National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 11) (PB 100 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01842 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. 11)

 

PB 100 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. 11) (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 100 of 2016 include addition of new pharmaceutical items, addition of new brands, amending and addition of restrictions, and addition of brand premiums. 

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.  This includes consultation through the PBAC process.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 December 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. 11).  It can also be cited as PB 100 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 December 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 9  Schedules 1 and 3

Items 1 to 9 provide for addition of new pharmaceutical items, addition of new brands, amending and addition of restrictions. These changes are summarised below:                             

 

Listed Drug

Type of Change

Apomorphine

Addition of pharmaceutical item

Entecavir

Addition of new brands

Infliximab

Remodelled restrictions

Omalizumab

Remodelled restrictions

Tenofovir with emtricitabine

Addition of pharmaceutical item

Vedolizumab

Remodelled restrictions

 

 

Item 10   Schedule 4 – Patient Contributions

Item 10 amends Schedule 4 – Patient Contributions of the Special Arrangement by adding brand premiums to ‘Zeffix’ and ‘Valtrex’ for the listed drugs ‘Lamivudine’ and ‘Valaciclovir’.

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 11) was enacted to amend the existing National Health (Highly Specialised Drugs Program) Special Arrangement 2010, updating the Highly Specialised Drugs (HSD) program. This legislative instrument is authorised by subsection 100(1) of the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits. The primary policy objective of this amendment is to reflect recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include the addition of new pharmaceutical items, brands, restrictions, and brand premiums. These amendments are consistent with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the Act that advises on which drugs should be included in the Pharmaceutical Benefits Scheme (PBS). The PBAC ensures that decisions regarding drug listings on the PBS are informed by clinical effectiveness, safety, and cost-effectiveness. The changes introduced by this amendment are designed to keep the HSD program aligned with the most current pharmaceutical standards and recommendations.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 11) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to update the Highly Specialised Drugs (HSD) program. This instrument applies to the Minister for Health, pharmaceutical companies, and patients who require highly specialised drugs under the HSD program, impacting the supply and listing of pharmaceutical benefits in Australia. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, including additions of new pharmaceutical items and brands, amendments to restrictions, and the introduction of brand premiums. These amendments are informed by recommendations from the Pharmaceutical Benefits Advisory Committee, which ensures that the changes align with clinical effectiveness, safety, and cost-effectiveness considerations. The instrument commenced on 1 December 2016, and it is subject to the provisions of the Legislation Act 2003.

Key Provisions

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 11) amends the National Health (Highly specialised drugs program) Special Arrangement 2010. This legislation introduces changes to the Highly Specialised Drugs (HSD) program, which is governed by Part VII of the National Health Act 1953 (the Act) (sections 1, 3). The changes include the addition of new pharmaceutical items and brands, amendments to existing restrictions, and the addition of brand premiums for certain drugs (Schedule, items 1 to 9). The amendments also affect patient contributions by adding brand premiums to specific drugs (Schedule, item 10). Under the Act, the Minister for Health is responsible for making special arrangements for the supply of pharmaceutical benefits and can vary or revoke these arrangements (sections 100(1)-(3)). The changes introduced by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) (Attachment). The PBAC is an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits (Attachment). This process involves consultation with pharmaceutical companies and other stakeholders. The entities and parties governed by this Act must comply with the changes introduced by the Amendment Instrument, including the addition of new pharmaceutical items and brands, amendments to restrictions, and the addition of brand premiums. These changes impact the availability and cost of certain drugs under the HSD program (Schedule, items 1 to 10). There are no specific offences, penalties, or civil/criminal consequences outlined for breach of this legislation in the provided text. However, failure to comply with the provisions of the National Health Act 1953 or the special arrangements made under it could potentially lead to legal action, including enforcement actions by the Minister or proceedings in the Federal Court. The penalties for breaches of health-related legislation can vary, but may include fines and other sanctions depending on the nature and severity of the breach.

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