EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2014 (No. 13)
PB 101 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 January 2015.
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. 13)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13) and may also be cited as PB 101 of 2014.
Section 2 Commencement
This section provides that this Instrument commences on 1 January 2015.
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 Drugs Added
Empagliflozin |
Ezetimibe and rosuvastatin |
Listed Drug Deleted
Sodium Chloride Compound |
Form Added
Oestradiol | Pessary (modified release) 10 micrograms (as hemihydrate) |
Forms Deleted
Docetaxel | Powder for I.V. infusion 20 mg with solvent |
Lignocaine | Injection containing lignocaine hydrochloride 100 mg in 5 mL |
Sodium Chloride | I.V. infusion 513 mmol per L, 1 L |
Sodium Chloride with Glucose | I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL |
Brands Added
Amlodipine | Tablet 5 mg (as besylate) (Pharmacor Amlodipine) |
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) (Esomeprazole Actavis; Esomeprazole Apotex) |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets (Eleanor 150/30 ED) |
Paracetamol | Tablet 665 mg (modified release) (APO-Osteo Paracetamol 665 mg; Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg; Chem mart Pharmacy Osteo Relief Paracetamol 665 mg; Terry White Chemists Osteo Relief Paracetamol 665 mg) |
Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms |
Risperidone | Tablet 0.5 mg (Risperidone Actavis 0.5) |
Sildenafil | Tablet 20 mg (as citrate) (SILDENAFIL-DRx) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine AN) |
Brands Deleted
Baclofen | Tablet 25 mg (Terry White Chemists Baclofen) |
Cromoglycic Acid | Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL (Cromolux) |
Nifedipine | Tablet 20 mg (Nifehexal) |
Raloxifene | Tablet containing raloxifene hydrochloride 60 mg (Raloxifene AN) |
Risedronic Acid and Calcium | Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate) (Risedronate Winthrop EC Combi) |
Risedronic acid and calcium with colecalciferol | Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms (Risedronate Winthrop EC Combi D) |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Ampicillin | Powder for injection 1 g (as sodium) | From: Aspen Ampicyn To: Ampicyn |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person |
Clarithromycin | Tablet 250 mg | Klacid | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Epoetin Lambda | Injection 1,000 units in 0.5 mL pre-filled syringe | Novicrit | From: Novartis Pharmaceuticals Australia Pty Limited (NV) To: Sandoz Pty Ltd (SZ) |
Eprosartan | Tablet 400 mg (as mesylate) | Teveten | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Eprosartan with Hydrochlorothiazide | Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide | Teveten Plus 600/12.5 | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Fenofibrate | Tablet 48 mg | Lipidil | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Luvox | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Glucose Indicator—Blood | Test strips, 50 (CareSens) | CareSens | From: Life Bioscience Pty Ltd (LB) To: Pharmaco (Australia) Ltd (PB) |
Ibuprofen | Tablet 400 mg | Brufen | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Zanidip | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Lercanidipine with enalapril | Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg | Zan-Extra 10/10 | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Moxonidine | Tablet 200 micrograms | Physiotens | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Oestradiol | Tablet 2 mg | Zumenon | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Oestradiol and Oestradiol with Dydrogesterone | Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg | Femoston 1/10 | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO)
|
Oestradiol with dydrogesterone | Tablet 1 mg-5 mg | Femoston-Conti | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Pancreatic Extract | Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g | Creon Micro | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity | Creon 10,000 | ||
Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity | Creon 25,000 | ||
Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity | Creon 40,000 | ||
Risedronic Acid | Tablet containing risedronate sodium | Actonel | From: sanofi-aventis Australia Pty Ltd (SW) To: Actavis Pty Ltd (UA) |
Risedronic Acid and Calcium | Pack containing 4 enteric coated tablets risedronate sodium | Actonel EC Combi | From: sanofi-aventis Australia Pty Ltd (SW) To: Actavis Pty Ltd (UA) |
Risedronic acid and calcium with colecalciferol | Pack containing 4 enteric coated tablets risedronate sodium | Actonel EC Combi D | From: sanofi-aventis Australia Pty Ltd (SW) To: Actavis Pty Ltd (UA) |
Trandolapril | Capsule 500 micrograms | Gopten | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Trandolapril with Verapamil | Tablet containing trandolapril | Tarka 2/180 | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO)
|
Verapamil | Tablet containing verapamil hydrochloride 80 mg | Isoptin | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
| Tablet containing verapamil hydrochloride 180 mg (sustained release) | Cordilox 180 SR | From: Abbott Australasia Pty Ltd (KN) To: BGP Products Pty Ltd (GT) |
| Tablet containing verapamil hydrochloride 180 mg (sustained release) | Isoptin 180 SR | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Cordilox SR | From: Abbott Australasia Pty Ltd (KN) To: BGP Products Pty Ltd (GT) |
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Isoptin SR | From: Abbott Australasia Pty Ltd (AB) To: BGP Products Pty Ltd (GO) |
Addition of Responsible Person Code
BGP Products Pty Ltd [GO] |
BGP Products Pty Ltd [GT] |
Pharmaco (Australia) Limited [PB] |
Deletion of Responsible Person Code
Abbott Australasia Pty Ltd [KN] |
Life Bioscience Pty Ltd [LB] |
Alteration of Circumstances
Listed Drug | Alteration |
Canagliflozin | Circumstances remodelled following the listing of empagliflozin |
Cetuximab | Circumstances amended to include only patients with RAS wild-type metastatic colorectal cancer (rather than KRAS wild-type metastatic colorectal cancer as previously) |
Etanercept | Restriction relating to rheumatoid arthritis has been remodelled |
Panitumumab | Circumstances amended to include only patients with RAS wild-type metastatic colorectal cancer (rather than KRAS wild-type metastatic colorectal cancer as previously) |
Phenoxybenzamine | Circumstances amended to now comply with authority required procedures |
Sapropterin | Circumstances amended to correct the criteria for continuing treatment |
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. 13)
(PB 101 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. 13) 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