EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 92 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM
Summary
This legislative instrument amends Special Arrangements – Chemotherapy Pharmaceuticals Access Program (PB55 of 2009) made under subparagraph 100(1) of the National Health Act 1953 (the Act).
The purpose of this instrument is to ensure that Schedule 4 of PB 55 of 2009 is amended to adjust the special patient contribution which clause 20A and Schedule 4 of PB 55 of 2009 provides an approved hospital authority may charge a person supplied with a certain chemotherapy pharmaceutical under the s.100 arrangement, being, Bleomycin, Powder for injection containing bleomycin sulphate 15,000 I.U (Blenoxane).
An amendment to effect this change was previously made by PB 76 of 2010, with a commencement date of 1 August 2010. This instrument is made to rectify a misdescription in item 6, Schedule 1 of PB 76 of 2010.
Authority
The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
Subsection 85(1) of the Act provides that benefits shall be provided by the Commonwealth in accordance with Part VII of the Act in respect of pharmaceutical benefits.
Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefitsection Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
The Chemotherapy Pharmaceuticals Access Program is a set of Arrangements made under subparagraph 100(1) of the Act for the purpose of the supply of chemotherapy pharmaceuticals at participating public hospitals to non-admitted patients, day admitted patients and patients on discharge.
These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Commencement
This instrument commences on 1 October 2010.
Consultations
This amendment is a minor and mechanical change. Approved hospital authorities which supply under the section100 arrangement have been notified of the change to the special patient contribution.
Overview
The National Health Act 1953, enacted by the Australian Parliament, serves as the foundational framework for regulating the Australian Pharmaceutical Benefits Scheme (PBS), ensuring accessible, reliable, and affordable medicines for the community. Under this Act, the Minister is empowered to create special arrangements to supply necessary pharmaceutical products to individuals in isolated areas or those receiving medical treatment where conventional PBS provisions are inefficient or inadequate. This legislative instrument, F2010L02530, amends the Chemotherapy Pharmaceuticals Access Program under subsection 100(1) of the Act to rectify a misdescription in a previous amendment concerning the special patient contribution for Bleomycin, a chemotherapy pharmaceutical. This correction aims to ensure that the approved hospital authorities can charge the appropriate contribution to patients supplied with this medication, maintaining the integrity and effectiveness of the Chemotherapy Pharmaceuticals Access Program.
Scope and Application
This legislative instrument amends Special Arrangements concerning the Chemotherapy Pharmaceuticals Access Program under subparagraph 100(1) of the National Health Act 1953 (the Act), aiming to rectify a misdescription in a previously issued instrument (PB 76 of 2010). This adjustment affects the special patient contribution that an approved hospital authority may charge for the supply of Bleomycin, a chemotherapy pharmaceutical, to individuals under the special arrangements. The Act applies to persons receiving medical treatment in circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act or are inadequate for their treatment. The special arrangements outlined in the Act apply nationally, as they are designed to ensure that adequate supplies of necessary chemotherapy pharmaceuticals are available to patients in isolated areas or those receiving medical treatment in settings where the standard provisions of the Act are not sufficient. This legislative amendment ensures that the patient contributions are correctly specified, thus maintaining the integrity of the special arrangements under the Act.
Key Provisions
The main operative sections of this legislative instrument (PB 92 of 2010) pertain to the amendment of Schedule 4 in PB 55 of 2009, which relates to the special patient contribution for Bleomycin, Powder for injection containing bleomycin sulphate 15,000 I.U (Blenoxane) under the Chemotherapy Pharmaceuticals Access Program. Specifically, section 1 of PB 92 of 2010 corrects a misdescription found in item 6, Schedule 1 of PB 76 of 2010, ensuring that the special patient contribution is accurately reflected. This amendment ensures that the legislative instrument aligns with the intended adjustments to the patient contribution as initially proposed in PB 76 of 2010.
The obligations and requirements imposed by this Act on the parties involved primarily concern the approved hospital authorities supplying chemotherapy pharmaceuticals under the special arrangements outlined in section 100 of the National Health Act 1953. These authorities must ensure compliance with the adjusted special patient contributions as specified in the amended Schedule 4. The Act mandates that these hospitals charge patients the correct contribution amount as set forth in the legislative instrument, reflecting the corrected details for Bleomycin, Powder for injection containing bleomycin sulphate 15,000 I.U (Blenoxane). This obligation ensures that the patients are not overcharged and that the program's financial parameters are adhered to.
In terms of potential offences, penalties, or civil/criminal consequences for breach, the legislative instrument does not explicitly state penalties for non-compliance with the special patient contribution adjustments. However, under the broader framework of the National Health Act 1953, any failure by an approved hospital authority to comply with the specified contributions could potentially lead to administrative penalties or legal actions for non-compliance with legislative requirements. The precise consequences would depend on the specific provisions of the Act and any related regulations or guidelines. The maximum penalties, if applicable, would be determined in accordance with the relevant legislative provisions governing the administration and enforcement of the National Health Act 1953.