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.
Overview
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2017 (No. 1) was enacted to address gaps in patient access to botulinum toxin treatments under the existing special arrangement provisions of the National Health Act 1953. This legislative instrument was introduced to amend the National Health (Botulinum Toxin Program) Special Arrangement 2015, ensuring that patients requiring treatment with botulinum toxin have adequate access to pharmaceutical benefits. This Instrument was made under the authority of subsection 100(2) of the National Health Act 1953, allowing the Minister to make special arrangements for the supply of pharmaceutical benefits. The primary policy objective of this amendment is to provide clarity on issues affecting patient access to botulinum toxin by enabling eligible prescribers to write more than one prescription for the same patient on the same day, where there is a clinical need to treat multiple conditions. This change aims to streamline the provision of necessary treatments and ensure efficient supply under the special arrangement.
Scope and Application
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument 2017 (No. 1) applies to the regulation of pharmaceutical benefits under the National Health Act 1953, specifically amending the National Health (Botulinum Toxin Program) Special Arrangement 2015. This legislative instrument enables the Minister to make special arrangements for the supply of botulinum toxin treatments, which are subject to restrictions to ensure their efficient and convenient provision to patients. It applies to eligible prescribers of Pharmaceutical Benefits Scheme (PBS)-subsidised botulinum toxin, allowing them to write more than one prescription for the same patient on the same day if there is a clinical need to treat more than one condition. The instrument has a Commonwealth jurisdictional reach, as it is made under the authority of the National Health Act 1953 and applies nationally. The amendments clarify that two prescriptions for botulinum toxin written on the same day by the same prescriber for the same person are considered for the same or an equivalent pharmaceutical benefit if they relate to the same condition or have the same circumstances code. This Instrument does not specify any exclusions or thresholds beyond those detailed in the National Health (Pharmaceutical Benefits) Regulations 1960.
Key Provisions
The main provisions of this amendment to the National Health (Botulinum Toxin Program) Special Arrangement 2015 are outlined in Schedule 1, which adjusts the conditions under which eligible prescribers can write multiple prescriptions for botulinum toxin for the same patient on the same day. According to the amendment (Schedule 1, Item 1), these prescriptions are considered for the same or an equivalent pharmaceutical benefit if they relate to the same condition or have the same circumstances code, as determined by the Minister. This change aims to provide flexibility for treating multiple conditions on the same day where clinically necessary.
The obligations imposed by this Act on the parties involved, particularly eligible prescribers, are to ensure that any multiple prescriptions written for botulinum toxin on the same day either pertain to the same condition or possess the same circumstances code. This requirement is intended to streamline the process while ensuring that patients receive the necessary treatments without unnecessary delays or administrative hurdles.
The Act does not explicitly state any offences, penalties, or civil/criminal consequences for breaches of its provisions. However, any non-compliance with the special arrangement or failure to adhere to the stipulated conditions for writing multiple prescriptions could potentially lead to administrative actions, such as the revocation of eligibility to prescribe botulinum toxin under the scheme, or other regulatory consequences as deemed appropriate by the Minister or relevant authorities. The overarching purpose of the Act is to facilitate access to necessary treatments while maintaining the integrity and efficiency of the Pharmaceutical Benefits Scheme.