EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 1)
PB 3 of 2015
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 3 of 2015 involve the deletion of the drug Cidofovir.
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 February 2015.
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 2015 (No. 1) was enacted by the Australian Parliament to amend the existing National Health Act 1953. The primary purpose of this amendment was to update the highly specialised drugs program for hospitals by aligning it with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Specifically, this amendment involved the removal of the drug Cidofovir from the list of drugs supplied under the Special Arrangement. This legislative instrument was made under the authority of subsections 100(1) and 100(2) of the National Health Act, which allow the Minister to establish special arrangements for the supply of pharmaceutical benefits and to vary or revoke those arrangements as necessary. The changes were made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that recommends which drugs should be available as pharmaceutical benefits, taking into account their clinical effectiveness, safety, and cost-effectiveness.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2015 (No. 1) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, which is established under the National Health Act 1953. The Act applies to the provision of highly specialised pharmaceutical benefits, specifically targeting treatments for chronic conditions that require specialised facilities, which can only be supplied to patients receiving treatment in public or private hospitals. This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, resulting in the deletion of the drug Cidofovir from the list of drugs available under the Special Arrangement. The amendment is effective from 1 February 2015 and aligns with recommendations made by the Pharmaceutical Benefits Advisory Committee, an independent body that advises the Minister on which drugs should be included in the Pharmaceutical Benefits Scheme. The Instrument does not specify exclusions, exemptions, or thresholds, but it is subject to the broader provisions of the National Health Act 1953 and any subordinate instruments that may further define the scope of the Special Arrangement.
Key Provisions
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2015 (No. 1) modifies the existing Special Arrangement concerning highly specialised drugs for hospital patients, as established under the National Health Act 1953 (the Act) (sections 100(1) and 100(2)). This Amendment Instrument introduces changes to the Special Arrangement 2010, specifically addressing the pharmaceutical benefits supplied for treating chronic conditions in public and private hospitals with appropriate specialised facilities (section 100(3)). The most significant change is the removal of Cidofovir from the list of drugs covered by the Special Arrangement, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These changes were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and followed consultations with relevant parties, including pharmaceutical companies.
The Act imposes several obligations on the parties involved, including the Minister for Health, who has the authority to make special arrangements for the supply of pharmaceutical benefits (section 100(1)). The Act also grants the Minister the power to vary or revoke these arrangements as necessary (section 100(2)). The Special Arrangement itself, as amended, must be adhered to by hospitals participating in the highly specialised drugs program. These hospitals must ensure they have access to the appropriate specialised facilities required to administer the listed drugs. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on which drugs should be included in the Special Arrangement, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness.
Failure to comply with the provisions of the Special Arrangement could lead to legal consequences. Although the specific offences and penalties are not detailed in the explanatory statement, the Act provides a framework under which breaches of the special arrangements could be subject to legal action. The consequences could include civil penalties or criminal charges, depending on the nature and severity of the breach. The Pharmaceutical Benefits Advisory Committee (PBAC) ensures that the recommendations and amendments are thoroughly considered and agreed upon, aiming to minimise the risk of non-compliance. The ongoing consultation process, involving experts from various relevant fields, helps to maintain the integrity and effectiveness of the Special Arrangement.