EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 10)
PB 102 of 2014
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 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 102 of 2014 involve the addition of a new brand for the drug Sildenafil, and changes to the Responsible Person Codes for the drugs Clarithromycin, and Epoetin Lambda.
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.
This Instrument commences on 1 January 2015.
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 2014 (No.10)
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 2014 (No.10) and that it may also be cited as PB 102 of 2014.
Section 2 Commencement
This section provides that this instrument commences on 1 January 2015.
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 Schedule 1, entry for Clarithromycin
This item amends the Responsible Person for Clarithromycin (all forms) from Abbott Australasia Pty Ltd to BGP Products Pty Ltd.
Item 2 Schedule 1, entry for Epoetin Lambda
This item amends the Responsible Person for Epoetin Lambda (all forms) from Novartis Pharmaceuticals Australia Pty Limited to Sandoz Pty Ltd.
Item 3 Schedule 1, entry for Sildenafil
This item adds the brand SILDENAFIL-DRx for Sildenafil in the form Tablet 20 mg (as citrate) with the responsible person Dr Reddy’s Laboratories Australia Pty Ltd (RZ).
Item 4-6 Schedule 2, Responsible Person Codes
These items provide for the deletion of the Responsible Person Abbott Australasia Pty Ltd (AB) and the addition of BGP Products Pty Ltd (GO) and Dr Reddy’s Laboratories Australia Pty Ltd (RZ).