National Health Act 1953 - Amendment special arrangements under subparagraph 100(1)(b)(i) - Botulinum Toxin Program (No. PB 33 of 2010)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00776 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 33 of 2010

 

 

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 Arrangements for the Botulinum Toxin Program made on the 27th day of November 2008, with effect from 1 December 2008, are amended by these Arrangements.

 

These Arrangements, which have effect from 1 April 2010, now extend to the group of medical practitioners who are eligible to be registered to participate under these Arrangements to include medical practitioners with specialist qualifications in plastic surgery for the treatment of moderate to severe spasticity of the upper limbs in a cerebral palsy patient 2 years of age or older.

 

These Arrangements commence on 1 April 2010.

 

Details of these Arrangements are provided in the Attachment.

 

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 as it manages the payment for the supply of botulinum toxin under these Arrangements.

 

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

 

 

ATTACHMENT

 

Paragraph 1 provides that these Amendment Special Arrangements commence on 1 April 2010.

 

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

 

Item [1])  Paragraph 5(A)(iv) has been amended to include plastic surgery as a specialist qualification medical practitioners can hold to participate in these Arrangements.

.

Overview

The National Health Act 1953, as amended by the legislation F2010L00776, addresses the issue of ensuring an adequate supply of botulinum toxin for patients in remote areas or those receiving medical treatment where conventional supply methods under the Pharmaceutical Benefits Scheme (PBS) are inadequate. Enacted by the Parliament of Australia, this legislation aims to facilitate the availability of special pharmaceutical products, such as botulinum toxin, to patients who otherwise might face significant delays in treatment due to the high cost and storage requirements of the drug. The policy objective is to enhance access to necessary medications for specific medical conditions, particularly in isolated areas or under unique medical circumstances. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by recommending drugs for inclusion on the PBS based on clinical effectiveness, safety, and cost-effectiveness. These arrangements ensure that the PBS can adapt to meet the specific needs of certain patient groups, thereby improving overall healthcare outcomes.

Scope and Application

The National Health Act 1953, as amended, enables the Minister for Health to make special arrangements for the supply of special pharmaceutical products under certain conditions, such as when patients reside in isolated areas or when conventional pharmaceutical benefits are inadequate for their medical treatment. Specifically, subparagraph 100(1)(b)(i) allows the Minister to establish special arrangements to ensure an adequate supply of necessary pharmaceutical products that may not be readily available or efficiently supplied under the general provisions of the Act. The Botulinum Toxin Program Special Arrangement, falling under this subparagraph, was established to address the challenges associated with the supply and storage of botulinum toxin, a costly drug requiring cold storage, thus making it difficult for patients to access in a timely manner. These special arrangements, which came into effect on 1 April 2010, were further amended to include medical practitioners with specialist qualifications in plastic surgery for the treatment of moderate to severe spasticity of the upper limbs in cerebral palsy patients aged two years or older. These arrangements ensure that the special pharmaceutical products, in this case, botulinum toxin, are available under specific conditions where the standard provisions of the Act are insufficient, thereby facilitating timely and efficient access to necessary medical treatments.

Key Provisions

The key provisions of the National Health Act 1953 Amendment Special Arrangements Under Subparagraph 100(1)(b)(i) Botulinium Toxin Program No. PB 33 of 2010 revolve around ensuring adequate access to botulinum toxin for patients in specific circumstances, as outlined in section 100(1) of the Act. This section allows the Minister to make special arrangements for the supply of special pharmaceutical products, such as botulinum toxin, to patients living in isolated areas or those receiving medical treatment where pharmaceutical benefits under Part VII of the Act are inadequate or cannot be conveniently supplied. Section 100(2) permits the Minister to vary or revoke these special arrangements if necessary. The arrangements made under subparagraph 100(1)(b)(i) specifically address the high cost and storage requirements of botulinum toxin, ensuring its availability for patients who need it for the treatment of certain conditions. The Act imposes several obligations and requirements on the parties involved. The Minister, as the authority responsible for these special arrangements, must ensure that they are implemented effectively to meet the needs of eligible patients. Medical practitioners who wish to participate in the Botulinum Toxin Program must hold specialist qualifications in the relevant medical fields, as specified in the arrangements. The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A of the Act, plays a critical role in advising the Minister on which drugs and preparations should be included in the PBS and in recommending the listing of medicines based on their clinical effectiveness, safety, and cost-effectiveness. Medicare Australia is also involved in managing payments for the supply of botulinum toxin under these arrangements. For breaches of the provisions outlined in the Act, the National Health Act 1953 may impose various penalties and consequences. Although specific penalties are not detailed in the explanatory statement, it is common for breaches of health-related legislation in Australia to be subject to both civil and criminal penalties. Civil penalties can include fines, while criminal penalties may involve imprisonment, depending on the severity and intent of the breach. The maximum penalties would be determined by the specific nature of the violation and the relevant sections of the Act under which the breach occurs. It is essential for all parties to adhere to the provisions of the Act to avoid these potential consequences.

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