National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 3) (PB 30 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00489 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 2017 (No. 3)

 

PB 30 of 2017

 

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 2017 (No. 3) (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 30 of 2017 include amendments to the definition of medication for the treatment of HIV or AIDS, addition of new pharmaceutical items and a new brand, changes to circumstances for prescribing and removing pharmaceutical items. 

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.  Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication. 

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 May 2017.

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 2017

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 2017 (No. 3).  It can also be cited as PB 30 of 2017.

 

Section 2 Commencement
This section provides that this instrument commences on 1 May 2017.

 

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 (Definitions)

Item 1 amends Division 1, Section 4 (Definitions) of the Special Arrangement by adding Emtricitabine with rilpivirine with tenofovir alafenamide, Emtricitabine with tenofovir alafenamide and Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat to the definition of medication for the treatment of HIV or AIDS. 

Items 2 to 21  Schedule 1 and Schedule 3 

Items 2 to 21 provide for addition of new pharmaceutical items and a new brand, changes to circumstances for prescribing and removing pharmaceutical items. 

 

Listed Drug

Type of Change

Alemtuzumab

Remodelled restrictions

Boceprevir

Deletion of listed drug

Emtricitabine with rilpivirine with tenofovir alafenamide

Addition of new pharmaceutical item

Emtricitabine with tenofovir alafenamide

Addition of new pharmaceutical item

Interferon Alfa-2a

Deletion of form and strength

Ivacaftor

Addition of new form and strength; remodelled restriction

Levodopa with Carbidopa

Remodelled restrictions

Natalizumab

Remodelled restrictions

Nevirapine

Addition of new brand

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

Addition of new pharmaceutical item

Tenofovir with Emtricitabine

Deletion of form and strength

Tenofovir with emtricitabine, elvitegravir and cobicistat

Deletion of form and strength

 

 

 

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, addresses the provision of health services and pharmaceutical benefits. To further refine the supply of highly specialised drugs, the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 3) was introduced. This legislative instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, aligning with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective of this amendment is to update the Highly Specialised Drugs Program in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, established under the Act, comprises experts from various healthcare fields, ensuring comprehensive and evidence-based recommendations regarding the availability of drugs on the Pharmaceutical Benefits Scheme. The amendments, which include updates to drug definitions, the addition of new pharmaceutical items, and modifications to prescribing conditions, are intended to reflect current medical practices and ensure the continued provision of effective and cost-efficient treatments.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 3) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to adjust the Highly Specialised Drugs (HSD) program under the National Health Act 1953. This legislative instrument applies to entities and individuals involved in the supply, prescription, and administration of pharmaceutical benefits within the HSD program. The changes primarily affect pharmaceutical companies, healthcare providers, and patients who rely on medications listed under the HSD program. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and they are designed to align the HSD program with updated recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The geographic reach of this legislation is national, as it pertains to the Australian Pharmaceutical Benefits Scheme (PBS) and is implemented across all states and territories. The amendments include adjustments to the definition of certain medications for the treatment of HIV or AIDS, the addition of new pharmaceutical items and brands, and modifications to prescribing conditions. The instrument does not explicitly state exclusions, but its focus is on drugs and treatments within the HSD program. The application of this Act is extended through subordinate instruments, ensuring that the changes are effectively integrated into the existing regulatory framework.

Key Provisions

The main sections of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 3) (the Amending Instrument) primarily focus on amending the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (the Special Arrangement) to incorporate changes relating to the Highly Specialised Drugs (HSD) program (Section 3). Specifically, the amendments address the definition of medication for the treatment of HIV or AIDS (Item 1) and introduce new pharmaceutical items and brands, as well as changes to prescribing and removal conditions (Items 2 to 21). The Amending Instrument aims to reflect amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The obligations imposed by the Amending Instrument on the parties involved include ensuring compliance with the updated definitions and conditions regarding pharmaceutical items, particularly those related to HIV or AIDS treatment. Pharmaceutical companies and healthcare providers must adhere to the new restrictions, additions, and removals specified in the amended Special Arrangement. This includes accurately identifying and supplying the newly listed drugs and adhering to the revised prescribing conditions. Breaches of the obligations and conditions set out in the Amending Instrument may result in civil or criminal consequences. While the Amending Instrument itself does not specify detailed penalties, breaches of related provisions in the National Health Act 1953 can attract significant penalties. For instance, under the National Health Act, penalties for contravening provisions related to the supply of pharmaceutical benefits can include substantial fines and, in some cases, imprisonment. The exact penalties would depend on the specific breach and the provisions of the National Health Act applicable to the situation.

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