National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10) (PB 89 of 2017)

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10) was enacted to refine the arrangements for the efficient funding of chemotherapy medicines provided under the National Health Act 1953. This legislative instrument was introduced to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, addressing the need for more efficient payment systems for chemotherapy and related pharmaceutical benefits. The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which was itself established to implement the 2010 Budget measure aimed at improving the funding of chemotherapy drugs, was updated to align with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment was made under the authority provided by subsection 100(2) of the Act, which allows the Minister to vary or revoke special arrangements for the supply of pharmaceutical benefits. The objective of these amendments is to ensure that the funding mechanisms for chemotherapy drugs remain efficient and reflective of the latest recommendations and market conditions. The enactment of this instrument by the relevant authority under the National Health Act 1953 was supported by extensive consultation processes, particularly through the Pharmaceutical Benefits Advisory Committee (PBAC), which involves various stakeholders including pharmaceutical companies and experts from different health-related fields. The PBAC plays a crucial role in recommending drugs for listing on the Pharmaceutical Benefits Scheme, ensuring that the recommendations consider clinical effectiveness, safety, and cost-effectiveness. Given the comprehensive nature of prior consultations, it was determined that additional consultation for this specific amendment was not necessary. The amendments took effect on 1 November 2017, marking the commencement of the updated arrangements for the efficient funding of chemotherapy and related benefits under the National Health Act 1953.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to align with the changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument applies to the efficient funding of chemotherapy pharmaceutical benefits and related pharmaceutical benefits, specifically those associated with the side effects of cancer and cancer treatment at certain public hospitals. The amendments cover the addition, deletion, and modification of various pharmaceutical forms, brands, and prescribing conditions. This amendment applies nationally, following the authority granted under Subsection 100(1) of the National Health Act 1953. The National Health Act 1953 provides the overarching framework for the administration of public health services in Australia, and the special arrangement pertains to the efficient funding of chemotherapy drugs as per the 2010 Budget measure. The Pharmaceutical Benefits Advisory Committee plays a pivotal role in the consultation process, ensuring that recommendations about pharmaceutical benefits are based on clinical effectiveness, safety, and cost-effectiveness. This amendment does not introduce new exclusions or exemptions but rather refines existing provisions to enhance the efficiency of the pharmaceutical benefits scheme. The Instrument commenced on 1 November 2017, and it is subject to further variations or revocations as per Subsection 100(2) of the Act. The changes made by this Instrument are detailed in Schedules 1, 2, 3, and 4, which include updates to forms, brands, maximum quantities, prescribing conditions, and pricing. The amendments ensure consistency with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, thereby streamlining the administration and funding of chemotherapy and related pharmaceutical benefits. This legislative instrument is a specific application of the broader National Health Act 1953, ensuring that the efficient funding of chemotherapy remains aligned with national health objectives.

Key Provisions

The main operative sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10) involve amendments to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011). Specifically, this Instrument amends Schedules 1, 2, 3 and 4 of the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). These amendments include additions, deletions, and modifications to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), and claimed and approved ex-manufacturer price. The changes are detailed in the Attachment, which provides a summary of the modifications by subject matter. The Act imposes obligations on the parties and entities it governs by ensuring that the supply of pharmaceutical benefits, specifically chemotherapy medicines and related pharmaceutical benefits, is efficiently funded and managed. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, providing expert advice and recommendations on which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC's recommendations are based on 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 are also consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process. There are no explicit offences, penalties, or civil/criminal consequences for breach specified in the Explanatory Statement for the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 10). However, non-compliance with the provisions of the National Health Act 1953 or the Special Arrangement could potentially result in legal consequences. The penalties for breaches of the National Health Act 1953 or any associated regulations can vary depending on the nature and severity of the breach. In general, penalties may include fines, imprisonment, or both, as determined by the relevant court or tribunal. It is important for parties and entities governed by the Act to adhere to the provisions and requirements set out in the Act and any associated instruments to avoid potential legal consequences.