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 2010 (No. 1)
PB 123 of 2010
Purpose
This legislative instrument is made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act) and amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010, also known as PB 117 of 2010 (the Special Arrangement), with respect to the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients and patients on discharge.
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).
Section 100 special arrangements and Part VII of the Act
Special arrangements are made under section 100 to ensure an adequate supply of pharmaceutical benefits is available to persons in the situations set out in subsection 100(1) when supply under Part VII, the regulations and other instruments made for the purposes of Part VII is not appropriate. Part VII of the Act, the regulations and other instruments made for the purposes of Part VII have effect subject to a special arrangement (subsection 100(3)). A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
Changes to the Special Arrangement made by this Amendment Instrument
This Amendment Instrument provides for certain new pharmaceutical benefits to be added to PB 117 of 2010 at the same time that they are listed on the PBS by another legislative instrument made under section 85 of the Act and for the addition of a new responsible person in the responsible person schedule.
This Amendment Instrument also provides for amended circumstances in which a prescription for the supply of chemotherapy pharmaceutical benefits with the listed drug Aprepitant may be written. These amendments accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). The amended circumstances have been determined by the Minister under subsection 85(7) of the Act in another legislative instrument and are included in the Amendment Instrument for transparency.
This Amendment Instrument also amends the references to two legislative instruments referred to in PB 117 of 2010 and corrects an error in section 11.
A provision by provision description of this Amendment Instrument is contained in the Attachment.
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 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 new listings to the PBS and for changes to the prescribing circumstances for listings on the PBS and for this Amendment Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Amendment Instrument commences on 1 January 2011.
This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESSS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2010 (No.1)
Section 1 Name of Amendment Instrument
This section provides that this Amendment Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2010 (No. 1) and that it may also be cited as PB 123 of 2010.
Section 2 Commencement
This section provides that this Amendment Instrument commences on 1 January 2011.
Section 3 Amendments to PB 117 of 2010
Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) which was made on 29 November 2010 and commenced on 1 December 2010. A summary of the changes provided for in Schedule 1 is set out below.
SUMMARY OF CHANGES
Reference to Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010
The reference in section 4 of PB 117 of 2010 to the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010 is amended so that the reference is to the more general ‘determination made under paragraph 98B(1)(a) of the Act’.
Information to be included in a medication chart
A requirement to record the letters ‘PBS’ or RPBS’ as appropriate is inserted.
Reference to the National Health Act 1953 Pharmaceutical Benefits Rules under Subsection 99AAA(8)
The reference in paragraph 28(2)(b) of PB 116 of 2010 to the National Health Act 1953 Pharmaceutical Benefits Rules under Subsection 99AAA(8) is amended so that the reference is to the more general ‘rules determined by the Minister under subsection 99AAA(8)’
Forms Added
Docetaxel | Solution concentrate for I.V. infusion 20 mg in 1 mL Solution concentrate for I.V. infusion 80 mg in 4 mL |
Brands Added
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) (Gemcitabine Kabi, Gemcitabine Sun) Powder for I.V. infusion 1 g (as hydrochloride) (Gemcitabine Kabi, Gemcitabine Sun) Powder for I.V. infusion 2 g (as hydrochloride) (Gemcitabine Kabi) |
Oxaliplatin | Powder for I.V. infusion 50 mg (Xalox) Powder for I.V. infusion 100 mg (Xalox) Solution concentrate for I.V. infusion 50 mg in 10 mL (Oxaliplatin Kabi) |
Paclitaxel | Solution concentrate for I.V infusion 30 mg in 5 mL (Paclitaxel Kabi) Solution concentrate for I.V infusion 100 mg in 16.7 mL (Paclitaxel Kabi) Solution concentrate for I.V infusion 300 mg in 50 mL (Paclitaxel Kabi) |
Addition of Responsible Person
Responsible Person | Code | ABN |
Sun Pharmaceutical Industries (Australia) Pty Ltd | ZF | 64 130 119 603 |
Alteration of Circumstances
Aprepitant | Circumstances amended to add new Streamlined Authority Code |