EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 4)
PB 42 of 2013
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.
This item adds a new brand, Lamivudine 150 mg + Zidovudine 300 mg Alphapharm, for the drug Lamivudine with Zidovudine in the form Tablet 150 mg – 300 mg with manner of administration Oral. The responsible person for this brand is Alphapharm Pty Ltd ABN 93 002 359 739.
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 August 2013.
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 2013 (No. 4) was enacted to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010. This amendment responds to the evolving landscape of pharmaceutical benefits, particularly in relation to highly specialised drugs used for treating chronic conditions within hospitals. The amendment was introduced to align with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the special arrangement remains relevant and effective. This legislative instrument was made under the authority provided by subsections 100(1) and 100(2) of the National Health Act 1953, enabling the Minister to make and modify special arrangements for the supply of pharmaceutical benefits. The policy objective of these amendments is to ensure that the highly specialised drugs program remains aligned with recommendations from the Pharmaceutical Benefits Advisory Committee and reflects the latest clinical and cost-effectiveness data.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 pertains to the amendment of the existing special arrangement made under the National Health Act 1953, specifically concerning the highly specialised drugs program for hospitals. This arrangement enables the Minister to make special provisions for the supply of pharmaceutical benefits, which are tailored for the treatment of chronic conditions requiring specialised facilities available in public and private hospitals. The amendment made by this Instrument introduces a new brand, Lamivudine 150 mg + Zidovudine 300 mg Alphapharm, into the program, reflecting the changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment responds to recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body that advises the Minister on which drugs should be included in the Pharmaceutical Benefits Scheme. The amendment ensures that the special arrangement remains aligned with the current listings on the PBS and adheres to the stringent criteria of clinical effectiveness, safety, and cost-effectiveness. This legislative instrument applies across the Commonwealth of Australia, ensuring that all hospitals within the jurisdiction can benefit from the updated special arrangement.
Key Provisions
The primary operative sections of the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2013 (No. 4) involve amendments to the existing Special Arrangement under section 100(1) of the National Health Act 1953 (the Act) (section 1). This amendment specifically updates the listing of pharmaceutical benefits to include a new brand, Lamivudine 150 mg + Zidovudine 300 mg Alphapharm, for the treatment of chronic conditions requiring highly specialised drugs (section 2). The amendment is made in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which come into effect on the same day as the amendment (section 3).
The obligations imposed by this Act on the parties involved are primarily related to the provision and supply of the newly listed pharmaceutical benefit. The Act mandates that the pharmaceutical benefits be supplied to patients receiving treatment at or from public or private hospitals with access to appropriate specialised facilities (section 2). The responsible entity, Alphapharm Pty Ltd, must ensure that the drug meets the required standards and is available for use as specified under the amended arrangement (section 2). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in the ongoing consultation process, providing expert recommendations on the suitability and effectiveness of the listed drugs (section 5).
Failure to comply with the provisions of this Instrument may result in civil or criminal consequences. Under section 100(3) of the Act, Part VII of the Act and instruments made for its purposes are subject to the special arrangement. The potential penalties for non-compliance are not explicitly stated in the text, but generally, breaches of the National Health Act can lead to fines or imprisonment, depending on the severity of the offence. The maximum penalties for contraventions of the Act are detailed in other sections of the Act, which would apply accordingly.
The Instrument also highlights the formal consultation process involving the PBAC, ensuring that the amendments reflect expert advice and stakeholder input (section 5). This includes consultation with pharmaceutical companies and agreement on the final listing details. The amendments made by this Instrument are in line with recommendations from the PBAC, an independent expert body appointed to provide recommendations on pharmaceutical benefits (section 5). The Instrument comes into effect on 1 August 2013, as stated in section 4, and it is a legislative instrument under the Legislative Instruments Act 2003.