EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT (NO. 1) 2026
PB 22 of 2026
Purpose
The National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument (No. 1) 2026 (PB 22 of 2026) (this Instrument) amends the National Health (Botulinum Toxin Program) Special Arrangement 2025 to make changes to the Special Arrangement relating to the Botulinum Toxin Program.
Schedule 1 to this Instrument amends the National Health (Botulinum Toxin Program) Special Arrangement 2025 (Special Arrangement) to include a new treatment condition, chronic sialorrhea, as a condition for the treatment of which more than one prescription for the special arrangement supply of a botulinum toxin pharmaceutical benefit for the same patient cannot be written by a Pharmaceutical Benefits Scheme (PBS) prescriber on the same day for supply under the PBS. This will ensure there are consistent rules around when more than one prescription for the same patient may or may not be written by a PBS prescriber on the same day for all conditions for which botulinum toxin pharmaceutical benefits may be prescribed for PBS supply, noting that botulinum toxin pharmaceutical benefits are prescribed for localised treatment.
Authority
Subsection 100(1) of the National Health Act 1953 (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).
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
The PBAC is an independent expert body established by section 100A of the Act, 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. In addition, an industry nominee has been appointed to the PBAC membership. 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.
Pharmaceutical companies were consulted throughout the process for changes to the listings on the PBS. This includes consultation through the PBAC process.
Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that has already taken place in the decision to list the new treatment condition outlined under ‘Purpose’.
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 March 2026.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT A
DETAILS OF THE NATIONAL HEALTH (BOTULINUM TOXIN PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT (NO. 1) 2026
Section 1 Name
This section provides that the name of the Instrument is the National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument (No. 1) 2026 and that it may also be cited as PB 22 of 2026.
Section 2 Commencement
This section provides that this Instrument commences on 1 March 2026.
Section 3 Authority
This section states that this Instrument is made under subsection 100(2) of the National Health Act 1953 (Act).
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to this Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Instrument has effect according to its terms.
Schedule 1 Amendments
National Health (Botulinum Toxin Program) Special Arrangement 2025 (PB 111 of 2025)
Item 1 – At the end of paragraph 11(a)
Paragraph 40(3)(a) of the National Health (Pharmaceutical Benefits) Regulations 2017 (Regulations) relevantly provides that a prescription (other than a medication chart prescription) must not provide for the supply of a pharmaceutical benefit if the PBS prescriber has written another PBS prescription for the same person, on the same day, that is for the supply of the same pharmaceutical benefit, another brand of the same benefit or a Schedule equivalent benefit.
Section 11 of the Special Arrangement modifies the application of paragraph 40(3)(a) of the Regulations to:
• allow two prescriptions for the supply of two of the same botulinum toxin pharmaceutical benefits to be written by a PBS prescriber for the same person on the same day, but only if the prescriptions are written in relation to the treatment of different conditions or in circumstances that have different circumstances codes (as specified in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (Listing Instrument)); and
• preclude two prescriptions for the supply of two of the same botulinum toxin pharmaceutical benefits from being written by a PBS prescriber for the same person on the same day, but only if the prescriptions are written in relation to the treatment of the same condition or in circumstances that have the same circumstances code (as specified in the Listing Instrument).
For example:
• Botulinum toxin type A purified neurotoxin complex and clostridium botulinum type A toxin ‑ haemagglutinin complex could not both be prescribed on the same day for a patient with moderate to severe spasticity of the upper limb. That is because both prescriptions would be written in relation to the treatment of a condition listed in subparagraph 11(a)(i) (i.e. the same condition). Additionally, the prescriptions for both benefits would be written in circumstances that have the same circumstances code (C5178 as specified in the Listing Instrument). Both paragraphs 11(a) and (b) would treat these benefits as being the same, and paragraph 40(3)(a) of the Regulations would apply.
• Botulinum toxin type A purified neurotoxin complex could be prescribed for a patient with spasmodic torticollis, a condition listed in subparagraph 11(a)(iv) (in circumstances that have the circumstances code C5406 as specified in the Listing Instrument), and another prescription could be written for that same benefit on the same day for the same patient with chronic migraine, a condition listed in subparagraph 11(a)(viii) (in circumstances that have the circumstances code C11784 as specified in the Listing Instrument). Both paragraphs 11(a) and (b) would not treat these benefits as being the same, and paragraph 40(3)(a) of the Regulations would not apply.
Item 1 adds the condition chronic sialorrhea to the list of treatment conditions in paragraph 11(a) of the Special Arrangement.
The Listing Instrument is being separately amended with effect from 1 March 2026 to add the treatment of chronic sialorrhea as a circumstance for which the pharmaceutical benefits listed in Schedule 1 to the Special Arrangement as botulinum toxin pharmaceutical benefits can be prescribed under the PBS.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Botulinum Toxin Program) Special Arrangement Amendment Instrument (No. 1) 2026
(PB 22 of 2026)
This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (Act), is to amend the National Health (Botulinum Toxin Program) Special Arrangement 2025 (PB 111 of 2025) (Special Arrangement), to make changes to the Special Arrangement relating to the Botulinum Toxin Program.
The Special Arrangement makes provision for prescribing and supplying subsidised botulinum toxin pharmaceutical benefits to eligible patients by eligible medical practitioners. The Special Arrangement regulates how claims for payment for the supply of such pharmaceutical benefits may be made, the amount of payment that the relevant supplier is entitled to receive from the Commonwealth for each supply, and the amount the patient may be required to pay for each supply.
Human Rights Implications
This Instrument engages Articles 9 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), specifically the rights to social security and health.
The Right to Social Security
The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The UN Committee on Economic, Social and Cultural Rights (the Committee) reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under the ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The Committee has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
Analysis
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with the advancement of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health by providing for subsidised access by patients to medicines. The PBS provides timely, reliable and affordable access to necessary medicines for Australians. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence based.
The Botulinum Toxin Program provides access to specialised PBS medicines to eligible patients to assist in the treatment of specific conditions including facial spasms, spasticity due to cerebral palsy or stroke, severe sweating, urinary incontinence and chronic migraine.
The botulinum toxin injection contains a muscle relaxant obtained from the bacterium Clostridium botulinum. It works by temporarily relaxing overactive or spastic (contracting) muscles and is used to treat associated medical conditions. It can also block signals to the sweat glands thus reducing excessive sweating (hyperhidrosis), and can also block the release of chemicals in the brain associated with the cause of pain (chronic migraine). In the treatment of excessive drooling (chronic sialorrhea), botulinum toxin blocks signals from the brain to saliva glands, to reduce the production of saliva. When injected into the bladder wall, botulinum toxin works on the bladder muscle to prevent leakage of urine (urinary incontinence). It has been shown to reduce the symptoms and improve the quality of life of patients suffering from these conditions.
There are checks and balances on the provision of botulinum toxin to prevent harmful effects on patients by restricting who can be an eligible prescriber (prescribers with the appropriate qualifications and experience in the treatment of patients and the use of required equipment).
Separate amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (Listing Instrument) effective 1 March 2026 will enable botulinum toxin pharmaceutical benefits to be prescribed for the treatment of chronic sialorrhea under the PBS.
The amendments to the Special Arrangement made by this Instrument will align rules around when a PBS prescriber may write more than one prescription for the same or equivalent botulinum toxin pharmaceutical benefit(s) for the same patient on the same day by adding chronic sialorrhea to section 11 of the Special Arrangement.
Paragraph 40(3)(a) of the National Health (Pharmaceutical Benefits) Regulations 2017 usually prevents a PBS prescriber from writing more than one prescription for the PBS supply of the same or an equivalent pharmaceutical benefit for the same patient on the same day, irrespective of the reason for which the prescription was written. Section 11 of the Special Arrangement modifies the operation of paragraph 40(3)(a) so that it only prevents the writing of more than one PBS prescription for a botulinum toxin pharmaceutical benefit for the same patient on the same day if both prescriptions are written for the treatment of the same condition specified in paragraph 11(a) or in the same circumstances (by reference to ‘circumstances codes’ as specified in the Listing Instrument). This reflects the localised nature of botulinum toxin treatment.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Sarah Norris
Assistant Secretary
Community Access Programs Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing