EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 9)
PB 96 of 2012
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.
This instrument:
- Inserts the titles for Section 37 and Section 40 that were inadvertently omitted in the last amendment instrument No. 8 (PB 76 of 2012) which commenced on 1 October 2012.
Consultation
The amendments made by this Instrument are minor and mechanical in nature, as such no formal consultation process has been undertaken.
This Instrument commences upon registration.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health Act 1953, as amended by the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 9), aims to address the specific needs of patients requiring highly specialised drugs for the treatment of chronic conditions. This amendment was enacted to correct a procedural oversight in the previous amendment instrument, which omitted titles for Sections 37 and 40. The authority for these amendments stems from subsection 100(1) of the National Health Act, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The instrument is designed to ensure that highly specialised drugs are available to patients in public and private hospitals that possess the necessary facilities to administer such treatments. This legislative instrument is a minor, mechanical correction and did not require formal consultation. It commenced upon registration and is considered 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 2012 (No. 9) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 to correct the inadvertent omission of titles for Section 37 and Section 40, which were overlooked in the previous amendment instrument No. 8 (PB 76 of 2012). The purpose of this legislative instrument is to ensure the accurate administration of the highly specialised drugs program for hospitals by rectifying these omissions. The Act applies to the supply of pharmaceutical benefits under the special arrangement for the treatment of chronic conditions requiring specialised facilities, which are administered through public or private hospitals. The amendment affects entities and individuals involved in the procurement and supply of these drugs, as well as hospitals participating in the program. This instrument has a national reach, aligning with the overarching provisions of the National Health Act 1953. The amendment does not introduce any new exclusions, exemptions, or thresholds but corrects previous errors to maintain the integrity and effectiveness of the special arrangement.
Key Provisions
The key provisions of the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2012 (No. 9) primarily revolve around making amendments to the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010. Section 3 of the Instrument rectifies an oversight by inserting the titles for Section 37 and Section 40, which were inadvertently omitted in the previous amendment instrument (No. 8, PB 76 of 2012). This amendment ensures that the legislative framework is complete and accurately reflects the intended provisions.
The obligations and requirements imposed by this Act on the parties involved, particularly those administering the highly specialised drugs program for hospitals, include ensuring that the pharmaceutical benefits are supplied in accordance with the special arrangement. This involves adhering to the criteria that the drugs should only be supplied to patients receiving treatment in hospitals with access to appropriate specialised facilities. The Act mandates that these drugs are intended for the treatment of chronic conditions, which due to their clinical use or other special features, cannot be administered in settings without the necessary infrastructure and expertise.
The Instrument also outlines the consequences for any breach of the provisions within the special arrangement. While specific penalties are not detailed in the text, breaches of the National Health Act 1953, in general, can lead to civil or criminal penalties, including fines and imprisonment. The severity of the penalties would depend on the nature and extent of the breach, as well as any associated harm caused. It is crucial for entities and individuals governed by this Act to comply fully to avoid these potential legal repercussions.