National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1) - PB 13 of 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00198 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No.1)

PB 13 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 (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 relating to the Botulinum Toxin Program.

The purpose of the Special Arrangement is to allow for botulinum toxin to be supplied to specific patients through eligible medical practitioners. 

Schedule 1 to this instrument inserts one new treatment condition for the treatment of chronic migraine under the Special Arrangement to commence on 1 March 2014.  Patients must have:

(a)   experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months; and

(b)   experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications; and

(c)   have been appropriately managed for medication overuse headache by their medical practitioner prior to treatment with botulinum toxin pharmaceutical benefit,

to qualify for treatment with the listed brand ‘Botox’ under the Special Arrangement.

In addition this instrument makes consequential changes to reflect the new treatment condition.

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 March 2014.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 


ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 1)

Section 1  Name of Instrument

This section provides that this instrument is the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1) and that it may also be cited as PB 13 of 2014.

Section 2  Commencement

This section provides that this instrument commences on 1 March 2014.

Section 3   Amendments to PB 89 of 2011

This section provides that Schedule 1 amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) (the Special Arrangement).

Schedule 1

Item 1 makes a consequential amendment to subsection 10(1) of the Special Arrangement to reflect the insertion of new section 12B.

Item 2 makes an editing amendment to remove the second occurring ‘is’ from subsection 12A(2)(a).

Item 3 inserts a new section 12B into the Special Arrangement that provides the criteria a person needs to meet to be eligible to receive a botulinum toxin pharmaceutical benefit for the treatment of chronic migraine.

Item 4 inserts a new section 17A into the Special Arrangement that provides that a medical practitioner with the specialist qualification of neurology for other indications under the Programme is taken to be an eligible medical practitioner in relation to chronic migraine.

Item 5 removes subsection 18(2)(e) as it is considered to be unnecessary to require doctors to provide this consent.

Item 6 makes a consequential amendment to subsection 18(3) of the Special Arrangement to reflect the insertion of new subsection 18(7).

Item 7 inserts a new subsection 18(7) into the Special Arrangement providing the evidence of training that needs to be provided for authorisation of an applicant practitioner to administer botulinum toxin pharmaceutical benefits for the treatment of chronic migraine.

Item 8 amends schedule 3 of the Special Arrangement by adding new treatment condition number 10, i.e. chronic migraine.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1) was enacted to amend the existing National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011). This amendment was introduced to address the need for updating the criteria and conditions for the supply of botulinum toxin for the treatment of chronic migraine, a condition that significantly impacts the quality of life for many patients. The instrument was enacted under the authority granted by the National Health Act 1953, specifically subsections 100(1) and (2), which allow the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke such arrangements. The policy objective is to ensure that botulinum toxin is supplied to eligible patients through appropriate medical practitioners, in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) regarding clinical effectiveness, safety, and cost-effectiveness. This legislative instrument was developed following consultation with PBAC and pharmaceutical companies, ensuring that the amendments reflect the latest medical evidence and expert advice. The primary change introduced by this instrument is the addition of a new treatment condition for chronic migraine, which specifies that patients must meet certain criteria, including experiencing a significant number of headache days with migraines and having tried multiple prophylactic treatments without success. This amendment also includes consequential changes to reflect the new treatment condition and to streamline the process for medical practitioners to administer botulinum toxin for this condition.

Scope and Application

The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1) pertains to the regulation of the supply of botulinum toxin for pharmaceutical benefits under the National Health Act 1953. This amendment applies specifically to eligible medical practitioners and their patients who seek treatment for chronic migraine using botulinum toxin, marketed under the brand 'Botox', as part of the Botulinum Toxin Program. The changes introduced by this instrument apply nationally, aligning with the jurisdictional reach of the Commonwealth in regulating pharmaceutical benefits. The amendment adds stringent criteria that patients must meet to qualify for treatment, including a history of chronic migraine and failed responses to conventional treatments, and stipulates that only medical practitioners with the appropriate specialist qualifications can administer the treatment. The amendment does not explicitly state any exclusions but implies that only those meeting the specified conditions and qualifications are eligible. The application of this Act may be further detailed or restricted by subordinate instruments, which are not outlined in the provided text.

Key Provisions

The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2014 (No. 1) (PB 13 of 2014) amends the National Health (Botulinum Toxin Program) Special Arrangement 2011 (PB 89 of 2011) to introduce new treatment conditions for the use of botulinum toxin in the treatment of chronic migraine (section 3). This amendment is effective from 1 March 2014 (section 2). Specifically, a new section 12B is inserted into the Special Arrangement, setting out the criteria for eligibility to receive botulinum toxin for chronic migraine treatment. This includes a requirement for patients to have experienced a specific number of headache days with migraines over a defined period, and to have tried and not responded adequately to at least three prophylactic migraine medications (Schedule 1, Item 3). Additionally, medical practitioners with neurology qualifications are considered eligible to administer botulinum toxin for chronic migraine, and practitioners must provide evidence of relevant training to be authorised (Schedule 1, Items 4 and 7). Under the amended Special Arrangement, patients seeking botulinum toxin treatment for chronic migraine must meet stringent eligibility criteria, including a documented history of migraine frequency and severity, as well as a documented failure to respond to at least three different migraine medications (section 12B). Medical practitioners authorised to administer botulinum toxin must have the necessary specialist qualifications and provide evidence of relevant training (section 17A and subsection 18(7)). This ensures that only qualified practitioners with the requisite expertise administer the treatment. The changes also streamline the process by removing certain redundant requirements, such as the need for specific consent from doctors, which is deemed unnecessary (Schedule 1, Item 5). Failure to comply with the provisions of the Special Arrangement could result in legal consequences. Specifically, unauthorised administration of botulinum toxin could be considered a breach of the National Health Act 1953, potentially leading to civil or criminal penalties. While the specific penalties are not detailed in the explanatory statement, breaches of the National Health Act generally could result in substantial fines and, in severe cases, imprisonment. Additionally, healthcare providers found to be non-compliant may face professional disciplinary actions from relevant medical boards, further impacting their ability to practice. The amendments are made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), which provides expert advice on the inclusion of medications in the Pharmaceutical Benefits Scheme (PBS). This process ensures that the changes are evidence-based and reflect current best practices in migraine management. Pharmaceutical companies are also consulted to ensure that the modifications align with their obligations and responsibilities under the Special Arrangement. This collaborative approach helps to maintain the integrity and effectiveness of the botulinum toxin program while ensuring patient access to necessary treatments.

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