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.
Overview
The National Health (Trastuzumab) Special Arrangement Amendment Instrument 2011 (No. 1) was enacted to amend the National Health (Trastuzumab) Special Arrangement Instrument 2010, addressing the need for a special arrangement under subsection 100(1) of the National Health Act 1953. This special arrangement aims to ensure the availability of an adequate supply of pharmaceutical benefits, specifically for patients receiving treatment for early stage breast cancer when the generally available pharmaceutical benefits are inadequate for their treatment. Enacted by authority of the Minister for Health and Ageing, the policy objective of this legislative instrument is to facilitate the provision of necessary pharmaceutical benefits in circumstances where standard arrangements under Part VII of the Act are not suitable, thereby enhancing the efficiency and effectiveness of treatment for eligible patients. The instrument incorporates recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the amendments align with expert advice on the clinical effectiveness and cost-effectiveness of the pharmaceutical benefits involved.
Scope and Application
The National Health (Trastuzumab) Special Arrangement Amendment Instrument 2011 (No. 1) amends the existing National Health (Trastuzumab) Special Arrangement Instrument 2010, extending the special arrangement under subsection 100(1) of the National Health Act 1953 to include an additional form of the drug trastuzumab, specifically Powder for I.V. infusion 60mg, for patients receiving treatment for early-stage breast cancer. This special arrangement is designed to ensure that patients in certain circumstances, such as those living in isolated areas or receiving treatment where generally available pharmaceutical benefits are inadequate, have access to an adequate supply of the necessary pharmaceutical benefits. This special arrangement modifies the operation of Part VII of the Act and other relevant regulations and instruments to accommodate the specific needs of these patients. The amendment reflects recommendations made by the Pharmaceutical Benefits Advisory Committee and is subject to the ongoing consultation process involving relevant stakeholders, including pharmaceutical companies and members of the PBAC. The instrument commenced on 1 February 2011 and operates under the authority of the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of the National Health (Trastuzumab) Special Arrangement Amendment Instrument 2011 (No. 1) include Section 100(1), which empowers the Minister to create special arrangements for the supply of pharmaceutical benefits to individuals in specific circumstances where the standard provisions under Part VII of the National Health Act 1953 are deemed inadequate. This is particularly relevant in cases where individuals live in isolated areas, are receiving treatment where generally available pharmaceutical benefits are insufficient, or where the benefits can be supplied more conveniently or efficiently under a special arrangement. Section 100(3) stipulates that the operation of Part VII, as well as regulations and other instruments made for its purposes, is subject to any special arrangement made under Section 100(1). Essentially, this means that the special arrangements can modify the standard operation of Part VII and related instruments to meet specific needs.
The obligations and requirements imposed by this Act on the parties and entities it governs primarily revolve around the establishment and implementation of the special arrangement for the supply of trastuzumab, a drug used in the treatment of early-stage breast cancer. The Minister is tasked with ensuring that these special arrangements are made to address the inadequacies in the standard supply of pharmaceutical benefits under Part VII. This includes consulting with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, to make recommendations on which drugs should be available as pharmaceutical benefits. Additionally, pharmaceutical companies are consulted throughout the process to agree on final listing details. The Act also requires the Minister to ensure that the special arrangement is consistent with the recommendations made by PBAC and to ensure that any amendments to the special arrangement are implemented effectively.
Breaches of the provisions outlined in this Act can lead to various civil and criminal consequences. While the specific penalties are not detailed in the Explanatory Statement, it is implied that non-compliance with the special arrangement or failure to adequately consult with relevant parties such as PBAC could result in legal repercussions. The Minister's duty to ensure that the special arrangement is implemented correctly and in accordance with recommendations is crucial to avoiding such consequences. Failure to do so could potentially lead to legal actions, though the exact nature and severity of these penalties are not explicitly stated in the provided text. The overarching aim is to ensure that patients in need receive the necessary pharmaceutical benefits in a manner that is both efficient and effective.