EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURE) AMENDMENT DETERMINATION 2025 (No. 1)
PB 164 of 2025
Purpose
The purpose of the National Health (Continued Dispensing – Emergency Measure) Amendment Determination 2025 (No. 1) (this Instrument) is to amend the National Health (Continued Dispensing – Emergency Measure) Determination 2025 (No. 3) (PB 162 of 2025) (Principal Determination).
The Principal Determination provides for temporary access under Continued Dispensing arrangements to a wider range of medicines than those available under ongoing arrangements under the National Health (Continued Dispensing) Determination 2022, and is primarily intended to support patients affected by the bushfire disaster in six Local Government Areas (LGAs) in New South Wales (namely, Central Coast, Mid Coast, Upper Hunter, Muswellbrook, Warrumbungle, and Dubbo) to continue to access their Pharmaceutical Benefits Scheme (PBS) subsidised medicines, where there is an immediate need for the medicine but the PBS prescriber is unable to be contacted and/or is unable to provide an electronic PBS prescription or owing prescription.
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) (the Listing Instrument), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), and amendments to that instrument, are made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act).
Schedule 1 to this Instrument provides for the addition of the drugs odevixibat and praziquantel to the list of pharmaceutical benefits that may be supplied temporarily as a Continued Dispensing supply. These changes are summarised, by subject matter, in the Attachment.
Authority
This Instrument is made under subsection 89A(3) of the Act. It determines pharmaceutical benefits that can be supplied by an approved pharmacist without presentation of a prescription where the conditions in the Instrument are met.
Consultation
This Instrument affects approved pharmacists who are supplying pharmaceutical benefits at or from premises in respect of which the pharmacist is for the time being approved. Prior to commencement of the National Health (Continued Dispensing) Determination 2022, consultation was undertaken with relevant peak bodies including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. The Department of Health, Disability and Ageing (the Department) undertook direct consultation with Services Australia and consulted with state and territory Departments of Health about implementation for the National Health (Continued Dispensing) Determination 2022.
It was considered that further consultation for this instrument was unnecessary due to the nature of the consultation that had already taken place and the nature and urgency of the bushfire disaster in six LGAs in New South Wales.
This amendment is minor and machinery in nature.
General
A provision-by-provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 January 2026.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURE) AMENDMENT DETERMINATION 2025 (No. 1)
Section 1 Name of Instrument
This section provides that the name of the Instrument is the National Health (Continued Dispensing – Emergency Measure) Amendment Determination 2025 (No. 1) (Instrument) and may also be cited as PB 164 of 2025.
Section 2 Commencement
This section provides that the Instrument commences on 1 January 2026.
Section 3 Authority
This section provides that the Instrument is made under subsection 89A(3) of the National Health Act 1953 (Act).
Section 4 Schedules
This section provides that each instrument specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule, and any other item in a Schedule has effect according to its terms.
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of drugs to the list of pharmaceutical benefits that may be supplied temporarily as a Continued Dispensing supply. These changes are summarised below.
SUMMARY OF CHANGES TO THE NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURE) DETERMINATION 2025 (No. 3) MADE BY THIS INSTRUMENT
Drug Addition
Listed Drug |
Odevixibat |
Praziquantel |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURE) AMENDMENT DETERMINATION 2025 (No. 1)
(PB 164 of 2025)
This Legislative 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 Legislative Instrument
The National Health (Continued Dispensing – Emergency Measure) Amendment Determination 2025 (No. 1) (this Instrument) amends the National Health (Continued Dispensing – Emergency Measure) Determination 2025 (No. 3) (PB 162 of 2025) (Principal Determination).
The Principal Determination temporarily expands the list of pharmaceutical benefits that may be supplied by an approved pharmacist to a patient who is unable to present a prescription to the pharmacist, where a number of conditions are met (Continued Dispensing). These conditions include that the approved pharmacist is satisfied that:
- the patient’s Pharmaceutical Benefits Scheme (PBS) prescriber cannot be contacted and/or is unable to provide an electronic prescription for the patient;
- the patient has previously been supplied the pharmaceutical benefit based on a prescription from a PBS prescriber and that the patient was prescribed the benefit in at least one of the circumstances determined under paragraph 85(7)(b) of the National Health Act 1953 (the Act) as an authorised circumstance for prescribing the benefit under the PBS;
- the patient’s therapy is stable;
- the patient has been taking the pharmaceutical benefit regularly for an uninterrupted period during which the relevant PBS prescriber assessed the patient’s condition and decided a need for ongoing treatment with the particular pharmaceutical benefit.
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 health and social security.
The Right to Social Security
The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (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 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
This Instrument advances the right to health and the right to social security by ensuring that amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) (the Listing Instrument), that affect the pharmaceutical benefits that may be supplied temporarily as a Continued Dispensing supply, are also made in the Principal Determination. This Instrument provides for the addition of the drugs odevixibat and praziquantel to the list of pharmaceutical benefits that may be supplied temporarily as a Continued Dispensing supply.
The Listing Instrument determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. 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 Instrument continues to provide the option for patients to have subsidised access to eligible PBS medicines through continued dispensing arrangements.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Alex Doyle
Assistant Secretary (Acting)
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing