EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2012 (No. 3)
PB 27 of 2012
Purpose
The purpose of this legislative instrument, made under sections 84AF, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 108 of 2010 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 and numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Authority
PB 108 of 2010 exercises numerous provisions 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)).
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).
Variation and revocation of subsection 85(2) declaration
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 108 of 2010 made by this instrument
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). These changes are summarised, by subject matter, in Attachment 2.
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, and agreement to final listing details.
Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.
General
A provision by provision description of this Instrument is contained in Attachment 1.
The Instrument commences on 1 May 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT 1
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2012 (No. 3)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3) and may also be cited as PB 27 of 2012.
Section 2 Commencement
This section provides that the Instrument commences on 1 May 2012.
Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
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 section 100 only status. These changes are summarised in Attachment 2.
ATTACHMENT 2
SUMMARY OF CHANGES
Forms Deleted
Cisplatin | I.V. injection 10 mg in 10 mL |
Darunavir | Tablet 300 mg (as ethanolate) |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial |
Etravirine | Tablet 100 mg |
Glucose Indicator—Blood | Test strips, 50 (Advantage II) |
Mitozantrone | Injection 10 mg (as hydrochloride) in 5 mL |
Naproxen | Oral suspension 125 mg per 5 mL, 474 mL |
Promethazine | Tablet containing promethazine hydrochloride 10 mg Tablet containing promethazine hydrochloride 25 mg Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL |
Brands Added
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Densate 70) |
Anastrozole | Tablet 1 mg (Anastrozole Synthon; Arianna) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Beprol 2.5) Tablet containing bisoprolol fumarate 5 mg (Beprol 5) Tablet containing bisoprolol fumarate 10 mg (Beprol 10) |
Doxorubicin – Pegylated Liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL (Lipodox) |
| Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL (Lipodox 50) |
Letrozole | Tablet 2.5 mg (Letrozole-Synthon) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Glucobete 500) Tablet containing metformin hydrochloride 850 mg (Glucobete 850) Tablet containing metformin hydrochloride 1 g (Glucobete 1000) |
Mirtazapine | Tablet 30 mg (Aurozapine 30) Tablet 45 mg (Aurozapine 45) Tablet 15 mg (orally disintegrating) (Milivin OD 15) Tablet 30 mg (orally disintegrating) (Milivin OD 30) Tablet 45 mg (orally disintegrating) (Milivin OD 45) |
Mycophenolic Acid | Tablet containing mycophenolate mofetil 500 mg (Pharmacor Mycophenolate 500) |
Olanzapine | Tablet 2.5 mg (as benzoate) (Olanzapine-Synthon) Tablet 5 mg (as benzoate) (Olanzapine-Synthon) Tablet 7.5 mg (as benzoate) (Olanzapine-Synthon) Tablet 10 mg (as benzoate) (Olanzapine-Synthon) Tablet 5 mg (orally disintegrating) (Olanzapine ODT generichealth 5; Tablet 10 mg (orally disintegrating) (Olanzapine ODT generichealth 10; |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) (Zilfojim 4) Tablet 8 mg (as hydrochloride dihydrate) (Zilfojim 8) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Torzole 20) Tablet (enteric coated) 40 mg (as sodium sesquihydrate) ((Torzole 40) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin Actavis 10) Tablet containing pravastatin sodium 20 mg (Pravastatin Actavis 20) Tablet containing pravastatin sodium 40 mg (Pravastatin Actavis 40) |
Quetiapine | Tablet 25 mg (as fumarate) (Seronia 25; Syquet) Tablet 100 mg (as fumarate) (Seronia 100; Syquet) Tablet 200 mg (as fumarate) (Seronia 200; Syquet) Tablet 300 mg (as fumarate) (Seronia 300; Syquet) |
Ramipril | Tablet 1.25 mg (Ramipril Tabs Pfizer; Vascalace 1.25) Tablet 2.5 mg (Ramipril Tabs Pfizer; Vascalace 2.5) Tablet 5 mg (Ramipril Tabs Pfizer; Vascalace 5) Tablet 10 mg (Ramipril Tabs Pfizer; Vascalace 10) |
Risperidone | Tablet 0.5 mg (Risperidone Actavis 0.5) Tablet 1 mg (Risperidone Actavis 1) Tablet 2 mg (Risperidone Actavis 2) Tablet 3 mg (Risperidone Actavis 3) Tablet 4 mg (Risperidone Actavis 4) |
Simvastatin | Tablet 10 mg (Synthon Simvastatin) Tablet 20 mg (Synthon Simvastatin) Tablet 40 mg (Simvastatin Sandoz; Synthon Simvastatin) Tablet 80 mg (Synthon Simvastatin) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Shilova 500) |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) (Altven) Capsule (modified release) 75 mg (as hydrochloride) (Altven) Capsule (modified release) 150 mg (as hydrochloride) (Altven) |
Brands Deleted
Carboplatin | Solution for I.V. injection 50 mg in 5 mL (Pfizer Australia Pty Ltd) |
Carvedilol | Tablet 3.125 mg (Kredex) |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial (Adriamycin Solution) |
Enalapril | Tablet containing enalapril maleate 5 mg (Enalapril Winthrop) Tablet containing enalapril maleate 10 mg (Enalapril Winthrop) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL (Pharmorubicin Solution) Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL (Pharmorubicin Solution) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Camptosar) |
Lisinopril | Tablet 5 mg (Lisinopril Winthrop) Tablet 10 mg (Lisinopril Winthrop) Tablet 20 mg (Lisinopril Winthrop) |
Mitozantrone | Injection 25 mg (as hydrochloride) in 12.5 mL (Pfizer Australia Pty Ltd) |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL (Pfizer Australia Pty Ltd) I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL (Pfizer Australia Pty Ltd) |
Oxaliplatin | Powder for I.V. infusion 100 mg (Winthrop Oxaliplatin) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertraline Winthrop) |
Topiramate | Tablet 25 mg (Topiramate generichealth) Tablet 50 mg (Topiramate generichealth) Tablet 100 mg (Topiramate generichealth) Tablet 200 mg (Topiramate generichealth) |
Vincristine | I.V. injection containing vincristine sulfate 1 mg in 1 mL (Pfizer Australia Pty Ltd) |
Alteration of Brand
Quinapril | Tablet 5 mg (as hydrochloride) | From: Filpril To: Quinapril Pfizer |
| Tablet 10 mg (as hydrochloride) | From: Filpril To: Quinapril Pfizer |
| Tablet 20 mg (as hydrochloride) | From: Filpril To: Quinapril Pfizer |
Alteration of Responsible Person Code (no change to Responsible Person)
Listed Drug | Form | Brand | Responsible Person Code |
Simvastatin | Tablet 40 mg | Simvahexal | From: SZ To: HX |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Bicalutamide | Tablet 50 mg | Cosudex | From: AstraZeneca Pty Ltd (AP) To: Sandoz Pty Ltd (SZ) |
Bivalirudin | Powder for I.V. injection 250 mg (as trifluoroacetate) | Angiomax | From: CSL Limited (CS) To: The Medicines Company (Australia) Pty Limited (XM) |
Pimecrolimus | Cream 10 mg per g, 15 g | Elidel | From: To: |
Addition of Responsible Person Code
HM [Meda Pharmaceuticals Pty Ltd] |
XM [The Medicines Company (Australia) Pty Limited] |
ZT [Synthon A.U. Pty Ltd] |
Name change for Responsible Person
YM [From: Genzyme Australia Pty Ltd To: sanofi-aventis Australia Pty Ltd] |
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 2012
(No. 3)
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 2012
(No. 3) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 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, and whether the pharmaceutical benefit is to be available only under special arrangements).
Human rights implications
This legislative instrument engages Article 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.
Kim Bessell
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing