National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 63 of 2009)

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Legislation au F2009L02706 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 63 OF 2009

NATIONAL HEALTH ACT 1953

DETERMINATIONS UNDER SECTIONS 85, 85A and 88

 

Purpose and operation

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2).  These are listed drugs as defined in subsection 84(1).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.

Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).

Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item.  A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item,  or if there is no trade name, the name of the responsible person.  The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.

Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit.  Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose.  Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose.  Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used. 

Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits.  Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.

This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).    

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 114 of 2008 which came into effect on 1 December 2008.  The amendments are set out in the items of Schedule 1 to the instrument.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 August 2009, was made on 6 July 2009.


Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.

The PBAC is an independent expert body established by section 100A 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the 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.

 

ATTACHMENT

Paragraph 1: provides that this instrument commences on 1 August 2009.

Paragraph 2: provides that Schedule 1 amends PB 114 of 2008.

Schedule 1: provides for the following amendments:

 

 

SCHEDULE 1 ― PART 1

 

Listed Drugs Added

Arsenic

Bimatoprost with timolol

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Praziquantel

Rivaroxaban

Sitagliptin with metformin

Soy lecithin

 

Forms Added

Etanercept

Injection 50 mg in 1 mL single use injection pen, 4

Gemcitabine

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL

Glucose

I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL

I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL

I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL

Glucose Indicator―Blood

Electrode strips, 50 (MyGlucoHealth)

Oxybutynin

Transdermal patches 36 mg, 8

Sodium Chloride

I.V. infusion 38.5 mmol per 250 mL, 250 mL

I.V. infusion 77 mmol per 500 mL, 500 mL

Voriconazole

Powder for oral suspension 40 mg per mL, 70 mL

 

Alteration of Form

Teriparatide

From:

Injection 250 micrograms per mL, 3 mL in multi-dose pre-filled pen

To:

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

 

Brands Added

Amoxycillin with Clavulanic Acid

Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (APO-Amoxycillin/Clavulanic Acid 500/125)

Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (Curam)

Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
(Curam Duo)

Azithromycin

Tablet 500 mg (as dihydrate) (Azithromycin Sandoz)

Bisoprolol

Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol Sandoz, Bispro 2.5)

Tablet containing bisoprolol fumarate 5 mg (Bisoprolol Sandoz, Bispro 5)

Tablet containing bisoprolol fumarate 10 mg (Bisoprolol Sandoz, Bispro 10)

Cabergoline

Tablet 500 micrograms (Tinexa)

Tablet 1 mg (Bergoline 1)

Tablet 2 mg (Bergoline 2)

Citalopram

Tablet 20 mg (as hydrobromide) (APO-Citalopram)

Clarithromycin

Tablet 250 mg (APO-Clarithromycin)

Codeine with Paracetamol

Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
(APO-Paracetamol/Codeine 500/30)

Escitalopram

Tablet 10 mg (as oxalate) (Lexam 10)

Tablet 20 mg (as oxalate) (Lexam 20)

Glucose

I.V. infusion 278 mmol (anhydrous) per L, 1 L (B. Braun Australia Pty Ltd)

Lisinopril

Tablet 20 mg (Lisinopril Sandoz)

Morphine

Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10)

Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30)

Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60)

Tablet containing morphine sulfate 100 mg (controlled release)
(Momex SR 100)

Nifedipine

Tablet 30 mg (controlled release) (APO-Nifedipine XR)

Tablet 60 mg (controlled release) (APO-Nifedipine XR)

Paclitaxel

Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Actavis)

Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Paclitaxel Actavis)

Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Actavis)

Solution concentrate for I.V. infusion 300 mg in 50 mL (Paclitaxel Actavis)

Paracetamol

Tablet 500 mg (APO-Paracetamol)

Paroxetine

Tablet 20 mg (as hydrochloride) (Paroxetine-GA)

Ramipril

Tablet 1.25 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril)

Tablet 2.5 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril)

Tablet 5 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril)

Tablet 10 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril)

Sodium Chloride

I.V. infusion 154 mmol per L, 1 L (B. Braun Australia Pty Ltd)

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), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL (Pharmatel Fresenius Kabi Pty Limited)

I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride),
29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L
(B. Braun Australia Pty Ltd)

Temazepam

Tablet 10 mg (APO-Temazepam)

 

Alteration of Brands

Insulin Lispro

Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

From:

Humalog Pen

To:

Humalog KwikPen

Insulin Lispro with Insulin Lispro Protamine Suspension

Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5

From:

Humalog Mix25 Pen

To:

Humalog Mix25 KwikPen

Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5

From:

Humalog Mix50 Pen

To:

Humalog Mix50 KwikPen

 

Forms Deleted

Chorionic Gonadotrophin

Injection set containing 3 ampoules powder for injection 500 units and
3 ampoules solvent 1 mL

Glucose Indicator―Blood

Electrode strips, 100 (TrueSense)

 

Brands Deleted

Bisacodyl

Suppositories 10 mg, 12 (Fleet Laxative Suppositories)

Paracetamol

Tablet 500 mg (Parmol)

 

 

SCHEDULE 1 ― PART 2

Listed Drug Added

Rivaroxaban

 

Forms Added

Etanercept

Injection 50 mg in 1 mL single use injection pen, 4

Glucose Indicator―Blood

Electrode strips, 50 (MyGlucoHealth)

 

Brands Added

Azithromycin

Tablet 500 mg (as dihydrate) (Azithromycin Sandoz)

Cabergoline

Tablet 500 micrograms (Tinexa)

Codeine with Paracetamol

Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
(APO-Paracetamol/Codeine 500/30)

Escitalopram

Tablet 10 mg (as oxalate) (Lexam 10)

Tablet 20 mg (as oxalate) (Lexam 20)

Morphine

Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10)

Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30)

Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60)

Tablet containing morphine sulfate 100 mg (controlled release)
(Momex SR 100)

Paracetamol

Tablet 500 mg (APO-Paracetamol)

Temazepam

Tablet 10 mg (APO-Temazepam)

 

Listed Drug Deleted

Chorionic Gonadotrophin

 

Form Deleted

Glucose Indicator―Blood

Electrode strips, 100 (TrueSense)

 

Brand Deleted

Paracetamol

Tablet 500 mg (Parmol)

 

 

SCHEDULE 2 ― PART 1

Listed Drug Added

Hypromellose

 

Brand Added

Temazepam

Tablet 10 mg (APO-Temazepam)

 

Brand Deleted

Bisacodyl

Suppositories 10 mg, 12 (Fleet Laxative Suppositories)

 

 

SCHEDULE 2 ― PART 2

Listed Drug Added

Hypromellose

 

Brand Added

Temazepam

Tablet 10 mg (APO-Temazepam)

 

Brand Deleted

Bisacodyl

Suppositories 10 mg, 12 (Fleet Laxative Suppositories)

 

 

SCHEDULE 3 ― PART 1

Forms Added

Glucose

I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL

Sodium Chloride

I.V. infusion 77 mmol per 500 mL, 500 mL

 

Brands Added

Amoxycillin with Clavulanic Acid

Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (APO-Amoxycillin/Clavulanic Acid 500/125)

Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (Curam)

Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
(Curam Duo)

Codeine with Paracetamol

Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
(APO-Paracetamol/Codeine 500/30)

Glucose

I.V. infusion 278 mmol (anhydrous) per L, 1 L (B. Braun Australia Pty Ltd)

Morphine

Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10)

Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30)

Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60)

Tablet containing morphine sulfate 100 mg (controlled release)
(Momex SR 100)

Paracetamol

Tablet 500 mg (APO-Paracetamol)

Sodium Chloride

I.V. infusion 154 mmol per L, 1 L (B. Braun Australia Pty Ltd)

Temazepam

Tablet 10 mg (APO-Temazepam)

 

Brand Deleted

Paracetamol

Tablet 500 mg (Parmol)

 

SCHEDULE 3 ― PART 2

Brand Added

Paracetamol

Tablet 500 mg (APO-Paracetamol)

 

Brand Deleted

Paracetamol

Tablet 500 mg (Parmol)

 

Overview

The National Health Act 1953, enacted by the Commonwealth of Australia, establishes the Pharmaceutical Benefits Scheme (PBS) which provides Australians with reliable, timely, and affordable access to a wide range of medicines. This legislation was introduced to address the need for a structured and funded system to make essential medications accessible to the general public. The enactment of this Act was overseen by the Parliament of Australia, with the primary policy objective being to ensure the provision of affordable and necessary pharmaceutical benefits to all Australians. The explanatory statement outlines amendments to the PBS, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which include updates to listed drugs, forms, and brands, and modifications to prescription regulations. These changes aim to enhance the effectiveness, safety, and cost-efficiency of the medications covered under the PBS.

Scope and Application

The legislative instrument F2009L02706 pertains to the National Health Act 1953, specifically focusing on the Pharmaceutical Benefits Scheme (PBS). The Act applies to the Commonwealth, which provides pharmaceutical benefits to all Australians through the PBS. These benefits are provided in accordance with Part VII of the Act, which encompasses the declaration of listed drugs and certain extemporaneously-prepared medicinal preparations by the Minister. The Act also authorises the Minister to determine various aspects of these listed drugs, such as their form, manner of administration, and brand, as well as matters relating to the writing of prescriptions by specified classes of persons. The instrument amends previous determinations to include new listed drugs, forms, and brands, and to modify existing entries. The amendments reflect recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), which advises the Minister on the inclusion of medicines on the PBS based on clinical effectiveness, safety, and cost-effectiveness. The instrument, which commenced on 1 August 2009, includes a schedule detailing the specific changes to be made to the listed drugs, forms, and brands covered under the PBS. The geographic reach of the Act is national, applying to all Australians, and it extends to various subordinate instruments as authorised by the Act.

Key Provisions

The National Health Act 1953, specifically under sections 85, 85A, and 88, governs the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth ensures access to a wide range of affordable medicines. Under subsection 85(1), the Commonwealth is mandated to provide benefits as outlined in Part VII of the Act. The Minister is authorised by subsection 85(2) to declare by legislative instrument which drugs and medicinal preparations are listed, thus eligible for PBS benefits. Subsection 85(3) allows the Minister to determine the form of a listed drug by reference to strength, type of unit, size of unit, or otherwise. Furthermore, subsection 85(5) permits the Minister to specify the manner of administration for these forms. Under subsection 85(6), the Minister can also determine a brand of a pharmaceutical item, defined as the trade name or the name of the responsible person if there is no trade name. Subsection 85A(2) authorises the Minister to determine various prescription-related matters, such as the maximum quantity or number of units that can be supplied in one prescription, the maximum number of occasions for which the supply may be repeated, and the manner of administration. The Act imposes several obligations on parties and entities it governs. Firstly, the Minister must ensure that the list of drugs eligible for PBS benefits is accurately and comprehensively maintained, as per the declarations under subsection 85(2). The Minister must also make determinations regarding the forms of listed drugs, their administration, and brands under subsections 85(3), 85(5), and 85(6) respectively. Furthermore, the Minister must regulate prescription-related matters such as the maximum quantities, repetitions, and administration methods under subsection 85A(2). The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body, plays a crucial role in advising the Minister on which drugs should be listed on the PBS, taking into account their medical efficacy, safety, and cost-effectiveness. Failure to comply with the provisions of the National Health Act 1953 may result in various consequences. While the Act does not explicitly outline specific offences or penalties for breaches, it is understood that violations could lead to legal actions under other relevant legislation or regulations. Penalties could include fines, imprisonment, or other civil or criminal sanctions, depending on the nature and severity of the breach. The precise penalties would be determined by the applicable laws under which the prosecution is made. In summary, the National Health Act 1953, through its sections 85, 85A, and 88, sets out the framework for the PBS, requiring the Minister to declare and determine various aspects of pharmaceutical benefits, ensuring their provision is both effective and affordable. The obligations placed on the Minister and other entities ensure that the PBS operates efficiently and fairly, with the PBAC providing expert advice. While the Act does not explicitly state penalties for non-compliance, breaches could lead to legal consequences under other relevant laws.

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