National Health Act 1953 - Amendment special arrangements made under subparagraph 100(1)(b)(i) - Botulinum Toxin Program (No. PB 29 of 2009)

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Legislation au F2009L01221 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

 AMENDMENT SPECIAL ARRANGEMENTS UNDER

SUBPARAGRAPH 100(1)(b)(i)

BOTULINUM TOXIN PROGRAM

No. PB 29 of 2009

 

 

The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.

 

The PBS is regulated by Part VII of the National Health Act 1953 (the Act) which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits, and for the supply of special pharmaceutical products.

 

Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:

 

a)      who are living in isolated areas; or

b)     who are receiving medical treatment in such circumstances that                                                                                             pharmaceutical benefits:

  1. cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
  2. are inadequate for that medical treatment.

 

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

 

Section 100AA(1) provides that a special pharmaceutical product includes a drug or medicinal preparation declared under section 85(2) of the Act.

 

The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies.  Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.

 

The drugs that are the subject of the Botulinum Toxin Program Special Arrangement made under subparagraph 100(1)(b)(i) of the Act (these Arrangements) are declared under subsection 85(2) of the Act.

 

Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).  Therefore, in the case of inconsistency between these Arrangements and other provisions of Part VII of the Act, then these Arrangements will prevail.

 

 

These Arrangements relate specifically to the supply of two forms of botulinum toxin to patients who are receiving treatment for the following conditions:

(a) Botulinum Toxin Type A Purified Neurotoxin Complex, lyophilised powder for intramuscular injection 100 units (Botox) (manufactured by Allergan Australia Pty Ltd) for:

  1. the treatment of blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (hemifacial spasm) in patients 12 years and older; or
  2. the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
  3. continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment  with  botulinum toxin as a paediatric patient; or
  4. the treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care; or
  5. the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older; or
  6. the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke as second line therapy when standard management has failed ( e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments of botulinum toxin to be authorised is 4 per upper limb per lifetime.  Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture and known sensitivity to botulinum toxin.

(b) Clostridium Botulinum Type A Toxin–Haemagglutinin Complex lyophilised powder for intramuscular injection 500 units (Dysport) (manufactured by Ipsen Pty Limited, and distributed by Clifford Hallam Pharmaceutical) for:

  1.     the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, 2 to 17 years of age inclusive; or
  2.     continuing treatment of dynamic equinus foot deformity due to spasticity in ambulant cerebral palsy patient 18 years of age or older who was commenced on PBS-subsidised treatment  with  botulinum toxin as a paediatric patient; or
  3.     the treatment of spasmodic torticollis, either as monotherapy or as adjunctive therapy to current standard care; or
  4.     the treatment of moderate to severe spasticity (defined as MAS greater than or equal to 3 using the modified Ashworth scale) of the upper limbs in adults following a stroke as second line therapy when standard management has failed ( e.g. physiotherapy and/or oral spasticity agents) or as an adjunct to physical therapy. Maximum number of treatments of botulinum toxin to be authorised is 4 per upper limb per lifetime.  Treatment should not be initiated until 3 to 6 months post-stroke in patients who do not have established severe contracture. Treatment should be discontinued if the patient does not respond (decrease of MAS greater than 1 in at least one joint) after two treatments. Contra-indications to treatment include established severe contracture and known sensitivity to botulinum toxin.

The high cost of botulinum toxin and the need for cold storage means that the drug is unlikely to be held as part of an approved pharmacist’s normal stock. This makes it difficult for patients who require botulinum toxin for treatment of their conditions referred to in these Arrangements to access it, causing undue delay in their treatment.

 

The purpose of these Arrangements is therefore to ensure that an adequate supply of botulinum toxin is available for the treatment of certain patients, in circumstances where botulinum toxin cannot otherwise be conveniently or efficiently supplied in accordance with Part VII of the Act.

 

The Special Arrangements for the Botulinum Toxin Program made on the 27th day of November 2008, which commenced on 1 December 2008, referred to as No PB 122 of 2008 (the Principal Arrangements) are amended by these Amendment Arrangements.

 

These Amendment Arrangements, which have effect from 1 April 2009, now extend to supply of the Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) under these Arrangements to treat patients who are 2 years of age or older for upper limb spasticity due to cerebral palsy, and to treat adult patients with moderate to severe spasticity of the upper limbs following stroke as a second line therapy when standard management has failed.

 

These Amendment Arrangements commence on 1 April 2009.

 

Consultations

 

These Amendment Arrangements have been made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits or as special pharmaceutical products.  When making recommendations, the PBAC takes into account the medical conditions for which a medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

 

PBAC members are selected 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.

 

Medicare Australia has also been consulted and had provided advice on the program management aspects for these Amendment Arrangements because order and payment for the supply of botulinum toxin under these Arrangements is managed by Medicare Australia.

 

The Australian suppliers of the two forms of botulinum toxin that are affected by this Amendment Arrangement have been consulted.

 

These Amendment Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

Details of the Amendments to the Principal Arrangements are set out in the Attachment


ATTACHMENT

 

Paragraph 1 provides that these Amendment Special Arrangements commence on 1 April 2009.

 

Paragraph 2 provides that the Schedule to this Instrument amends the Special Arrangements made under subparagraph 100(1)(b)(i) of the National Health Act 1953 (Botulinum Toxin Program) on 27 November 2008 (known as PB 122 of 2008) (the Principal Arrangements. 

 

Schedule 1 sets out the amendments to the Principal Arrangements.

 

Summary of Changes

 

Paragraph 3(A)(i) has been amended to include the new indications which Botox may be used to treat which are moderate to severe upper limb spasticity in cerebral palsy patients  2 years of age or older, and (where special conditions are met) moderate to severe spasticity of the upper limbs in adults following stroke.

 

Paragraph 3(A)(ii)(d) has been amended to note the maximum number of treatments of botulinum toxin per upper limb per lifetime is 4, regardless of the form of botulinum toxin used.

 

Paragraph 5(A) has been amended to include that medical practitioners that hold certain specialist qualifications are eligible to be registered to participate in the Botulinum Toxin Program Special Arrangements for treatment of upper limb spasticity in cerebral palsy patients 2 years of age or older.

 

Paragraph 5(C) has been amended to include the requirements for applications to be made in writing to the Medicare Australia CEO for practitioners who wish to use botulinum toxin for the treatment of upper limb spasticity in cerebral palsy patients.

 

Paragraph 5(D)(iii)(b) has been amended to state that applicant practitioners need to be involved in at least 20 procedures using botulinum toxin rather than being the primary operator in these procedures.

 

Paragraph 6(B) has been amended to include that medical practitioners registered to participate under the arrangements for the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older, or moderate to severe spasticity of the upper limbs in adults following stroke may retain a maximum of 5 vials of Botox.

 

Paragraph 7(A)(Part 1) has been amended to state that this part also refers to each administration of botulinum toxin made for  moderate to severe spasticity of the upper limbs in cerebral palsy patients 2 years of age or older.

Paragraph 7 (Part 2) has been amended to ensure that the part relates to both forms of botulinum toxin for the treatment of moderate to severe spasticity of the upper limbs in adults following stroke.

 

Paragraph 7(B) has been amended to ensure that the appropriate information is included in the Patient Usage Form given the addition of the new indications in Paragraph 3(A)(i).

 

Paragraph 7(C) has been amended to clearly indicate that this paragraph only refers to upper limb spasticity following stroke.

Overview

The National Health Act 1953, enacted by the Parliament of Australia, aims to regulate the Pharmaceutical Benefits Scheme (PBS) to ensure Australians have access to necessary, cost-effective medicines. The Act was amended in 2008 to introduce special arrangements under subsection 100(1)(b)(i) to facilitate the supply of botulinum toxin for specific medical conditions where standard supply methods under the PBS are inefficient. These special arrangements address the high cost and storage requirements of botulinum toxin, which often result in limited availability for patients in need. The 2009 Amendment Special Arrangements further extended the scope of the Botulinum Toxin Program to include additional conditions and patients, ensuring a more comprehensive supply of botulinum toxin for eligible patients. These amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee and other relevant stakeholders, reflecting a policy objective to improve access to essential medications for specific medical needs.

Scope and Application

The National Health Act 1953, specifically as amended by the Amendment Special Arrangements under Subparagraph 100(1)(b)(i) Botulinium Toxin Program No. PB 29 of 2009, pertains to the regulation of the Pharmaceutical Benefits Scheme (PBS) and the supply of special pharmaceutical products. The Act applies to individuals who reside in isolated areas or are receiving medical treatment under circumstances where standard pharmaceutical benefits cannot be conveniently or efficiently supplied. The Act also extends to the supply of botulinum toxin for specific conditions, as outlined in the arrangements. These conditions include the treatment of blepharospasm associated with dystonia, dynamic equinus foot deformity due to spasticity in ambulant paediatric and adult cerebral palsy patients, spasmodic torticollis, and moderate to severe spasticity of the upper limbs in both paediatric and adult patients following stroke. The geographic and jurisdictional reach of the Act is national, as it is a Commonwealth Act. The provisions of the Act apply across Australia, ensuring uniform access to the specified treatments. The arrangements explicitly detail the types of botulinum toxin products covered, the specific conditions they can treat, and the maximum number of treatments permitted per patient per lifetime. The Act does not specify exclusions, exemptions, or thresholds, but it does set out strict conditions for the administration of botulinum toxin, including contra-indications and the necessity for certain medical qualifications. The Act is further extended and detailed through subordinate instruments, such as the Amendment Special Arrangements, which provide specific operational guidelines and eligibility criteria for medical practitioners involved in the administration of botulinum toxin.

Key Provisions

The key provisions of the Botulinum Toxin Program Special Arrangements under the National Health Act 1953, as amended, relate to the supply of botulinum toxin for specific medical conditions. Under section 100(1)(b)(i) of the Act, the Minister has made special arrangements to ensure an adequate supply of botulinum toxin for patients in isolated areas or those receiving medical treatment where standard pharmaceutical benefits cannot be conveniently or efficiently supplied. These arrangements were amended to include new indications for the use of Botox, such as the treatment of moderate to severe upper limb spasticity in cerebral palsy patients aged two years or older, and moderate to severe spasticity of the upper limbs in adults following stroke, provided certain conditions are met (section 100(1)(b)(i)). The Act imposes several obligations on the parties involved. Medical practitioners who wish to use botulinum toxin for the treatment of upper limb spasticity in cerebral palsy patients aged two years or older must hold certain specialist qualifications and apply in writing to the CEO of Medicare Australia (section 5(A) and 5(C) of the Schedule). These practitioners must also be involved in at least 20 procedures using botulinum toxin, rather than being the primary operator in these procedures (section 5(D)(iii)(b)). Furthermore, registered medical practitioners for the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients aged two years or older or in adults following stroke can retain a maximum of five vials of Botox (section 6(B)). Failure to comply with the provisions of the Act may result in various consequences. While specific offences and penalties are not detailed in the explanatory statement, non-compliance with the requirements for the supply of botulinum toxin could potentially lead to civil or criminal penalties under the Act or other relevant legislation. These may include fines, imprisonment, or other sanctions as prescribed by law. It is important for all parties involved to adhere to the provisions and requirements of the Act to ensure the safe and effective use of botulinum toxin for the specified medical conditions.

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