National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 2) (PB 20 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00378 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. 2)

 

PB 20 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. 2) (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 20 of 2017 include additions of new pharmaceutical items, new brands, new manufacturer code and amendment of proportional ex-manufacturer and claimed price.

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 April 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. 2).  It can also be cited as PB 20 of 2017.

 

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

Items 1 to 4  Schedule 1  

Items 1 to 4 provide for additions of new pharmaceutical items and new brands. 

 

Listed Drug

Type of Change

Apomorphine

Addition of pharmaceutical item

Entecavir

Addition of a brand

Epoprostenol

Addition of pharmaceutical item

Pegfilgrastim

Addition of a brand

 

Item 5  Schedule 2

Item 5 amends Schedule 2 of the Special Arrangement by adding the new responsible person GV ‘Amgen Australia Pty Limited’, to the list of Responsible Persons Codes.

 

Item 6  Schedule 4

Item 6 amends Schedule 4 – Patient Contributions of the Special Arrangement by amending the proportional ex-manufacturer price and claimed price for brand ‘Valtrex’ for the listed drug ‘Valaciclovir’.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Act 1953, enacted by the Australian Parliament, was introduced to establish and maintain public health services across Australia, including the Pharmaceutical Benefits Scheme (PBS). This Act provides the legislative foundation for the highly specialised drugs program, which is designed to ensure Australians have access to essential medicines that treat rare and life-threatening conditions. The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 2) was introduced to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 to align with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment ensures the PBS continues to provide access to the most effective and cost-efficient treatments available, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body appointed by the Minister for Health, advises on which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 2) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, modifying provisions relating to the Highly Specialised Drugs (HSD) program. The amendments, which reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, include the addition of new pharmaceutical items, new brands, and a new manufacturer code, as well as the amendment of proportional ex-manufacturer and claimed prices. This Instrument applies to the Minister for Health under subsection 100(1) of the National Health Act 1953, allowing the Minister to make special arrangements for the supply of pharmaceutical benefits. The changes are designed to align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on the listing of drugs on the Pharmaceutical Benefits Scheme (PBS). The amendments came into effect on 1 April 2017 and are a legislative instrument for the purposes of the Legislation Act 2003.

Key Provisions

The main operative sections of this legislative instrument pertain to amendments to the National Health (Highly specialised drugs program) Special Arrangement 2010 (No. 2) (sections 1-4). Specifically, these sections introduce new pharmaceutical items and brands to the Special Arrangement, adding Apomorphine and Epoprostenol as pharmaceutical items (section 1) and Entecavir and Pegfilgrastim as new brands (section 2). The Schedule also includes a new responsible person, GV ‘Amgen Australia Pty Limited’, in the list of Responsible Persons Codes (section 5), and revises the proportional ex-manufacturer price and claimed price for the brand ‘Valtrex’ for the drug ‘Valaciclovir’ (section 6). The obligations and requirements imposed by this Act on the parties or entities it governs primarily relate to compliance with the updated Special Arrangement. This includes ensuring that pharmaceutical benefits are supplied in accordance with the new provisions, particularly the inclusion of newly listed pharmaceutical items, brands, and responsible persons. Pharmaceutical companies and healthcare providers must also ensure that they are aware of and adhere to the updated proportional ex-manufacturer prices and claimed prices for the affected drugs. The Act outlines several potential consequences for non-compliance. Although specific offences and penalties are not detailed in the text, breaches of provisions under the National Health Act 1953 can result in civil or criminal penalties. These may include fines, imprisonment, or other sanctions as prescribed by law. The exact penalties would depend on the nature and severity of the breach, as well as any additional provisions specified in related legislation or regulations. It is essential for parties to comply with the updated Special Arrangement to avoid any legal repercussions.

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Pharmaceutical Law
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Amending Act
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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.