National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 107 of 2009)

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Legislation au F2009L04284 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 107 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 provide for changes to the names, forms, manners of administration, and brands of listed drugs on the PBS and the conditions for prescribing pharmaceutical benefits.  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 December 2009, was made on 12 November 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 December 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

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

Artemether with lumefantrine

Calcipotriol with betamethasone

Clopidogrel with aspirin

Hydroxyethyl starch 130/0.4

Polyethylene glycol 400

Prasugrel

 

Forms Added

Calcium

Tablet 600 mg (as carbonate)

Glucose Indicator—Blood

Reagent strips, 50 (Lifeline Attest)

Olanzapine

Powder for injection 210 mg (as pamoate monohydrate) with diluent

Powder for injection 300 mg (as pamoate monohydrate) with diluent

 

Brands Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (APO-Diclofenac)

Glucose

I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL (Glucose 5% Freeflex)

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan Alphapharm)

I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Alphapharm)

Quinapril

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

Simvastatin

Tablet 20 mg (Simvastatin-GA 20)

Tablet 40 mg (Simvastatin-GA 40)

Tablet 80 mg (Simvastatin-GA 80)

Sodium Chloride

I.V. infusion 38.5 mmol per 250 mL, 250 mL (Sodium Chloride 0.9% Freeflex)

Topiramate

Tablet 25 mg (Epiramax 25)

Tablet 50 mg (Epiramax 50)

Tablet 100 mg (Epiramax 100)

Tablet 200 mg (Epiramax 200)

Tramadol

Injection containing tramadol hydrochloride 100 mg in 2 mL (Tramahexal)

Valproic Acid

Tablet (enteric coated) containing sodium valproate 200 mg (Valprease 200)

Tablet (enteric coated) containing sodium valproate 500 mg (Valprease 500)

 

 

Alteration of Brands

Fluconazole

Capsule 100 mg

From:

Fluconazole Hexal

To:

Fluconazole Sandoz

Fluconazole

Capsule 200 mg

From:

Fluconazole Hexal

To:

Fluconazole Sandoz

Paracetamol

Tablet 500 mg

From:

Chem mart Chemadol

To:

Chem mart Paracetamol

 

Listed Drug Deleted

Tamarindus indica seed polysaccharide

 

Forms Deleted

Calcipotriol

Ointment 50 micrograms per g, 30 g

Paliperidone

Tablet 12 mg (prolonged release)

 

Brands Deleted

Cabergoline

Tablet 500 micrograms (Tinexa)

Cimetidine

Tablet 200 mg (Tagamet)

Paroxetine

Tablet 20 mg (as hydrochloride) (Paroxetine Winthrop)

Quinine

Tablet containing quinine sulfate 300 mg (Quinsul)

Sertraline

Tablet 100 mg (as hydrochloride) (Sertraline Winthrop)

 

 

SCHEDULE 1 ― PART 2

Listed Drug Added

Polyethylene glycol 400

 

Form Added

Glucose Indicator—Blood

Reagent strips, 50 (Lifeline Attest)

 

Alteration of Purpose

Pramipexole (in respect of the tablet containing pramipexole hydrochloride 250 micrograms)

Sunitinib (additional availability for the treatment of metastatic or unresectable malignant gastrointestinal stromal tumour)

 

Brands Added

Simvastatin

Tablet 20 mg (Simvastatin-GA 20)

Tablet 40 mg (Simvastatin-GA 40)

Tablet 80 mg (Simvastatin-GA 80)

Alteration of Brand

Paracetamol

Tablet 500 mg

From:

Chem mart Chemadol

To:

Chem mart Paracetamol

 

Brand Deleted

Cabergoline

Tablet 500 micrograms (Tinexa)

 

 

SCHEDULE 2 ― PART 1

Brand Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (APO-Diclofenac)

 

 

SCHEDULE 2 ― PART 2

Brand Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (APO-Diclofenac)

 

 

SCHEDULE 3 ― PART 1

Brands Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (APO-Diclofenac)

Tramadol

Injection containing tramadol hydrochloride 100 mg in 2 mL (Tramahexal)

 

Alteration of Brand

Paracetamol

Tablet 500 mg

From:

Chem mart Chemadol

To:

Chem mart Paracetamol

 

SCHEDULE 3 ― PART 2

Alteration of Brand

Paracetamol

Tablet 500 mg

From:

Chem mart Chemadol

To:

Chem mart Paracetamol

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medicines. This Act addresses the need for a structured framework to manage and subsidise pharmaceutical products. The Act empowers the Minister for Health to make various determinations concerning the listing of drugs, their forms, brands, and the conditions for prescribing these pharmaceutical benefits. The objective is to maintain a cost-effective and efficient healthcare system by regulating the types of medicines available under the PBS and the circumstances under which they can be prescribed. This legislative instrument, F2009L04284, which came into effect on 1 December 2009, updates previous determinations to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). These amendments include changes to the names, forms, brands, and prescribing conditions of listed drugs on the PBS, ensuring that the scheme remains responsive to medical advancements and public health needs.

Scope and Application

The National Health Act 1953, through its Part VII, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures that all Australians have reliable, timely, and affordable access to a wide range of medicines. This Act applies to pharmaceutical benefits provided by the Commonwealth, specifically to drugs and medicinal preparations listed under subsection 85(2), and certain extemporaneously-prepared medicinal preparations declared by the Minister. The Act extends to determining the form, manner of administration, and brand of these pharmaceutical items, as well as the conditions for prescribing these benefits. The Minister's authority to make such determinations is exercised through legislative instruments, thereby extending or restricting the application of the Act as necessary. The geographic reach of the Act is national, encompassing the entire Commonwealth of Australia. Exclusions or exemptions are not explicitly stated in the explanatory statement, but the legislative instrument details amendments that affect the listing, forms, manners of administration, and brands of drugs on the PBS, as well as the conditions for prescribing pharmaceutical benefits.

Key Provisions

The legislative instrument amends determinations under sections 85, 85A and 88 of the National Health Act 1953, effective from 1 December 2009. It makes changes to the Pharmaceutical Benefits Scheme (PBS) concerning the names, forms, brands, and prescribing conditions of pharmaceutical benefits. Under section 85, the Minister has the authority to declare specific drugs and medicinal preparations as pharmaceutical benefits and to determine their forms, brands, and manner of administration. This instrument introduces new drugs and modifies existing ones, such as altering brand names and forms of listed drugs. For instance, it includes new drugs like "Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid" and modifies brands like changing "Fluconazole Hexal" to "Fluconazole Sandoz." The obligations under this Act require the Minister to ensure that the PBS provides reliable, timely, and affordable access to medicines for Australians. This involves declaring drugs and their forms, brands, and prescribing conditions, as well as considering recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body, consults with various stakeholders to recommend drugs for inclusion on the PBS based on their clinical effectiveness, safety, and cost-effectiveness. The Minister must also determine the conditions for prescribing pharmaceutical benefits, such as the maximum quantity or number of units that can be supplied in a single prescription and the manner of administration. There are no specific offences, penalties, or consequences mentioned in the instrument itself for breaches of the provisions. However, any breach of the Act or regulations made under it could potentially lead to civil or criminal penalties, depending on the nature of the breach. For example, if a person unlawfully supplies a pharmaceutical benefit, they could be subject to criminal penalties, including fines and imprisonment. Similarly, if a health service provider or pharmaceutical company does not comply with the regulations, they could face civil penalties or other administrative consequences. The exact penalties would depend on the specific breach and the applicable laws.

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