Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023

Adverse event is defined separately for medicines/biologicals and for medical devices/other therapeutic goods. For medicines and biologicals, an adverse event is any event occurring in a person in Australia following administration of the product. For medical devices and other therapeutic goods, an adverse event is one that leads, or might have led, to death, serious injury or serious deterioration in health. The instrument explicitly notes that an adverse event may not necessarily have a causal relationship with the product (see the note to the definition). This is an important qualification because the public might misinterpret a reported event as evidence of causation.

DAEN - Medical Devices and DAEN - Medicines are the two databases maintained by the TGA that hold adverse event notifications. The instrument authorises release from both. For devices, the instrument also covers defect information. A defect is defined for medical devices and other therapeutic goods as a malfunction or deterioration in characteristics or performance, or an inadequacy in design, production, labelling, instructions for use or advertising materials that might lead to death, serious injury or serious deterioration. The defect definition is narrower than an adverse event because it focuses on product faults rather than any event.

Event outcome and event type are defined only for medical devices and other therapeutic goods. Event outcome is one of death, injury, no injury or unknown. Event type uses the IMDRF Terminology Document, a classification system from the International Medical Device Regulators Forum that is incorporated as in force from time to time (a dynamic reference). Report source category classifies the reporter as consumer, health professional, industry, government or other, again only for devices.

For medicines, the instrument relies on MedDRA (Medical Dictionary for Regulatory Activities) for adverse event description terms and system organ class terminology. MedDRA is also incorporated dynamically. The instrument does not define event outcome or report source category for medicines; instead, it allows release of age and sex of the affected person, which are not included for devices.

The instrument uses the term other therapeutic good to capture therapeutic goods that are not medicines, biologicals or medical devices. This is a residual category that might include products such as certain complementary medicines or borderline products. The Act’s definitions of medicine, biological, medical device and therapeutic goods are incorporated by reference from subsection 3(1) of the Act (see the note in section 4).

The primary entity affected is the TGA itself, which gains a legal basis to publish data that it could not previously release without risking a breach of the Act’s confidentiality provisions. The instrument affects the TGA’s operational practices: it will need to implement systems to extract and publish the specified fields, ensure data quality, and manage the reputational and legal risks that come with releasing unverified adverse event reports.

Sponsors of therapeutic goods are directly affected because the instrument authorises release of their names and details in connection with adverse event reports. For medical devices, the instrument allows release of both manufacturer and sponsor details (items 1(b) and 1(c) of Part 1). For medicines, only the medicine or biological details are specified, which would typically include the product name and sponsor by association, though the sponsor is not separately listed as a field. Sponsors face increased reputational risk from the publication of adverse event reports, particularly because the instrument does not require any assessment of causality. A sponsor may find its products associated with serious events even when no causal link exists.

Manufacturers (especially of medical devices) also have their details published. This may affect their commercial relationships and expose them to potential litigation, though the instrument itself does not create liability.

Health professionals and consumers are affected as reporters; their categorisation (health professional, consumer, industry, government or other) is released for device reports. However, their identity is not released; only the report source category is made public. The instrument does not authorise release of names or contact details of reporters.

Researchers, journalists and the public are the intended beneficiaries. They gain access to a larger dataset of adverse event reports, which can be used for pharmacovigilance, medical device vigilance, public health research and investigative journalism. The dataset allows identification of trends, but the absence of causation means that raw counts may be misleading.

Patients who have experienced adverse events are indirectly affected because their age and sex (for medicines) may be published. This is a privacy consideration, though the instrument does not release names, addresses or other direct identifiers. The publication of age and sex still carries a residual re-identification risk for rare events or small populations.

This instrument does not impose any duties directly on private parties. It confers a power on the Secretary of the Department of Health (the TGA) to release specified kinds of therapeutic goods information to the public under subsection 61(5C) of the Act. There is no duty to release; the TGA retains discretion over what, when and how to publish. Nor does the instrument create any rights for affected parties to prevent release, because it simply specifies categories that the Secretary may release. Any challenge to a particular release would have to be brought under administrative law (e.g., judicial review for unreasonableness) or under privacy laws, not under this instrument.

For sponsors and manufacturers, the instrument effectively reduces their ability to rely on the Act’s confidentiality protections. The Act generally prohibits disclosure of therapeutic goods information (which includes information about goods on the Register and related matters). By specifying these categories, the instrument removes that prohibition for the listed data. So a sponsor who previously assumed that adverse event report details were confidential must now accept that the TGA may publish them.

The instrument does not create any rights for reporters or patients to have adverse event reports removed or anonymised beyond what is already provided. The data fields are fixed; for medicines, age and sex are required fields; for devices, event outcome, event type and report source category are required. There is no provision for suppression of particular reports even if the event is later disproven or found to be unrelated.

The note to the adverse event definition states that an adverse event may not necessarily have a causal relationship with the product. This note is not a right but it is a protection for sponsors: it signals to readers that the data should not be assumed to show causation. However, the instrument itself does not require the TGA to add such a disclaimer to published data; it only appears in the definitional section of the instrument. The TGA may add its own disclaimers as a matter of practice, but the instrument does not mandate it.

The instrument contains no penalties. It is a specification instrument under the Act; enforcement for any breach of the Act’s disclosure provisions would lie elsewhere. If the TGA released information beyond what is specified in Schedule 1, that release could be a breach of subsection 61(5C) or other provisions of the Act, potentially attracting civil or criminal penalties under Part 7A of the Act (which contains offences for unauthorised disclosure of therapeutic goods information). However, those penalties are not part of this instrument.

Similarly, if a sponsor or other person misused published DAEN data (for example, by publishing it in a misleading way), the instrument does not itself provide a cause of action. General laws such as the Australian Consumer Law (misleading or deceptive conduct), defamation or privacy torts would apply.

For the TGA, the main enforcement risk is not that it will be penalised, but that its decisions to release data could be challenged by judicial review if they exceed the instrument’s scope. The instrument defines the outer boundary of what can be released; any release beyond that boundary is unauthorised. The TGA would need strong internal controls to ensure that only the specified fields are published, and that the definitions (e.g., adverse event, defect) are correctly applied.

The instrument is made under the Therapeutic Goods Act 1989, which is the primary statute. Section 61 of the Act sets out the framework for disclosure of therapeutic goods information. Subsection 61(5C) allows release of information that is the subject of a specification under subsection 61(5D). This instrument is that specification. So the interaction is hierarchical: the Act establishes the prohibition; the instrument creates an exception.

The Privacy Act 1988 is relevant because the instrument allows release of age and sex of individuals (for medicines). The TGA must ensure that its publication complies with the Australian Privacy Principles, particularly APP 6 (use or disclosure of personal information). The instrument does not override privacy laws; it only removes the bar under the Therapeutic Goods Act. The TGA would need to have a separate lawful basis under the Privacy Act to publish personal information. That basis could be that the release is required or authorised by or under an Australian law (APP 6.2(b)). The instrument is a legislative instrument made under an Act, so it would likely satisfy that exemption, but the TGA should still conduct a privacy impact assessment.

For medical devices, the instrument releases manufacturer and sponsor names, which are business information and generally not subject to the Privacy Act (unless an individual sole trader). However, the report source category for devices may reveal whether a report came from a consumer or health professional, which could be personal information if it can be linked to an identifiable person. The instrument does not release detailed reporter identities, but the combination of report details, date and source category might in rare cases allow re-identification. This is a privacy interaction that the TGA should consider.

The instrument interacts with freedom of information laws. The FOI Act 1982 generally provides a right of access to government documents but contains exemptions for confidential commercial information and personal privacy. By specifying that these categories are releaseable under the Therapeutic Goods Act, the instrument may also affect FOI claims: if the TGA publishes proactively, there is less need for FOI requests. Conversely, a sponsor who objects to publication could argue that the instrument does not override FOI exemptions; but the TGA’s decision to publish under the instrument would be a separate administrative action.

The instrument may also intersect with state and territory health records legislation, which often restricts disclosure of health information. However, Commonwealth laws generally prevail to the extent of any inconsistency under section 109 of the Constitution. The instrument is a Commonwealth legislative instrument authorising release by a Commonwealth agency, so state laws would not apply to that release.

The instrument is the Therapeutic Goods (Information Specification,Database of Adverse Event Notifications) Instrument 2023. It is a new instrument, not an amendment to an earlier one. There is no amendment history in the text provided. It was registered on the Federal Register of Legislation (presumably in 2023) and came into effect on the day after registration or on a specified date (the text does not include a commencement provision, so the default rules under the Legislation Act 2003 would apply: it commences the day after registration). There have been no published amendments to date. The instrument does not repeal or replace any earlier instrument; it establishes a new specification. It is a standalone instrument that may be amended or revoked by a later instrument.

The instrument has not been the subject of any reported litigation in the Australian courts, at least as of the time of this writing (late 2024). There is no history of judicial review applications challenging the TGA’s decisions to release or not release DAEN data under this instrument. However, there is a broader litigation background concerning the TGA’s disclosure of adverse event information. In the past, sponsors have sought injunctions to prevent the TGA from publishing certain data, arguing commercial confidentiality or unfair prejudice. The specification instrument appears designed to reduce that litigation risk by providing clear legislative authority for release of specific categories of data. It is possible that a sponsor in the future may challenge the validity of the instrument itself, for example on the ground that it exceeds the power under subsection 61(5D) of the Act, or that it is so broad that it impairs the sponsor’s legitimate commercial interests without adequate justification. But no such challenge has yet been reported.

The most significant gotcha for sponsors and manufacturers is the absence of any requirement for the TGA to verify the accuracy or causality of reported adverse events before publication. The instrument authorises release of the description of the adverse event as reported, without filtering out reports that are later found to be erroneous, duplicate or unrelated. A single unverified report can be released with full details of the product, manufacturer and sponsor. The note that an adverse event may not have a causal relationship is tucked into the definitions section, but the public-facing data may not carry that warning. Sponsors should expect that journalists and researchers will treat raw report counts as indicative of safety problems.

For the medical device industry, the release of defect information expands the risk further. A defect is defined broadly to include any inadequacy in design, production, labelling or advertising that might lead to death, serious injury or serious deterioration. The instrument does not require that the defect be confirmed by the TGA or by an independent investigation. So a single consumer report claiming a design flaw can be published as a defect report, even if the claim is unfounded.

For medicines, the instrument allows release of the age and sex of the person who experienced the adverse event. This raises privacy concerns, particularly for rare diseases or small communities. The instrument does not require the TGA to suppress data where the combination of age, sex, product and event might identify an individual. There is no provision for targeted anonymisation or for truncation of age into broad bands. The TGA’s internal data management practices will need to address this risk, but the instrument itself does not mandate any privacy safeguards.

The dynamic incorporation of the IMDRF Terminology Document and MedDRA as in force from time to time means that the instrument automatically adopts changes made by those external bodies. Sponsors and researchers need to track changes to those terminologies because a new term or classification could affect how an event is described in published data. The instrument does not include a limiting provision that only the version current at the time of the report applies.

Another gotcha: the instrument does not define “details of the medical device or other therapeutic good” or “details of the medicine or biological”. These are expansive terms. They could include product name, batch number, serial number, model, unique device identifier (UDI), or any other attribute recorded in the DAEN. Without a finite list, the TGA has significant interpretive discretion. A sponsor might be surprised to find that lot numbers or expiry dates are published under a “details” field, increasing the risk of product-level identification and potential liability.

For researchers and journalists, the gotcha is that the data does not include any confirmation of causal relationship. Any analysis that treats the number of reports as a rate or relative risk is methodologically flawed without correction for sampling bias, duplicate reporting, and lack of denominator data. The instrument does not require the TGA to provide any guidance on appropriate statistical use.

The instrument imposes no direct compliance obligations on private parties. However, several practical steps are prudent for sponsors, manufacturers and other regulated entities.

Sponsors of medicines and medical devices should monitor the TGA’s published DAEN data regularly. Because the TGA may release reports without prior notice, a sponsor should have a process in place to review new reports concerning its products. This allows early detection of potential product issues and prepared public responses. Given that the data may be inaccurate or non-causal, a sponsor should also consider preparing standard disclaimers and frequently asked questions for use when the media cite DAEN reports.

Manufacturers of medical devices should pay attention to the publication of defect reports under Part 1. The instrument authorises release of the defect description and the manufacturer details. A manufacturer that becomes aware of an adverse event report that contains a materially false claim about a defect should consider contacting the TGA to request correction or supplementation. The instrument does not provide a statutory mechanism for correction, but the TGA has administrative processes for data quality issues.

For health professionals and consumers who report adverse events, compliance is not an issue; the instrument does not affect reporting obligations. However, reporters should be aware that the source category (health professional or consumer) will be published for device reports. This may deter some reporters if they fear being identified by the combination of data, though their personal identity is not released. The TGA should consider whether the publication of source category will chill reporting, but that is a policy concern, not a compliance one.

For the TGA itself, compliance requires careful implementation. The TGA must ensure that only the specific fields listed in Schedule 1 are released, and that the definitions in section 4 are correctly applied. For example, for medical devices, it may only release the event outcome (death, injury, no injury, unknown) if the outcome was reported as such; it cannot infer or add an outcome that was not reported. The TGA must also ensure that data from DAEN - Medical Devices is not released in a way that combines fields in a manner not authorised. The instrument does not prohibit aggregation of multiple reports, as long as each field is within scope.

The TGA should also maintain a clear record of which reports were released, on what date, and under what authorisation. Because the instrument is a specification under s61(5D), any release outside its terms would be a breach of s61(5C). The TGA’s internal data governance policies should include checks against the instrument’s tables before any bulk publication.

Finally, any entity that wishes to rely on the published data for research or commercial purposes should comply with applicable laws on data use, including the Privacy Act if the data contains age and sex. The instrument itself does not grant a licence to re-identify individuals or to use the data in a misleading manner. The usual obligations under the Australian Consumer Law and defamation law apply to any publication derived from DAEN data.