National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 8) (PB 72 of 2015)

Overview

The National Health Act 1953, enacted by the Australian Parliament, provides the framework for the provision of health services and the regulation of pharmaceutical benefits in Australia. To address the need for a specialised program for highly specialised drugs, the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 8) was introduced. This amendment, effective from 1 August 2015, was made under the authority granted by the Act, specifically subsections 100(1) and 100(2), to modify the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. The primary policy objective of this amendment was to align the Special Arrangement with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency and accuracy in the listing of pharmaceutical benefits. The amendment involved additions, deletions, and modifications to drugs, forms, brands, responsible person codes, and prescribing conditions, all of which were recommended by the Pharmaceutical Benefits Advisory Committee and reflect considerations of clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 8) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, under subsections 100(1) and 100(2) of the National Health Act 1953. This amendment pertains to the highly specialised drugs program and reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on 1 August 2015. The amendments include additions, deletions, and changes to drugs, forms, brands, responsible person codes, maximum quantities, and the circumstances for prescribing various pharmaceutical benefits, including authority requirements. The changes are detailed in the attached schedule, which provides a summary by drug name. The Instrument is applicable to entities and individuals involved in the supply of pharmaceutical benefits, specifically those affected by the changes in the highly specialised drugs program. The geographic reach of the Act is national, as it is a Commonwealth Act, and applies across Australia. The Instrument does not explicitly state exclusions, exemptions, or thresholds but operates within the broader framework of the National Health Act 1953 and its regulations. The application of the Act may be further defined or restricted through subordinate instruments made under the authority of the Act.

Key Provisions

The main operative sections of this legislative instrument, specifically the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 8), pertain to amendments made to the National Health (Highly specialised drugs) Special Arrangement 2010. This amendment, detailed in Schedule 1, encompasses changes such as additions, deletions, and modifications to drugs, their forms, brands, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (sections 1 and 2). The purpose of these amendments is to align with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the special arrangement for highly specialised drugs reflects the most current pharmaceutical benefits available. These changes include the addition of new drugs, such as pomalidomide and vedolizumab, and adjustments to the prescribing conditions and responsible parties for existing drugs (section 1, Item 1, Item 2-15). The obligations and requirements imposed by this Act on the parties or entities it governs include adherence to the updated special arrangement. Pharmaceutical companies and prescribing medical practitioners must comply with the new drug listings, prescribing conditions, and any changes to responsible person codes. Additionally, the Act mandates that all pharmaceutical benefits provided under the highly specialised drugs program must align with the criteria set out in the amended special arrangement, ensuring that only authorised drugs are prescribed under the correct conditions (section 3). The legislative instrument also outlines the consequences for non-compliance with the provisions of the amended special arrangement. While the Act does not explicitly detail specific offences or penalties for breach, breaches of the National Health Act 1953 generally carry civil or criminal penalties, depending on the severity and intent of the breach. The Minister has the authority to vary or revoke the special arrangement, and non-compliance could potentially lead to legal action under the Act, including fines and other penalties as prescribed by law (subsections 100(2) and 100(3)).