EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 6)
PB 48 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 48 of 2014 involve changes to the maximum quantity, number of repeats and re-models the restriction text for two drugs.
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), the 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 July 2014.
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 2014 (No. 6), addresses the need for specialised pharmaceutical benefits for patients with chronic conditions requiring treatment in hospitals with appropriate facilities. Enacted by the Australian Parliament, this legislation allows the Minister to establish and modify special arrangements for the supply of these highly specialised drugs. The amendment instrument reflects recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an expert body involved in ongoing consultation with various stakeholders, including pharmaceutical companies. The policy objective is to align the highly specialised drugs program with the latest updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the provision of these critical medications is both effective and cost-efficient. This legislative change aims to improve patient access to necessary treatments while maintaining the integrity of the Pharmaceutical Benefits Scheme (PBS).
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 pertains to the highly specialised drugs program for hospitals, specifically amending the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010. This legislation applies to the supply of pharmaceutical benefits under the Special Arrangement, which is aimed at treating chronic conditions requiring specialised facilities available in public or private hospitals. The Act operates within the Commonwealth jurisdiction and applies to pharmaceutical companies, hospitals, and patients requiring treatment for specified chronic conditions. The amendments, which reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, involve alterations to the maximum quantity, number of repeats, and re-modelling the restriction text for two drugs. These amendments are subject to the recommendations of the Pharmaceutical Benefits Advisory Committee, ensuring a thorough consultation process involving various stakeholders, including pharmaceutical companies and experts in the field. The Instrument commenced on 1 July 2014 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Key Provisions
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 6) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 (sections 1 to 3). This legislative instrument updates the special arrangement relating to the supply of highly specialised drugs for hospital patients. The Act allows the Minister to make special arrangements for the supply of pharmaceutical benefits (subsection 100(1)), and this amendment specifically updates the supply parameters for certain drugs used in treating chronic conditions in hospital settings (subsection 100(3)). The changes involve adjustments to the maximum quantity, the number of repeats, and the re-modelling of restriction text for two drugs (section 4). These amendments ensure that the Special Arrangement remains aligned with current clinical practices and cost-effectiveness evaluations.
Entities governed by this Act, including pharmaceutical companies, hospitals, and the Department of Health, must adhere to the updated specifications for the supply of these highly specialised drugs. Pharmaceutical companies are required to supply the drugs according to the revised maximum quantities and repeat prescriptions as stipulated in the updated Special Arrangement. Hospitals must ensure that the drugs are administered in accordance with the new restrictions and supply parameters, particularly ensuring that they are used only for eligible patients under appropriate clinical supervision. The Department of Health is responsible for overseeing the implementation of these changes and ensuring compliance among the entities involved.
Failure to comply with the provisions of this Act or the amended Special Arrangement can result in legal consequences. The Act does not explicitly state specific offences or penalties, but breaches could potentially lead to administrative actions, fines, or other legal remedies under the broader legislative framework of the National Health Act 1953. The severity of penalties would depend on the nature and extent of the breach, and could include civil or criminal sanctions as determined by the courts or relevant authorities.