EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 4)
PB 30 of 2014
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.
The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 30 of 2014 involve the deletion of an item, and two item additions.
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account 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 were consulted throughout the process of changes to the listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
This Instrument commences on 1 May 2014.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 4) was enacted to amend the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, made under the National Health Act 1953. This legislation was introduced to align the special arrangement with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and involve modifications to the items listed under the highly specialised drugs program for hospitals, including the deletion of one item and the addition of two new items. The purpose of these changes is to ensure that the pharmaceutical benefits supplied under the special arrangement remain aligned with the most current clinical and cost-effectiveness standards. The amendment is effective from 1 May 2014 and is subject to the provisions of the Legislative Instruments Act 2003.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 4) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, which is governed by the National Health Act 1953. The amended arrangement pertains to the supply of highly specialised drugs for the treatment of chronic conditions that can only be administered in hospitals with appropriate specialised facilities. The instrument specifically addresses the deletion of an item and the addition of two new items to the list of pharmaceutical benefits, aligning with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment is applicable across the Commonwealth of Australia and involves the Pharmaceutical Benefits Advisory Committee (PBAC), an expert body established under the Act, which provides recommendations to the Minister regarding the availability of drugs as pharmaceutical benefits. The amendment reflects recommendations from PBAC and ensures consultation with pharmaceutical companies throughout the process. This legislative instrument commenced on 1 May 2014 and operates as a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of this legislative instrument are subsections 100(1), 100(2), and 100(3) of the National Health Act 1953 (the Act) which enable the Minister to make special arrangements for the supply of pharmaceutical benefits, vary or revoke those arrangements, and ensure that Part VII of the Act and related instruments are subject to these special arrangements. This instrument specifically amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (the Special Arrangement) by deleting one item and adding two new items to align with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on 1 May 2014. These changes are intended to reflect updated recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and ensure that the pharmaceutical benefits supplied under the Special Arrangement remain effective for treating chronic conditions requiring specialised facilities.
This Act imposes several obligations on the parties involved. Firstly, the Minister must ensure that any special arrangement made under subsection 100(1) aligns with the broader objectives of the National Health Act and its Part VII provisions. The Minister is also responsible for consulting with the PBAC, an independent expert body, which includes members from various healthcare-related fields. These members provide recommendations based on clinical effectiveness, safety, and cost-effectiveness of the pharmaceutical benefits. Furthermore, pharmaceutical companies must be consulted throughout the process to agree on the final listing details, ensuring that the changes are thoroughly vetted and considered from multiple perspectives.
Breaches of the obligations set forth in the Act can lead to various consequences. While the Act does not explicitly state offences or penalties within the provided text, the authority to vary or revoke special arrangements under subsection 100(2) implies that failure to comply with the Act's requirements could result in the Minister taking action against non-compliant entities or individuals. Such actions might include the revocation of special arrangements or other administrative measures deemed necessary to enforce compliance. Given the nature of the Act, breaches could potentially lead to civil or criminal liabilities depending on the severity and intent behind the non-compliance, although specific penalties are not detailed in this legislative instrument.