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. 8)
PB 63 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 changes all references to ‘Medicare Australia CEO’ in PB 117 of 2010 to ‘Chief Executive Medicare’. These changes are made as a consequence of the commencement of the Human Services Legislation Amendment Act 2011.
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.
This instrument:
- inserts 2 new chemotherapy pharmaceutical benefits; and
- makes changes to the circumstances and purposes for two chemotherapy pharmaceutical benefits.
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 September 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. 8)
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. 8) and that it may also be cited as PB 63 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 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
Items 1 to 24 change all references to ‘Medicare Australia CEO’ in the Principal Instrument to the new title ‘Chief Executive Medicare’. These changes are made as a consequence of the commencement of the Human Services Legislation Amendment Act 2011.
Item 25 amends Schedule 1 of the Principal Instrument to substitute a new entry for the listed drug ‘Cetuximab’. This new entry inserts the new circumstance codes ‘C3843’ and ‘C3844’ as additional circumstance codes for the two chemotherapy pharmaceutical benefits with the listed drug ‘Cetuximab’. This new entry also inserts the new purpose codes ‘P3843’ and ‘P3844’ as additional purpose codes for the two chemotherapy pharmaceutical benefits with the listed drug ‘Cetuximab’ when there is a maximum number of repeats of ‘0’.
Item 26 amends Schedule 1 of the Principal Instrument to substitute a new entry for the listed drug ‘Ondansetron’ in the form ‘I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL’. This new entry adds the new chemotherapy pharmaceutical benefit with that drug and form and the new brand ‘Ondansetron Alphapharm’.
Item 27 amends Schedule 1 of the Principal Instrument to substitute a new entry for the listed drug ‘Ondansetron’ in the form ‘I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL’. This new entry adds the new chemotherapy pharmaceutical benefit with that drug and form and the new brand ‘Ondansetron Alphapharm’.
Item 28 amends the entry for the listed drug ‘Cetuximab’ in Schedule 3 of the Principal Instrument to insert descriptions for the two new circumstance codes ‘C3843’ and ‘C3844’ and the two new purpose codes ‘P3843’ and ‘P3844’.