National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 1) (No. PB 1 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00039 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH ACT (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 1)

PB 1 of 2013

 

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, and whether the pharmaceutical benefit is to be available only under special arrangements).

Authority

PB 71 of 2012 exercises numerous provisions in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies.  A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)).  Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug.  A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB).  The Minister may also determine a brand of a pharmaceutical item (subsection 85(6)).  The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit.  Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the PBAC has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100. 

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Variation and revocation of subsection 85(2) declaration

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation.  Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 71 of 2012 made by this instrument

Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status.  These changes are summarised, by subject matter, in the Attachment.

 

Consultation

The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation.  PBAC is an independent expert body established by section 100A of the Act 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the PBS, 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.

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, and agreement to final listing details.

Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.

 

General

A provision by provision description of this Instrument is contained in the Attachment.

This Instrument commences on 1 February 2013.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

 

 

ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 1)

 

Section 1   Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 1) and may also be cited as PB 1 of 2013.

Section 2   Commencement

This section provides that this Instrument commences on 1 February 2013.

Section 3   Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1   Amendments

The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status.  These changes are summarised below.

 

 

SUMMARY OF CHANGES

Brands Added

Alendronic acid

Tablet 70 mg (as alendronate sodium) (Fonat)

Atenolol

Tablet 50 mg (Atenolol GH)

Cyproterone

Tablet containing cyproterone acetate 50 mg (Cyproterone Sandoz)

Exemestane

Tablet 25 mg (Exemestane-GA)

Fludarabine

Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
(AS-Fludarabine)

Gabapentin

Capsule 100 mg (Gabapentin Pfizer)
Capsule 300 mg (Gabapentin Pfizer)
Capsule 400 mg (Gabapentin Pfizer)
Tablet 800 mg (Gabapentin Pfizer)

Gemcitabine

Powder for I.V. injection 200 mg (as hydrochloride) (AS-Gemcitabine)
Powder for I.V. injection 1 g (as hydrochloride) (AS-Gemcitabine)
Powder for I.V. injection 2 g (as hydrochloride) (AS-Gemcitabine)

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg (Ledip)
Tablet containing lercanidipine hydrochloride 20 mg (Ledip)

Letrozole

Tablet 2.5 mg (Pharmacy Choice Letrozole)

Metronidazole

I.V. infusion 500 mg in 100 mL (Metronidazole-Claris)


Oxaliplatin

Solution concentrate for I.V. infusion 50 mg in 10 mL (AS-Oxaliplatin)
Solution concentrate for I.V. infusion 100 mg in 20 mL (AS-Oxaliplatin)
Solution concentrate for I.V. infusion 200 mg in 40 mL (AS-Oxaliplatin)

Paclitaxel

Solution concentrate for I.V. infusion 30 mg in 5 mL (GN-Paclitaxel)
Solution concentrate for I.V. infusion 100 mg in 16.7 mL (GN-Paclitaxel)
Solution concentrate for I.V. infusion 300 mg in 50 mL (GN-Paclitaxel)

Topotecan

Powder for I.V. infusion 4 mg (as hydrochloride) (Topotecan Agila)

Tramadol

Tablet (sustained release) containing tramadol hydrochloride) 100 mg (Tramadol SR generichealth)
Tablet (sustained release) containing tramadol hydrochloride) 150 mg (Tramadol SR generichealth)
Tablet (sustained release) containing tramadol hydrochloride) 200 mg (Tramadol SR generichealth)
Injection containing tramadol hydrochloride 100 mg in 2 mL (Tramadol Sandoz)

Vinorelbine

Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (AS-Vinorelbine)
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL (AS-Vinorelbine)

Brands Deleted

Atenolol

Tablet 50 mg (Atenolol generichealth)

Lisinopril

Tablet 5 mg (Prinivil 5)

Pravastatin

Tablet containing pravastatin sodium 10 mg (Pravastatin Winthrop)
Tablet containing pravastatin sodium 20 mg (Pravastatin Winthrop)
Tablet containing pravastatin sodium 40 mg (Pravastatin Winthrop)

Simvastatin

Tablet 10 mg (Simvastatin Winthrop)
Tablet 20 mg (Simvastatin Winthrop)
Tablet 40 mg (Simvastatin Winthrop)
Tablet 80 mg (Simvastatin Winthrop)

Tramadol

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

Alteration of Responsible Person

Listed Drug

Form

Brand

Responsible Person

Clopidogrel

Tablet 75 mg (as hydrogen sulfate)

Iscover

From: Bristol-Myers Squibb Australia Pty Ltd (BQ)

To: sanofi-aventis Australia Pty Ltd (AV)

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

DuoCover

From: Bristol-Myers Squibb Australia Pty Ltd (BQ)

To: sanofi-aventis Australia Pty Ltd (AV)

Irbesartan

Tablet 75 mg
Tablet 150 mg
Tablet 300 mg

Avapro
Avapro
Avapro

From: Bristol-Myers Squibb Australia Pty Ltd (BQ)

To: sanofi-aventis Australia Pty Ltd (AV)

Irbesartan with Hydrochlorothiazide

Tablet 150 mg-12.5 mg

Tablet 300 mg-12.5 mg

Tablet 300 mg-25 mg

Avapro HCT 150/12.5
Avapro HCT 300/12.5
Avapro HCT 300/25

From: Bristol-Myers Squibb Australia Pty Ltd (BQ)

To: sanofi-aventis Australia Pty Ltd (AV)


Nebivolol

Tablet 1.25 mg (as hydrochloride)
Tablet 5 mg (as hydrochloride)
Tablet 10 mg (as hydrochloride)

Nebilet

Nebilet
Nebilet
 

From: CSL Biotherapies Pty Ltd (CS)

To: A.Menarini Australia Pty Ltd (FK)

Oxybutynin

Transdermal patches 36 mg, 8
 

Oxytrol
 

From: Hospira Pty Limited (HH)

To: Ascent Pharma Pty Ltd (GM)

Testosterone

Transdermal patches 12.2 mg, 60
Transdermal patches 24.3 mg, 30

Androderm

Androderm

From: Hospira Pty Limited (HH)

To: Ascent Pharma Pty Ltd (GM)

Addition of Responsible Person Code

YA [Agila Australasia Pty Ltd]

Name change of Responsible Person

From: Invida Australia Pty Ltd [FK]  To: A.Menarini Australia Pty Ltd [FK]


 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 1)

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 1) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantities, pack quantities and whether the pharmaceutical benefit is to be available only under special arrangements).

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing

 

Overview

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 1) was enacted to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which determines the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the National Health Act 1953 by the Minister for Health, with the policy objective of ensuring that the PBS provides access to affordable and effective medications. The amendments involve additions, deletions, and changes to drugs, forms, brands, responsible person codes, maximum quantities, prescribing circumstances, determined quantities, pack quantities, and special arrangements. The changes were developed with consultation from the Pharmaceutical Benefits Advisory Committee and various interested parties, including pharmaceutical companies, medical and pharmacy professional groups, and State and Territory health departments. This legislative instrument is compatible with human rights, as it engages with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 1) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which establishes the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) by declaring drugs and medicinal preparations, and determining forms, manners of administration, and brands. The Instrument also addresses related matters such as responsible persons, prescribing circumstances, maximum quantities, repeat prescriptions, determined quantities, pack quantities, and the availability of certain benefits under special arrangements. The purpose of this legislative instrument is to make changes to the pharmaceutical benefits listed on the PBS and related matters by exercising various provisions in Part VII of the National Health Act 1953. The changes made by this instrument include additions, deletions, and alterations to brands, forms, responsible person codes, maximum quantities, prescribing circumstances, determined quantities, pack quantities, and section 100 only status. The Instrument applies to drugs and medicinal preparations listed on the PBS, their forms and manners of administration, and related matters such as responsible persons, prescribing circumstances, and supply conditions. The changes made by this instrument are applicable nationally across Australia, as the PBS is a Commonwealth-administered scheme. There are no specific exclusions, exemptions, or thresholds mentioned in the text. The application of this Act may be extended or restricted through subordinate instruments, such as the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which this amendment instrument modifies.

Key Provisions

The main operative sections of this legislative instrument concern the amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (subsection 3(1)) under the authority of the National Health Act 1953 (the Act). These amendments include additions, deletions, and changes to drugs, forms, brands, responsible person codes, maximum quantities, prescribing circumstances, determined quantities, pack quantities, and the availability of pharmaceutical benefits under special arrangements only (Schedule 1). Section 85(2) allows the Minister to declare drugs and medicinal preparations that are listed on the Pharmaceutical Benefits Scheme (PBS), while subsections 85(3) and 85(5) allow the Minister to determine the forms and manner of administration of a listed drug. Subsections 85(7) and 85A(2) provide the Minister with the authority to determine the circumstances in which a pharmaceutical benefit may be prescribed and the maximum quantity or number of repeats allowed in one prescription. The obligations imposed on the parties or entities governed by this legislation include compliance with the changes outlined in Schedule 1, such as the addition or deletion of specific pharmaceutical benefits on the PBS, changes to the responsible person for a brand of a pharmaceutical item, and alterations to prescribing circumstances, maximum quantities, and the availability of pharmaceutical benefits under special arrangements only. Pharmaceutical companies, medical and pharmacy professional groups, key stakeholder groups, State and Territory health departments, the Department of Human Services, and the Medical Software Industry Association are also required to participate in consultations throughout the process of developing legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy. Offences, penalties, or civil/criminal consequences for breach of the provisions in this legislation are not explicitly stated in the text. However, as this legislative instrument is made under the authority of the National Health Act 1953, it is likely that any breaches of the provisions in this legislation would be subject to the penalties outlined in the Act, such as fines or imprisonment. The maximum penalties would depend on the specific nature and severity of the breach.

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Area of Law
Health Law
Instrument
Instrument
Concepts
Reporting & Disclosure Obligations
Regulatory Standards
Licensing & Registration
Enforcement Powers
Catchwords
Pharmaceutical Benefits
Pharmaceutical Benefits Scheme

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.