EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Medicines and OTG—Authorised Supply) Amendment Rules 2026
The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health, Disability and Ageing (“the Department”).
Subsection 19(7A) of the Act provides that the Minister may, by legislative instrument, make rules authorising specified classes of health practitioners to supply specified therapeutic goods (or classes of such goods) for use in the treatment of specified recipients, provided the goods are supplied in specified circumstances and the specified conditions (if any) are satisfied.
Subsection 19(7B) of the Act provides that, in making rules under subsection 19(7A), the Minister must comply with such requirements, restrictions or limitations (if any) prescribed in the regulations. Subregulation 12B(5) of the Therapeutic Goods Regulations 1990 (“the Regulations”) provides that rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard. Health practitioners who supply therapeutic goods pursuant to rules made under subsection 19(7A) are required to notify the Secretary in accordance with subsections 19(7C) and 19(7D) of the Act.
These provisions are mainly intended to facilitate access to therapeutic goods with an established history of use in Australia and overseas, in circumstances where those goods are not included in the Australian Register of Therapeutic Goods (“the Register”), or not otherwise the subject of an exemption, approval or authority under the Act. A legislative instrument made under these provisions support what is known as the ‘Special Access Scheme – Category C pathway’ (“the SAS C pathway”).
The Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 (“the Principal Rules”) are made under subsection 19(7A) of the Act. The Principles Rules specify health practitioners, medicines, circumstances and conditions for the purposes of that subsection.
The Therapeutic Goods (Medicines and OTG—Authorised Supply) Amendment Rules 2026 (“the Amendment Rules”) amends Schedule 1 to the Principal Rules to remove the active ingredient buspirone, which has now been included in the Register for general supply in Australia and does not need to be available through the SAS C pathway.
Background
In Australia, therapeutic goods (medical devices, medicines and biologicals) are required to be included in the Register before they can be lawfully imported into, exported from or supplied in Australia. Therapeutic goods that are not included in the Register are referred to as ‘unapproved’ therapeutic goods.
The TGA encourages the use of therapeutic goods that are included in the Register; however, there are times whereby a patient requires a therapeutic good that is not included in the Register. The Special Access Scheme (“SAS”) provides a pathway for Australian patients to access ‘unapproved’ therapeutic goods.
Australian health practitioners are expected to have trialled or considered treatment options that are included in the Register and are available for supply in Australia prior to any consideration of seeking access to an ‘unapproved’ therapeutic good for their patient.
The SAS C pathway is a notification pathway, allowing specified classes of health practitioners to supply certain specified unapproved therapeutic goods that are considered by the TGA to have an establish safe use history. The TGA will periodically review the ‘unapproved’ therapeutic goods accessed through the SAS C pathway to determine if any amendments are required to the Principal Rules, including the removal of therapeutic goods that are on the Register or due to safety concerns.
Purpose
The purpose of the Amendment Rules is to remove the active ingredient buspirone from Schedule 1 of the Principal Rules. This amendment is being made because medicines containing buspirone have been approved for lawful supply in Australia and are in the Register.
Medicines containing buspirone could previously be accessed through the SAS C pathway as they have an established history of safe use. However, on 16 January 2025, ANKSILON™ (buspirone hydrochloride) tablets was included in the Register (ID: 422890 and 422891) and therefore may be available for general supply in Australia without needing to be accessed under one of the special access scheme pathways.
The Amendment Rules amends the Principal Rules to remove buspirone as access through the SAS C pathway is no longer necessary.
Consultation
Consultation on the removal of buspirone from the Amendment Rules was not undertaken as the change is a minor, routine administrative amendment resulting from the medicine being available for general supply in Australia (having been included in the Register) and no longer needing to be accessed through the SAS C pathway.
Details of the Amendment Rules are set out in Attachment A.
The Amendment Rules are compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
The Amendment Rules is a disallowable instrument for the purposes of the Legislation Act 2003 and commences on the day after the Amendment Rules are registered on the Federal Register of Legislation.
Attachment A
Details of the Therapeutic Goods (Medicines and OTG—Authorised Supply) Amendment Rules 2026
Section 1 – Name
This section provides that the name of the Instrument is the Therapeutic Good (Medicines and OTG—Authorised Supply) Amendment Rules 2026 (“the Amendment Rules”).
Section 2 – Commencement
This section provides that the Amendment Rules commence the day after the Amendment Rules are registered on the Federal Register of Legislation.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Rules is subsection 19(7A) of the Therapeutic Goods Act 1989 (“the Act”).
Subsection 33(3) of the Acts Interpretation Act 1901 relevantly provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. The Amendment Rules is made in accordance with that provision.
Section 4- Schedules
This section provides that each instrument that is specified in a Schedule to the Amendment Rules is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the Amendment Rules has effect according to its terms.
Schedule 1 – Amendments
Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022
Item 1 – Schedule 1 (table item 6)
This item removes buspirone from the Principal Rules as access through the SAS C pathway is no longer necessary due to the inclusion of medicine containing buspirone in the Register.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 2 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Medicines and OTG−Authorised Supply) Amendment Rules 2026
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 legislative instrument
Subsection 19(7A) of the Act provides that the Minister may, by legislative instrument, make rules authorising specified classes of health practitioners to supply specified therapeutic goods (or classes of such goods) for use in the treatment of specified recipients, provided the goods are supplied in specified circumstances and the specified conditions (if any) are satisfied.
Subsection 19(7B) of the Act provides that, in making rules under subsection 19(7A), the Minister must comply with such requirements, restrictions or limitations (if any) prescribed in the regulations. Subregulation 12B(5) of the Therapeutic Goods Regulations 1990 (“the Regulations”) provides that rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard. Health practitioners who supply therapeutic goods pursuant to rules made under subsection 19(7A) are required to notify the Secretary in accordance with subsections 19(7C) and 19(7D) of the Act.
These provisions are mainly intended to facilitate access to therapeutic goods with an established history of use in Australia and overseas, in circumstances where those goods are not included in the Australian Register of Therapeutic Goods (“the Register”), or not otherwise the subject of an exemption, approval or authority under the Act. A legislative instrument made under these provisions support what is known as the ‘Special Access Scheme – Category C pathway’ (“the SAS C pathway”).
The Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 (“the Principal Rules”) are made under subsection 19(7A) of the Act. The Principles Rules specify health practitioners, medicines, circumstances and conditions for the purposes of that subsection.
The Therapeutic Goods (Medicines and OTG—Authorised Supply) Amendment Rules 2026 (“the Amendment Rules”) amends Schedule 1 to the Principal Rules to remove the active ingredient buspirone, which has now been included in the Register for general supply in Australia and does not need to be available through the SAS C pathway.
Background
In Australia, therapeutic goods (medical devices, medicines and biologicals) are required to be included in the Register before they can be lawfully imported into, exported from or supplied in Australia. Therapeutic goods that are not included in the Register are referred to as ‘unapproved’ therapeutic goods.
The TGA encourages the use of therapeutic goods that are included in the Register; however, there are times whereby a patient requires a therapeutic good that is not included in the Register. The Special Access Scheme (“SAS”) provides a pathway for Australian patients to access ‘unapproved’ therapeutic goods.
Australian health practitioners are expected to have trialled or considered treatment options that are included in the Register and are available for supply in Australia prior to any consideration of seeking access to an ‘unapproved’ therapeutic good for their patient.
The SAS C pathway is a notification pathway, allowing specified classes of health practitioners to supply certain specified unapproved therapeutic goods that are considered by the TGA to have an establish safe use history. The TGA will periodically review the ‘unapproved’ therapeutic goods accessed through the SAS C pathway to determine if any amendments are required to the Principal Rules, including the removal of therapeutic goods that are on the Register or due to safety concerns.
Purpose
The purpose of the Amendment Rules is to remove the active ingredient buspirone from Schedule 1 of the Principal Rules. This amendment is being made because medicines containing buspirone have been approved for lawful supply in Australia and are in the Register.
Medicines containing buspirone could previously be accessed through the SAS C pathway as they have an established history of safe use. However, on 16 January 2025, ANKSILON™ (buspirone hydrochloride) tablets was included in the Register (ID: 422890 and 422891) and therefore may be available for general supply in Australia without needing to be accessed under one of the special access scheme pathways.
The Amendment Rules amends the Principal Rules to remove buspirone as access through the SAS C pathway is no longer necessary.
Human rights implications
The Amendment Rules engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural rights (“the ICESCR”). Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health and includes an obligation to take reasonable measures within available resources to progressively secure broader enjoyment of the right.
In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.
The Amendment Rules support the right to health by supporting access to approved medicines that contain buspirone, which have been evaluated for safety, quality and efficacy and no longer need to be accessed through the SAS C pathway. This reduces administrative burden for medical practitioners as they do not need to comply with the reporting requirements for the SAS C pathway and can prescribe and lawfully supply therapeutic goods that are included in the Register.
Conclusion
This Amendment Rules is compatible with human rights because it supports the right to health in Article 12 of the ICESCR and otherwise does not raise any other human rights issues.