National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 3)

Overview

The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.3) was enacted to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This instrument was introduced by the Australian Parliament to address the need for updating the supply of pharmaceutical benefits for highly specialised drugs used in the treatment of chronic conditions in hospitals. The Pharmaceutical Benefits Advisory Committee, which makes recommendations to the Minister about the availability of drugs as pharmaceutical benefits, was consulted throughout the process. The objective of the amendments was to align the special arrangement with the updated listings on the Pharmaceutical Benefits Scheme, ensuring that the supply of highly specialised drugs to hospitals remains effective and cost-efficient. The instrument commenced on 1 June 2013, and is a legislative instrument under the Legislative Instruments Act 2003.

Scope and Application

The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.3) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, under the authority provided by the National Health Act 1953. The amendment affects the highly specialised drugs program for hospitals, which supplies pharmaceutical benefits for the treatment of chronic conditions that require specialised facilities, typically available in public or private hospitals. This instrument, which commences on 1 June 2013, reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, specifically deleting a form of the drug Epoetin beta from the program. The amendments were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body established under the Act that consults with various stakeholders, including pharmaceutical companies, in recommending drugs for the Pharmaceutical Benefits Scheme. The amendments apply to the pharmaceutical benefits provided under the Special Arrangement, impacting the supply and listing of highly specialised drugs for hospital use. The changes are limited to the deletion of a specific drug formulation and do not extend to other drugs or treatments under the program. The amendment is effective nationwide, as it operates under the Commonwealth’s legislative framework. The instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003, and its provisions are detailed in the accompanying attachment, which outlines the specific changes made to the Special Arrangement.

Key Provisions

The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.3) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010. The primary operative sections include the name of the Instrument (Section 1), the commencement date (Section 2), and the specific amendments to the 2010 Special Arrangement (Section 3 and Schedule 1). Section 3 directs that Schedule 1 amends the 2010 Special Arrangement, and Schedule 1 specifically removes the brand NeoRecormon for the drug Epoetin Beta in the form of a 20,000 units in 0.6 mL pre-filled syringe (Item [1]). This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The obligations imposed by the Act on the parties or entities it governs include the requirement to adhere to the special arrangement for the supply of pharmaceutical benefits. The Minister has the authority to make special arrangements for the supply of pharmaceutical benefits under subsection 100(1) of the National Health Act 1953, and these arrangements are subject to the Act and any instruments made for its purposes under subsection 100(3). The amendments made by this Instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and must be implemented by the relevant parties in accordance with the Act. Any offences, penalties, or civil/criminal consequences for breach of the Act or the special arrangement are not explicitly stated in the provided text. However, it is reasonable to infer that failure to comply with the Act or the special arrangement could result in legal action, as is typical with legislative instruments. The consequences could include fines, sanctions, or other legal remedies depending on the nature and severity of the breach. The maximum penalties for such breaches would be determined by the relevant courts based on the specific circumstances of the case and applicable laws.