EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2017 (No. 1)
PB 8 of 2017
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 (this Instrument), made under subsection 100(2) of the Act, is to amend the National Health (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015) (the Special Arrangement) to make changes relating to the Botulinum Toxin Program.
The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with botulinum toxin. Restrictions on the provision of this treatment mean that these pharmaceutical benefits can be more conveniently or efficiently supplied under a special arrangement.
This Instrument allows eligible prescribers of Pharmaceutical Benefits Scheme (PBS)-subsidised botulinum toxin to write more than one prescription for the same patient on the same day, where there is a clinical need to treat more than one condition.
A provision-by-provision description of this Instrument is contained in the Attachment.
Consultation
This amendment to the Special Arrangement was made having regard to advice received from an external stakeholder (the manufacturer of a botulinum toxin medicine) regarding an issue affecting patient access to botulinum toxin. The associated legislative amendments have been implemented to provide clarity on this issue.
In developing the operational aspects of the revised approach, the Department has consulted with the Department of Human Services and has sought clinical and compliance-related advice internal to the Department.
This Instrument commences on 1 March 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 1)
Section 1 Name
This section provides that this Instrument is the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2017 (No. 1) and that it may also be cited as PB 8 of 2017.
Section 2 Commencement
This section provides that the whole of this Instrument commences on 1 March 2017.
Section 3 Authority
This section provides that this Instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
This section specifies that amendments are made to each instrument as set out in the Schedule.
Schedule 1—Amendments
Item 1 amends the National Health (Botulinum Toxin Program) Special Arrangement 2015 (PB 87 of 2015) by providing that, for the purposes of paragraph 19(2)(a) of the National Health (Pharmaceutical Benefits) Regulations 1960, two prescriptions for botulinum toxin written by a prescriber for the same person on the same day are only considered prescriptions for the same or an equivalent pharmaceutical benefit if both prescriptions:
a) relate to the same condition from among the following:
moderate to severe spasticity of the upper limb (whether or not following a stroke);
urinary incontinence;
spasmodic torticollis;
dynamic equinus foot deformity;
blepharospasm;
hemifacial spasm;
chronic migraine; or
severe primary axillary hyperhidrosis; or
b) relate to conditions (other than those listed above) that have the same circumstances code (streamlined authority code) as determined by the Minister under paragraph 85(7)(b) of the National Health Act 1953.