EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023
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.
Subsection 30EK(1) of the Act provides that the Minister may, by legislative instrument, declare that there is a serious scarcity of specified medicines (the scarce medicine) across the whole or a specified part or parts of Australia, and specify the medicines (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, 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) (Cefalexin) Instrument 2023 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. It declares that there is a serious scarcity across Australia of specified medicines (“the scarce medicine”), specifies the medicines that pharmacists are permitted to dispense in substitution for the scarce medicine (“the substitutable medicine”), and the circumstances in which they may do so.
The Principal Instrument declares registered medicines that contain cefalexin in various strengths in the dosage form of a powder for oral liquid or suspension, to be scarce medicines. The Principal Instrument also declares that where a pharmacist is unable to dispense a scarce medicine prescribed to the patient, they may instead dispense a substitutable medicine (with various substitutable medicines specified for each scarce medicine), in accordance with the Principal Instrument.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023 (“the Amendment Instrument”) is made in the context of the ongoing shortage of medicines containing cefalexin. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force to 30 April 2024.
Consequentially, the Amendment Instrument also changes the date on which the Principal Instrument is repealed, from 1 November 2023 to the start of 1 May 2024.
Background
Pharmacist Substitution
Medicine shortages continue to occur for a number of reasons, including manufacturing issues, such as long-term shortages of raw materials, as well as logistic issues, increases in demand. The TGA receives an average of 120 new medicine shortage notifications every month.
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.
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 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 allowing 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, shortages of registered medicines containing cefalexin have occurred in relation to multiple strengths and products. These include medicines containing cefalexin of various strengths that are manufactured in capsule and powder for oral liquid or suspension dosage forms. The shortages of the different strengths and dosage forms are either due to manufacturing issues or an unexpected increase in demand.
Medicines containing cefalexin are used to treat a variety of bacterial infections, including some forms of pneumonia and chest infections, ear infections, skin infections, tonsillitis, bacterial sinusitis, and urinary tract infections. The scarcity of these medicines 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 medicines.
The Principal Instrument supports the management of the shortages of medicines containing cefalexin. It declares that there is a serious scarcity of medicines containing cefalexin in the dosage form of a powder for oral liquid or suspension (i.e. the scarce medicines) and specifies the substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicine.
The Principal Instrument enables pharmacists to substitute the specified substitutable medicine for a 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 a scarce medicine can access suitable treatment without delay, reducing the risk of interrupted treatment.
The Principal Instrument also specifies a number of specific and general permitted circumstances that have the effect of confining when a pharmacist may substitute each of the substitutable medicines for the relevant scarce medicine for a patient. The 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 cefalexin are included in Schedule 4 to the current Poisons Standard, and the scarce medicines do not contain a substance in Schedule 8 to the current Poisons Standard.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specifies the period of time for which it remains in force, being until 31 October 2023, unless sooner revoked. This reflects the period that the scarce medicines were 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 2023 to 30 April 2024. The shortages of cefalexin in the dosage form of a powder for oral liquid or suspension are expected to persist beyond the date the Principal Instrument was to remain in force until, with supply and demand expected to stabilise by late April 2024.
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 30 April 2024. 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 also makes a further, consequential amendment to the Principal Instrument — namely, to change the date on which the Principal Instrument is repealed, from 1 November 2023 to 1 May 2024.
Consultation
An impact analysis was not required in relation to the development of the Amendment 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.
To develop the Principal Instrument, in July 2023, the TGA consulted with 17 stakeholders to ensure that the substitution protocol and associated permitted circumstances were appropriate. These stakeholders included the Royal Australian College of General Practitioners, Royal Australasian College of Physicians, Australian Paediatric Society, Australasian Society of Infectious Diseases, Royal Australasian College of Surgeons, Australian Medical Association, state and territory Chief Pharmacists, the Pharmaceutical Society of Australia, the Pharmacy Guild of Australia, and the Society of Hospital Pharmacists of Australia. The TGA received 5 responses, which were all supportive of the proposed instrument. The TGA has also consulted with sponsors of substitutable medicines about the substitution protocol, permitted circumstances, and to alert them to the potential change in demand.
In developing this Amendment Instrument, the TGA consulted with the same 17 stakeholders and sponsors, to ensure the continued substitution protocol remains appropriate and inform them of its continuation. The TGA received 6 responses, which were all supportive of the proposed amendment.
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 October 2023.
Attachment A
Details of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023 (“the Amendment Instrument”).
Section 2 – Commencement
This section provides that the Amendment Instrument commences on 31 October 2023.
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 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 that any other item in a Schedule to the Amendment Instrument has effect to its terms.
Schedule 1 - Amendments
Schedule 1 amends Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023 (“the Principal Instrument”).
Item 1 repeals and replaces section 7 of the Principal Instrument to provide that the Amendment Instrument remains in force until 30 April 2024.
Item 2 repeals and replaces section 8 of the Principal Instrument to provide that, unless repealed earlier, the Amendment Instrument is repealed at the start of 1 May 2024.
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) (Cefalexin) Amendment Instrument 2023
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 Act provides that the Minister may, by legislative instrument, declare that there is a serious scarcity of specified medicines (the scarce medicine) across the whole or a specified part or parts of Australia, and specify the medicines (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, 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) (Cefalexin) Instrument 2023 (“the Principal Instrument”) is a legislative instrument made under subsection 30EK(1) of the Act. It declares that there is a serious scarcity across Australia of specified medicines (“the scarce medicine”), specifies the medicines that pharmacists are permitted to dispense in substitution for the scarce medicine (“the substitutable medicine”), and the circumstances in which they may do so.
The Principal Instrument declares registered medicines that contain cefalexin in various strengths in the dosage form of a powder for oral liquid or suspension, to be scarce medicines. The Principal Instrument also declares that where a pharmacist is unable to dispense a scarce medicine prescribed to the patient, they may instead dispense a substitutable medicine (with various substitutable medicines specified for each scarce medicine), in accordance with the Principal Instrument.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023 (“the Amendment Instrument”) is made in the context of the ongoing shortage of medicines containing cefalexin. The purpose of the Amendment Instrument is to extend the period of time that the Principal Instrument remains in force to 30 April 2024.
Consequentially, the Amendment Instrument also changes the date on which the Principal Instrument is repealed, from 1 November 2023 to the start of 1 May 2024.
Background
Pharmacist Substitution
Medicine shortages continue to occur for a number of reasons, including manufacturing issues, such as long-term shortages of raw materials, as well as logistic issues, increases in demand. The TGA receives an average of 120 new medicine shortage notifications every month.
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.
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 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 allowing 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, shortages of registered medicines containing cefalexin have occurred in relation to multiple strengths and products. These include medicines containing cefalexin of various strengths that are manufactured in capsule and powder for oral liquid or suspension dosage forms. The shortages of the different strengths and dosage forms are either due to manufacturing issues or an unexpected increase in demand.
Medicines containing cefalexin are used to treat a variety of bacterial infections, including some forms of pneumonia and chest infections, ear infections, skin infections, tonsillitis, bacterial sinusitis, and urinary tract infections. The scarcity of these medicines 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 medicines.
The Principal Instrument supports the management of the shortages of medicines containing cefalexin. It declares that there is a serious scarcity of medicines containing cefalexin in the dosage form of a powder for oral liquid or suspension (i.e. the scarce medicines) and specifies the substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicine.
The Principal Instrument enables pharmacists to substitute the specified substitutable medicine for a 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 a scarce medicine can access suitable treatment without delay, reducing the risk of interrupted treatment.
The Principal Instrument also specifies a number of specific and general permitted circumstances that have the effect of confining when a pharmacist may substitute each of the substitutable medicines for the relevant scarce medicine for a patient. The 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 cefalexin are included in Schedule 4 to the current Poisons Standard, and the scarce medicines do not contain a substance in Schedule 8 to the current Poisons Standard.
In accordance with subsection 30EK(5) of the Act, the Principal Instrument specifies the period of time for which it remains in force, being until 31 October 2023, unless sooner revoked. This reflects the period that the scarce medicines were 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 2023 to 30 April 2024. The shortages of cefalexin in the dosage form of a powder for oral liquid or suspension are expected to persist beyond the date the Principal Instrument was to remain in force until, with supply and demand expected to stabilise by late April 2024.
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 30 April 2024. 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 also makes a further, consequential amendment to the Principal Instrument — namely, to change the date on which the Principal Instrument is repealed, from 1 November 2023 to 1 May 2024.
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 medicines, and to ameliorate the effects of the limited availability or unavailability of the scarce medicines 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 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.