EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) 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 is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health, Disability and Ageing (“the Department”).
Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that therapeutic goods information means, for the purposes of the section, information relating to therapeutic goods that is held by the department and relates to the performance of the department’s functions.
Subsection 61(5C) of the Act provides that the Secretary may release to the public therapeutic goods information of a kind specified under subsection 61(5D). Subsection 61(5D) of the Act provides that the Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purposes of subsection 61(5C).
The Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 (“the Principal Instrument”) is a legislative instrument made under subsection 61(5D) of the Act. Broadly, it specifies for the purposes of subsection 61(5C) of the Act the kinds of therapeutic goods information that the Secretary may release to the public concerning adverse event reports that the TGA receives about therapeutic goods.
The effect of the Principal Instrument is that, under subsection 61(5C) of the Act, the Secretary (or a delegate) may release to the public:
- therapeutic goods information in the Database of Adverse Event Notifications – Medicines (“DAEN – Medicines”) relating to adverse events involving medicines and biologicals; and
- —therapeutic goods information in the Database of Adverse Event Notifications – Medical Devices (“DAEN – Medical Devices”) relating to adverse events involving, and defects of, medical devices and other therapeutic goods.
The Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Amendment Instrument 2025 (“the Amendment Instrument”) is a legislative instrument made under subsection 61(5D) of the Act. It amends the Principal Instrument to more accurately describe the kind of therapeutic goods information about a person who is reported to have suffered the adverse event (“relevant person”), that may be published through the DAEN – Medicines in accordance with paragraph (d) in column 2 of table item 1 in Part 2 of Schedule 1 to the Principal Instrument.
Specifically, the Amendment Instrument replaces paragraph (d) which specifies “the gender of the relevant person”, with a new paragraph (d) which specifies “the sex of the relevant person”. This clarificatory amendment corrects the reference in paragraph (d) as it is the sex of a relevant person, not necessarily their gender, that is published in the DAEN – Medicines.
Background
The DAEN – Medicines and DAEN – Medical Devices are essential components of the TGA’s work to maintain the transparency of adverse event and defect information relating to the administration or use of therapeutic goods in Australia. These databases are accessed daily by the public and there is a high level of community interest in adverse event information, and therefore importance in ensuring public access to it. These databases also support research and analysis relating to therapeutic goods adverse events, which may in turn inform, and provide insights to improve, future regulation to prevent and better address adverse events.
Relevantly, members of the public, including consumers, health practitioners, sponsors and manufacturers, can search the DAEN – Medicines and view data about adverse event reports relating to medicines and biologicals. This includes, for example, the name of the medicine or biological, certain de-identified patient details, and scientific terms that describe the adverse event. The search results also include summaries of the total number of reported adverse events in relation to a medicine or biological, the number of cases where death was a reported outcome, and the number of cases where the medicine or biological was the only therapeutic good suspected of being related to the adverse event.
Part 2 of Schedule 1 to the Principal Instrument sets out in detail the kinds of therapeutic goods information that the Secretary (or a relevant delegate) may release through the DAEN – Medicines. Relevantly, item 1 of the table in Part 2 specifies the “gender of the relevant person” as a kind of therapeutic goods information that may be released under subsection 61(5C) of the Act (paragraph (d) in column 2 of the table item refers).
There is a concern that paragraph (d) in column 2 of table item 1 does not accurately reflect the kind of information that may be published through the DAEN – Medicines. Specifically, the reference to “the gender of the relevant person” may be misleading as, in practice, it is the sex of the relevant person, and not their gender, that may be released through the DAEN – Medicines. Data relating to a person’s sex supports comprehensive and inclusive risk assessment and analysis of potential medicine safety signals, as biological differences may lead to differences in adverse event profiles.
Purpose
The purpose of the Amendment Instrument is to clarify that the Secretary or a relevant delegate may, under subsection 61(5C) of the Act, publish the sex of a relevant person through the DAEN – Medicines. That is, rather than the gender of the relevant person. This amendment is consistent with the Australian Government Guidelines on the Recognition of Sex and Gender, which recognises that the terms ‘gender’ and ‘sex’ are not interchangeable, and that a person’s sex and gender may not necessarily be the same.
This amendment makes no substantive change to kinds of therapeutic goods information that may be published through the DAEN – Medicines. This is because it is the sex, not necessarily the gender, of a relevant person that is already published through the DAEN – Medicines. However, the Principal Instrument could be clearer in this respect.
Notably, the provision of details about a person’s sex is completely optional in the TGA’s online adverse event notification form. This means the relevant person, or a person making the notification on behalf of the relevant person, may notify the TGA of an adverse event without providing such details, if that is their preference. In that case, the DAEN will not include the relevant person’s sex.
Consultation
Consultation was not undertaken in relation to the Amendment Instrument as the amendment is a minor and machinery change to the wording of the Principal Instrument to better reflect current standards. The purpose of the amendment is to align with the TGA’s practices with respect to the collection of data relating to adverse events and publication of adverse event information in the DAEN.
Details of the Amendment Instrument are set out in Attachment A.
The Amendment Instrument is compatible with the 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 the day after the instrument is registered on the Federal Register of Legislation.
Attachment A
Details of the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Amendment Instrument 2025
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Amendment Instrument 2025 (“the Amendment Instrument”).
Section 2 – Commencement
This section provides that the Amendment Instrument commences the day after registration on the Federal Register of Legislation.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Instrument is subsection 61(5D) 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. The Amendment Instrument is made in accordance with that provision.
Section 4 – Schedules
This section provides that each instrument that is specified in a Schedule to the Amendment Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Amendment Instrument has effect according to its terms.
Schedule 1 – Amendments
This Schedule amends the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 (“the Principal Instrument”).
The item in the Schedule amends table item 1 in Part 2 of Schedule 1 to the Principal Instrument. It does so by replacing paragraph (d) in column 2 of that table item with a new paragraph (d) which specifies “the sex of the relevant person”.
The effect of this amendment is to clarify that the Secretary (or a delegate) may publish the sex, rather than the gender, of a person who is reported to have suffered the adverse event in the DAEN – Medicines, to align with the TGA’s current practice. This information would only be published in the DAEN where it was provided to the TGA – noting that provision of this information in an adverse event notification is optional.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) 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 legislative instrument
Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that therapeutic goods information means, for the purposes of the section, information relating to therapeutic goods that is held by the department and relates to the performance of the department’s functions.
Subsection 61(5C) of the Act provides that the Secretary may release to the public therapeutic goods information of a kind specified under subsection 61(5D). Subsection 61(5D) of the Act provides that the Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purposes of subsection 61(5C).
The Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 (“the Principal Instrument”) is a legislative instrument made under subsection 61(5D) of the Act. Broadly, it specifies for the purposes of subsection 61(5C) of the Act the kinds of therapeutic goods information that the Secretary may release to the public concerning adverse event reports that the TGA receives about therapeutic goods.
The effect of the Principal Instrument is that, under subsection 61(5C) of the Act, the Secretary (or a delegate) may release to the public:
- therapeutic goods information in the Database of Adverse Event Notifications – Medicines (“DAEN – Medicines”) relating to adverse events involving medicines and biologicals; and
- —therapeutic goods information in the Database of Adverse Event Notifications – Medical Devices (“DAEN – Medical Devices”) relating to adverse events involving, and defects of, medical devices and other therapeutic goods.
The Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Amendment Instrument 2025 (“the Amendment Instrument”) is a legislative instrument made under subsection 61(5D) of the Act. It amends the Principal Instrument to more accurately describe the kind of therapeutic goods information about a person who is reported to have suffered the adverse event (“relevant person”), that may be published through the DAEN – Medicines in accordance with paragraph (d) in column 2 of table item 1 in Part 2 of Schedule 1 to the Principal Instrument.
Specifically, the Amendment Instrument replaces paragraph (d) which specifies “the gender of the relevant person”, with a new paragraph (d) which specifies “the sex of the relevant person”. This clarificatory amendment corrects the reference in paragraph (d) as it is the sex of a relevant person, not necessarily their gender, that is published in the DAEN – Medicines.
Background
The DAEN – Medicines and DAEN – Medical Devices are essential components of the TGA’s work to maintain the transparency of adverse event and defect information relating to the administration or use of therapeutic goods in Australia. These databases are accessed daily by the public and there is a high level of community interest in adverse event information, and therefore importance in ensuring public access to it. These databases also support research and analysis relating to therapeutic goods adverse events, which may in turn inform, and provide insights to improve, future regulation to prevent and better address adverse events.
Relevantly, members of the public, including consumers, health practitioners, sponsors and manufacturers, can search the DAEN – Medicines and view data about adverse event reports relating to medicines and biologicals. This includes, for example, the name of the medicine or biological, certain de-identified patient details, and scientific terms that describe the adverse event. The search results also include summaries of the total number of reported adverse events in relation to a medicine or biological, the number of cases where death was a reported outcome, and the number of cases where the medicine or biological was the only therapeutic good suspected of being related to the adverse event.
Part 2 of Schedule 1 to the Principal Instrument sets out in detail the kinds of therapeutic goods information that the Secretary (or a relevant delegate) may release through the DAEN – Medicines. Relevantly, item 1 of the table in Part 2 specifies the “gender of the relevant person” as a kind of therapeutic goods information that may be released under subsection 61(5C) of the Act (paragraph (d) in column 2 of the table item refers).
There is a concern that paragraph (d) in column 2 of table item 1 does not accurately reflect the kind of information that may be published through the DAEN – Medicines. Specifically, the reference to “the gender of the relevant person” may be misleading as, in practice, it is the sex of the relevant person, and not their gender, that may be released through the DAEN – Medicines. Data relating to a person’s sex supports comprehensive and inclusive risk assessment and analysis of potential medicine safety signals, as biological differences may lead to differences in adverse event profiles.
Purpose
The purpose of the Amendment Instrument is to clarify that the Secretary or a relevant delegate may, under subsection 61(5C) of the Act, publish the sex of a relevant person through the DAEN – Medicines. That is, rather than the gender of the relevant person. This amendment is consistent with the Australian Government Guidelines on the Recognition of Sex and Gender, which recognises that the terms ‘gender’ and ‘sex’ are not interchangeable, and that a person’s sex and gender may not necessarily be the same.
This amendment makes no substantive change to kinds of therapeutic goods information that may be published through the DAEN – Medicines. This is because it is the sex, not necessarily the gender, of a relevant person that is already published through the DAEN – Medicines. However, the Principal Instrument could be clearer in this respect.
Notably, the provision of details about a person’s sex is completely optional in the TGA’s online adverse event notification form. This means the relevant person, or a person making the notification on behalf of the relevant person, may notify the TGA of an adverse event without providing such details, if that is their preference. In that case, the DAEN will not include the relevant person’s sex.
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”) and the right to protection against arbitrary and unlawful interferences with privacy in Article 17 of the International Covenant on Civil and Political Rights (“the ICCPR”).
Right to Health
Article 12 of the ICESCR recognises 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 Nation’s 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 improving the clarity and accuracy of the information describing data relating to patient sex in the Principal Instrument. The DAEN was introduced in July 2012 as a transparency initiative by the then Department of Health and Ageing to support the research and analysis of adverse events in relation to medical devices and medicines. From a public health perspective, clearly describing this demographic information will assist in the comprehensive analysis of adverse event data and potential safety signals associated with particular therapeutic goods.
Right to protection against arbitrary and unlawful interferences with privacy
Article 17 of the ICCPR provides for the right of every person not to be subjected to arbitrary or unlawful interference with privacy. The prohibition on interference with privacy prohibits unlawful or arbitrary interferences with a person’s privacy, family, home and correspondence. It also prohibits unlawful attacks on a person’s reputation. Limitations on the right to privacy must be according to law and not arbitrary, i.e. limitations must be reasonable and necessary in the particular circumstances, as well as proportionate to the objectives the limitations seek to achieve.
The TGA, as part of the Australian Government, Department of Health, Disability and Ageing, is an APP entity for the purposes of the Privacy Act 1988 (“the Privacy Act”) and in turn the Australian Privacy Principles. Any use or disclosure of personal information by the TGA is consistent with the Privacy Act. The collection and use by the TGA of the information specified in the Principal Instrument, and its disclosure, is critically important to promote transparency and the safety of patients, users and the public.
The Amendment Instrument amends the Principal Instrument to clarify that the Secretary (or a delegate) may publish in the DAEN – Medicines the sex of the relevant person.
Importantly, such information is only published in circumstances where the relevant person, or person making the adverse event notification on their behalf, has advised the TGA of the sex of the relevant person, noting that the provision of such information is optional. Notifiers are informed that such information, if provided to the TGA, may be published through the DAEN – Medicines.
Therefore, the disclosure of the sex of a relevant person is not an arbitrary or unlawful interference with a person’s privacy under Article 17 of the ICCPR, as the disclosure would be reasonable given it supports the research and analysis of adverse events associated with therapeutic goods. The disclosure would also be necessary and proportionate to the objective of promoting the safety of therapeutic goods in Australia.
Conclusion
The Amendment Instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and any engagement with the right to privacy in Article 17 of ICCPR is reasonable, necessary and proportionate.