Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019

The instrument introduces several defined terms that are essential to understanding how information may be released. A “case” means a file created by the TGA either in response to a complaint or following a decision to investigate on its own initiative where it reasonably suspects a contravention of the Act, Regulations or Therapeutic Goods Advertising Code. This is a broad definition: it covers both reactive and proactive enforcement. A “complaint” is an allegation of a contravention made by any person to the TGA, or to the Complaints Resolution Panel under the old Regulations (which led to a recommendation to the Secretary), or referred to the TGA by another body or authority. This captures complaints made under the earlier regulatory framework as well as current ones. “Outcome” includes a finding of no contravention, action taken by a responsible person in response (such as a corrective advertisement), action taken or a decision made by the Secretary, a court decision on an offence or civil penalty under Part 5‑1 of the Act, or an injunction ordered under Part 5A‑4. This means that even a determination that no breach occurred is an outcome that can be published. “Responsible person” is the person who appears to be responsible for advertising or disseminating generic information about therapeutic goods. This is defined by appearance rather than legal liability. “Generic information” has the same meaning as in section 42B of the Act, which generally refers to information about therapeutic goods that does not refer to a specific product but is intended to promote a class of goods. The instrument also defines “risk category” as the level of risk assigned by the TGA to a case, though the criteria for assignment are not specified in the instrument. The Complaints Resolution Panel and “old Regulations” are referenced to preserve the link to complaints processed before 1 July 2018, when the advertising complaints framework changed. The nine categories of information listed in Schedule 2 are exhaustive; the Secretary cannot release information outside these categories under this power. The instrument does not qualify when or how often information may be released, nor does it require the Secretary to give notice to affected persons before publication. The definitions of “case number” and “reference number” are broad, allowing any combination of numbers, symbols and letters. The instrument does not limit publication to finalised cases: case details can include the alleged breach and circumstances even if the case is ongoing. This distinguishes the specification from a mere final‑determination register; it allows the TGA to disclose investigative stages.

The instrument directly affects any person who advertises therapeutic goods or who disseminates generic information about therapeutic goods. This includes manufacturers, sponsors, importers, retailers, health practitioners, and any agent acting on their behalf. Because the “responsible person” is defined by appearance rather than by a formal role, a person can be named in published information even if they are not the ultimate legal entity responsible. This broadens the pool of potentially affected parties. Companies in the complementary medicine sector, which are frequent subjects of advertising complaints, will be particularly exposed because their products often have lower registration thresholds but still attract advertising scrutiny. Professional advertisers, marketing firms, and media outlets that place advertisements for therapeutic goods may also be named if they appear responsible. Health practitioners who promote products, such as doctors endorsing supplements, could be identified as responsible persons. The TGA itself is affected: its staff must decide which information to release, when, and with what level of detail, which requires administrative resources and may lead to litigation. The public, including competitors, consumer groups, journalists, and researchers, will have access to information that was previously confidential. Competitors may use published case details to monitor rivals’ compliance and even to bring commercial pressure. Consumers may benefit from knowing which products have been the subject of complaints and what the TGA did in response. The instrument also affects persons who made complaints: the case details may include a summary of the complaint or the reason for investigation. If a complaint identifies the complainant, that could be indirectly disclosed, though the instrument does not explicitly require naming complainants. Entities that were subject to Complaints Resolution Panel recommendations under the old Regulations are also captured because the definition of “complaint” includes those made to the Panel that led to a recommendation. The instrument therefore has retrospective effect in the sense that cases arising before its commencement can be published. In total, the instrument expands the state’s capacity to impose reputational costs on businesses and individuals, which changes the cost‑benefit calculus of non‑compliance. For small businesses, the risk of being named publicly for an alleged breach may be disproportionate to the violation, especially if the TGA releases case details before the responsible person has had an opportunity to respond or rectify. The instrument does not impose any new obligations on those affected; rather, it removes a previous shield of confidentiality.

The instrument does not create new duties. It confers a discretionary power on the Secretary: the right to release the specified kinds of information to the public. The Secretary has no duty to release any information; the decision to publish is at the Secretary’s discretion, subject to any other legal constraints such as the Administrative Decisions (Judicial Review) Act 1977 or general principles of procedural fairness. The instrument does not impose a duty on the TGA to consult or notify the responsible person before publication. This means a responsible person has no statutory right to prior notice or to object to the release of case details. However, under general administrative law, there may be an implied obligation to accord procedural fairness if the publication could damage reputation, particularly if the case details include unsubstantiated allegations. The instrument is silent on timing; the Secretary could release case details immediately after a case is opened, before any investigation has occurred. The instrument also does not require the Secretary to update the public record if the outcome changes (for example, if an alleged breach is later found to be not contravened). The outcomes category includes a finding of no contravention, but that information may be published separately or not at all. Responsible persons have no right to force the TGA to publish a favourable outcome or to remove earlier published allegations. Under section 61(5C) of the Act, the Secretary is authorised to release the specified information despite any other provision of the Act or any other law. This override extends to secrecy provisions within the Act and possibly to privacy laws, giving the Secretary a broad discretion. The only limitation is that the information must fall within the kinds specified in Schedule 2. If the Secretary attempts to release information outside these categories, a responsible person may have grounds to challenge the release in a court or tribunal. The instrument does not create a right for complainants to have their complaint published; the Secretary may choose not to act. Similarly, the instrument does not give competitors a right to access information; it only allows the Secretary to publish it. For practical purposes, the rights of responsible persons are diminished relative to the previous regime where advertising complaints were largely confidential. The trade‑off is that the public gains a right to know about regulatory actions, but that right is exercised through the Secretary’s discretion, not through a freedom of information request.

The instrument itself carries no penalties. It does not create offences or civil penalties. Its enforcement significance lies in the deterrent effect of public disclosure. By making case details and outcomes public, the TGA can increase the cost of non‑compliance through reputational damage, which may encourage advertisers to comply with the Therapeutic Goods Advertising Code and the Act. This indirect enforcement mechanism may be more effective for some firms than the formal penalties in the Act, which include fines, infringement notices, and injunctions. However, the instrument does not guarantee that disclosure will be proportionate: the TGA could release information about a minor alleged breach that causes disproportionate harm to a small business. There is no statutory requirement for the Secretary to consider the potential reputational impact before publishing. The instrument also does not prescribe any internal review or appeal mechanism for a responsible person who objects to publication. If a responsible person believes the TGA has acted unreasonably, the only recourse is judicial review under the ADJR Act or an injunction to prevent publication. This places the onus on the affected party to seek relief, which can be costly and time‑sensitive. The enforcement function is therefore shifted from formal penalties to public exposure, which is less predictable and may be capricious if the TGA does not consistently apply its discretion. The instrument also captures court decisions and injunctions as outcomes, so if a court imposes a penalty, that information will be published as part of the outcome. This may increase the publicity of court proceedings, but the instrument does not add any new penalty. In practice, the main penalty is the naming and shaming. The instrument does not specify any process for verifying the accuracy of published information before release; errors could lead to defamation claims or administrative challenges. The TGA’s own quality assurance procedures will determine whether the information is accurate. In summary, the instrument changes enforcement from a closed system to an open one, which may improve compliance but raises questions about due process and the proportionality of reputational penalties.

The instrument is made under the Therapeutic Goods Act 1989, specifically subsection 61(5D), and operates in conjunction with subsection 61(5C) which allows the Secretary to release information that would otherwise be confidential. It therefore overrides secrecy provisions within the Act itself, such as section 61 which generally prohibits disclosure of therapeutic goods information. The instrument is part of a broader framework that includes the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code. It specifically references the old Regulations (the Therapeutic Goods Regulations 1990 as in force before 1 July 2018) to capture complaints made to the Complaints Resolution Panel under that earlier regime. This means the instrument has a transitional character; it allows publication of information about cases that arose under the previous complaints system. The instrument interacts with privacy laws, such as the Privacy Act 1988. Because the information may include the name of the responsible person (an individual), the release of personal information could engage the Privacy Act’s obligations. However, the Therapeutic Goods Act is a Commonwealth law that authorises the disclosure, and the Privacy Act generally permits disclosure where required or authorised by law. The instrument may also interact with freedom of information laws: information that is released under s 61(5C) may become publicly available, which could affect FOI requests for the same information. The instrument does not affect the operation of state or territory fair trading laws that regulate advertising, but any publication by the TGA could be used as evidence in proceedings under those laws. If a court or tribunal decision is published with a link, that may interact with the rules of court regarding publication of judgments. The instrument does not create any new interaction with the Competition and Consumer Act 2010, but misleading advertising about therapeutic goods may also be a breach of the Australian Consumer Law; TGA publications could inform ACCC investigations. The instrument also interacts with the TGA’s own internal policies on publication, such as the “Compliance and Enforcement Policy”, which may impose additional conditions on when information is released. The instrument is not subject to any sunsetting provision mentioned in the source; it is a standing specification. Finally, the instrument does not interact with international trade obligations directly, but if it results in publication of information about specific products, it could affect commercial reputation in foreign markets.

The source text does not show any amendment history. The instrument is titled “Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019”, which suggests it was made in 2019. The note in the instrument references the commencement of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 on 1 July 2018, indicating the specification was prepared after that regulatory change. There is no indication in the source of any amending instruments. Given that the instrument is relatively recent, it may not yet have been amended. However, users should check the Federal Register of Legislation to confirm whether any amendments have been made after the version provided here. The instrument was made under a provision (s 61(5D)) that was inserted into the Act by the Therapeutic Goods Legislation Amendment Act 2018? That is not directly stated, but the reference to the 2018 Regulations suggests the framework was amended in 2018. The instrument itself appears to be a one‑off specification; future amendments could add, remove, or modify the kinds of information in Schedule 2. The definition of “old Regulations” may become outdated over time, but it is frozen as at 1 July 2018. If the Regulations are further amended, new instruments may be needed to capture complaints under later regimes. The instrument does not contain a sunset clause or review provision. The absence of amendment history does not mean the instrument will remain static; it can be amended or replaced by a new specification. Practitioners should monitor the TGA’s website for any changes.

The source text does not mention any litigation concerning this instrument. Because the instrument is a specification of information that may be released, it is unlikely to be the direct subject of litigation; rather, litigation may arise from the Secretary’s decision to release information under it. Potential grounds for judicial review include: (a) the Secretary released information that does not fall within the specified kinds; (b) the Secretary failed to accord procedural fairness before publishing information that names a person and includes allegations; (c) the Secretary acted unreasonably or for an improper purpose. If the instrument itself were challenged, a court could consider whether it is a valid exercise of the regulation‑making power under s 61(5D), including whether the kinds of information specified are consistent with the Act. No such challenges are recorded in the source. There may be decisions of the Administrative Appeals Tribunal or the Federal Court about the exercise of the Secretary’s discretion under s 61(5C), but those would turn on the facts of each case. The instrument is also likely to be cited in proceedings where the TGA seeks to rely on published information as evidence of a contravention or where a responsible person seeks to prevent publication. Given the instrument’s 2019 date, it is possible that litigation is still nascent. The instrument may also be referenced in complaints to the Ombudsman or in FOI disputes. In summary, there is no reported litigation history from the source, but potential litigation areas are identifiable.

The instrument contains several traps for the unwary. First, the definition of “responsible person” turns on what “appears to be” the case, not on legal liability. This means an advertising agency or a marketing consultant could be named as the responsible person even if the ultimate sponsor is the legal entity responsible. The TGA does not need to make a final determination of responsibility before publishing the name. Second, “case details” can include the alleged breach and the circumstances of the alleged contravention. This means the TGA can publicise serious allegations before any investigation is completed or before the responsible person has had an opportunity to respond. There is no statutory requirement for the TGA to wait until a finding is made. Even if the outcome later shows no contravention, the initial allegation may have already been disseminated and could cause reputational harm. Third, “outcomes” includes a finding of no contravention, but the instrument does not require the TGA to publish that outcome with the same prominence as the initial case details. A responsible person could be left with a publicly available record of an allegation without a clear statement that it was unfounded. Fourth, the instrument applies to complaints made under the old Regulations. This means that cases that were already closed or still pending under the previous CRP system can be published retrospectively. Companies that thought their complaints were resolved confidentially may find them publicised. Fifth, the definition of “case” includes investigations commenced on the TGA’s own initiative where it reasonably suspects a contravention. The threshold is “reasonable suspicion”, which is low. The TGA can open a case based on a suspicion, and then publish the case details immediately. Sixth, the instrument does not require the TGA to notify the responsible person before publication. There is no built‑in mechanism for the responsible person to request corrections or provide context. Seventh, “risk category” is assigned by the TGA, but the criteria are not specified. This means the TGA has broad discretion to classify a case as high‑risk, which may influence how the information is perceived by the public. Eighth, the instrument does not address the handling of confidential commercial information, such as trade secrets that might be embedded in case details (e.g., advertising strategy or product formulation). The TGA could release such details if they fall within the specified kinds. Ninth, the instrument permits release of “any identifying number assigned to the complaint by the Complaints Resolution Panel”. This could allow cross‑referencing of old complaints, which may expose patterns of conduct. Finally, the table in Schedule 2 includes the phrase “a summary of, and reasons for, the outcomes”. If the TGA releases its reasoning, it may contain criticisms that go beyond the mere finding, creating a public record that can be used in civil litigation or by competitors. These gotchas mean that any person who advertises therapeutic goods or disseminates generic information should assume that any interaction with the TGA regarding an advertising complaint could become public.

Because the instrument does not impose duties but expands the TGA’s disclosure powers, compliance strategies focus on reducing the risk that the TGA will open a case or, if a case is opened, minimising the damage from public disclosure. First, ensure that all advertising of therapeutic goods and any dissemination of generic information complies strictly with the Therapeutic Goods Act, the Regulations, and the Therapeutic Goods Advertising Code. This includes pre‑approval requirements for certain advertisements, ensuring that claims are substantiated, and that the advertising is not misleading. Second, implement an internal advertising review process that catches breaches before they occur. This may involve training marketing staff, engaging legal review, and conducting pre‑publication audits, especially for products that are high‑risk (e.g., those listed on the Australian Register of Therapeutic Goods with low risk but that make implied therapeutic claims). Third, monitor the TGA’s published information regularly to see if any case details about your products or company have been released. If information is published that you believe is inaccurate or beyond the scope of the specification, seek legal advice immediately on whether to request correction or seek judicial review. Fourth, if you receive notification that a complaint has been made or that the TGA has opened a case on its own initiative, treat the matter seriously and respond promptly. Provide full cooperation to the TGA, as this may influence the TGA’s decision on what to publish and when. The TGA may be more likely to publish a balanced outcome if you demonstrate a willingness to rectify. Fifth, consider whether to make a proactive public statement if the TGA publishes adverse allegations, to provide your own version of events. However, be careful not to breach any confidentiality obligations under the Act. Sixth, keep records of all advertising and communications with the TGA, including dates and decisions, so that you can challenge any inaccurate publication. Seventh, for complaints that originated under the old Regulations with the Complaints Resolution Panel, be aware that the TGA can now publish those details. Review any old cases and consider contacting the TGA to understand if they intend to publish. Eighth, engage with industry associations or lobby for procedural safeguards if the instrument is revised. Ninth, ensure that any contractual arrangements with advertising agencies or other parties clearly assign responsibility for compliance and indemnify for losses arising from adverse TGA publication. Finally, consult with a lawyer experienced in therapeutic goods advertising law to develop a compliance plan that addresses the increased transparency risk. Compliance is not just about avoiding a breach; it is about managing the reputational consequences when something goes wrong. Because the instrument gives the Secretary wide discretion, the most effective protection is to minimise the probability of any case being opened.