National Health Act 1953 - Amendment special arrangements made under subparagraph 100(1)(b)(i) - Botulinum Toxin Program (No. PB 58 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L02408 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 58 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.

 

 

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 31st day of March 2009, which commenced on 1 April 2009, referred to as No PB 122 of 2008 – taking account of PB 29 of 2009 (F2009C00246) (the Principal Arrangements) are amended by these Amendment Arrangements.

 

These Amendment Arrangements, which have effect from 1 July 2009, allow for the supply of Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) for the treatment of severe spasticity of the upper limb in a cerebral palsy patient aged between 2 and 17 years of age inclusive and 18 years of age or older (so long as the patient has received treatment as a child).

 

These Amendment Arrangements also clarify that the use of Botox or Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) for the treatment of moderate to severe spasticity of the upper limb in adults following a stroke should occur at least three months post stroke.  The date of the stroke must be included in the application to Medicare.

 

A provision by provision description of the Instrument is contained at Attachment. A.

 

 

Consultations

 

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.

The PBAC is an independent expert body established by section 100A 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the 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

 

Medicare Australia has also been consulted and 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.

 

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

 


ATTACHMENT A

 

Paragraph 1 provides that these Amendment Special Arrangements commence on 1 July 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

 

(1)  Paragraph 3(A)(i) has been amended to clarify the circumstances for when Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) may be used to treat:

  • a moderate to severe spasticity or the upper limbs in cerebral palsy patients; and
  • moderate to severe spasticity of the upper limb in adults following a stroke.

 

(2)  Paragraph 3(A)(ii) has been amended to clarify the circumstances for when Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) may be used to treat moderate to severe spasticity of the upper limb in adults following a stroke.

Overview

The National Health Act 1953, as amended by the legislation F2009L02408, was enacted to address the problem of ensuring an adequate supply of special pharmaceutical products, particularly botulinum toxin, to patients in isolated areas or those receiving medical treatment where standard pharmaceutical benefits under the Act could not be conveniently or efficiently supplied. This legislation was introduced by the Australian Parliament and aims to provide special arrangements to ensure the availability of necessary pharmaceutical products, such as botulinum toxin, under the Pharmaceutical Benefits Scheme (PBS). The policy objective of these arrangements is to ensure that patients who require botulinum toxin for specific treatments, such as severe spasticity in cerebral palsy patients and adults post-stroke, have timely and convenient access to these medications, thereby improving their medical outcomes. The explanatory statement for this legislation highlights that the high cost and need for cold storage of botulinum toxin make it challenging for patients to access this medication through normal supply channels. To address this, the Act allows the Minister to make special arrangements to ensure the supply of these pharmaceuticals. The legislative instrument, which took effect from 1 July 2009, amends previous special arrangements to specifically allow the supply of Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) for severe spasticity in cerebral palsy patients and moderate to severe spasticity in adults post-stroke, subject to certain conditions. Additionally, it clarifies the timing requirements for the use of Botox and Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) in post-stroke patients.

Scope and Application

The National Health Act 1953 Amendment Special Arrangements under subparagraph 100(1)(b)(i) Botulinium Toxin Program No. PB 58 of 2009 applies to the supply of botulinum toxin for specific medical treatments, particularly targeting patients in isolated areas or those undergoing medical treatment where conventional pharmaceutical supply under the Pharmaceutical Benefits Scheme (PBS) is inefficient or inadequate. These special arrangements are made to ensure that an adequate supply of botulinum toxin is available to those in need, particularly in cases where the high cost and cold storage requirements of the drug make it difficult for patients to access it through regular pharmaceutical channels. The arrangements primarily concern the use of Botulinum Toxin Type A Purified Neurotoxin Complex (Botox) and Clostridium Botulinum Type A Toxin-Haemagglutinin Complex (Dysport) for the treatment of severe spasticity in cerebral palsy patients and for the treatment of moderate to severe spasticity in adults following a stroke, with specific timelines and conditions applying to these treatments. The Act applies nationally across Australia, as it is a Commonwealth Act, and its provisions are subject to modifications through subordinate instruments, such as the amendment arrangements specified in this legislative instrument.

Key Provisions

The key provisions of the Amendment Special Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953 (the Act) relate to the special arrangements for the Botulinum Toxin Program, specifically targeting the supply of botulinum toxin for certain medical conditions. Section 100(1)(b)(i) allows the Minister to make special arrangements to ensure an adequate supply of special pharmaceutical products for persons in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied. The arrangements clarify the use of Botox and Dysport for treating severe spasticity of the upper limb in cerebral palsy patients and moderate to severe spasticity of the upper limb in adults following a stroke, with specific conditions on the timing of treatment post-stroke. The Act imposes several obligations on the parties involved. Firstly, it requires the Pharmaceutical Benefits Advisory Committee (PBAC) to recommend which drugs and medicinal preparations should be available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness. The PBAC's recommendations are essential for the Minister’s decision-making process. Secondly, Medicare Australia is responsible for managing the order and payment for the supply of botulinum toxin under these arrangements, ensuring that eligible patients can access the medication through the Pharmaceutical Benefits Scheme (PBS). Breaches of these arrangements could lead to various consequences. Although specific penalties are not detailed in the explanatory statement, under the general provisions of the National Health Act 1953, non-compliance with the Act's provisions can result in civil or criminal penalties. For example, supplying pharmaceutical benefits in a manner inconsistent with the Act can result in fines or imprisonment, depending on the severity of the breach. Additionally, any fraudulent activities related to the PBS, such as making false claims for benefits, can lead to more severe penalties, including significant fines and imprisonment terms. In summary, these Amendment Special Arrangements aim to ensure that botulinum toxin is readily available for treating specific conditions under the PBS, while placing obligations on the PBAC and Medicare Australia to facilitate this process. Any non-compliance with these arrangements could result in civil or criminal penalties, reinforcing the importance of adhering to the specified provisions.

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