Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Isophane Human) Instrument 2024

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

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 and Aged Care (“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 or, alternatively, 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) (Insulin Isophane Human) Instrument 2024 (“the Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act in relation to medicines containing insulin isophane human that are in the form of a solution for injection. It declares that there is a serious scarcity across Australia of a specified scarce 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 Instrument declares one registered medicine, being PROTAPHANE INNOLET human insulin (rys) 100 IU/mL injection multidose cartridge, Australian Register of Therapeutic Goods (“ARTG”) registration number 169633 (“PROTAPHANE INNOLET”), to be a scarce medicine.

The 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. To this end, the Instrument specifies PROTAPHANE PENFILL human insulin (rys) 100 IU/mL injection multidose cartridge, ARTG registration number 169635 (“PROTAPHANE PENFILL”) as the substitutable medicine.

Background

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.

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 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.

Purpose

The TGA has been advised that supply of the scarce medicine, PROTAPHANE INNOLET, is to be discontinued, with a market deletion date of 1 February 2025. Consequently, there will be a reduction in supply of the scarce medicine until supply is exhausted.

The scarce medicine is approved in Australia for the treatment of diabetes, and 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. There is a significant risk of adverse health consequences for patients in Australia if they are unable to access the scarce medicine.

The specified substitutable medicine is PROTAPHANE PENFILL. The scarce medicine and substitutable medicine contain the same active ingredient.

The making of the Instrument enables pharmacists to substitute the 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. This substitution is proposed to minimise the burden on health professionals and assist with timely access to medicine supply for patients.

The 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.

Certain specific permitted circumstances are specified for the substitutable medicine. These include that the pharmacist must have:

ensured that the patient, or person acting on behalf of the patient, has, or is given, a suitable insulin delivery system to administer the substitutable medicine; and
advised the patient, or person acting on behalf of the patient:

- of suitable instructions for safely and effectively administering the substitutable medicine, including using the insulin delivery system; or

- where the pharmacist is unable to provide suitable instructions—to obtain suitable instructions for administering the substitutable medicine, including using the insulin delivery system, from their prescriber, a suitably qualified health practitioner or a credentialed diabetes educator; and

advised the patient, or person acting on behalf of the patient of the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the Instrument; and
advised the patient, or person acting on behalf of the patient, of the differences between the scarce and substitutable medicine.

The general permitted circumstances specified for the substitutable medicine include, for example, that the patient (or person acting on behalf of the patient) has evidence of a valid prescription for the scarce medicine unless otherwise permitted by law, and that the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted.

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, insulin 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.

In accordance with subsection 30EK(5) of the Act, the Instrument specifies the period that the Instrument remains in force, being until 28 February 2026, unless sooner revoked. This cessation date allows patients over 12 months from the market deletion date of the scarce medicine to consult their health practitioner about appropriate alternative treatments.

Unless repealed earlier, this Instrument will be automatically repealed at the start of 1 March 2026.

Consultation

An impact analysis was not required in relation to the development of the Instrument, as the making of legislative instruments under section 30EK of the Act is the subject of a standing exemption from the requirement to prepare an impact analysis (OBPR23-04289).

The TGA has been working closely with stakeholders since the relevant provisions in the Amendment Act commenced in February 2021 and has developed the general permitted circumstances in consultation with these groups. Stakeholders include (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.

In preparing the Instrument, the TGA consulted with Australasian Diabetes in Pregnancy Society, Australia and New Zealand Society for Paediatric Endocrinology and Diabetes, the Royal Australian College of General Practitioners, the Royal Australasian College of Physicians, Australian College of Rural and Remote Medicine, the Endocrine Society of Australia, the Australia Diabetes Society, the Australian Diabetes Educators Association, Diabetes Australia, National Aboriginal Community Controlled Health Organisation, the Australian Medical Association, the Pharmaceutical Society of Australia, the Pharmacy Guild of Australia, Advanced Pharmacy Australia, and State and Territory Chief Pharmacists or health departments.

The TGA received ten responses that were supportive of the Instrument. Stakeholder feedback was considered in the preparation of the Instrument. The TGA also consulted with the sponsors of the substitutable medicine to ensure sufficient supplies are available.

Details of the Instrument are set out in Attachment A.

The 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 Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 16 December 2024. The Instrument will be repealed at the start of 1 March 2026, unless it is repealed earlier.

Attachment A

Details of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Isophane Human) Instrument 2024

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Isophane Human) Instrument 2024 (“the Instrument”).

Section 2 – Commencement

This section provides that the Instrument commences on 16 December 2024.

Section 3 – Authority

This section provides that the legislative authority for making the Instrument is section 30EK of the Therapeutic Goods Act 1989 (“the Act”).

Section 4 – Definitions

This section provides the definition of terms used in the Instrument. This section also notes that some expressions used in the Instrument, including ‘medicine’, ‘nurse practitioner’, ‘pharmacist’ and ‘registration number’, have the same meaning as in the Act.

Section 5 – Declaration of serious scarcity of medicine

This section provides a declaration that a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 exists across the whole of Australia.

Section 6 – Substitution of scarce medicine by pharmacists

This section provides that, for each item in the table in Schedule 1, a medicine specified in column 3 is a substitutable medicine that may be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in column 5 of that item (the specific permitted circumstances) and in the table in Schedule 2 (the general permitted circumstances).

Section 7 – Period instrument in force

This section provides that the Instrument remains in force until 28 February 2026.

Section 8 – Repeals

This section provides that, unless repealed earlier, the Instrument is repealed at the start of 1 March 2026.

Schedule 1─Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

This Schedule specifies the scarce medicine, substitutable medicine and specific permitted circumstances for the purpose of sections 5 and 6.

Columns 2 and 3 of item 1 in the table in Schedule 1 specify:

the scarce medicine as being PROTAPHANE INNOLET human insulin (rys) 100IU/mL injection multidose cartridge, Australian Register of Therapeutic Goods (“ARTG”) registration number 169633; and
the substitutable medicine as being PROTAPHANE PENFILL human insulin (rys) 100IU/mL injection multidose cartridge, ARTG registration number 169635.

Column 4 of item 1 in the table in Schedule 1 specifies the equivalent dose of the scarce medicine and the substitutable medicine for the purposes of the permitted circumstances in column 5. It specifies that one 3 mL cartridge of the substitutable medicine (containing 300 IU) is equivalent to one 3 mL pre-filled cartridge of the scarce medicine (containing 300 IU).

Column 5 of item 1 in the table in Schedule 1 sets out the specific permitted circumstances that apply in relation to the item.

The specific permitted circumstances are that the pharmacist has:

ensured that the patient, or person acting on behalf of the patient, has, or is given, a suitable insulin delivery system to administer the substitutable medicine. As the substitutable medicine is a cartridge of insulin that must be loaded into a re-usable device before administration, this ensures that the patient has the appropriate insulin delivery system needed to administer the substitutable medicine; and
advised the patient, or person acting on behalf of the patient, of suitable instructions for safely and effectively administering the substitutable medicine, including using the insulin delivery system. This requires the pharmacist to explain that the patient, or person acting on behalf of the patient, is required to load a cartridge into a re-usable insulin delivery system prior to administration. Where the pharmacist is unable to provide suitable instructions, the pharmacist must advise the patient, or person acting on behalf of the patient, to obtain suitable instructions for administering the substitutable medicine, including using the insulin delivery system, from their prescriber, a suitably qualified health practitioner or a credentialed diabetes educator; and
advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4 of the table in Schedule 1. This ensures that the patient, or person acting on behalf of the patient, understands the amount of substitutable medicine that must be administered to the patient for the patient to obtain a therapeutic benefit equivalent to that provided by the prescribed dose of scarce medicine; and
advised the patient, or person acting on behalf of the patient, of the differences between the scarce medicine and substitutable medicine. This ensures that the patient, or person acting on behalf of the patient, understands that the insulin delivery system to administer each of the medicines is different.

Schedule 2─General permitted circumstances

This Schedule specifies the general permitted circumstances in which a substitution of medicine may occur. For the purpose of section 6, substitution may only occur where these circumstances exist.

The general permitted circumstances prescribed are as follows:

the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law, i.e. there must be evidence of a prescription for the scarce medicine, which authorises the pharmacist to dispense the scarce medicine (if it were available) to the patient;
the pharmacist does not have access to the scarce medicine, i.e. the pharmacist must only substitute a medicine if the scarce medicine is not available to the pharmacist;
the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted, i.e. if the prescriber has indicated on the prescription that substitution is not permitted, the pharmacist must not dispense the substitutable medicine as this may pose a significant safety risk to the patient. If a prescriber has indicated that substitution, even with a generic product, is not suitable then the substitutable medicine must not be dispensed;
the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine. This requires the pharmacist to exercise professional judgement in relation to the particular patient and their circumstances to assess whether substitution is appropriate for the particular patient. For example, if the pharmacist is of the view that the patient may be sensitive to an excipient ingredient in the substitutable medicine, then the pharmacist must not dispense the substitutable medicine to the patient;
the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine. This is to ensure the pharmacist dispenses enough of the substitutable medicine to provide the patient with an equivalent treatment regimen (dosage and duration) as the scarce medicine;
the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine. If a person does not wish to receive the substitutable medicine, then the pharmacist must not dispense the substitutable medicine;
the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing. This is to ensure that there is a record of the medicine that was actually dispensed to a patient, in case any safety concerns arise;
the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine. There are strong safety reasons for ensuring that the prescriber is aware of the particular medicine that has been dispensed to their patient. The prescriber would otherwise assume that the patient was dispensed the prescribed medicine and would not know about the substitution without notice of this from the dispensing pharmacist.

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) (Insulin Isophane Human) Instrument 2024

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

Background

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.

Purpose

The specified substitutable medicine is PROTAPHANE PENFILL. The scarce medicine and substitutable medicine contain the same active ingredient.

Certain specific permitted circumstances are specified for the substitutable medicine. These include that the pharmacist must have:

ensured that the patient, or person acting on behalf of the patient, has, or is given, a suitable insulin delivery system to administer the substitutable medicine; and
advised the patient, or person acting on behalf of the patient:

- of suitable instructions for safely and effectively administering the substitutable medicine, including using the insulin delivery system; or

advised the patient, or person acting on behalf of the patient of the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the Instrument; and
advised the patient, or person acting on behalf of the patient, of the differences between the scarce and substitutable medicine.

Unless repealed earlier, this Instrument will be automatically repealed at the start of 1 March 2026.

Human rights implications

The 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 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 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.

Administered by Department of Health, Disability and Ageing

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