EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 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 also provides for a scheme allowing pharmacists to substitute certain medicine for other medicine if the Minister has declared there is a serious scarcity of the other medicine. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health, Disability and Ageing (“the Department”).
Subsection 30EK(1) of the Act provides that the Minister may, by legislative instrument, declare that there is a serious scarcity of specified medicine (i.e. the scarce medicine) across the whole or a specified part or parts of Australia, and specify the medicine (i.e. the substitutable medicine) that pharmacists are permitted to dispense in substitution for the scarce medicine and the circumstances in which that substitution is permitted. Where such an instrument is in force, and a pharmacist is authorised to dispense the scarce medicine under a law of a State or Territory, a pharmacist may dispense the substitutable medicine to that person in the circumstances specified in the instrument, despite any law of a State or Territory prohibiting substitution (section 30EL of the Act refers).
Subsection 30EK(2) of the Act provides that the Minister may only make an instrument under subsection 30EK(1) if satisfied that the supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine. Alternatively, the Minister must be satisfied that there is an imminent risk that supply of the scarce medicine in Australia will not, or will not be likely to, meet the demand for that medicine for all of the patients in Australia who take, or who may need to take, that medicine. In either case, there must be a significant risk of adverse health consequences for patients in Australia if they are not able to take the scarce medicine.
Subsection 30EK(3) of the Act provides that both the scarce medicine and the substitutable medicine must contain one or more substances included in Schedule 4 to the current Poisons Standard (i.e. prescription medicines) and must not contain any substances included in Schedule 8 to the current Poisons Standard (i.e. substances for which particular levels of control are required or recommended in order to avoid abuse, misuse or dependence).
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. The Principal Instrument:
- declares that there is a serious scarcity across Australia of a specified scarce medicine—being CATAPRES 150 Clonidine hydrochloride 150 microgram tablet blister pack, Australian Register of Therapeutic Goods (“ARTG”) registration number 78376;
- specifies substitutable medicine—being any of the following:
- CATAPRES 100 clonidine hydrochloride 100 microgram tablet blister pack, ARTG registration number 17921;
- APO-CLONIDINE clonidine hydrochloride 100 micrograms tablet bottle, ARTG registration number 265776;
- CLONIDINE Lupin clonidine hydrochloride 100 micrograms tablet bottle, ARTG registration number 265778; and
- specifies the circumstances in which a pharmacist may dispense the specified substitutable medicine instead of the specified sparce medicine.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 2026 (“the Amendment Instrument”) is also made under subsection 30EK(1) of the Act. The Amendment Instrument is made in the context of the ongoing shortage of CATAPRES 150 clonidine hydrochloride 150 microgram tablet blister pack, ARTG registration number 78376. Its primary purpose is to extend the period that the Principal Instrument remains in force, from 28 April 2026 to 28 June 2026.
Background
Across Australia, there is a shortage of the medicine CATAPRES 150 clonidine hydrochloride 150 microgram tablet blister pack (ARTG 78376), which is the only clonidine 150 microgram tablet available in Australia. The shortage is due to manufacturing issues and is expected to continue until the end of June 2026, when supply is anticipated to return to normal.
Medicines containing 150 micrograms of clonidine are indicated for use in patients with all grades of essential hypertension and renal hypertension. Medicines containing 100 micrograms of clonidine have additional indications for menopausal flushing and migraine prophylaxis. Only the medicine containing 150 micrograms of clonidine is in shortage.
The current shortage of the scarce medicine is having, and is anticipated to continue to have, a significant impact on the patients who take clonidine 150 micrograms. If patients cannot access their usual dose, they may use inappropriate alternatives or stop treatment entirely. Abrupt discontinuation of, or sudden interruption to, treatment can cause rebound hypertension or severe withdrawal symptoms, such as rapid rise in blood pressure, headache, flushing, sweating, insomnia, agitation and tremors. This could potentially lead to increased hospital admissions and increased burden on the health system.
The Principal Instrument declares that there is a serious scarcity of the scarce medicine, and specifies the substitutable medicine that pharmacists are permitted to dispense in substitution for the scarce medicine. Its effect is to enable pharmacists to substitute the specified substitutable medicine for the scarce medicine, in limited circumstances, without the patient affected by the unavailability of the medicine needing to return to their prescriber for a new prescription. This means that patients who are prescribed the scarce medicine can access suitable treatment without delay, reducing the risk of interrupted treatment.
The Principal Instrument also specifies a number of circumstances that must exist for a pharmacist to dispense the specified substitutable medicine for the specified scarce medicine. These circumstances have the effect of confining when a pharmacist may dispense the substitutable medicine, instead of the scarce medicine, to a patient. The circumstances are designed to ensure that there are carefully determined safety-parameters in place for patients. For example, the specific permitted circumstances require that, among other things, the pharmacist has advised the patient (or person acting on their behalf) of the dose unit equivalence between the scarce and substitutable medicine.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specifies the period of time that the Principal Instrument remains in force, being until 28 April 2026, unless sooner revoked. This reflects the Department’s initial expectation that the serious scarcity of the scarce medicine would continue until late April 2026.
Purpose
The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 28 April 2026 to 28 June 2026. This reflects that the serious scarcity of the scarce medicine is now expected to persist beyond the date on which the Principal Instrument was to lapse, with the Department now anticipating that supply and demand will stabilise by the middle of 2026.
The effect of the Amendment Instrument is to enable pharmacists to continue substituting the specified substitutable medicine for the scarce medicine, in the specific and general permitted circumstances that are specified in the Principal Instrument, until 28 June 2026. This ensures that patients who are affected by the ongoing scarcity of the scarce medicine can still access treatment without delay, reducing the risk of uninterrupted treatment.
The Amendment Instrument also makes a further, consequential amendment to the Principal Instrument – namely, to change the date on which the Principal Instrument self-repeals, from 29 April 2026 to 29 June 2026 (unless sooner revoked).
In accordance with subsection 30EK(2) of the Act, the rule-maker is satisfied that the supply of the scarce medicine in Australia is still not currently meeting, or that there continues to be an imminent risk that supply of the scarce medicine in Australia will not likely meet, the demand for that medicine for all of the patients in Australia who take that medicine. The rule-maker is also satisfied that there is a significant risk of adverse health consequences for patients in Australia if those patients are unable to take the scarce medicine. There are no other matters prescribed by the regulations for the purposes of paragraph 30EK(2)(c).
In accordance with subsection 30EK(3) of the Act, clonidine is included in Schedule 4 to the current Poisons Standard, and the scarce medicine does not contain a substance in Schedule 8 to the current Poisons Standard.
Consultation
In developing the Amendment Instrument, the TGA conducted targeted consultation between 14 April 2026 and 16 April 2026. The TGA consulted with the same stakeholders that were consulted prior to the making of the Principal Instrument – namely, the Royal Australian College of General Practitioners (RACGP), Australian Medical Association (AMA), Royal Australasian College of Physicians (RACP), Royal Australian and New Zealand College of Psychiatrists (RANZCP) , Cardiac Society of Australia and New Zealand (CSANZ), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Australian and New Zealand Society of Nephrology (ANZSN), Australian and New Zealand Association of Neurologists (ANZAN), Renal Society of Australasia, Kidney Health Australia, Heart foundation, Migraine Australia, Advanced Pharmacy Australia (AdPha), Pharmacy Guild, Pharmaceutical Society of Australia and state and territory health departments. The TGA received 3 responses in total, all of which were supportive of the proposal to extend the period that the Principal Instrument remains in force.
The TGA has also consulted further with the sponsor of the specified scarce medicine in relation to the expected duration of the serious scarcity.
Other details
Details of the Amendment Instrument are set out in Attachment A.
The Amendment Instrument is 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 Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 27 April 2026.
Attachment A
Details of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 2026
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 2026 (“the Amendment Instrument”).
Section 2 – Commencement
This section provides that the Amendment Instrument commences on 27 April 2026.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Instrument is section 30EK of the Therapeutic Goods Act 1989.
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 Instrument 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 Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Amendment Instrument has effect according to its terms.
Schedule 1 – Amendments
This Schedule amends the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025 (“the Principal Instrument”).
Item 1 repeals and replaces section 7 of the Principal Instrument to provide that the Principal Instrument remains in force until 28 June 2026.
Item 2 repeals and replaces section 8 of the Principal Instrument to provide that, unless repealed earlier, the Principal Instrument is repealed at the start of 29 June 2026.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 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 legislative instrument
Subsection 30EK(1) of the Therapeutic Goods Act 1989 (“the Act”) provides that the Minister may, by legislative instrument, declare that there is a serious scarcity of specified medicine (i.e. the scarce medicine) across the whole or a specified part or parts of Australia, and specify the medicine (i.e. the substitutable medicine) that pharmacists are permitted to dispense in substitution for the scarce medicine and the circumstances in which that substitution is permitted. Where such an instrument is in force, and a pharmacist is authorised to dispense the scarce medicine under a law of a State or Territory, a pharmacist may dispense the substitutable medicine to that person in the circumstances specified in the instrument, despite any law of a State or Territory prohibiting substitution (section 30EL of the Act refers).
Subsection 30EK(2) of the Act provides that the Minister may only make an instrument under subsection 30EK(1) if satisfied that the supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine. Alternatively, the Minister must be satisfied that there is an imminent risk that supply of the scarce medicine in Australia will not, or will not be likely to, meet the demand for that medicine for all of the patients in Australia who take, or who may need to take, that medicine. In either case, there must be a significant risk of adverse health consequences for patients in Australia if they are not able to take the scarce medicine.
Subsection 30EK(3) of the Act provides that both the scarce medicine and the substitutable medicine must contain one or more substances included in Schedule 4 to the current Poisons Standard (i.e. prescription medicines) and must not contain any substances included in Schedule 8 to the current Poisons Standard (i.e. substances for which particular levels of control are required or recommended in order to avoid abuse, misuse or dependence).
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. The Principal Instrument:
- declares that there is a serious scarcity across Australia of a specified scarce medicine—being CATAPRES 150 Clonidine hydrochloride 150 microgram tablet blister pack, Australian Register of Therapeutic Goods (“ARTG”) registration number 78376;
- specifies substitutable medicine—being any of the following:
- CATAPRES 100 clonidine hydrochloride 100 microgram tablet blister pack, ARTG registration number 17921;
- APO-CLONIDINE clonidine hydrochloride 100 micrograms tablet bottle, ARTG registration number 265776;
- CLONIDINE Lupin clonidine hydrochloride 100 micrograms tablet bottle, ARTG registration number 265778; and
- specifies the circumstances in which a pharmacist may dispense the specified substitutable medicine instead of the specified sparce medicine.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Amendment Instrument 2026 (“the Amendment Instrument”) is also made under subsection 30EK(1) of the Act. The Amendment Instrument is made in the context of the ongoing shortage of CATAPRES 150 clonidine hydrochloride 150 microgram tablet blister pack, ARTG registration number 78376. Its primary purpose is to extend the period that the Principal Instrument remains in force, from 28 April 2026 to 28 June 2026.
Background
Across Australia, there is a shortage of the medicine CATAPRES 150 clonidine hydrochloride 150 microgram tablet blister pack (ARTG 78376), which is the only clonidine 150 microgram tablet available in Australia. The shortage is due to manufacturing issues and is expected to continue until the end of June 2026, when supply is anticipated to return to normal.
Medicines containing 150 micrograms of clonidine are indicated for use in patients with all grades of essential hypertension and renal hypertension. Medicines containing 100 micrograms of clonidine have additional indications for menopausal flushing and migraine prophylaxis. Only the medicine containing 150 micrograms of clonidine is in shortage.
The current shortage of the scarce medicine is having, and is anticipated to continue to have, a significant impact on the patients who take clonidine 150 micrograms. If patients cannot access their usual dose, they may use inappropriate alternatives or stop treatment entirely. Abrupt discontinuation of, or sudden interruption to, treatment can cause rebound hypertension or severe withdrawal symptoms, such as rapid rise in blood pressure, headache, flushing, sweating, insomnia, agitation and tremors. This could potentially lead to increased hospital admissions and increased burden on the health system.
The Principal Instrument declares that there is a serious scarcity of the scarce medicine, and specifies the substitutable medicine that pharmacists are permitted to dispense in substitution for the scarce medicine. Its effect is to enable pharmacists to substitute the specified substitutable medicine for the scarce medicine, in limited circumstances, without the patient affected by the unavailability of the medicine needing to return to their prescriber for a new prescription. This means that patients who are prescribed the scarce medicine can access suitable treatment without delay, reducing the risk of interrupted treatment.
The Principal Instrument also specifies a number of circumstances that must exist for a pharmacist to dispense the specified substitutable medicine for the specified scarce medicine. These circumstances have the effect of confining when a pharmacist may dispense the substitutable medicine, instead of the scarce medicine, to a patient. The circumstances are designed to ensure that there are carefully determined safety-parameters in place for patients. For example, the specific permitted circumstances require that, among other things, the pharmacist has advised the patient (or person acting on their behalf) of the dose unit equivalence between the scarce and substitutable medicine.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specifies the period of time that the Principal Instrument remains in force, being until 28 April 2026, unless sooner revoked. This reflects the Department’s initial expectation that the serious scarcity of the scarce medicine would continue until late April 2026.
Purpose
The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 28 April 2026 to 28 June 2026. This reflects that the serious scarcity of the scarce medicine is now expected to persist beyond the date on which the Principal Instrument was to lapse, with the Department now anticipating that supply and demand will stabilise by the middle of 2026.
The effect of the Amendment Instrument is to enable pharmacists to continue substituting the specified substitutable medicine for the scarce medicine, in the specific and general permitted circumstances that are specified in the Principal Instrument, until 28 June 2026. This ensures that patients who are affected by the ongoing scarcity of the scarce medicine can still access treatment without delay, reducing the risk of uninterrupted treatment.
The Amendment Instrument also makes a further, consequential amendment to the Principal Instrument – namely, to change the date on which the Principal Instrument self-repeals, from 29 April 2026 to 29 June 2026 (unless sooner revoked).
In accordance with subsection 30EK(2) of the Act, the rule-maker is satisfied that the supply of the scarce medicine in Australia is still not currently meeting, or that there continues to be an imminent risk that supply of the scarce medicine in Australia will not likely meet, the demand for that medicine for all of the patients in Australia who take that medicine. The rule-maker is also satisfied that there is a significant risk of adverse health consequences for patients in Australia if those patients are unable to take the scarce medicine. There are no other matters prescribed by the regulations for the purposes of paragraph 30EK(2)(c).
In accordance with subsection 30EK(3) of the Act, clonidine is included in Schedule 4 to the current Poisons Standard, and the scarce medicine does not contain a substance in Schedule 8 to the current Poisons Standard.
Human rights implications
The Amendment Instrument 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 Instrument takes positive steps to promote the right to health by facilitating improved access to the substitutable medicine, and to ameliorate the effects of the limited availability or unavailability of the scarce medicine across the Australian market. By enabling pharmacists to continue to substitute these important medicines, the Amendment Instrument supports the right to health by protecting Australian patients from the suffering that may otherwise occur due to an interruption in treatment for their condition.
Conclusion
The Amendment Instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and otherwise does not raise any other human rights issues.