Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) 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 (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 (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 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) (Estradiol) Instrument 2024 (the Principal Instrument) is a legislative instrument made under subsection 30EK(1) of the Act in relation to certain medicines containing estradiol, that are in the form of transdermal patches. It declares that there is a serious scarcity across Australia of the specified scarce medicines, specifies substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicine, and the circumstances in which they may do so.

The Principal Instrument declares eight registered medicines to be scarce medicines, being:

• ESTRADERM MX 25 estradiol 25 microgram/24 hours transdermal drug delivery system sachet, Australian Register of Therapeutic Goods (ARTG) registration number 67089, and ESTRADOT 25 estradiol 25 microgram transdermal drug delivery system sachet, ARTG registration number 3380586;
• ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet, ARTG registration number 56658, and ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet, ARTG registration number 338058;
• ESTRADERM MX 75 estradiol 75 microgram/24hr transdermal drug delivery system sachet, ARTG registration number 76117, and ESTRADOT 75 estradiol 75 microgram transdermal drug delivery system, ARTG registration number 338059; and
• ESTRADERM MX 100 estradiol 100 microgram/24 hours transdermal drug delivery system sachet, ARTG registration number 67090, and ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system, ARTG registration number 338060.

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 Principal Instrument. To this end, the substitutable medicines that are specified in the Principal Instrument are medicines that are registered on the ARTG or subject to an approval under section 19A of the Act, that contain estradiol as the only active ingredient, are manufactured in the dosage form of a patch, and that release, individually or when combined, the same dose of estradiol as the scarce medicine.

The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026 (the Amendment Instrument) is made in the context of the continuing shortages of estradiol transdermal patches. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 31 January 2026 to 28 February 2027. Consequently, the Amendment Instrument also changes the date on which the Principal Instrument is repealed (unless repealed earlier), from the start of 1 February 2026 to the start of 1 March 2027.

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 dosage form and strength 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 timely availability of medicines and risks interruption to treatment, which can impact patient health and cause anxiety and stress for patients.

During 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 allows 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 (but does not 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. Such an instrument 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

The TGA has been managing intermittent shortages of estradiol transdermal patches since 2019. Following the discontinuation of Climara brand Hormone Replacement Therapy transdermal patches in late 2023, shortages of remaining estradiol transdermal patch products have become more frequent. There are ongoing shortages across Australia of all marketed ARTG registered estradiol transdermal patch brands.

The scarce medicines administer estradiol through the transdermal drug delivery system. They are approved in Australia to treat menopausal symptoms. The scarcity of this medicine is having, and is anticipated to have, a significant impact on the health and wellbeing of many patients in Australia. As such, there is a significant risk of adverse health consequences for patients in Australia if they are unable to take the scarce medicine.

The specified substitutable medicines are either medicines that are included in the ARTG as a registered good or medicines that are subject to an approval under section 19A of the Act, and that contain estradiol as the only active ingredient, are manufactured in the dosage form of a transdermal drug delivery system (i.e. patch), and release the same amount of estradiol per day as the scarce medicine individually or when combined. The scarce medicine and the substitutable medicine contain the same active ingredient and use the transdermal drug delivery system for administration.

The Principal Instrument enables pharmacists to substitute the specified substitutable medicine for the relevant 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 the substitutable medicine 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 medicine in Australia is not currently meeting, or that there is 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, medicines that contain estradiol 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 that it was initially intended to remain in force, being until 31 January 2026, unless revoked sooner. This reflected the period that the scarce medicines were expected to be the subject of a serious scarcity across Australia. If the shortage of the scarce medicines resolved sooner or if safety concerns were identified, the Principal Instrument may have been revoked before its cessation date.

Purpose

The purpose of the Amendment Instrument is to extend the period of time for which the Principal Instrument remains in force, from 31 January 2026 to 28 February 2027 (unless repealed earlier). This extension is intended to support the management of the continuing shortage of estradiol transdermal patches, which is expected to persist beyond the date the Principal Instrument was intended to remain in force until. It is anticipated that availability of estradiol transdermal patches will only stabilise in early 2027.

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 28 February 2027. This supports patients who are affected by the continued unavailability of the scarce medicines to 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 February 2026 to 1 March 2027.

Consultation

In developing the Amendment Instrument, the TGA has consulted with 21 stakeholders in December 2025 and January 2026, including:

• the Royal Australian and New Zealand College of Obstetricians and Gynaecologists,
• the Royal Australian College of General Practitioners;
• the Royal Australasian College of Physicians;
• the Endocrine Society of Australia;
• the Australian Medical Association;
• the Australian Menopause Society;
• state and territory Chief Pharmacists or health departments;
• the Pharmaceutical Society of Australia;
• the Pharmacy Guild of Australia and
• Advanced Pharmacy Australia.

No issues or concerns were raised by stakeholders in relation to the proposed amendments.

To develop the Principal Instrument, the TGA consulted with the same 21 stakeholders in October and November 2024, including those listed above. The TGA received 6 responses that were all supportive of the proposed Principal Instrument, and feedback was incorporated into the Principal Instrument. The TGA also consulted with the sponsor of the substitutable medicines to alert them of the 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.

The Amendment Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 31 January 2026. The Principal Instrument will be repealed at the start of 1 March 2027, unless it is repealed earlier.

Attachment A

Details of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026 (the Amendment Instrument).

Section 2 – Commencement

This section provides that the Amendment Instrument commences on 31 January 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. This 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) (Estradiol) Instrument 2024 (the Principal Instrument).

Item 1 repeals and replaces section 7 of the Principal Instrument to specify that the Principal Instrument remains in force until 28 February 2027.

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 March 2027.

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) (Estradiol) 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 (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 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) (Estradiol) Instrument 2024 (the Principal Instrument) is a legislative instrument made under subsection 30EK(1) of the Act in relation to certain medicines containing estradiol, that are in the form of transdermal patches. It declares that there is a serious scarcity across Australia of the specified scarce medicines, specifies substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicine, and the circumstances in which they may do so.

The Principal Instrument declares eight registered medicines to be scarce medicines, being:

• ESTRADERM MX 25 estradiol 25 microgram/24 hours transdermal drug delivery system sachet, Australian Register of Therapeutic Goods (ARTG) registration number 67089, and ESTRADOT 25 estradiol 25 microgram transdermal drug delivery system sachet, ARTG registration number 3380586;
• ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet, ARTG registration number 56658, and ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet, ARTG registration number 338058;
• ESTRADERM MX 75 estradiol 75 microgram/24hr transdermal drug delivery system sachet, ARTG registration number 76117, and ESTRADOT 75 estradiol 75 microgram transdermal drug delivery system, ARTG registration number 338059; and
• ESTRADERM MX 100 estradiol 100 microgram/24 hours transdermal drug delivery system sachet, ARTG registration number 67090, and ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system, ARTG registration number 338060.

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 Principal Instrument. To this end, the substitutable medicines that are specified in the Principal Instrument are medicines that are registered on the ARTG or subject to an approval under section 19A of the Act, that contain estradiol as the only active ingredient, are manufactured in the dosage form of a patch, and that release, individually or when combined, the same dose of estradiol as the scarce medicine.

The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026 (the Amendment Instrument) is made in the context of the continuing shortages of estradiol transdermal patches. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force, from 31 January 2026 to 28 February 2027. Consequently, the Amendment Instrument also changes the date on which the Principal Instrument is repealed (unless repealed earlier), from the start of 1 February 2026 to the start of 1 March 2027.

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 dosage form and strength 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 timely availability of medicines and risks interruption to treatment, which can impact patient health and cause anxiety and stress for patients.

During 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 allows 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 (but does not 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. Such an instrument 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

The TGA has been managing intermittent shortages of estradiol transdermal patches since 2019. Following the discontinuation of Climara brand Hormone Replacement Therapy transdermal patches in late 2023, shortages of remaining estradiol transdermal patch products have become more frequent. There are ongoing shortages across Australia of all marketed ARTG registered estradiol transdermal patch brands.

The scarce medicines administer estradiol through the transdermal drug delivery system. They are approved in Australia to treat menopausal symptoms. The scarcity of this medicine is having, and is anticipated to have, a significant impact on the health and wellbeing of many patients in Australia. As such, there is a significant risk of adverse health consequences for patients in Australia if they are unable to take the scarce medicine.

The specified substitutable medicines are either medicines that are included in the ARTG as a registered good or medicines that are subject to an approval under section 19A of the Act, and that contain estradiol as the only active ingredient, are manufactured in the dosage form of a transdermal drug delivery system (i.e. patch), and release the same amount of estradiol per day as the scarce medicine individually or when combined. The scarce medicine and the substitutable medicine contain the same active ingredient and use the transdermal drug delivery system for administration.

The Principal Instrument enables pharmacists to substitute the specified substitutable medicine for the relevant 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 the substitutable medicine 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 medicine in Australia is not currently meeting, or that there is 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, medicines that contain estradiol 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 that it was initially intended to remain in force, being until 31 January 2026, unless revoked sooner. This reflected the period that the scarce medicines were expected to be the subject of a serious scarcity across Australia. If the shortage of the scarce medicines resolved sooner or if safety concerns were identified, the Principal Instrument may have been revoked before its cessation date.

Purpose

The purpose of the Amendment Instrument is to extend the period of time for which the Principal Instrument remains in force, from 31 January 2026 to 28 February 2027 (unless repealed earlier). This extension is intended to support the management of the continuing shortage of estradiol transdermal patches, which is expected to persist beyond the date the Principal Instrument was intended to remain in force until. It is anticipated that availability of estradiol transdermal patches will only stabilise in early 2027.

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 28 February 2027. This supports patients who are affected by the continued unavailability of the scarce medicines to 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 February 2026 to 1 March 2027.

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 substitute these important medicines, the Amendment Instrument will support the right to health 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.