EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listing of Pharmaceutical Benefits)
Amendment Instrument 2012 (No. 4)
PB 33 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 June 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. 4)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 4) and may also be cited as PB 33 of 2012.
Section 2 Commencement
This section provides that the Instrument commences on 1 June 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
Listed Drug Added
Tenofovir with emtricitabine and rilpivirine |
Forms Added
Glucose Indicator—Blood | Test strips, 100 - (Contour) |
Forms Deleted
Amoxycillin | Sachet containing oral powder 3 g (as trihydrate) |
Brands Added
Amlodipine with Atorvastatin | Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) (Cadatin 5/10) Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) (Cadatin 5/20) Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) (Cadatin 5/40) Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) (Cadatin 5/80) Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) (Cadatin 10/10) Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) (Cadatin 10/20) Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) (Cadatin 10/40) Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) (Cadatin 10/80) |
Atorvastatin | Tablet 10 mg (as calcium) (APO-Atorvastatin; Atorvachol; Atorvastatin GH; Atorvastatin Sandoz; Chem mart Atorvastatin; Lorstat 10; Terry White Chemists Atorvastatin; Torvastat 10) Tablet 20 mg (as calcium) (APO-Atorvastatin; Atorvachol; Atorvastatin GH; Atorvastatin Sandoz; Chem mart Atorvastatin; Lorstat 20; Terry White Chemists Atorvastatin; Torvastat 20) Tablet 40 mg (as calcium) (APO-Atorvastatin; Atorvachol; Atorvastatin GH; Atorvastatin Sandoz; Chem mart Atorvastatin; Lorstat 40; Terry White Chemists Atorvastatin; Torvastat 40) Tablet 80 mg (as calcium) (APO-Atorvastatin; Atorvachol; Atorvastatin GH; Atorvastatin Sandoz; Chem mart Atorvastatin; Lorstat 80; Terry White Chemists Atorvastatin; Torvastat 80) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Biso 2.5) Tablet containing bisoprolol fumarate 5 mg (Biso 5) Tablet containing bisoprolol fumarate 10 mg (Biso 10) |
Carvedilol | Tablet 3.125 mg (Volirop 3.125) Tablet 6.25 mg (Volirop 6.25) Tablet 12.5 mg (Volirop 12.5) Tablet 25 mg (Volirop 25) |
Cephazolin | Powder for injection 500 mg (as sodium) (Cefazolin-AFT) Powder for injection 1 g (as sodium) (Cefazolin-AFT) |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg (Diltiazem Sandoz CD) |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (Gemaccord) Powder for I.V. infusion 1 g (as hydrochloride) (Gemaccord) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinoccord) I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinoccord) |
Lamotrigine | Tablet 25 mg (Torlemo DT 25) Tablet 50 mg (Torlemo DT 50) Tablet 100 mg (Torlemo DT 100) Tablet 200 mg (Torlemo DT 200) |
Mycophenolic Acid | Capsule containing mycophenolate mofetil 250 mg (Phamacor Mycophenolate 250) |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL (Oxaliccord) Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliccord) |
Paroxetine | Tablet 20 mg (as hydrochloride) (Roxet 20) Tablet 20 mg (as mesilate) (Paroxetine Synthon) |
Simvastatin | Tablet 5 mg (Simvastatin Sandoz) Tablet 10 mg (Simvastatin Sandoz) Tablet 20 mg (Simvastatin Sandoz) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Valaciclovir Pfizer) |
Brands Deleted
Anastrozole | Tablet 1 mg (Anastrozole LW) |
Carvedilol | Tablet 3.125 mg (Dilasig 3.125) Tablet 6.25 mg (Dilasig 6.25) Tablet 12.5 mg (Dilasig 12.5) Tablet 25 mg (Dilasig 25) |
Fluconazole | Capsule 50 mg (Fluzole 50) |
Fosinopril | Tablet containing fosinopril sodium 10 mg (Fosinopril Sandoz) Tablet containing fosinopril sodium 20 mg (Fosinopril Sandoz) |
Fosinopril with Hydrochorothiazide | Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Sandoz 10mg/12.5mg) Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Sandoz 20mg/12.5mg) |
Alteration of Responsible Person Code (no change to Responsible Person)
Listed Drug | Form | Brand | Responsible Person Code |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg | Diltahexal CD | From: SZ To:HX |
Simvastatin | Tablet 5 mg | Simvahexal | From: SZ To:HX |
| Tablet 10 mg | Simvahexal | From: SZ To:HX |
| Tablet 20 mg | Simvahexal | From: SZ To:HX |
Addition of Responsible Person Code
IK [Medtronic Australasia 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. 4)
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. 4) 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.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing