National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 11) (No. PB 110 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02508 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 11)

 

PB 110 of 2012

 

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

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.

The amendments made by this Instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

This instrument:

  • deletes 1 brand; and
  • deletes 1 responsible person code.

 

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), 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.

This Instrument commences on 1 January 2013.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

 


ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No.11)

 

Section 1 Name of Instrument

This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.11) and that it may also be cited as PB 110 of 2012.

Section 2 Commencement

This section provides that this Instrument commences on 1 January 2013.

Section 3 Amendments to PB 116 of 2010

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement).

Schedule 1  Amendments

Items [1] Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250mg, brand Cellplant 

This item deletes the brand Cellplant for the drug mycophenolic acid in the form of a 250mg capsule.

Item [2] Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500mg, brand Cellplant

This item deletes the brand Cellplant for the drug mycophenolic acid in the form of a 500mg tablet.

Item [3] Schedule 2, entry for Willow Pharmaceuticals Pty Ltd

This item deletes a responsible person code for Willow Pharmaceuticals Pty Ltd.  

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Act 1953, amended by the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 11), aims to update the special arrangement governing the supply of highly specialised drugs to hospitals. Enacted by the Parliament of Australia, this amendment responds to the need for flexibility in the supply of pharmaceutical benefits, particularly for drugs used in treating chronic conditions in specialised hospital settings. The policy objective is to ensure that the highly specialised drugs program remains aligned with current medical practices and cost-effectiveness considerations, as recommended by the Pharmaceutical Benefits Advisory Committee. This legislative instrument, effective from 1 January 2013, reflects changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, focusing on the removal of specific brands and responsible person codes to streamline the program and maintain its integrity and efficacy.

Scope and Application

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 11) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010. This Act applies to pharmaceutical benefits supplied under the highly specialised drugs program for hospitals, specifically for the treatment of chronic conditions requiring specialised facilities. The amendment pertains to the deletion of a specific drug brand and a responsible person code, reflecting changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument is made under subsections 100(1) and 100(2) of the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke such arrangements. The changes are effective from 1 January 2013 and are subject to the provisions of Part VII of the National Health Act 1953 and any special arrangements made under subsection 100(1). The amendments were made in accordance with recommendations by the Pharmaceutical Benefits Advisory Committee, ensuring an ongoing and formal process of consultation with relevant parties, including pharmaceutical companies.

Key Provisions

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 11) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 (PB 116 of 2010). The primary amendments include the removal of a specific brand of mycophenolic acid from the program, which is supplied in the form of 250mg capsules and 500mg tablets under the brand name Cellplant, and the deletion of a responsible person code associated with Willow Pharmaceuticals Pty Ltd (Schedule 1, items [1] and [2], and Schedule 2, item [3]). This legislative instrument was made under the authority granted by subsection 100(1) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits, subject to potential variation or revocation by the Minister (subsection 100(2)). This Act imposes specific obligations on the parties involved, including the responsible persons and entities managing the supply of these highly specialised drugs. They must ensure compliance with the amendments set out in the Instrument, which involve removing certain pharmaceutical products from the list of approved drugs available under the program. The Act also requires that the amendments reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency across related legislation. Responsible persons must also notify relevant stakeholders of these changes and update their records accordingly. Failure to comply with the provisions of this Instrument can result in legal consequences. While the specific penalties are not detailed in the Instrument, breaches of provisions under the National Health Act 1953 can lead to significant civil and criminal penalties. These may include fines and, in severe cases, imprisonment. The exact penalties depend on the nature and severity of the breach, as well as any relevant jurisdictional provisions. It is crucial for all parties to adhere to the amendments to avoid any potential legal repercussions.

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Pharmaceutical Law
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Legislative Instrument
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Repeal & Amendment
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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.