National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 4) (No. PB 35 of 2011)

Overview

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 4) was introduced to amend the existing National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010. Enacted under the authority of the Minister for Health and Ageing and pursuant to the National Health Act 1953, this legislative instrument addresses the need to update the chemotherapy pharmaceuticals access program, ensuring that the supply of necessary pharmaceutical benefits at public hospitals remains adequate and aligned with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument. The overarching policy objective is to guarantee that persons, particularly those in isolated areas or undergoing treatment where generally available pharmaceutical benefits are insufficient, have access to necessary chemotherapy pharmaceuticals. The instrument was developed through formal consultations involving the Pharmaceutical Benefits Advisory Committee and pharmaceutical companies, ensuring that the amendments reflect the most current clinical and cost-effectiveness standards.

Scope and Application

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 4) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010, which deals with the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients, and patients on discharge. This amendment, made under the National Health Act 1953, introduces changes to the special arrangement to align with recent updates to the National Health (Listing of Pharmaceutical Benefits) Instrument. Specifically, the Instrument inserts two new chemotherapy pharmaceutical benefits: Docetaxel in the form of Solution concentrate for I.V. infusion 160 mg in 16 mL and Folinic Acid in the form of Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL for the brand Calcium Folinate Ebewe. These changes ensure that the special arrangement continues to provide an adequate supply of pharmaceutical benefits for patients receiving treatment in circumstances where generally available pharmaceutical benefits are inadequate. The Instrument is applicable to persons receiving chemotherapy treatment in public hospitals across Australia, ensuring that the special arrangement extends to meet the needs of patients in these specific treatment circumstances.

Key Provisions

The National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 4) (section 1) amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 to include two new chemotherapy pharmaceutical benefits. Specifically, the amendments add Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL and Folinic Acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL for the new brand Calcium Folinate Ebewe (section 3, Schedule 1). These changes are intended to enhance the availability of pharmaceutical benefits for patients under the Chemotherapy Pharmaceuticals Access Program, ensuring that they have access to necessary medications at public hospitals. The obligations under this special arrangement (subsection 100(1)) primarily concern the Minister for Health and Ageing, who is responsible for making special arrangements to ensure an adequate supply of pharmaceutical benefits for certain patients, including those in isolated areas or receiving treatment where generally available pharmaceutical benefits are inadequate. The arrangement must be made in a way that ensures these benefits are supplied conveniently or efficiently (subsection 100(1)(c)). Part VII of the Act, along with any regulations and other legislative instruments, operates subject to these special arrangements (subsection 100(3)). The Minister also has the authority to vary or revoke any special arrangement made under this subsection (subsection 100(2)). Non-compliance with the special arrangement requirements could potentially lead to legal consequences, although specific offences and penalties are not detailed in the explanatory statement. Generally, breaches of provisions under the National Health Act 1953 could result in civil or criminal penalties, depending on the nature and severity of the breach. For example, unauthorized supply or administration of pharmaceutical benefits could lead to criminal charges under the Act. However, the exact penalties are not explicitly stated in this explanatory statement but would typically be found in the relevant sections of the Act or associated regulations. Consultation with stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), is a key part of the process for making changes to the special arrangement. PBAC, established under section 100A of the Act, comprises members from various relevant fields who provide expert advice on which drugs should be included as pharmaceutical benefits. Pharmaceutical companies are consulted throughout the process to agree on final listing details, ensuring that the changes reflect current medical needs and practices. The amendments made by this instrument commence on 1 May 2011 (section 2). As a legislative instrument under the Legislative Instruments Act 2003, it follows the formal process for making such amendments, ensuring that all changes are properly documented and communicated to relevant parties. This commencement date ensures that the new chemotherapy pharmaceutical benefits are available from the specified date, enhancing the program's effectiveness in providing necessary medications to patients.