By Dr. Teresa Nicoletti, Partner, Geoff Bloom, Partner, Julian Grover, Special Counsel, and Meghan Carruthers, Special Counsel.
The Therapeutic Goods Administration has published new guidance, accessible here, on the restrictions that apply to advertising prescription medicines to the public. The guidance is important for sponsors, pharmacies, telehealth providers, cosmetic clinics, medicinal cannabis businesses and other health product or service providers whose services may involve prescription medicines.
The central message is straightforward: prescription medicines must not be advertised to the public except in limited circumstances. The orthodox policy rationale is that prescription medicines may carry material risks and require individual clinical assessment, and decisions about whether they are appropriate should be made in consultation with qualified health practitioners, rather than being driven by consumer marketing.
However, the practical significance of the guidance lies in how broadly the TGA approaches indirect references to prescription medicines. The guidance makes clear that the TGA will not confine its attention to express product names, active ingredient names or conventional brand advertising. In forming a view as to what constitutes advertising, the TGA will also consider substitute terms, colloquial expressions, abbreviations, visual cues, business names, logos, booking systems, product catalogues, price information, condition-specific landing pages, social media content and third-party links.
The guidance proceeds from the general prohibition on advertising prescription medicines to the public. For the purposes of the guidance, the TGA uses “prescription medicines” to include substances in Schedules 3, 4 and 8 of the Poisons Standard, unless a Schedule 3 substance is included in Appendix H. The same broad advertising principles apply across websites, social media, emails, text messages, booking systems, shopfront material, catalogues, price lists and other promotional material.
The TGA’s position is that businesses must not include, and should remove, direct and indirect references to prescription medicines from material directed to the public. Direct references include product names, trade names and active ingredient names. Indirect references may include class references, abbreviations, colloquial names, euphemisms, imagery or other contextual cues that point to a prescription medicine or class of prescription medicines.
This means that a business cannot assume that deleting the product name is enough. A webpage that avoids the words “semaglutide”, “botulinum toxin” or “medicinal cannabis” may still be problematic if the overall impression is that the business is promoting access to weight loss injections, wrinkle-reduction injections, cannabis-based treatments, peptides, erectile dysfunction medicines or another prescription medicine category.
The guidance accepts that health services may be advertised. A clinic, pharmacy or telehealth provider may describe the services it offers, the qualifications of practitioners, the consultation process and the conditions for which clinical assessment is available. The important limitation is that the advertising must not directly or indirectly promote the use or supply of prescription medicines.
The distinction is easy to state but difficult to apply. A pharmacy may advertise a UTI assessment service within its authorised scope of practice. However, if the advertising tells consumers that they can obtain “the antibiotics you need”, the TGA regards that as promoting the use and supply of prescription medicines. Similarly, a cosmetic clinic may advertise aesthetic consultations, but may not present “cosmetic injectables” as the route to a desired cosmetic outcome.
Businesses that rely on online booking systems, intake forms, symptom checkers, eligibility questionnaires or condition-specific landing pages should therefore review not only the words used, but the entire consumer journey. These tools may be legitimate components of a clinical service. They become higher risk if they create the impression that the consumer is being funnelled toward a particular medicine or class of medicines as the assumed treatment.
The guidance identifies a number of activities that are likely to be treated as advertising prescription medicines. These include business names or logos that refer directly or indirectly to prescription medicines; service pages that promote consultations as a means of obtaining particular medicines; public catalogues that allow consumers to browse through a range of prescription medicines by condition; price lists for prescription-only treatments outside the limited exceptions in the Therapeutic Goods Advertising Code; and “before and after” images that imply the result was achieved through use of a prescription medicine.
The guidance also treats direct marketing as a significant risk area. Mass emails, text messages, webinars and other communications to former patients or prospective customers may be deemed advertising to the public if they promote prescription medicines and are not provided in the course of treatment. The fact that a communication is sent to former patients does not, by itself, bring it within the patient-treatment exception that allows health practitioners to provide information about prescription-only medicines directly to patients in the course of their treatment.
Restricted-access content also remains risky. The TGA’s view is that putting prescription medicine content behind a login, membership wall, subscription service or paywall will not necessarily prevent it being advertising to the public. Unless the content is directed exclusively to health professionals or provided directly to a patient in the course of treatment, access restrictions may not be enough.
The guidance also warns against using third-party links, shared content, testimonials and social media material to achieve indirectly what cannot be done directly. A business that links to articles, testimonials or other material promoting a prescription medicine may create an overall impression that promotes the use or supply of that medicine.
The guidance is strongest where the material names a prescription medicine, identifies a scheduled substance, describes the benefits of a prescription medicine, lists prices for prescription-only treatment, presents a catalogue of prescription medicines, or uses recognised substitute terms in a context that clearly points to a prescription medicine. In those cases, the connection between the communication and the promotion of the use or supply of therapeutic goods is relatively clear.
The more difficult issue is whether the guidance sometimes treats contextual indicators as if they are automatically prohibited references. The statutory concept of advertising requires attention to whether the material is intended, directly or indirectly, to promote the use or supply of therapeutic goods. It should not be enough that a regulator can identify a possible coded meaning or that prescription of a medicine may be one possible clinical outcome of a consultation.
That analysis is also consistent with the way the Therapeutic Goods Advertising Code frames the assessment of advertisements. The Code applies, in relation to a particular advertisement, by reference to its likely impact on a reasonable person to whom the advertisement is directed. That formulation necessarily requires attention to audience, context and overall impression. It does not support an approach under which a word, image or phrase is treated as impermissible merely because it could, in some other setting, be associated with a prescription medicine.
The phrase “Find out if plant-based medicine is right for you” illustrates the issue. The TGA’s apparent view is that, in that context, a reference to “plant-based medicine” is likely to be understood as a prohibited reference to medicinal cannabis. That may be so where the expression appears with other cues that point to medicinal cannabis, such as cannabis imagery, pain claims, references to authorised prescribers, patient eligibility screening or a pathway to obtain treatment; in that case, the surrounding context may point to the advertising of a prescription medicine. However, the phrase “plant-based medicine” itself is not inherently a reference to a Schedule 3, 4 or 8 substance. It may also refer to herbal medicine, complementary medicines, naturopathic preparations, traditional medicines or general wellness products.
For that reason, the better analysis is not that “plant-based medicine” is always impermissible, but that it may be impermissible where the surrounding context makes clear that the communication is promoting medicinal cannabis or another identifiable prescription medicine. Without that context, treating broad service-oriented language as an indirect reference risks expanding the prohibition beyond its proper work.
A similar issue arises with references to “peptides”. In some contexts, that term may point to prescription-only substances, particularly where the material refers to injectable treatments, performance enhancement, weight loss, anti-ageing, hormone optimisation or named peptide products. In those circumstances, the TGA may have a reasonable basis for treating the communication as an indirect reference to prescription medicines. But “peptides” is also a broad scientific, physiological and cosmetic term, and may be used in relation to skincare ingredients, research, compounding discussions, practitioner education or general wellness claims (e.g., collagen peptides for general wellness purposes). Treating the word itself as necessarily promotional would risk capturing material that does not, in context, promote the use or supply of a prescription medicine.
It is also significant that the guidance appears to have been produced without prior consultation with affected stakeholders. That is particularly concerning because the guidance addresses practical boundaries that are highly fact-sensitive and commercially important, including how clinics, pharmacies, telehealth providers and other health service businesses may lawfully describe their services. Consultation may have assisted the TGA to test its examples against real-world service models, identify where legitimate clinical communications could be inadvertently captured, and draw clearer distinctions between promotional medicine advertising and ordinary information about health services.
A related concern is that the guidance may understate the distinction between advertising a clinical service and advertising the medicines that may be used in that service. A statement inviting consumers to speak with a practitioner about whether treatment options may be appropriate should not automatically be characterised as advertising a prescription medicine. Nor should a pre-consultation questionnaire or booking process be treated as promotional merely because it supports clinical triage.
The TGA is right to be concerned about business models that present prescription medicines as available on demand. However, ordinary clinical onboarding should not be collapsed into advertising. The distinction should turn on the overall impression created by the material – whether it promotes access to a medicine, or whether it facilitates a genuine practitioner-led assessment without suggesting that a prescription outcome is likely or available on request.
The same caution applies to condition-specific services. It should be possible to advertise that a clinic provides consultations for hair loss, weight management, pain, UTI assessment, sexual health or smoking cessation, provided the material does not promote particular prescription medicines or create an impression that prescription treatment is a foregone conclusion. If the guidance is applied too rigidly, it may stifle legitimate communication about the availability of lawful health services.
Businesses should review consumer-facing content by asking what the ordinary consumer would understand the material, taken as a whole, to be promoting. The review should include websites, landing pages, social media, paid advertisements, business names, logos, booking pathways, intake forms, patient portals, price lists, shopfront signage, direct marketing and linked content.
As a general rule, the safer approach is to describe the health service, condition being treated and/or therapeutic goal rather than the medicine, such as “pain management”, “sexual health”, “sleep improvement” or “weight loss”. Businesses should focus on the nature of the consultation, practitioner qualifications, clinical assessment process, eligibility for assessment and the need for individualised advice, and leave the question of treatment modality open. They should avoid product names, active ingredients, substitute terms, medicine class references, price information for prescription-only treatment, and language implying that a medicine can or will be prescribed as the applicable treatment.
Businesses should also be careful with imagery and user journeys. A consumer pathway that begins with a condition, presents a treatment category, offers an eligibility check and ends with a “request treatment” button will come across as promotional even if no medicine is named. Disclaimers advising consumers to speak with a practitioner will not cure material that otherwise funnels consumers towards prescription medicines.
The guidance is a useful and timely reminder that prescription medicine advertising restrictions apply to modern digital health models, not only to traditional product advertisements. It also provides practical examples that will assist businesses to identify higher-risk content and amend it before enforcement action is taken.
However, as the guidance appears to have been developed without stakeholder consultation, there is a heightened need for the TGA to apply it proportionately and to remain open to refining aspects of the guidance as practical issues emerge.
The guidance should also be applied with care. The prohibition is not a general ban on advertising health services, nor should it prevent consumers from being told that legitimate practitioner-led consultations are available. The critical question remains whether the material, viewed as a whole and in context, promotes the use or supply of prescription medicines. That contextual inquiry is where some of the most difficult—and potentially contestable—boundaries will arise.
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