National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9) (PB 84 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01559 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. 9)

 

PB 84 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. 9) (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 84 of 2016 include addition of a new pharmaceutical item, changes to circumstances for prescribing, removing a pharmaceutical item and removing a brand. 

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 October 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. 9).  It can also be cited as PB 84 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 October 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   Division 1, Section 4

Item 1 amends section 4 (Definitions) of the Special Arrangements to add the listed drug ‘Darunavir with Cobicistat’ to the definition of medication for the treatment of HIV or AIDS.

 

Items 2 to 15  Schedules 1 and 3

Items 2 to 15 provide for addition of a new pharmaceutical item, changes to circumstances for prescribing, removing a pharmaceutical item and removing a brand.  These changes are summarised below:                             

 

Listed Drug

Type of Change

Darunavir with cobicistat

Addition of new pharmaceutical item

Deferasirox

Remodelled restrictions

Deferiprone

Remodelled restrictions

Desferrioxamine

Remodelled restrictions

Infliximab

Remodelled restrictions

Interferon alfa-2a

Deletion of pharmaceutical item

Nevirapine

Deletion of brand

Octreotide

Remodelled restrictions

 

 

Item 16    Schedule 4

Item 16 removes entries related to the brand name Desferal, which has been delisted, from Schedule 4 – Patient Contributions.

 

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 9) is an amendment to the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, enacted by the Minister for Health under the authority granted by the National Health Act 1953. This legislative instrument aims to make adjustments to the Highly Specialised Drugs (HSD) program, aligning it with recent amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes include adding a new pharmaceutical item, altering prescribing conditions, and removing certain pharmaceutical items and brands. These amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established to advise the Minister on the availability of drugs as pharmaceutical benefits. The PBAC's recommendations consider factors such as clinical effectiveness, safety, and cost-effectiveness. The instrument commenced on 1 October 2016, ensuring that the HSD program remains current and effective in meeting the healthcare needs of Australians.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9) applies to the amendments of the Highly Specialised Drugs (HSD) program under the National Health Act 1953. This Act is a Commonwealth legislation that enables the Minister for Health to make special arrangements for the supply of pharmaceutical benefits, including those related to the HSD program. The Amending Instrument modifies the National Health (Highly specialised drugs program) Special Arrangement 2010, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. It specifically addresses the addition of new pharmaceutical items, modifications to prescribing circumstances, and the removal of certain pharmaceutical items and brands. The changes are designed to align with recommendations from the Pharmaceutical Benefits Advisory Committee, which consults with various stakeholders including pharmaceutical companies, to determine the availability of drugs on the Pharmaceutical Benefits Scheme. The Amending Instrument has a national reach as it is a Commonwealth legislation and impacts the provision of pharmaceutical benefits across Australia. The changes it enacts apply to all entities involved in the supply and prescription of highly specialised drugs, including healthcare providers, pharmaceutical companies, and patients. The instrument does not specify any exclusions or thresholds for its application, indicating that the changes are broadly applicable to all relevant entities and drugs within the HSD program. The authority to make and amend these special arrangements is derived from subsections 100(1), 100(2), and 100(3) of the National Health Act 1953, with further details and provisions outlined in the accompanying Schedule. This legislative instrument commenced on 1 October 2016, ensuring that the HSD program is updated to reflect current medical standards and recommendations.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 9) (the Amending Instrument) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (the Special Arrangement) to make changes to the Highly Specialised Drugs (HSD) program. Section 4 of the Special Arrangement is amended to include a new drug, Darunavir with Cobicistat, in the definition of medication for the treatment of HIV or AIDS (Section 4(1)). Additionally, there are changes to the pharmaceutical items listed in Schedules 1 and 3, including the addition of a new pharmaceutical item, changes to circumstances for prescribing, and the removal of certain pharmaceutical items and brands (Schedules 1 and 3). The Amending Instrument imposes obligations on pharmaceutical companies, healthcare providers, and patients to comply with the updated Special Arrangement. Pharmaceutical companies must ensure that the drugs listed in the Special Arrangement meet the required standards and are available for prescription under the amended conditions. Healthcare providers must adhere to the updated prescribing guidelines and ensure that patients have access to the necessary medications. Patients, in turn, must follow the prescribed treatment plans and comply with any changes to their medication regimen as advised by their healthcare providers. Breach of the obligations set out in the Amending Instrument may lead to various consequences. While specific offences, penalties, or civil/criminal consequences are not detailed in the provided text, non-compliance with the amended Special Arrangement could result in administrative actions, fines, or other regulatory measures. The maximum penalties for such breaches are not explicitly stated in the provided information, but they would typically be aligned with the regulatory framework governing pharmaceutical benefits and healthcare practices in Australia.

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