil 4 mg (Candesartan AN) |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Candesartan HCTZ AN 16/12.5) |
Carvedilol | Tablet 3.125 mg (Carvedilol AN) |
Cephalexin | Capsule 250 mg (anhydrous) (Cephalexin AN) |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ciprofloxacin AN) |
Citalopram | Tablet 20 mg (as hydrobromide) (Citalopram AN) |
Clarithromycin | Tablet 250 mg (Clarithromycin AN) |
Clopidogrel | Tablet 75 mg (as hydrogen sulfate) (Clopidogrel AN) |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Cyproterone AN) |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg (Diltiazem AN) |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (Donepezil AN) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine AN) |
Escitalopram | Tablet 10 mg (as oxalate) (Escitalopram AN) |
Exemestane | Tablet 25 mg (Exemestane AN) |
Famciclovir | Tablet 125 mg (Famciclovir AN) |
Famotidine | Tablet 20 mg (Famotidine AN) |
Fludarabine | Powder for I.V. injection containing fludarabine phosphate 50 mg (Fludarabine ACT) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine AN) |
Frusemide | Tablet 20 mg (Frusemide AN) |
Gabapentin | Tablet 600 mg (Gabapentin AN) |
Glimepiride | Tablet 1 mg (Glimepiride AN) |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg (Indapamide AN) |
Irbesartan | Tablet 75 mg (Irbesartan AN) |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg (Irbesartan HCTZ AN 150/12.5) |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) (Isosorbide AN) |
Isotretinoin | Capsule 10 mg (Dermatane; Isotretinoin AN) |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg (Lercanidipine AN) |
Letrozole | Tablet 2.5 mg (Letrozole AN) |
Levetiracetam | Tablet 250 mg (Levetiracetam AN) |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets (Evelyn 150/30 ED) |
Lisinopril | Tablet 5 mg (Lisinopril AN) |
Meloxicam | Tablet 7.5 mg (Meloxicam AN) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Metformin AN) |
Mirtazapine | Tablet 15 mg (Mirtazapine AN) |
Moclobemide | Tablet 150 mg (Moclobemide AN) |
Montelukast | Tablet, chewable, 4 mg (as sodium) (Montelukast AN) |
Norfloxacin | Tablet 400 mg (Norfloxacin AN) |
Olanzapine | Tablet 2.5 mg (Olanzapine AN) |
Omeprazole | Tablet 20 mg (Omeprazole AN) |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) (Ondansetron AN) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole AN) |
Paroxetine | Tablet 20 mg (as hydrochloride (Paroxetine AN) |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone AN) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin AN) |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Prochlorperazine AN) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiapine AN) |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) (Rabeprazole AN) |
Ramipril | Tablet 1.25 mg (Ramipril AN) |
Risedronic Acid | Tablet containing risedronate sodium 35 mg (Risedronate AN) |
Risperidone | Tablet 0.5 mg (Risperidone AN) |
Rosuvastatin | Tablet 5 mg (as calcium) (Rosuvastatin AN) |
Simvastatin | Tablet 10 mg (Simvastatin AN) |
Sumatriptan | Tablet 50 mg (as succinate) (Sumatriptan AN) |
Telmisartan | Tablet 40 mg (APO-Telmisartan; Chem mart Telmisartan; Mizart; Pharmacor Telmisartan 40; Telmigen; Telmisartan AN; Telmisartan-DRLA; Telmisartan GH; Telmisartan Sandoz; Teltartan; Terry White Chemists Telmisartan) |
Telmisartan with Hydrochlorothiazide | Tablet 40 mg-12.5 mg (APO-Telmisartan HCTZ 40/12.5; Chem mart Telmisartan HCTZ 40/12.5; Mizart HCT; Telmigen HCT 40/12.5; Telmisartan/HCT Sandoz; Telmisartan HCTZ AN 40/12.5; Teltartan HCT 40/12.5; Terry White Chemists Telmisartan HCTZ 40/12.5) |
Temozolomide | Capsule 5 mg (Temozolomide AN) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine Actavis) |
Topiramate | Tablet 25 mg (Topiramate GH) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (Tramadol AN) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Valaciclovir Actavis; Valaciclovir AN) |
Valsartan | Tablet 40 mg (APO-Valsartan) |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) (Venlafaxine AN SR) |
Brands Deleted
Carboplatin | Solution for I.V. injection 50 mg in 5 mL (Carboplatin Ebewe) |
Cephazolin | Powder for injection 1 g (as sodium) (Cephazolin Alphapharm) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan SZ) |
Oxaliplatin | Powder for I.V. infusion 50 mg (Oxaliplatin Alphapharm) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Irbesartan | Tablet 75 mg | From: Irbesat GH To: Irbesartan GH |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg | From: Irbesatzide GH 150/12.5 To: Irbesartan HCT GH 150/12.5 From: Irbesatzide GH 300/12.5 To: Irbesartan HCT GH 300/12.5 To: Irbesartan HCT GH 300/25 |
Alteration of Brand Name and Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in | From: Epirubicin Actavis 50 To: Epirubicin ACT To: Epirubicin ACT | From: Actavis Pty Ltd (UA) To: Actavis Pty Ltd (VN) To: Actavis Pty Ltd (VN) |
Addition of Responsible Person Code
Amneal Pharmaceuticals Pty Ltd [EA] |
Alteration of Circumstances
Listed Drug | Alteration |
Adalimumab | Circumstances amended as a consequence of the listing of certolizumab pegol for the treatment of adults with active ankylosing spondylitis |
Certolizumab pegol | Circumstances amended to extend availability for the treatment of adults with active ankylosing spondylitis who meet certain criteria |
Etanercept | Circumstances amended as a consequence of the listing of certolizumab pegol for the treatment of adults with active ankylosing spondylitis |
Everolimus | Circumstances amended to extend availability for the treatment of stage IV clear cell variant renal cell carcinoma |
Golimumab | Circumstances amended as a consequence of the listing of certolizumab pegol for the treatment of adults with active ankylosing spondylitis |
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 2014
(No. 9)
(PB 61 of 2014)
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 2014
(No. 9) 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