National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 6) (No. PB 63 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01736 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 2013 (No.6)

 

PB 63 of 2013

 

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 inserts two new restrictions for the 5 mg and 10 mg forms of the drug Lenalidomide, removes the brand Pamidronate Strides for the drug Pamidronic Acid, amends the responsible person for the drug Valaciclovir from Ascent Pharma Pty Ltd to Actavis Pty Ltd and updates the schedule of Responsible Person Codes.

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 October 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 2013 (No.6)

 

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 2013 (No.6) and that it may also be cited as PB 63 of 2013.

Section 2 Commencement

This section provides that this Instrument commences on 1 October 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

Item 1 Section 24, HSD pharmaceutical benefits that have CAR drugs—quantity exceptions

This item amends the existing section 24 to clarifythat the existing quantity exception for lenalidomide is specific to the treatment of multiple myeloma.  It also inserts the new quantity exception for the treatment of myelodysplastic syndrome to be limited to up to 21 tablets.

Item 2 Section 25, HSD pharmaceutical benefits that have CAR drugs—repeat exceptions

This item amends the existing section 25 to clarify that   the existing repeat exception for lenalidomide is specific to the treatment of multiple myeloma.  It also inserts the new quantity exception for the treatment of myelodysplastic syndrome to be limited to up to three repeats.

Item 3 Schedule 1, entry for Lenalidomide in the form Capsule 5 mg, manner of administration Oral

This item replaces the existing entry and inserts two new circumstance codes,  C4282 and C4287, in relation to the treatment of myelodysplastic syndrome for the 5mg capsule form of the drug lenalidomide.

Item 4 Schedule 1, entry for Lenalidomide in the form Capsule 10 mg, manner of administration Oral

This item replaces the existing entry and inserts two new circumstance codes, C4282 and C4287, in relation to the treatment of myelodysplastic syndrome for the 10mg capsule form of the drug lenalidomide.

Item 5 Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL, manner of administration injection

This item deletes the brand Pamidronate Strides for the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL with the manner of administration injection.

Item 6 Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL, manner of administration injection

This item deletes the brand Pamidronate Strides for the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL with the manner of administration injection.

Item 7 Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with the manner of administration Oral and brand Zelitrex

This item deletes the current responsible person code GM, (Ascent Pharma Pty Ltd), and inserts the new responsible person code of UA, (Actavis Pty Ltd).

Item 8 Schedule 2 – Responsible Person Codes

This item replaces the existing schedule with an updated table of Responsible Person Codes for the Highly Specialised Drugs program.  It amends typographical errors, includes the new listing of UA, Actavis Pty Ltd, and lists all entries in alphabetical order by manufacturer code.

Item 9 Schedule 3, entry for Lenalidomide

This item inserts the new restriction text for initiation and maintenance treatment for the condition myelodysplastic syndrome.

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No.6) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, which was enacted to establish a program for the supply of highly specialised drugs to hospitals for the treatment of chronic conditions. The amendments are made to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency between the Special Arrangement and the Pharmaceutical Benefits Schedule. This instrument was enacted by the Parliament of Australia under the authority provided in the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits. The policy objective of the amendments is to ensure that the highly specialised drugs program for hospitals remains aligned with the latest clinical and cost-effectiveness recommendations, as advised by the Pharmaceutical Benefits Advisory Committee. The amendments address specific changes to the listing of pharmaceutical benefits, including restrictions on the use of certain drugs, changes in responsible persons, and updates to the schedule of Responsible Person Codes.

Scope and Application

The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.6) is a legislative instrument made under the National Health Act 1953, which provides the Minister with the authority to make special arrangements for the supply of pharmaceutical benefits. This instrument amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, specifically relating to the highly specialised drugs program for hospitals. It applies to the treatment of chronic conditions that require specialised facilities, and is subject to the recommendations of the Pharmaceutical Benefits Advisory Committee. The amendments made by this instrument are in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and include modifications to quantity and repeat exceptions for certain drugs, as well as updates to responsible person codes. This instrument applies nationally, and its provisions are subject to the overarching framework of the National Health Act 1953. The amendments made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day. The instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003, and its provisions are subject to the overarching framework of the National Health Act 1953.

Key Provisions

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No.6) (Instrument) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 (Special Arrangement) to update and refine the pharmaceutical benefits supplied under the Highly Specialised Drugs Program. This is achieved through specific amendments to the Special Arrangement's Schedule 1 and Schedule 2, which detail the drugs covered, their specific uses, and the entities responsible for their provision. For instance, the amendments clarify the quantity exceptions for lenalidomide, restricting its use in the treatment of multiple myeloma, while also introducing new quantity exceptions for myelodysplastic syndrome (Section 24 and Section 25). Additionally, the amendments remove certain brands of drugs from the program, such as Pamidronate Strides for Pamidronic Acid, and update the responsible persons for specific drugs, such as changing the responsible person for Valaciclovir from Ascent Pharma Pty Ltd to Actavis Pty Ltd (Schedule 1, Item 5 and Item 7). The obligations imposed by the Instrument on the entities it governs, primarily hospitals and pharmaceutical companies, include ensuring compliance with the updated Special Arrangement. Hospitals must adhere to the new restrictions and quantity limits for the specified drugs, ensuring that they are used only for the conditions and in the quantities permitted. Pharmaceutical companies, particularly those whose drugs have been amended by the Instrument, must ensure they are listed as the responsible person and that their products comply with the new conditions. This includes updating their records and systems to reflect the changes made by the Instrument. The responsible persons must also ensure that the drugs they supply meet the required standards and are used appropriately within the scope defined by the Special Arrangement. The Instrument does not explicitly state any offences, penalties, or consequences for breach. However, non-compliance with the conditions set out in the Special Arrangement could potentially lead to administrative actions or sanctions under other related legislation, such as the National Health Act 1953 or the Therapeutic Goods Act 1989. Hospitals or pharmaceutical companies failing to comply with the drug usage restrictions or supply conditions could face scrutiny or penalties under these broader regulatory frameworks. The specific penalties would depend on the nature and severity of the breach, and the applicable provisions of other legislation.

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