EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 5)
PB 40 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 40 of 2014 involve the deletion of the brand Imulate for the drug Mycophenolic Acid in the forms Capsule containing mycophenolate mofetil 250 mg and Tablet containing mycophenolate mofetil 500 mg, and amendments to the restriction text for the drug Plerixafor.
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 June 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. 5) was enacted to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, addressing specific changes to the highly specialised drugs program for hospitals. This amendment was introduced under the authority granted by subsection 100(1) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits, and was enacted by the Parliament of Australia. The policy objective of these amendments is to align the special arrangement with the changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the program remains current and effective in providing necessary treatments for chronic conditions within hospital settings. The changes include the deletion of the brand Imulate for the drug Mycophenolic Acid and amendments to the restriction text for the drug Plerixafor, reflecting recommendations made by the Pharmaceutical Benefits Advisory Committee.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 applies to the supply of pharmaceutical benefits under the highly specialised drugs program for hospitals, which targets the treatment of chronic conditions requiring specialised facilities, typically found in public or private hospitals. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, impacting the availability of certain drugs such as Mycophenolic Acid and Plerixafor. This legislative instrument operates under the authority granted by the National Health Act 1953, specifically through subsections 100(1) and 100(2), which allow the Minister to establish and modify special arrangements for pharmaceutical supplies. The amendment aligns with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an expert body involved in the ongoing consultation process for matters relevant to the Special Arrangement. The amendments take effect from 1 June 2014 and are subject to the provisions of the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 5) (PB 40 of 2014) pertain to amendments of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010). These changes are made to reflect adjustments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day. Specifically, section 3 of the Instrument deletes the brand Imulate for the drug Mycophenolic Acid in the forms Capsule containing mycophenolate mofetil 250 mg and Tablet containing mycophenolate mofetil 500 mg. Additionally, it modifies the restriction text for the drug Plerixafor. These changes are made under the authority granted by subsection 100(1) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits, and subsection 100(2), which permits the Minister to vary or revoke such arrangements.
The obligations and requirements imposed by this Act on the parties and entities it governs include ensuring compliance with the newly amended Special Arrangement. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, as it provides recommendations based on expert assessment of the clinical effectiveness, safety, and cost-effectiveness of the pharmaceutical benefits. Pharmaceutical companies must consult with PBAC and agree to final listing details as stipulated in the Special Arrangement. This ensures that the drugs supplied under the program meet the required standards and are appropriate for treating chronic conditions in hospital settings with specialised facilities.
The Instrument also outlines potential consequences for non-compliance with its provisions. While the specific offences and penalties are not detailed within the text, it is clear that breaches of the amended Special Arrangement could result in significant legal repercussions. Given the context of the National Health Act 1953, penalties could include fines, revocation of certain benefits, or other administrative actions deemed necessary by the Minister. The precise nature and extent of these penalties would depend on the specific breach and the provisions of the primary Act. Nonetheless, the amendments underscore the importance of adhering to the Special Arrangement to ensure the continued supply of effective and appropriate pharmaceutical benefits for patients in hospitals.