EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 9)
PB 40 of 2013
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88, 99AEH, 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)).
Subsection 99AEH – delisting of guaranteed brand of guaranteed item
Paragraph 99AEH(2)(a) of the Act allows the Minister, by legislative instrument, to revoke a subsection 85(6) determination that a guaranteed brand of a guaranteed item is a listed brand where a responsible person for a guaranteed brand is unable to supply the guaranteed brand on one or more occasions.
The Minister’s delegate, having had regard to matters set out in subsection 99AEH(3) of the Act, is delisting the Gemcitabine Actavis 2000 brand of the listed drug gemcitabine in the form powder for I.V. infusion 2 g (as hydrochloride).The delisting will not impact the availability of this strength of gemcitabine to patients as other substitutable brands are available on the PBS. The drug company is able to apply to relist the brand on the PBS with appropriate assurances of continuity of supply.
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 August 2013.
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 2013 (No. 9)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9) and may also be cited as PB 40 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2013.
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
Addition of Listed Drugs
Abiraterone |
Glycomacropeptide and essential amino acids |
Glycomacropeptide and essential amino acids with vitamins and minerals |
Ipilimumab |
Mifepristone |
Alteration of Listed Drug Name
From: “BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain) To: Bacillus Calmette and Guerin, Connaught strain |
From: “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain) To: Bacillus Calmette and Guerin, Tice strain |
Forms Added
Amino acid formula with vitamins and minerals without methionine | Oral liquid 87 mL, 30 (HCU cooler 10) |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Oral liquid 87 mL, 30 (TYR cooler 10) |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Oral liquid 87 mL, 30 (MSUD cooler 10) |
Diazepam | Oral liquid 1 mg in 1 mL, 100 mL |
Glucose Indicator―Blood | Test strips, 50 (OneTouch Select) |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal 3:1) |
Brands Added
Atorvastatin | Tablet 10 mg (as calcium) (Atorvastatin SZ) |
Candesartan | Tablet containing candesartan cilexetil 4 mg (Adesan; APO-Candesartan; |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Adesan HCT 16/12.5; APO-Candesartan HCTZ 16/12.5; Candesartan Combi Aspen 16/12.5; Candesartan HCT GH 16/12.5; Candesartan HCTZ-GA 16/12.5; STADA Candesartan HCT 16/12.5) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Duloxetine DR GH) |
Famciclovir | Tablet 250 mg (Famlo) |
Gemcitabine | Powder for I.V. infusion 2 g (as hydrochloride) (Gemcitabine Actavis 2000) |
Lamivudine with Zidovudine | Tablet 150 mg-300 mg (Lamivudine 150mg + Zidovudine 300mg Alphapharm) |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 (LaxaCon) |
Metoprolol | Tablet containing metoprolol tartrate 50 mg (APO-Metoprolol) |
Mirtazapine | Tablet 30 mg (Mirtazapine-GA) |
Misoprostol | Tablet 200 micrograms (GyMiso) [see also Alteration of Circumstances] |
Montelukast | Tablet, chewable, 4 mg (as sodium) (APO-Montelukast; Chem mart Montelukast; Lukair; Montair 4; Montelukast GH; Montelukast RBX; Montelukast Sandoz 4; Respikast 4; Terry White Chemists Montelukast) |
Rosuvastatin | Tablet 5 mg (as calcium) (Cavstat; Rostor 5; Rosuvastatin GH) |
Telmisartan with Hydrochlorothiazide | Tablet 40 mg-12.5 mg (Pritor Plus 40/12.5mg) |
Brands Deleted
Amlodipine | Tablet 5 mg (as besylate) (Pharmacor Amlodipine 5) |
Anastrozole | Tablet 1 mg (Anastrozole-Synthon) |
Carvedilol | Tablet 25 mg (GenRx Carvedilol) |
Cephalexin | Capsule 250 mg (anhydrous) (Cephatrust 250) |
Citalopram | Tablet 20 mg (as hydrobromide) (Citalopram 20) |
Gemcitabine | Powder for I.V. infusion 2 g (as hydrochloride) (Gemcitabine Actavis 2000) |
Gemfibrozil | Tablet 600 mg (Pharmacor Gemfibrozil 600) |
Glimepiride | Tablet 1 mg (Pharmacor Glimepiride 1) |
Letrozole | Tablet 2.5 mg (Letrozole-Synthon) |
Lisinopril | Tablet 5 mg (Lisinopril 5) |
Norfloxacin | Tablet 400 mg (Chem mart Norfloxacin; Terry White Chemists Norfloxacin) |
Olanzapine | Tablet 2.5 mg (as benzoate) (Olanzapine-Synthon) |
Paroxetine | Tablet 20 mg (as hydrochloride) (Paroxetine 20) |
Perindopril | Tablet containing perindopril erbumine 2 mg (Perindopril 2) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiapine-Synthon) |
Quinapril | Tablet 5 mg (as hydrochloride) (Pharmacor Quinapril 5) |
Ramipril | Capsule 1.25 mg (Pharmacor Ramipril 1.25) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertraline 50) |
Simvastatin | Tablet 10 mg (Pharmacor Simvastatin 10; Synthon Simvastatin) |
Terbinafine | Tablet 250 mg (as hydrochloride) (Terbinafine 250) |
Alteration of Form and Brand Name
Listed Drug | Form | Brand Name |
Amino acid formula with vitamins and minerals without methionine | From: Oral liquid 130 mL, 30 (HCU Cooler) To: Oral liquid 130 mL, 30 (HCU cooler 15) | From: HCU Cooler To: HCU cooler 15 |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | From: Oral liquid 130 mL, 30 (TYR Cooler) To: Oral liquid 130 mL, 30 (TYR cooler 15) | From: TYR Cooler To: TYR cooler 15 |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | From: Oral liquid 130 mL, 30 (MSUD Cooler) To: Oral liquid 130 mL, 30 (MSUD cooler 15) | From: MSUD Cooler To: MSUD cooler 15 |
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | From: Oral liquid 130 mL, 30 (MMA/PA cooler) To: Oral liquid 130 mL, 30 (MMA/PA cooler 15) | From: MMA/PA cooler To: MMA/PA cooler 15 |
Alteration of Description of Form, Maximum Quantity and Pack Quantity
Listed Drug | Form | Maximum Quantity | Pack Quantity |
Lacosamine | From: Tablets 100 mg, 14 To: Tablet 100 mg From: Tablets 150 mg, 14 To: Tablet 150 mg | From: 1 To: 14 From: 1 To: 14 | From: 1 To: 14 From: 1 To: 14 |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Progesterone | Pessary 100 mg
| From: Orion Laboratories Pty Ltd To: Oripro From: Orion Laboratories Pty Ltd To: Oripro |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Citalopram | Tablet 20 mg (as hydrobromide) | Pharmacor Citalo 20 | From: Meditech Int. Pty Ltd (MI) To: Pharmacor Pty Limited (CR) |
Clopidogrel | Tablet 75 mg (as hydrogen sulfate) | Plavicor 75 | From: Meditech Int. Pty Ltd (MI) To: Pharmacor Pty Limited (CR) |
Felodipine | Tablet 2.5 mg (extended release) | Felodur ER 2.5 mg | From: AstraZeneca Pty Ltd (ZA) To: Apotex Pty Ltd (TX) |
Lamotrigine | Tablet 25 mg | Lamotrust 25 | From: Meditech Int. Pty Ltd (MI) To: Pharmacor Pty Limited (CR) |
Omeprazole | Tablet 20 mg (as magnesium) | Omepral | From: Pharmaceutical Manufacturing Company Pty Limited (PM) To: Apotex Pty Ltd (TX) |
Sertraline | Tablet 50 mg (as hydrochloride) | Sertracor 50 | From: Meditech Int. Pty Ltd (MI) To: Pharmacor Pty Limited (CR) |
Addition of Responsible Person Code
Boehringer Ingelheim Pty Ltd [FI] |
Cortex Health Pty Ltd [QH] |
MS Health Pty Ltd [XH] |
Deletion of Responsible Person Code
AstraZeneca Pty Ltd [ZA] |
Synthon A.U. Pty Ltd [ZT] |
Alteration of Circumstances
Listed Drug | Alteration |
Cabazitaxel | Circumstances amended as a consequence of the listing of abiraterone |
Cephalexin | A differential listing of cephalexin capsule 250 mg (anhydrous) is made available for prophylaxis of urinary tract infection (streamlined authority) |
Docetaxel | Circumstances amended as a consequence of the listing of abiraterone |
Lacosamide | Circumstances changed from “Authority Required” to “Authority Required―Streamlined” |
Misoprostol | Circumstances amended to extend availability to reflect a differential listing of misoprostol (brand GyMiso) for use in the termination of an intra-uterine pregnancy |
Risedronic Acid | Circumstances amended to the effect that a patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less, instead of a BMD T-score of -3.0 or less |
Risedronic Acid and Calcium | Circumstances amended to the effect that a patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less, instead of a BMD T-score of -3.0 or less |
Risedronic acid and calcium with colecalciferol | Circumstances amended to the effect that a patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less, instead of a BMD T-score of -3.0 or less |
Rivaroxaban | Circumstances amended in respect of the tablet 15 mg and tablet 20 mg only to extend availability for the prevention of stroke or embolism in non-valvular atrial fibrillation |
Strontium | Circumstances amended to remove the indication relating to osteoporosis in a patient aged 70 years or older |
Trimethoprim | A differential listing of trimethoprim tablet 300 mg is made available for prophylaxis of urinary tract infection (streamlined authority) |
Vinorelbine | Circumstances amended to extend availability for the treatment of advanced breast cancer |
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 2013
(No. 9)
(PB 40 of 2013)
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 2013
(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 and Ageing