National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 32 of 2009)

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Legislation au F2009L01249 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 32 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 May 2009, was made on 2 April 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 May 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

Lanthanum

Paclitaxel, nanoparticle albumin-bound

Sunitinib

Teriparatide

 

Forms Added

Gemcitabine

Powder for I.V. infusion 2 g (as hydrochloride)

Hydromorphone

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

Tablet (modified release) containing hydromorphone hydrochloride 16 mg

Tablet (modified release) containing hydromorphone hydrochloride 32 mg

Tablet (modified release) containing hydromorphone hydrochloride 64 mg

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL

Pancreatic Extract

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity

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

 

Brands Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin Ranbaxy)

Capsule 500 mg (as trihydrate) (Amoxycillin Ranbaxy)

Fluconazole

Capsule 200 mg (APO-Fluconazole)

Gemcitabine

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

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

Lamotrigine

Tablet 25 mg (Lamotrust 25)

Tablet 50 mg (Lamotrust 50)

Tablet 100 mg (Lamotrust 100)

Tablet 200 mg (Lamotrust 200)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate) (APO-Ondansetron)

Tablet 8 mg (as hydrochloride dihydrate) (APO-Ondansetron)

Simvastatin

Tablet 10 mg (APO-Simvastatin)

Tablet 20 mg (APO-Simvastatin)

Tablet 40 mg (APO-Simvastatin)

Tablet 80 mg (APO-Simvastatin)

 

Listed Drug Deleted

Zonisamide

 

Brand Deleted

Piroxicam

Dispersible tablet 10 mg (Feldene-D)

 

Alteration of Form

Etoposide

From:

Powder for I.V. infusion containing etoposide phosphate 113.6 mg

To:

Powder for I.V. infusion 100 mg (as phosphate)

From:

Powder for I.V. infusion containing etoposide phosphate 1.136 g

To:

Powder for I.V. infusion 1 g (as phosphate)

 

 

SCHEDULE 1 ― PART 2

Listed Drug Added

Sunitinib

 

Forms Added

Hydromorphone

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

Tablet (modified release) containing hydromorphone hydrochloride 16 mg

Tablet (modified release) containing hydromorphone hydrochloride 32 mg

Tablet (modified release) containing hydromorphone hydrochloride 64 mg

Pancreatic Extract

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity

 

Brands Added

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate) (APO-Ondansetron)

Tablet 8 mg (as hydrochloride dihydrate) (APO-Ondansetron)

Simvastatin

Tablet 10 mg (APO-Simvastatin)

Tablet 20 mg (APO-Simvastatin)

Tablet 40 mg (APO-Simvastatin)

Tablet 80 mg (APO-Simvastatin)

 

 

SCHEDULE 3 ― PART 1

Brands Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin Ranbaxy)

Capsule 500 mg (as trihydrate) (Amoxycillin Ranbaxy)

 

Forms Added

Hydromorphone

Tablet (modified release) containing hydromorphone hydrochloride 8 mg

Tablet (modified release) containing hydromorphone hydrochloride 16 mg

Tablet (modified release) containing hydromorphone hydrochloride 32 mg

Tablet (modified release) containing hydromorphone hydrochloride 64 mg

 

Brand Deleted

Piroxicam

Dispersible tablet 10 mg (Feldene-D)

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS). The PBS aims to ensure reliable, timely, and affordable access to a broad range of medicines for all Australians. Through this Act, the Commonwealth provides benefits in accordance with Part VII, which governs the listing of drugs and medicinal preparations eligible for PBS coverage. The Act empowers the Minister to declare, by legislative instrument, specific drugs and forms of drugs that qualify for pharmaceutical benefits under the PBS. This legislative instrument also addresses matters such as the maximum quantity or number of units in prescriptions, the number of occasions a prescription may be repeated, and the manner of administering pharmaceutical items. The instrument, which came into effect on 1 May 2009, implements recommendations from the Pharmaceutical Benefits Advisory Committee, amending earlier determinations made in 2008.

Scope and Application

The instrument F2009L01249, expressed to commence on 1 May 2009, pertains to amendments made to determinations under sections 85, 85A, and 88 of the National Health Act 1953, concerning the Pharmaceutical Benefits Scheme (PBS). This Act applies to pharmaceutical benefits provided by the Commonwealth to all Australians, focusing on the listing of drugs and medicinal preparations, their forms, brands, and the prescribing regulations for these items. The instrument amends previous determinations made by legislative instrument number PB 114 of 2008, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body established under the Act, consults with stakeholders to advise on the inclusion of drugs on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. This legislative instrument specifies the addition of certain drugs and their forms, the deletion of some items, and adjustments to brands and forms of listed drugs, all aimed at refining the PBS to better serve the healthcare needs of Australians.

Key Provisions

The legislation under discussion, F2009L01249, pertains to amendments to determinations under sections 85, 85A, and 88 of the National Health Act 1953, governing the Pharmaceutical Benefits Scheme (PBS). These sections are foundational in determining the availability and administration of pharmaceutical benefits in Australia. Section 85(1) establishes the framework by which the Commonwealth provides pharmaceutical benefits, while Section 85(2) specifies the drugs and preparations covered by the PBS. Subsections 85(3), 85(5), and 85(6) empower the Minister to define the forms, methods of administration, and brands of listed drugs through legislative instruments. Similarly, Section 85A(2) allows for the determination of prescription parameters such as maximum quantities and repetitions, and Section 88(1A) outlines the specific pharmaceutical benefits that dental practitioners are authorised to prescribe. The amendments, effective from 1 May 2009, introduce new listed drugs, modify existing drug forms and brands, and adjust prescription criteria. The obligations under this Act primarily involve the Minister in making determinations regarding the PBS, including the listing of drugs, their forms, brands, and prescription guidelines. These determinations must be made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that evaluates the clinical effectiveness, safety, and cost-effectiveness of medicines. The Minister is required to consider PBAC recommendations when deciding which drugs to include in the PBS. Additionally, healthcare providers must adhere to the prescription guidelines set forth in the determinations, ensuring that they comply with the authorised quantities, repetitions, and administration methods for the drugs they prescribe. Breaches of the provisions under the National Health Act 1953 may result in civil or criminal consequences. For instance, prescribing medications not covered under the PBS or exceeding the permitted quantities and repetitions could lead to penalties. The specific penalties are not detailed in the provided text, but generally, non-compliance with PBS regulations may result in fines or other sanctions. It is important to note that the precise penalties and enforcement mechanisms would be outlined in other sections of the Act or in associated regulations.

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