National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 8) (PB 76 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01365 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 2016 (No. 8)

 

PB 76 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. 8) (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 76 of 2016 include addition of a new pharmaceutical item and changes to circumstances for prescribing. 

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 September 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. 8).  It can also be cited as PB 76 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 September 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

 

Item 1   Section 4

Item 1 amends Section 4 (Definitions) of the Special Arrangements to add the listed drug ‘Pasireotide’ to the definition of CAR drug.

 

Items 2 to 5  Schedules 1 and 3

Items 2 to 5 provide for addition of a pharmaceutical item and changes to circumstances for prescribing.  These changes are summarised below:                             

 

Listed Drug

Type of Change

Pasireotide

Addition of new pharmaceutical item

Rifabutin

Remodelled restrictions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 8) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to reflect recent changes to the listing of pharmaceutical benefits under the National Health Act 1953. The instrument, which commences on 1 September 2016, was made under subsection 100(1) of the Act, which empowers the Minister to establish special arrangements for the supply of pharmaceutical benefits. The amendments include the addition of a new pharmaceutical item, Pasireotide, to the list of covered drugs, and changes to the prescribing conditions for Rifabutin, aimed at aligning the Special Arrangement with the latest updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes reflect recommendations from the Pharmaceutical Benefits Advisory Committee, which consults with a diverse range of stakeholders to ensure the recommendations align with clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 8) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, impacting the Highly Specialised Drugs (HSD) program under the National Health Act 1953. The Act applies to the Minister for Health, who has the authority to make special arrangements for the supply of pharmaceutical benefits, and it extends to the entities and individuals involved in the provision and prescription of these specialised drugs. The geographic reach of this legislation is national, as it pertains to the Pharmaceutical Benefits Scheme (PBS) across Australia. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, specifically adding a new pharmaceutical item, Pasireotide, and altering the prescribing conditions for Rifabutin. This Instrument does not specify exclusions or exemptions but is subject to variations or revocations by the Minister, as outlined in the Act. The Instrument commenced on 1 September 2016, and it is a legislative instrument governed by the Legislation Act 2003.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 8) amends the National Health (Highly specialised drugs program) Special Arrangement 2010. The primary operative sections include Section 4, which adds the drug 'Pasireotide' to the definition of CAR drug, and Items 2 to 5 in the Schedule, which introduce a new pharmaceutical item and modify the prescribing circumstances for certain drugs, such as 'Rifabutin'. This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring alignment in the Highly Specialised Drugs (HSD) program. The obligations imposed by this Act on the relevant parties include ensuring that the changes to the HSD program, as outlined in the Instrument, are implemented effectively. Pharmaceutical companies, healthcare providers, and patients must adhere to the new definitions and prescribing conditions set forth in the Instrument. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in guiding these changes, providing expert recommendations based on clinical effectiveness, safety, and cost-effectiveness. The Instrument also stipulates consequences for non-compliance. While the specific penalties are not detailed in the explanatory statement, breaches of the amended Special Arrangement may lead to legal repercussions. These could include administrative penalties, revocation of special arrangements, or other civil and criminal consequences as determined by relevant authorities. The Minister retains the authority to vary or revoke special arrangements under subsection 100(2) of the National Health Act 1953, ensuring that the provisions of the Act are upheld. Overall, the Amending Instrument aims to refine the HSD program by incorporating the latest recommendations from the PBAC and aligning it with the Pharmaceutical Benefits Scheme (PBS). This ensures that highly specialised drugs are accessible and appropriately prescribed, ultimately benefiting patients and the healthcare system.

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