National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 97 of 2009)

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Legislation au F2009L03821 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 97 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 November 2009, was made on 2 October 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 November 2009.

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

Schedule 1: provides for the following amendments:

 

 

 

SCHEDULE 1 ― PART 1

Forms Added

Ezetimibe with Simvastatin

Tablet 10 mg-10 mg

Tablet 10 mg-20 mg

Tobramycin

Injection 500 mg (as sulfate) in 5 mL (without preservative)

Valsartan with hydrochlorothiazide

Tablet 320 mg-12.5 mg

Tablet 320 mg-25 mg

 

Brands Added

Carvedilol

Tablet 6.25 mg (Carvedilol Sandoz)

Tablet 12.5 mg (Carvedilol Sandoz)

Tablet 25 mg (Carvedilol Sandoz)

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac-GA)

Frusemide

Injection 20 mg in 2 mL (Frusemide-Claris)

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride) (Gemcitabine Actavis)

Powder for I.V. infusion 1 g (as hydrochloride) (Gemcitabine Actavis)

Risperidone

Tablet 0.5 mg (Resdone 0.5)

Tablet 1 mg (Resdone 1)

Tablet 2 mg (Resdone 2)

Tablet 3 mg (Resdone 3)

Tablet 4 mg (Resdone 4)

 

Alteration of Form

Etanercept

From:

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

To:

Injection 50 mg in 1 mL single use auto-injector, 4

 

Alteration of Form and Brand

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

            From:

Form: Oral liquid 130 mL, 30 (MSUD Express Cooler)

Brand: MSUD Express Cooler

            To:

Form: Oral liquid 130 mL, 30 (MSUD Cooler)

Brand: MSUD Cooler

 

Alteration of Brand

Naltrexone

Tablet containing naltrexone hydrochloride 50 mg

From:

Naltrexone QP

To:

Naltrexone generichealth

 

Alteration of Maximum Number of Repeats

Voriconazole

Tablet 50 mg

From:

. .

To:

2

Tablet 200 mg

From:

. .

To:

2

 

Forms Deleted

Lansoprazole

Capsule 30 mg

Sachet containing granules for oral suspension, 30 mg per sachet

Terbutaline

Nebuliser solution containing terbutaline sulfate 5 mg in 2 mL single dose units, 30

 

 

SCHEDULE 1 ― PART 2

Alteration of Form

Etanercept

From:

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

To:

Injection 50 mg in 1 mL single use auto-injector, 4

 

Alteration of Purpose

Bortezomib

 

Forms Deleted

Lansoprazole

Capsule 30 mg

Sachet containing granules for oral suspension, 30 mg per sachet

 

Brands Added

Risperidone

Tablet 0.5 mg (Resdone 0.5)

Tablet 1 mg (Resdone 1)

Tablet 2 mg (Resdone 2)

 

 

SCHEDULE 2 ― PART 1

Brand Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac-GA)

 

 

SCHEDULE 2 ― PART 2

Brand Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac-GA)

 

 

SCHEDULE 3 ― PART 1

Brand Added

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac-GA)

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to affordable and timely medicines. The Act allows the Minister for Health to make various determinations under sections 85, 85A, and 88 to manage the PBS, including determining the forms of listed drugs, the brands of pharmaceutical items, and the conditions for prescribing pharmaceutical benefits. The explanatory statement for the instrument F2009L03821, which came into effect on 1 November 2009, outlines amendments to the determinations made under these sections, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. These amendments include adding new forms and brands of pharmaceutical items, altering existing forms and brands, and modifying prescription conditions to improve access and efficiency in the PBS.

Scope and Application

The Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953 ensures Australians have access to affordable and timely medicines. The Act applies to drugs and medicinal preparations that are declared by the Minister under subsection 85(2) to be pharmaceutical benefits, as well as certain extemporaneously-prepared medicinal preparations. The Minister has the authority to determine the form, administration, and brands of listed drugs through legislative instruments. Additionally, the Minister can set prescription limits for specified classes of prescribers under subsection 85A(2). The instrument, which amends earlier determinations made under sections 85, 85A and 88, takes effect from 1 November 2009 and modifies the forms, brands, and maximum repeats of certain medications. The amendments, outlined in the Schedule, are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which consults with various stakeholders to ensure comprehensive input in the decision-making process.

Key Provisions

The main operative sections of this legislation under the National Health Act 1953 pertain to the listing of pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS) and the regulation of prescriptions for these benefits. Section 85(1) mandates that the Commonwealth provides pharmaceutical benefits in accordance with Part VII of the Act. Subsection 85(2) allows the Minister to declare by legislative instrument the drugs and medicinal preparations to which Part VII applies, and these are referred to as listed drugs. Subsections 85(3) and 85(5) enable the Minister to determine the form and manner of administration of these listed drugs, respectively. Subsection 85(6) empowers the Minister to determine the brand of a pharmaceutical item, which is defined in subsection 84(1) as the trade name supplied by the responsible person or, in the absence of a trade name, the name of the responsible person. Section 85A(2) allows the Minister to set various prescription-related matters, such as the maximum quantity or number of units that can be supplied in one prescription and the manner of administration that can be specified in a prescription. Finally, subsection 88(1A) provides the Minister with the authority to determine the pharmaceutical benefits for which a dental practitioner can write a prescription. The Act imposes several obligations on the parties involved. The Minister is responsible for determining which drugs and preparations qualify as pharmaceutical benefits and for setting the forms, brands, and prescription-related matters as outlined in the legislation. This involves evaluating recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A. The PBAC’s recommendations are based on factors such as the medical conditions for which the medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. Pharmaceutical companies must ensure their products comply with the forms and brands determined by the Minister, and practitioners must adhere to the prescription regulations set forth in the Act. There are no explicit offences, penalties, or consequences for breach mentioned in the provided text. However, it is reasonable to infer that non-compliance with the Minister’s determinations regarding the PBS could result in legal consequences, as the Act is designed to regulate and ensure the reliability and affordability of medicines in Australia. Such breaches could potentially lead to administrative actions, fines, or other penalties as prescribed by relevant legislation. The precise penalties would depend on the specific nature and severity of the breach, as well as other applicable laws and regulations.

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