National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 5) (PB 45 of 2016)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 5)

 

PB 45 of 2016

 

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

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 5) (the Amending Instrument).  The purpose of the Amending Instrument 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 (HSD) program.

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

The amendments in PB 45 of 2016 include adding, removing and changing 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 June 2016.

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


ATTACHMENT

Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016

 

PART 1 PRELIMINARY

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 2016 (No. 5).  It can also be citied as PB 45 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 June 2016.

 

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

 

SCHEDULE

 

Items 1 to 6  Schedules 1 and 3

Items 1 to 6 provide for additions of and changes to pharmaceutical items and circumstances for prescribing.  These changes are summarised below:                             

 

Listed Drug

Type of Change

Azacitidine

Addition of new pharmaceutical item

Azacitidine; Levodopa with carbidopa; Omalizumab

Remodelled restrictions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 5) was enacted to make amendments to the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. This amendment was necessary to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes include the addition, removal, and modification of pharmaceutical benefits, as well as adjustments to responsible person codes. These amendments align with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act 1953 to advise the Minister on the listing of pharmaceutical benefits. The PBAC's recommendations consider factors such as the clinical effectiveness, safety, and cost-effectiveness of the drugs. The instrument was developed through consultation with the PBAC and pharmaceutical companies, ensuring a comprehensive and balanced approach to updating the highly specialised drugs program. This legislative instrument is intended to enhance the efficiency and efficacy of the pharmaceutical benefits scheme by keeping it current with the latest medical and pharmaceutical developments.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 5) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, focusing on adjustments to the Highly Specialised Drugs (HSD) program. The Act applies to the Minister for Health, as it pertains to the administration and regulation of the pharmaceutical benefits under the National Health Act 1953. The amendments include the addition, removal, and modification of pharmaceutical benefits and prescribing circumstances, with these changes aligning with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The geographic reach of the Act extends nationally, as it pertains to the Commonwealth's authority over the Pharmaceutical Benefits Scheme (PBS). There are no stated exclusions or exemptions in the instrument itself, though the operation of the Act is subject to the overarching provisions of the National Health Act 1953. This legislative instrument is effective from 1 June 2016, and its detailed provisions are outlined in the accompanying Attachment.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 5) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, bringing changes to the Highly Specialised Drugs (HSD) program. The main operative sections of this Instrument, such as Section 1, provide the name of the Instrument, and Section 2, detail the commencement date, which is 1 June 2016. Section 3 of the Instrument outlines the amendments that have been made to the 2010 Special Arrangement. The obligations and requirements imposed by this Act on the parties it governs are primarily centred around the changes made to the HSD program. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in the decision-making process for these changes, as they provide recommendations based on the clinical effectiveness, safety, and cost-effectiveness of the pharmaceutical items. Pharmaceutical companies are also required to consult with PBAC and agree to the final listing details. Any offences, penalties, or civil/criminal consequences for breach are not explicitly stated in the text. However, it is implied that failure to comply with the requirements of the Act or the special arrangement could result in legal consequences. The maximum penalties for breach would depend on the specific nature of the breach and the relevant legislation governing such actions. It is essential for parties involved in the HSD program to adhere to the provisions of the Act and the special arrangement to avoid potential penalties or consequences.

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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.