National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 11) (PB 104 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01723 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 11)

 

PB 104 of 2015

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

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

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

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the highly specialised drugs program.

The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 104 of 2015 include adding and removing and changes to the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes.

These changes are summarised, by drug name, in the Attachment.

A provision by provision Description of this instrument is contained in the Attachment.

 

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). 

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the 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 Pharmaceutical Benefits Scheme (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.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS and for this Instrument.  This includes consultation through the PBAC process, and agreement to final listing details.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 November 2015.

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


ATTACHMENT

Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015

Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 11).  It can also be citied as PB 104 of 2015.

Section 2 Commencement
This section provides that this instrument commences on 1 November 2015.

Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Items 1 - 14
Provide for deletions to drugs, forms, brands, and changes to the circumstances for prescribing various pharmaceutical benefits.

These changes are summarised below.

Summary of Changes

Alteration of Circumstances

 

Eculizumab

Remodelled restrictions

Everolimus

Remodelled restrictions

Infliximab

Remodelled restrictions

Mycophenolic acid

Remodelled restrictions

Peginterferon Alfa-2a

Remodelled restrictions

Sirolimus

Remodelled restrictions

Tacrolimus

Remodelled restrictions

Tocilizumab

Remodelled restrictions

Vedolizumab

Remodelled restrictions

 

Removal of brands

Desferrioxamine       Desferal 500 mg

 

Addition of Brands

Mycophenolic acid       Mycophenolate AN

Tacrolimus        Tacrolimus Apotex

 

Add new Responsible Person codes

TK        Takeda Pharmaceuticals Australia Pty Ltd

 


 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 11) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This amendment was introduced to align the Special Arrangement with the changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include modifications to the circumstances for prescribing various pharmaceutical benefits, addition and removal of brands, and changes to responsible person codes. The instrument was made under the authority granted by subsections 100(1) and 100(2) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The policy objective of the amendment is to ensure that the Special Arrangement remains current and reflective of the latest recommendations and changes in the pharmaceutical landscape, as determined by the Pharmaceutical Benefits Advisory Committee. The amendments are designed to incorporate the PBAC's recommendations, thereby ensuring the program's efficacy and relevance in providing highly specialised drugs to Australians.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 11) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, modifying the arrangement concerning the highly specialised drugs program. This legislative instrument is made under subsections 100(1) and 100(2) of the National Health Act 1953, which empowers the Minister to establish special arrangements for the supply of pharmaceutical benefits and to vary or revoke these arrangements. The amendments are intended to align with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting alterations to the conditions for prescribing various pharmaceutical benefits and updates to responsible person codes. This amendment instrument, which commences on 1 November 2015, reflects recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 11) (referred to as the Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (the Special Arrangement). This amendment specifically targets the highly specialised drugs program under the National Health Act 1953 (the Act). The main sections of the Instrument (Section 1) detail the name of the Instrument, while Section 2 provides the commencement date, 1 November 2015. Section 3 outlines the amendments made to the Special Arrangement, focusing on changes to the listing of pharmaceutical benefits, prescribing circumstances, and responsible person codes. The Instrument imposes obligations on parties and entities governed by the Act, particularly those involved in the highly specialised drugs program. Pharmaceutical companies, healthcare providers, and patients must comply with the changes to the listing of pharmaceutical benefits and the revised circumstances for prescribing. The Instrument requires adherence to the new restrictions and responsibilities outlined in the amendments. Additionally, responsible persons, such as Takeda Pharmaceuticals Australia Pty Ltd, must ensure that they comply with the updated responsible person codes. The Instrument does not explicitly outline offences, penalties, or consequences for breach within its text. However, breaches of the Act or the Special Arrangement could potentially lead to civil or criminal consequences, as provided under other sections of the Act. The maximum penalties for breaches under the National Health Act 1953 can include fines and imprisonment, depending on the nature and severity of the breach. It is important for parties to ensure compliance with the amended Special Arrangement to avoid any potential legal repercussions.

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