EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 1)
PB 5 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
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, 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 program.
The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 5 of 2016 include adding, removing and changing the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes.
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 and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 February 2016.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016
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. 1). It can also be citied as PB 5 of 2016.
Section 2 Commencement
This section provides that this instrument commences on 1 February 2016.
Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Items 1 - 16
Provide for deletions to drugs, forms, brands, and changes to the circumstances for prescribing various pharmaceutical benefits.
These changes are summarised below.
Summary of Changes
Alteration of Circumstances
Eculizumab Remodelled restrictions
Octreotide Remodelled restrictions
Thalidomide Remodelled restrictions
Addition of Brands
Apomorphine Movapo
Tacrolimus TACROLIMUS APOTEX
Deletion of Responsible Person codes
FM Fawns and McAllan Proprietary Limited
Add new Responsible Person codes
TD Stada Pharmaceuticals Australia Pty Limited
RF Arrow Pharma Pty Ltd
RW Arrow Pharma Pty Ltd
Changes in Responsible Persons
Lamivudine AS to RW
Valaciclovir AS to RW
Valaciclovir FM to RF
Deletion of Pharmaceutical Item
Stavudine Capsule 20 mg