National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 2) (No. PB 11 of 2013)

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 2) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, as introduced by the National Health Act 1953. This amendment aims to refine the efficient funding of chemotherapy, reflecting the 2010 budget measure titled 'Revised arrangements for the efficient funding of chemotherapy drugs'. The Act empowers the Minister to make special arrangements for the supply of pharmaceutical benefits, and this amendment seeks to enhance the payment efficiency for chemotherapy pharmaceutical benefits and related pharmaceutical benefits provided at certain public hospitals. It was developed through consultations with the Pharmaceutical Benefits Advisory Committee, an independent body that recommends drugs and medicinal preparations for the Pharmaceutical Benefits Scheme. The policy objective is to ensure that the funding arrangements for chemotherapy are both efficient and effective, while also considering factors such as clinical effectiveness, safety, and cost-effectiveness. The amendment instrument was enacted by the Australian Parliament and commenced on 1 March 2013.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 2) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to modify the special arrangement concerning the efficient funding of chemotherapy, specifically targeting the supply of chemotherapy medicines and related pharmaceutical benefits in public hospitals. This legislative instrument applies to entities involved in the provision of chemotherapy pharmaceutical benefits and related pharmaceutical benefits to eligible patients being treated for cancer, ensuring efficient payment structures as per the 2010 budget measure. The scope of the Act extends to the Commonwealth level, impacting the administration and funding of pharmaceutical benefits under the National Health Act 1953. The instrument incorporates changes to the pharmaceutical benefits available under the special arrangement, reflecting modifications made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments include the addition of a new listed brand for the drug 'Docetaxel', enhancing the list of available chemotherapy pharmaceuticals. The Act’s application is further governed by subordinate instruments, which may extend or restrict its provisions, ensuring alignment with overarching health policies and budgetary measures.

Key Provisions

The main operative sections of this legislation, the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 2) (referred to as PB 11 of 2013), pertain to amendments made to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (referred to as PB 79 of 2011). Specifically, section 3 of PB 11 of 2013 amends Schedule 1 Part 1 of PB 79 of 2011, introducing a new pharmaceutical benefit for the drug 'Docetaxel' in the form of 'Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent', with the brand 'AS-Docetaxel' (section 3, Schedule 1, Item 1). This amendment reflects the revised arrangements for the efficient funding of chemotherapy drugs, aligning with the 2010 budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. The obligations and requirements imposed by this Act on the parties and entities it governs primarily involve adherence to the amended arrangements for the efficient funding of chemotherapy drugs. This includes ensuring that the new pharmaceutical benefit for 'Docetaxel' is correctly implemented and that healthcare providers and patients are aware of the changes. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by recommending the listing of medicines on the Pharmaceutical Benefits Scheme (PBS), considering factors such as medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments (subsection 100A of the Act). In terms of offences, penalties, or civil/criminal consequences for breach, the Act does not explicitly outline specific penalties for non-compliance with the amended special arrangement. However, any breaches of the provisions under the National Health Act 1953, of which this amendment is a part, may be subject to the general penalties and enforcement measures provided under that Act. These could include administrative actions, fines, or other sanctions as deemed appropriate by the relevant authorities. It is also important to note that this Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003, which provides a framework for the creation and operation of such instruments.