National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 40 of 2009)

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Legislation au F2009L01712 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 40 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 June 2009, was made on 1 May 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 June 2009.

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

Schedule 1: provides for the following amendments:

 

 

SCHEDULE 1 ― PART 1

 

Form Added

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

 

Brands Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin Sandoz)

Escitalopram

Tablet 10 mg (as oxalate) (Esitalo)

Tablet 20 mg (as oxalate) (Esitalo)

Irinotecan

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

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

Lisinopril

Tablet 5 mg (Lisinopril Ranbaxy)

Tablet 10 mg (Lisinopril Ranbaxy)

Tablet 20 mg (Lisinopril Ranbaxy)

Pravastatin

Tablet containing pravastatin sodium 20 mg (APO-Pravastatin)

Tablet containing pravastatin sodium 40 mg (APO-Pravastatin)

Roxithromycin

Tablet 150 mg (APO-Roxithromycin, Chem mart Roxithromycin,
Terry White Chemists Roxithromycin)

Tablet 300 mg (APO-Roxithromycin, Chem mart Roxithromycin,
Terry White Chemists Roxithromycin)

Terbinafine

Tablet 250 mg (as hydrochloride) (Sebifin 250)

 

Listed Drugs Deleted

Efalizumab

Oestrogens―Conjugated

Oestrogens―Conjugated with Medroxyprogesterone

 

Forms Deleted

Glucose Indicator―Blood

Electrode strips, 50 (GlucoCare Super Sensor)

Metoprolol succinate

Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release)

 

Brands Deleted

Citalopram

Tablet 20 mg (as hydrobromide) (Citalopram Winthrop)

Enalapril

Tablet containing enalapril maleate 20 mg (Enalapril Winthrop)

Fosinopril

Tablet containing fosinopril sodium 10 mg (Fosinopril Winthrop)

Tablet containing fosinopril sodium 20 mg (Fosinopril Winthrop)

Fosinopril with Hydrochlorothiazide

Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Winthrop 10mg/12.5mg)

Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Winthrop 20mg/12.5mg)

Isotretinoin

Capsule 20 mg (Chem mart Isotretinoin, Terry White Chemists Isotretinoin)

Phenoxymethylpenicillin

Capsule 250 mg phenoxymethylpenicillin (as potassium) (Penhexal VK)

Capsule 500 mg phenoxymethylpenicillin (as potassium) (Penhexal VK)

 

Alteration of Maximum Number of Repeats

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

From:

2

To:

3

Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL

From:

2

To:

3

Injections 50 mg in 1 mL single use pre-filled syringes, 4

From:

2

To:

3

 

Alteration of Brand

Propylthiouracil

Tablet 50 mg

From:

Virgo Unit Trust

To:

PTU

Vinorelbine

Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

From:

Vinorelbine 10 Link

To:

Vinorelbine Link

Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

From:

Vinorelbine 50 Link

To:

Vinorelbine Link

 

 

SCHEDULE 1 ― PART 2

Form Added

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

 

Brands Added

Pravastatin

Tablet containing pravastatin sodium 20 mg (APO-Pravastatin)

Tablet containing pravastatin sodium 40 mg (APO-Pravastatin)

Terbinafine

Tablet 250 mg (as hydrochloride) (Sebifin 250)

 

Alteration of Purpose

Adalimumab [additional availability for the initial and continuing treatment of chronic plaque psoriasis]

Etanercept [additional availability for the continuing treatment of chronic plaque psoriasis]

 

Listed Drug Deleted

Efalizumab

 

Form Deleted

Glucose Indicator―Blood

Electrode strips, 50 (GlucoCare Super Sensor)

 

Brand Deleted

Phenoxymethylpenicillin

Capsule 250 mg phenoxymethylpenicillin (as potassium) (Penhexal VK)

 

 

SCHEDULE 3 ― PART 1

Brand Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin Sandoz)

 

Brands Deleted

Phenoxymethylpenicillin

Capsule 250 mg phenoxymethylpenicillin (as potassium) (Penhexal VK)

Capsule 500 mg phenoxymethylpenicillin (as potassium) (Penhexal VK)

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, serves as the legislative framework for the Pharmaceutical Benefits Scheme (PBS), aiming to provide affordable access to essential medicines for all Australians. This Act facilitates the Commonwealth's provision of pharmaceutical benefits in alignment with Part VII, with the Minister authorised to declare drugs and medicinal preparations to be included in the PBS. The 2009 legislative instrument PB 40, which amends determinations under sections 85, 85A, and 88 of the Act, updates the list of pharmaceutical items, their forms, brands, and prescription parameters in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee. This ongoing process ensures the PBS remains responsive to public health needs, maintaining its objective of delivering reliable, timely, and cost-effective medication access.

Scope and Application

The instrument F2009L01712 is a legislative instrument under the National Health Act 1953, which provides the legal framework for the Pharmaceutical Benefits Scheme (PBS). This instrument, which commenced on 1 June 2009, amends previous determinations made under sections 85, 85A, and 88 of the Act, which came into effect on 1 December 2008. It is based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on the availability of drugs and medicinal preparations as pharmaceutical benefits. The instrument applies to all entities and persons involved in the supply and administration of pharmaceutical benefits under the PBS, including pharmaceutical companies, healthcare providers, and patients. The geographic reach of the instrument is nationwide, as it is a Commonwealth Act. The instrument outlines specific changes to the PBS, including the addition and deletion of drugs and brands, alterations in the maximum number of repeats for certain medications, and changes to the purpose for which certain drugs are available. The instrument also extends or restricts application through subordinate instruments, allowing for further adjustments to the PBS as necessary.

Key Provisions

The Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953 (the Act) provides a framework for the Commonwealth to offer access to a range of medicines for all Australians, ensuring they are reliable, timely, and affordable (sections 85(1) and 85A(2)). The Minister has the authority to declare drugs and medicinal preparations as part of the PBS by legislative instrument, which includes listing drugs as defined in section 84(1) (subsection 85(2)). Additionally, the form, administration, and brand of pharmaceutical items can be determined by the Minister through further legislative instruments (subsections 85(3), 85(5), and 85(6)). This instrument amends previous determinations made by legislative instrument number PB 114 of 2008, effective from 1 December 2008. The obligations imposed by the Act on the parties governed by it primarily involve adherence to the forms, brands, and administration of pharmaceutical items as declared by the Minister. For example, pharmaceutical companies must ensure their products meet the specifications declared by the Minister, while healthcare providers must comply with prescription guidelines, including maximum quantities and the number of repeats (subsection 85A(2)). The Minister's role includes making determinations that facilitate the efficient and effective operation of the PBS, ensuring that the scheme meets its objectives of providing access to necessary medicines. Failure to comply with the provisions of the Act and the determinations made under it can result in civil or criminal consequences. For instance, unauthorised supply of pharmaceutical benefits can lead to penalties as outlined in the Act. The precise nature of these penalties, including maximum fines and potential imprisonment, would be detailed in the relevant sections of the Act, though such specifics are not provided in this explanatory statement. It is essential for all parties involved to understand and comply with the requirements to avoid legal repercussions.

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