EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2012 (No.1)
PB 21 of 2012
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). A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and (2) of the Act, is to amend the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) (the Special Arrangement) to make changes to the special arrangement relating to the Botulinum Toxin Program.
The Special Arrangement allows for botulinum toxin to be supplied to specific patients through eligible medical practitioners for the treatment of hyperhidrosis and for the treatment of facial spasms, neck spasms and spasticity due to cerebral palsy or stroke.
Schedule 1 to this instrument inserts one new strength of the listed drug ‘Clostridium Botulinum Type A Toxin-Haemagglutinin Complex’ with the listed brand ‘Dysport’ into the Special Arrangement on 1 April 2012. This provides for the supply under this Special Arrangement of a 300 unit strength in addition to the 500 unit strength already available.
This instrument also creates two treatment conditions for the treatment of blepharospasm or hemifacial spasm. Patients aged 12 and older may be treated with the listed brand ‘Botox’. Previously, no patient age requirement was specified. This instrument also permits the use of the listed brand ‘Dysport’ to cover treatment for blepharospasm or hemifacial spasm but limits its use for adults only.
In addition this instrument makes consequential and transitional changes to reflect that there are now two treatment conditions relating to blepharospasm and hemifacial spasm.
Consultation
The addition of these amendments was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (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 has broad representation with members appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists; at least one member is 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 for additions and changes to listings on the PBS and for this Special Arrangement. This includes consultation through the PBAC process, which provides for consumers making submissions to the Committee in respect of proposals to be discussed, and agreement to final listing details.
General
This instrument commences on 1 April 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2012 (No. 1) was enacted to amend the National Health (Botulinum Toxin Program) Special Arrangement 2011. This legislation, introduced by the Minister under the authority granted by the National Health Act 1953, aims to modify the special arrangement relating to the Botulinum Toxin Program. This program allows for the supply of botulinum toxin for the treatment of hyperhidrosis and for facial spasms, neck spasms, and spasticity due to cerebral palsy or stroke. The amendment responds to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which evaluates the clinical effectiveness, safety, and cost-effectiveness of medicines before advising the Minister. This legislative instrument, which includes consequential and transitional changes, commenced on 1 April 2012, ensuring updated and efficient management of the Botulinum Toxin Program within the National Health Act framework.
Scope and Application
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2012 (No. 1) amends the National Health (Botulinum Toxin Program) Special Arrangement 2011, modifying the supply of botulinum toxin for medical purposes under the National Health Act 1953. The Act allows for the Minister to make special arrangements for the supply of pharmaceutical benefits, and this instrument introduces new strengths of the drug and expands treatment conditions. Specifically, it adds a 300 unit strength of Clostridium Botulinum Type A Toxin-Haemagglutinin Complex, marketed as Dysport, to the Special Arrangement, alongside the existing 500 unit strength, effective from 1 April 2012. Additionally, the instrument establishes new treatment conditions for blepharospasm and hemifacial spasm, permitting the use of Botox for patients aged 12 and older, while limiting the use of Dysport to adults only. These changes were made in consultation with the Pharmaceutical Benefits Advisory Committee and pharmaceutical companies, reflecting advice on clinical effectiveness, safety, and cost-effectiveness. The instrument applies nationally, subject to the overarching provisions of the National Health Act 1953.
Key Provisions
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2012 (No.1) introduces significant changes to the existing Botulinum Toxin Program under the National Health Act 1953. This amendment, detailed in Schedule 1, allows for the addition of a new strength of the drug 'Clostridium Botulinum Type A Toxin-Haemagglutinin Complex' with the brand name 'Dysport', specifically a 300 unit strength, which is to be available from 1 April 2012. This addition complements the existing 500 unit strength already available under the special arrangement. Furthermore, the amendment introduces two new treatment conditions for blepharospasm or hemifacial spasm, permitting the use of 'Botox' for patients aged 12 and older, and 'Dysport' for adults only. These changes are intended to provide more tailored treatment options for patients suffering from various conditions.
The obligations imposed by this amendment are primarily on the entities supplying the botulinum toxin under the Special Arrangement. These entities must now comply with the new conditions specified in the amendment, ensuring that they supply the drugs only in accordance with the newly defined treatment conditions and strengths. Additionally, pharmaceutical companies must adhere to the transitional and consequential changes mandated by the amendment, ensuring that they update their listings and supply practices to reflect these changes. These obligations are critical to ensure that the amended special arrangement functions effectively and meets its intended purpose.
Failure to comply with the provisions of this amendment may result in legal consequences. Although the document does not explicitly detail the penalties for non-compliance, the general legislative framework under which the National Health Act operates implies that breaches of the Act and its special arrangements could result in administrative or legal penalties. Such penalties could include fines, revocation of the special arrangement, or other regulatory actions deemed necessary by the Minister. These consequences underscore the importance of adhering to the specified requirements and obligations to avoid potential legal repercussions.