National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 3) (No. PB 29 of 2011)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

Issued by Authority of the Minister for Health and Ageing

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 3)

PB 29 of 2011

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the chemotherapy pharmaceuticals access program.

The Special Arrangement deals with the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients and patients on discharge. 

Section 100 special arrangements and Part VII of the Act

Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:

(a)  who are living in isolated areas: or

(b) who are receiving treatment in circumstances in which generally available

                        pharmaceutical benefits are inadequate for that treatment; or

(c)                    if the pharmaceutical benefits covered by the arrangements can be more

                         conveniently or efficiently supplied under the arrangements.

 

Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1). 

 

Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).

 

Changes to the Special Arrangement made by this Instrument

This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the chemotherapy pharmaceuticals access program. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.

This instrument makes the following changes to the Special Arrangement:

  • 3 new chemotherapy pharmaceutical benefits are added;
  • the forms of 2 chemotherapy pharmaceutical benefits are amended.

 

Consultations

An ongoing and formal process of consultation in relation to matters relevant to this instrument includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). 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 were consulted throughout the process for additions and changes to listings on the PBS and for the Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.

General

This Instrument commences on 1 April 2011.

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

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

 

 

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No.3)

 

Section 1  Name of Instrument

This section provides that this Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011(No. 3) and that it may also be cited as PB 29 of 2011.

Section 2  Commencement

This section provides that this Instrument commences on 1 April 2011.

Section 3   Amendments to PB 117 of 2010

Section 3 provides that Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Principal Instrument). 

Schedule 1

Item 1 amends Schedule 1 of the Principal Instrument to add a new brand (DBL Epirubicin Hydrochloride Injection) to the chemotherapy pharmaceutical benefits containing the drug Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL.

Item 2 amends Schedule 1 of the Principal Instrument for the chemotherapy pharmaceutical benefits containing the drug Idarubicin to:

  • amend the description of the 2 forms listed to remove the words ‘single use vial’; and
  • add a new brand (Idarubicin Ebewe) to each of these forms.

 

 

Overview

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 3), PB 29 of 2011, was enacted to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010, addressing the need to update the chemotherapy pharmaceuticals provided under the special arrangement. The instrument was made under the authority of the Minister for Health and Ageing under subsections 100(1) and 100(2) of the National Health Act 1953, and its primary objective is to ensure that an adequate supply of pharmaceutical benefits is available to patients receiving chemotherapy treatment, particularly in circumstances where generally available pharmaceutical benefits are inadequate for that treatment. The instrument introduces changes to the chemotherapy pharmaceuticals access program, including the addition of three new chemotherapy pharmaceutical benefits and amendments to the forms of two existing chemotherapy pharmaceutical benefits. These changes are designed to align with recent updates to the National Health (Listing of Pharmaceutical Benefits) Instrument, ensuring the provision of up-to-date and efficient pharmaceutical care to patients.

Scope and Application

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 3) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 to update the chemotherapy pharmaceutical benefits provided under the special arrangement. The special arrangement applies to the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The amendments reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument, which add three new chemotherapy pharmaceutical benefits and amend the forms of two chemotherapy pharmaceutical benefits. The changes are intended to ensure the supply of adequate pharmaceutical benefits to patients receiving chemotherapy treatment in public hospitals. The amendments are made under the authority of the Minister for Health and Ageing and are subject to consultation with the Pharmaceutical Benefits Advisory Committee, which recommends which drugs should be available as pharmaceutical benefits. The Instrument commences on 1 April 2011 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Key Provisions

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 3) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010, which deals with the supply of chemotherapy pharmaceuticals at certain public hospitals to non-admitted patients, day admitted patients, and patients on discharge. Section 3 of this instrument amends the Principal Instrument (PB 117 of 2010) by adding a new brand of Epirubicin and amending the description and adding a new brand of Idarubicin. These changes reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument which also commence on 1 April 2011. The National Health Act 1953, specifically section 100, allows the Minister to make special arrangements to ensure adequate pharmaceutical supplies for specific groups, including those in isolated areas or receiving certain treatments. The Act also allows for the variation or revocation of these special arrangements. The obligations imposed by the Act require the Minister to ensure that pharmaceutical benefits are available to those in need, and the amendment instrument ensures that the Special Arrangement aligns with the latest updates to the Pharmaceutical Benefits Schedule. Failure to comply with the provisions of the National Health Act 1953 and the related legislative instruments could result in legal consequences. While the Explanatory Statement does not specify penalties for breaches of the Special Arrangement itself, breaches of the broader National Health Act could result in civil or criminal penalties. For example, under section 112 of the Act, a person who contravenes any provision of the Act or the regulations made under the Act may be liable to a penalty of up to $22,200 for an individual and $111,000 for a body corporate, depending on the severity of the breach. The consultation process for these amendments involved the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body appointed by the Minister, which includes members from various health-related fields. Pharmaceutical companies were also consulted throughout the process to ensure the final listing details were agreed upon. This ongoing consultation process is integral to ensuring the Special Arrangement remains effective and up-to-date with current medical needs and technological advancements.

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