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. 1)
PB 3 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 minor amendments to the listings of various chemotherapy pharmaceutical benefits that may be supplied under the Special Arrangement.
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).
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 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.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESSS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No.1)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011(No. 1) and that it may also be cited as PB 3 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 February 2011.
Section 3 Amendments to PB 117 of 2010
Section 3 provides that Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Principal Instrument) which was made on 29 November 2010 and commenced on
1 December 2010.
Schedule 1
Item 1 of Schedule 1 changes the responsible person for chemotherapy pharmaceutical benefits containing the drug Doxorubicin – Pegylated Liposomal, from Schering-Plough Pty Ltd (responsible person code SH) to Janssen-Cilag Pty Ltd (responsible person code JC), by amending Schedule 1 of the Principal Instrument.
Items 2 and 3 of Schedule 1 add a new brand (Ondansetron-DRLA) for two chemotherapy pharmaceutical benefits with the drug Ondansetron, by amending the relevant entries for those forms in Schedule 1 of the Principal Instrument.
Item 4 amends the name of the responsible person for PL from the “Virgo Unit Trust” to “The Trustee for Virgo Unit Trust (trading as Phebra)” by amending Schedule 2 of the Principal Instrument.
Overview
The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 1) was enacted to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010, addressing minor adjustments to the listings of various chemotherapy pharmaceutical benefits supplied under the program. This legislative instrument was introduced to refine the administration and provision of these vital pharmaceutical benefits, ensuring they meet the needs of patients in specific treatment circumstances. Enacted by the Minister for Health and Ageing under the National Health Act 1953, the policy objective of this amendment is to ensure that an adequate supply of pharmaceutical benefits is available to those in need, particularly for patients receiving treatment in situations where generally available pharmaceutical benefits are inadequate. This amendment underscores the commitment to providing efficient and effective access to necessary chemotherapy pharmaceuticals for non-admitted, day admitted, and discharge patients at certain public hospitals.
Scope and Application
The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 1) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 to modify the listings of various chemotherapy pharmaceutical benefits that may be supplied under the Special Arrangement. This legislative instrument applies to the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients, and patients on discharge. The geographic reach of the Act is national, as it pertains to the administration of the Pharmaceutical Benefits Scheme (PBS) across Australia. The Act applies to entities and individuals involved in the supply and administration of chemotherapy pharmaceuticals, including pharmaceutical companies and hospitals participating in the Chemotherapy Pharmaceuticals Access Program. The Instrument also references the involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in the consultation process regarding pharmaceutical listings and amendments. The Act allows for the Minister to make special arrangements under Section 100 for providing adequate pharmaceutical benefits to persons in isolated areas or receiving treatments where generally available pharmaceutical benefits are inadequate, or where the pharmaceutical benefits can be more conveniently or efficiently supplied under the arrangements. The Act is subject to variations or revocations by the Minister as stipulated in Section 100(2). This Amendment Instrument, which commenced on 1 February 2011, makes specific amendments to the responsible persons for certain chemotherapy pharmaceuticals and adds new brands for particular drugs, reflecting changes in the entities responsible for supplying these benefits.
Key Provisions
The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 1) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 to make minor changes to the listings of various chemotherapy pharmaceutical benefits that can be supplied under the program. These changes primarily involve adjustments to the responsible entities for certain pharmaceutical benefits, such as the transfer of responsibility for Doxorubicin – Pegylated Liposomal from Schering-Plough Pty Ltd to Janssen-Cilag Pty Ltd, the addition of a new brand (Ondansetron-DRLA) for two chemotherapy pharmaceutical benefits containing Ondansetron, and the amendment of the responsible person for PL from Virgo Unit Trust to The Trustee for Virgo Unit Trust (trading as Phebra).
The obligations imposed by this Act on the parties or entities it governs include ensuring that the amendments to the chemotherapy pharmaceutical benefits listings are implemented correctly and that the responsible persons for the listed benefits take on their designated roles. The responsible persons are required to ensure the supply of the listed chemotherapy pharmaceuticals under the Special Arrangement, adhering to the terms and conditions set forth in the National Health Act 1953. The Minister for Health and Ageing retains the authority to make special arrangements to ensure adequate supply of pharmaceutical benefits, which includes the ability to vary or revoke these arrangements as necessary.
Any breach of the obligations or provisions under this Act can result in legal consequences. Specifically, under the National Health Act 1953, there are potential offences and penalties for non-compliance. While the exact penalties are not detailed in the explanatory statement, breaches of provisions under the Act can lead to civil or criminal actions, depending on the nature and severity of the breach. The Minister has the power to impose sanctions, which could include fines or other penalties as stipulated by the Act or relevant regulations. These measures ensure that the provisions of the Act are upheld, maintaining the integrity and effectiveness of the Chemotherapy Pharmaceuticals Access Program.