EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (TRASTUZUMAB) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 1)
PB 4 of 2011
Purpose
This legislative instrument provides for a special arrangement under subsection 100(1) of the National Health Act 1953 (the Act) and amends the National Health (Trastuzumab) Special Arrangement Instrument 2010, also known as PB 115 of 2010 (the Special Arrangement).
This Special Arrangement concerns the supply of certain pharmaceutical benefits that have the drug trastuzumab to patients receiving treatment for early stage breast cancer in certain circumstances.
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).
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 Effected by this Amendment Instrument
This Instrument amends PB 115 of 2010 to provide for the addition of a new form of trastuzumab (Powder for I.V. infusion 60mg) to be covered by this Special Arrangement. Consequential amendments are also made to various provisions throughout PB 115 of 2010 to change references from ‘the trastuzumab pharmaceutical benefit’ to ‘a trastuzumab pharmaceutical benefit’ or ‘each trastuzumab pharmaceutical benefit’ (where appropriate). This is because this special arrangement now covers more than one pharmaceutical benefit.
The amendments accords with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
Consultations
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 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 of 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 Instrument commences on 1 February 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.