EXPLANATORY STATEMENT
National Health Act 1953
National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025
PB 150 of 2025
Purpose
The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.
The Principal Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).
Pharmaceutical benefits containing simvastatin 5 mg in the manner of oral administration under the brand Zimstat are anticipated to be in shortage from December 2025, with resolution expected by the end of January 2026. In response, the TGA is working on issuing the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025, which allows pharmacists to supply a different strength of simvastatin tablets at an equivalent dose for the duration of the shortage, provided specified conditions are met.
The purpose of the Amendment Determination is to allow PBS subsidisation of the arrangements that will be specified in the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025. The Amendment Determination will specify that a different strength of simvastatin tablets, at an equivalent dose, can be supplied without a new prescription, in accordance with the specifications and conditions outlined in the SSSI issued by the TGA. This minimises the burden on health care professionals and assists Australians with timely access to medicines.
The Amendment Determination permits the supply by an approved pharmacist of any one of the specified substitute pharmaceutical benefits containing the drug simvastatin, in the manner of oral administration, in situations where the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, and the following conditions are met:
- the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law;
- the pharmacist does not have access to the scarce medicine;
- the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted;
- the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine;
- the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine;
- the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine;
- the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing; and
- the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine.
In order for the specified substitute pharmaceutical benefits to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, the following specific permitted circumstances of substitution apply:
the pharmacist has advised the patient, or person acting on behalf of the patient, of:
- the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified; and
- suitable instructions for cutting a tablet of the substitutable medicine; and
- the differences between the scarce medicine and the substitutable medicine.
The Amendment Determination commences on 5 December 2025.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
A provision-by-provision description of the Amendment Determination is contained in the Attachment.
Consultation
The Amendment Determination reflects the intention of previous consultation.
In relation to the Amendment Determination, consultation was undertaken with the Chair and relevant expert members of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body that recommends medicines for listing on the PBS. Consultation with PBAC experts focused on specific advice about the appropriateness of PBS subsidisation for the Amendment Determination. The PBAC experts endorsed the proposed approach, as it was considered that the substitution arrangement is necessary, with limited other options available for patients needing replacement as quickly as possible during the current shortage.
It is noted the Therapeutic Goods Administration conducted consultation on the appropriateness of the substitutions and consultation on this Amendment Determination was limited to the appropriateness of a PBS subsidy for the substitute medicines. No further consultation was deemed necessary, as consultation with the PBAC Chair drew on the knowledge of relevant experts.
ATTACHMENT
Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025
Section 1 Name
This section provides that the name of the Amendment Determination is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025
This section also provides that the Amendment Determination may be cited as PB 150 of 2025
Section 2 Commencement
This section provides that the Amendment Determination commences on 5 December 2025.
Section 3 Authority
This section provides that the Amendment Determination is made under subsection 89A(3) of the National Health Act 1953.
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.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025
This Disallowable 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 Disallowable Legislative Instrument
The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.
The Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).
The pharmaceutical benefits containing the drug simvastatin in the manner of oral administration are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025).
The Amendment Determination specifies that a different strength of simvastatin tablets at equivalent dose can be effectively substitutable at the pharmacy level without the need to obtain a new prescription from the prescriber at PBS subsidised prices for the duration of the TGA approval, where conditions in the Principal Determination are met and the supply is in accordance with section 30EL of the Therapeutic Goods Act 1989.
This means that eligible patients accessing a substitute pharmaceutical benefit containing simvastatin under these arrangements will be paying PBS co-payment rates for the supply and will not be out of pocket. This minimises the burden of this shortage on health care professionals by reducing the need for interdisciplinary consultations, and assists Australians with timely and equitable access to simvastatin products during periods of shortage. It further bolsters the intended public health outcome of the serious shortage intervention by ensuring the substitution remains an affordable and practical alternative for patients.
Human rights implications
The Amendment Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Amendment Determination assists in the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme providing Australians with subsidised access to medicines. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the scheme. By ensuring that patients have continued access to their medicines while their supply is disrupted, the Amendment Determination assists in the progressive realisation by all appropriate means, of the universal right to the enjoyment of the highest attainable standard of physical and mental health.
Conclusion
The Amendment Determination is compatible with human rights, as it promotes the protection of human rights.
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing