EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Serious Scarcity and Substitutable Medicine (Labetalol) Amendment Instrument 2025
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 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 (“the scarce medicine”) across the whole or a specified part or parts of Australia, and specify the medicine (“the substitutable medicine”) that pharmacists are permitted to dispense in substitution for the scarce medicine and the circumstances in which that substitution is permitted.
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 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) (Labetalol) Instrument 2025 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. It declares that there is a serious scarcity cross Australia of a specified scare medicine, specifies the substitutable medicine that pharmacists are permitted to dispense in substitution for the scarce medicine, and specifies the circumstances in which they may do so.
The Principal Instrument declares one registered medicine, being PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle, Australian Register of Therapeutic Goods (“ARTG”) registration number 56475, to be a scarce medicine.
The Principal Instrument also declares that where a pharmacist is unable to dispense the scarce medicine that has been prescribed to a patient, they may instead dispense the substitutable medicine in accordance with the Instrument. The Principal Instrument specifies PRESOLOL 200 labetalol hydrochloride 200 mg tablet bottle, ARTG registration number 56476, as the substitutable medicine.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Amendment Instrument 2025 (“the Amendment Instrument”) is made in the context of the ongoing shortages of the PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 31 October 2025 to 31 December 2025. Consequentially, the Amendment Instrument also changes the date on which the Principal Instrument is repealed, from 1 November 2025 to 1 January 2026.
Background
Pharmacist Substitution
Medicine shortages continue to occur for a number of reasons, ranging from shortages of raw materials to national disasters, logistical difficulties, or unexpected increases in demand.
When a medicine is unavailable, community pharmacists have limited scope to substitute another medicine without the prior approval of the prescribing doctor. A pharmacist may substitute a different brand of an equivalent product, which may include an equivalent overseas-registered medicine approved for supply under section 19A of the Act. However, where there is no such equivalent available, the pharmacist cannot substitute a different medicine. If the pharmacist is unable to contact the prescriber to authorise a change to the prescription, the patient may be unable to obtain their medicine. This impedes the timely availability of medicines and risks interruption to treatment, which can impact patient health and cause anxiety and stress for patients.
In 2020, an informal arrangement was implemented between the Commonwealth and the States and Territories to allow pharmacist substitution of medicines that are in shortage, with patient consent. However, this informal arrangement was implemented through state and territory legislation, and some State and Territory legislation allowed for such provision to be made for pharmacist substitution only during a public health emergency. A need therefore arose for a more consistent and responsive pharmacist substitution scheme to help alleviate the effects of medicine shortages; one that allows substitution arrangements to be in place consistently across all states and territories more quickly (without the need to rely on state and territory legislation), and which reflects the fact that medicine shortages may occur in a range of circumstances, not only where there is a public health emergency.
The Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021 (“the Amendment Act”) amended the Act to introduce a pharmacist substitution scheme in Division 2C of Part 3-2 of the Act. This scheme was developed to help alleviate the effects of medicine shortages, by allowing substitution arrangements to be put in place quickly and consistently across Australia, and without being limited to circumstances where there is a public health emergency.
Under this scheme, section 30EK of the Act provides for the making of a legislative instrument declaring a serious scarcity of specified medicines and specifying the substitutable medicine and permitted circumstances. This operates in tandem with section 30EL of the Act, which provides that, where an instrument is in force under subsection 30EK(1) 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.
The Principal Instrument
Across Australia, there is a shortage of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottles. This shortage is due to manufacturing issues and it was anticipated that supply would return to normal by 31 October 2025.
Medicines that contain the active ingredient labetalol are used in the treatment of all grades of hypertension. As such, the scarcity of this medicine is having, and is anticipated to have, a significant risk of adverse health consequences for patients in Australia if they are unable to take the scarce medicine. Patients who suddenly stop taking their prescribed labetalol are at risk of adverse events including rebound hypertension, exacerbation of angina, precipitation of heart attack and other cardiovascular complications. Additionally, the scarce medicine is one of the few medicines that can be used for the treatment of hypertension in pregnancy, which is a potentially life-threatening condition as it can lead to eclampsia, placental abruption, pre-term delivery, and increased risk of foetal and maternal mortality. These outcomes not only affect both immediate pregnancy and delivery, but also contribute to long-term cardiovascular risks for the mother.
The Principal Instrument supports the management of the shortage of the scarce medicine. It declares that there is a serious scarcity of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottles and specifies the substitutable medicines as PRESOLOL 200 labetalol hydrochloride 200 mg tablet bottles.
The Principal Instrument enables pharmacists to substitute a specified substitutable medicine for the scarce medicine, without the patient affected by the unavailability of the scarce 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 specifies a number of specific and general permitted circumstances that have the effect of confining the circumstances in which a pharmacist may substitute each of the substitutable medicines for the scarce medicine prescribed to a patient. These circumstances are designed to ensure that there are carefully determined safety-related parameters in place for patients.
In accordance with subsection 30EK(2) of the Act, the rule-maker is satisfied that the supply of the scarce medicines in Australia is not currently meeting 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, medicines that contain labetalol are 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.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specified the period of time for which it remains in force, being until 31 October 2025, unless sooner revoked. This reflects the period that the scarce medicine was initially expected to be the subject of a serious scarcity across Australia.
Purpose
The purpose of the Amendment Instrument is to extend the period of time for which the Principal Instrument remains in force, from 31 October 2025 to 31 December 2025. The shortages of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle, and consequently the limited availability of the scarce medicine is due to manufacturing issues and these delays are expected to persist beyond the date the Principal Instrument was intended to remain in force until, with supply and demand expected to stabilise by late December 2025.
The effect of the Amendment Instrument is to enable pharmacists to continue substituting the specified substitutable medicine for the relevant scarce medicines, in the specific and general circumstances that are specified in Principal Instrument, until 31 December 2025. This ensures that patients who are affected by the continued unavailability of the scarce medicines can still access suitable treatment without delay, reducing the risk of interrupted treatment.
The Amendment Instrument makes a further, consequential amendment to the Principal Instrument — namely, to change the date on which the Principal Instrument is repealed, from 1 November 2025 to 1 January 2026.
Consultation
In developing the Amendment Instrument, the TGA conducted targeted consultation from 10 to 15 October 2025 with the same 17 stakeholders and sponsors that were consulted in relation to the Principal Instrument, to ensure the continued substitution protocol remains appropriate and inform them of its continuation. The TGA received 4 responses, which were all supportive of the proposed amendment.
To develop the Principal Instrument, in August 2025, the TGA consulted the Royal Australian College of General Practitioners, the Cardiac Society of Australia and New Zealand, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Royal Australasian College of Physicians, the Pharmaceutical Society of Australia, the Pharmacy Guild of Australia, the Australian Medical Association and the Advanced Pharmacy Australia, as well as state and territory health departments. Consultation was undertaken to ensure the substitution protocol and associated permitted circumstances are appropriate. The TGA received 7 responses that were all supportive of the proposed Principal Instrument, and feedback was incorporated into the Principal Instrument. The TGA has also consulted with the sponsor of the substitutable medicine to alert them to the potential change in demand.
The TGA has been working closely with stakeholders since the relevant provisions in the Amendment Act commenced in February 2021 and had developed the general permitted circumstances in consultation with these groups. Stakeholders included (but are not limited to) the Australian Medical Association, relevant clinical professional colleges and societies, sponsor peak bodies, wholesalers, state and territory Chief Pharmacists, and pharmacy and pharmacist peak bodies.
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
This Amendment Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 30 October 2025. The Amendment Instrument will be repealed at the start of 1 January 2026, unless it is repealed earlier.
Attachment A
Details of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Amendment Instrument 2025
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Amendment Instrument 2025 (“the Amendment Instrument”).
Section 2 – Commencement
This section provides that the Instrument commences on 30 October 2025.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Instrument is section 30EK 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. This Amendment Instrument is made in accordance with that provision.
Section 4 – Schedules
This section provides that each instrument 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 that any other item in a Schedule to the Amendment Insturment has effect according to its terms.
Schedule 1 – Amendments
Schedule 1 amends Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) 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 31 December 2025.
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 1 January 2026.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 2 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Amendment Instrument 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 legislative instrument
Subsection 30EK(1) of the Act provides that the Minister may, by legislative instrument, declare that there is a serious scarcity of specified medicine (“the scarce medicine”) across the whole or a specified part or parts of Australia, and specify the medicine (“the substitutable medicine”) that pharmacists are permitted to dispense in substitution for the scarce medicine and the circumstances in which that substitution is permitted.
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 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) (Labetalol) Instrument 2025 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. It declares that there is a serious scarcity cross Australia of a specified scare medicine, specifies the substitutable medicine that pharmacists are permitted to dispense in substitution for the scarce medicine, and specifies the circumstances in which they may do so.
The Principal Instrument declares one registered medicine, being PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle, Australian Register of Therapeutic Goods (“ARTG”) registration number 56475, to be a scarce medicine.
The Principal Instrument also declares that where a pharmacist is unable to dispense the scarce medicine that has been prescribed to a patient, they may instead dispense the substitutable medicine in accordance with the Instrument. The Principal Instrument specifies PRESOLOL 200 labetalol hydrochloride 200 mg tablet bottle, ARTG registration number 56476, as the substitutable medicine.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Amendment Instrument 2025 (“the Amendment Instrument”) is made in the context of the ongoing shortages of the PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 31 October 2025 to 31 December 2025. Consequentially, the Amendment Instrument also changes the date on which the Principal Instrument is repealed, from 1 November 2025 to 1 January 2026.
Background
Pharmacist Substitution
Medicine shortages continue to occur for a number of reasons, ranging from shortages of raw materials to national disasters, logistical difficulties, or unexpected increases in demand.
When a medicine is unavailable, community pharmacists have limited scope to substitute another medicine without the prior approval of the prescribing doctor. A pharmacist may substitute a different brand of an equivalent product, which may include an equivalent overseas-registered medicine approved for supply under section 19A of the Act. However, where there is no such equivalent available, the pharmacist cannot substitute a different medicine. If the pharmacist is unable to contact the prescriber to authorise a change to the prescription, the patient may be unable to obtain their medicine. This impedes the timely availability of medicines and risks interruption to treatment, which can impact patient health and cause anxiety and stress for patients.
In 2020, an informal arrangement was implemented between the Commonwealth and the States and Territories to allow pharmacist substitution of medicines that are in shortage, with patient consent. However, this informal arrangement was implemented through state and territory legislation, and some State and Territory legislation allowed for such provision to be made for pharmacist substitution only during a public health emergency. A need therefore arose for a more consistent and responsive pharmacist substitution scheme to help alleviate the effects of medicine shortages; one that allows substitution arrangements to be in place consistently across all states and territories more quickly (without the need to rely on state and territory legislation), and which reflects the fact that medicine shortages may occur in a range of circumstances, not only where there is a public health emergency.
The Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021 (“the Amendment Act”) amended the Act to introduce a pharmacist substitution scheme in Division 2C of Part 3-2 of the Act. This scheme was developed to help alleviate the effects of medicine shortages, by allowing substitution arrangements to be put in place quickly and consistently across Australia, and without being limited to circumstances where there is a public health emergency.
Under this scheme, section 30EK of the Act provides for the making of a legislative instrument declaring a serious scarcity of specified medicines and specifying the substitutable medicine and permitted circumstances. This operates in tandem with section 30EL of the Act, which provides that, where an instrument is in force under subsection 30EK(1) 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.
The Principal Instrument
Across Australia, there is a shortage of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottles. This shortage is due to manufacturing issues, and it was anticipated that supply would return to normal by 31 October 2025.
Medicines that contain the active ingredient labetalol are used in the treatment of all grades of hypertension. As such, the scarcity of this medicine is having, and is anticipated to have, a significant risk of adverse health consequences for patients in Australia if they are unable to take the scarce medicine. Patients who suddenly stop taking their prescribed labetalol are at risk of adverse events including rebound hypertension, exacerbation of angina, precipitation of heart attack and other cardiovascular complications. Additionally, the scarce medicine is one of the few medicines that can be used for the treatment of hypertension in pregnancy, which is a potentially life-threatening condition as it can lead to eclampsia, placental abruption, pre-term delivery, and increased risk of foetal and maternal mortality. These outcomes not only affect both immediate pregnancy and delivery but also contribute to long-term cardiovascular risks for the mother.
The Principal Instrument supports the management of the shortage of the scarce medicine. It declares that there is a serious scarcity of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottles and specifies the substitutable medicines as PRESOLOL 200 labetalol hydrochloride 200 mg tablet bottles.
The Principal Instrument enables pharmacists to substitute a specified substitutable medicine for the scarce medicine, without the patient affected by the unavailability of the scarce 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 specifies a number of specific and general permitted circumstances that have the effect of confining the circumstances in which a pharmacist may substitute each of the substitutable medicines for the scarce medicine prescribed to a patient. These circumstances are designed to ensure that there are carefully determined safety-related parameters in place for patients.
In accordance with subsection 30EK(2) of the Act, the rule-maker is satisfied that the supply of the scarce medicines in Australia is not currently meeting 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, medicines that contain labetalol are 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.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specified the period of time for which it remains in force, being until 31 October 2025, unless sooner revoked. This reflects the period that the scarce medicine was initially expected to be the subject of a serious scarcity across Australia.
Purpose
The purpose of the Amendment Instrument is to extend the period of time for which the Principal Instrument remains in force, from 31 October 2025 to 31 December 2025. The shortages of PRESOLOL 100 labetalol hydrochloride 100 mg tablet bottle, and consequently the limited availability of the scarce medicine is due to manufacturing issues, and these delays are expected to persist beyond the date the Principal Instrument was intended to remain in force until, with supply and demand expected to stabilise by late December 2025.
The effect of the Amendment Instrument is to enable pharmacists to continue substituting the specified substitutable medicine for the relevant scarce medicines, in the specific and general circumstances that are specified in Principal Instrument, until 31 December 2025. This ensures that patients who are affected by the continued unavailability of the scarce medicines can still access suitable treatment without delay, reducing the risk of interrupted treatment.
The Amendment Instrument makes a further, consequential amendment to the Principal Instrument — namely, to change the date on which the Principal Instrument is repealed, from 1 November 2025 to 1 January 2026.
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 be able to substitute these important medicines, the Amendment Instrument will support the right to heath through helping Australian patients avoid the suffering that may otherwise occur due to an interruption in treatment for their condition.
Conclusion
This legislative 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.