EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 9)
PB 70 of 2011
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the chemotherapy pharmaceuticals access program.
The Special Arrangement deals with the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients and patients on discharge.
Section 100 special arrangements and Part VII of the Act
Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas: or
(b) who are receiving treatment in circumstances in which generally available
pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more
conveniently or efficiently supplied under the arrangements.
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Changes to the Special Arrangement made by this Instrument
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the chemotherapy pharmaceuticals access program. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commences on the same day.
Consultations
An ongoing and formal process of consultation in relation to matters relevant to this instrument includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (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 for additions and changes to listings on the PBS and for the Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Instrument commences on 1 October 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 9)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011(No. 9) and that it may also be cited as PB 70 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2011.
Section 3 Amendments to PB 117 of 2010
This section provides that Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Principal Instrument).
Schedule 1
Item 1 inserts two new forms for the pharmaceutical benefit Docetaxel, Powder for I.V infusion 20 mg with solvent and Powder for I.V infusion 80 mg with solvent.
Item 2 adds two new brands ‘Docetaxel Sandoz’ for the pharmaceutical benefit Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL.
Item 3 adds two new brands ‘Docetaxel Sandoz’ for the pharmaceutical benefit Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL.
Item 4 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Fludarabine in the form Powder for I.V injection containing fludarabine phosphate 50 mg.
Item 5 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Gemcitabine in the form Powder for I.V infusion 200 mg (as hydrochloride).
Item 6 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Gemcitabine in the form Powder for I.V infusion 1 g (as hydrochloride).
Item 7 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) and adds the brand ‘Irinotecan Kabi’ for the pharmaceutical benefit Irinotecan in the form I.V injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL.
Item 8 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) and adds the brand ‘Irinotecan Kabi’ for the pharmaceutical benefit Irinotecan in the form I.V injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL.
Item 9 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Oxaliplatin in the form Powder for I.V infusion 50 mg.
Item 10 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Oxaliplatin in the form Powder for I.V infusion 100 mg.
Item 11 adds the brand ‘Oxaliplatin SUN for the pharmaceutical benefit Oxaliplatin in the form Solution concentrate for I.V infusion 50 mg in 10 mL.
Item 12 adds the brand ‘Oxaliplatin SUN for the pharmaceutical benefit Oxaliplatin in the form Solution concentrate for I.V infusion 100 mg in 20 mL.
Item 13 adds the brand ‘Oxaliplatin SUN for the pharmaceutical benefit Oxaliplatin in the form Solution concentrate for I.V infusion 200 mg in 40 mL.
Item 14 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Paclitaxel in the form Solution concentrate for I.V infusion 30 mg in 5 mL.
Item 15 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Paclitaxel in the form Solution concentrate for I.V infusion 100 mg in 16.7 mL.
Item 16 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Paclitaxel in the form Solution concentrate for I.V infusion 150 mg in 25 mL.
Item 17 amends the Responsible Person code from ‘GQ’ (Generic Health Pty Ltd) to ‘TA’ (Actavis Australia Pty Ltd) for the pharmaceutical benefit Paclitaxel in the form Solution concentrate for I.V infusion 300 mg in 50 mL.
Item 18 removes the brands ‘Vinorelbine Kabi’ and ‘Vinorelbine Link’ for the pharmaceutical benefit Vinorelbine.
Item 19 removes the Responsible Person Code ‘FU’ (Fresentius Kabi Australia Pty Limited).
Item 20 removes the Responsible Person Code ‘GQ’ (Generic Health Pty Ltd).