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:
- cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
- 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.
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