A small injection of strictness: The TGA’s clampdown on cosmetic injectables advertising

Last month, the Therapeutic Goods Administration (TGA) announced it had updated its guidance on advertising cosmetic injectables. I have written about the subject, and have been interviewed about these reforms here, here, here, and here. But I was again recently interviewed on ABC Drive Canberra about these reforms. That short but lively conversation, embedded below, inspired this post.

In essence, the updates make it abundantly clear that all direct or indirect advertising of prescription-only medicines is prohibited in Australia. Although unwieldy, direct-to-consumer advertising of prescription medicine is often denoted by the acronym DTCA-PM. In essence, because many dermal filler or nerve-killing cosmetic injectable products, such as Botox, are prescription-only medicines, they cannot be advertised legally in Australia (without specific and exceptional approval).

The updates also reinforce the broad scope of the prohibition on DTCA-PM, including for injectables. As the guidance suggests, health practitioners cannot refer to injectables in ‘coded’ or implied ways either — such as by using acronyms, abbreviations, acronyms or hashtags. While some commentators have lamented these apparent changes, they are, in fact, nothing new. The announcement signals no substantive change or update to the law. It only heralds an update to the enforcement position of the TGA.

The structure of this lengthy blog post

In this long blog post, I analyse several aspects of the ban on DTCA-PM in Australia as they relate to cosmetic injectables. The blog touches on the Commonwealth therapeutic goods law and its interaction with the states and territories’ poisons and therapeutic goods frameworks. It also briefly considers whether the NSW framework requires nurse practitioners to prescribe injectables that are schedule 4 drugs, such as Botox, in face-to-face or in person consultations — or allows them to do so through an audiovisual consultation. It then considers why the TGA is ‘clamping down’ on injectables now, before considering the broader policy reason why advertising prescription medicines (DTCA-PM) is banned in Australia to begin with.

In the final sections, the blog post considers commentary related to the putative issues arising from the clampdown, including the practitioner’s duty to warn in the context of cosmetic treatments (and any civil liability arising therefrom). It then considers the kinds of offence provisions laid down by the Therapeutic Goods Act 1989 (Cth) (TG Act) for practitioners who unlawfully advertise prescription medicines. As a post-script, the blog post briefly considers other sources of law related to advertising prescription medicines, including the still-in-draft guidelines for registered health practitioners who advertise non-surgical cosmetic procedures.

What’s the therapeutic goods law on advertising prescription medicines?

Direct-to-consumer advertising of prescription medicines — or DTCA-PM — is prohibited by ss 42DLB and 42DL of the TG Act. The former provision is titled ‘Civil penalty relating to advertisements — general’ and it states, relevantly, that

A person contravenes this subsection if … the person … advertises, by any means, therapeutic goods; or … causes the advertising, by any means, of therapeutic goods; and … subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.

Section 42DLB features a range of ‘triggering’ subsections (subsections (2) through (9)). These define when an advertisement is a contravention of the section. Relevant to advertisements of prescription medicines is subsection (7). Its terms are as follows:

(7) This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

The reason subsection (7) picks up prescription-only medicines is because prescription-only medicines, including botox (‘BOTULINUM TOXINS for human use’) are included in Schedule 4 to the Poisons Standard (discussed below).

As subsection (7) also indicates, representations or promotions by government agencies will be excluded from the DTCA-PM ban. Furthermore, a broad exception applies to would-be advertisements disseminated by broadcasters, datacasters and other prescribed persons. This exception appears in subsection (10) and its terms are as follows:

(10) Subsection (1) does not apply if … the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and … as a result of steps taken by the person, it was reasonable for the person to assume that subsections (2) to (9) did not apply to the advertisement.

If an individual or body corporate is found to have breached the section, then a maximum civil penalty of 5,000 penalty units (AUD $1,565,000 as of 9 May 2024) or 50,000 penalty units (AUS $15,650,000 as of 9 May 2024) applies to those respective parties.

Section 42DL of the TG Act largely mirrors the civil provision discussed above, except it makes the same conduct a criminal offence. As discussed below, there are three tiers of criminal offences for unlawful advertising of therapeutic goods in Australia. Just as s 42DLB(7) makes DTCA-PM a civil offence, so does s 42DL(7) make that conduct a criminal offence.

As with most offences, the difference between the civil and criminal offence relates to intention and proof. Those prosecuted criminally must have intended to have breached the advertising provisions. Furthermore, in the case of the most serious criminal offence under s 42DL(1), the advertiser must have advertised a product where

the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

And, in accordance with provisions in the Evidence Act 1995 (Cth) (see ss 140 and 141) the prosecution must prove the offence beyond a reasonable doubt. By contrast, those who are subject to civil prosecution by the TGA (Secretary) need only have been reckless as to the advertising; and the prosecution need only prove the offence on the balance of probabilities.

What does this all have to with poisons?

Poisons — many of which are also used as therapeutic goods — are governed by what is called the Poisons Standard in Australia. That instrument is sometimes known by its long title: the Standard for the Uniform Scheduling of Medicines and Poisons or SUSMP. In its current form, the Poisons Standard is a Commonwealth legal instrument made by the Secretary of the Department of Health and Aged Care Secretary under s 52D(2)(b) of the TG Act. It is organised into 10 schedules, each of which imposes a recommended “level of control” over the availability of the poisons listed therein.

Schedule 4 of the Poisons Standard is titled “Prescription only medicines and prescription animal remedies”; it contains tens of substances, including, for instance, arsenic and lithium. By contrast, schedule 9 is called “Prohibited substances”; and it contains many substances too: cannabis and lysergic acid, for instance.

While the Poisons Standard is not binding on the state and territories and is merely recommended to those legislatures, the standards are generally adopted by each state and territory. Critics of co-operative federalism might postulate that this is one of the many different ways in which the central government influences or controls the states without having a constitutional licence to do so. But it is is not all top-down. Different states adopt the Poisons Standard into their laws in different ways. They then also add their own jurisdictional laws on top of the general classification schedules so that they exercise clear independent control over the poisons (some of which are therapeutic goods too) in accordance with their own preferences.

New South Wales’ poisons and therapeutic goods framework

In New South Wales, the legal instrument that adopts the Poisons Standard is called the Poisons List (long title: Poisons and Therapeutic Goods (Poisons List) Proclamation 2016 (NSW)). It takes the form of a Proclamation, and it simply proclaims the adoption of the Commonwealth instrument as follows:

Schedules 1 to 9 of the current Poisons Standard (within the meaning of Part 6-3 of the Commonwealth Act), as in force from time to time, are adopted as the Poisons List.

But on top of this, the Poisons and Therapeutic Goods Act 1966 No 31 (NSW) imposes prohibitions on these proclaimed poisons, specifically in pt 3 (ss 9 — 18D) of that Act. Notably, div 1A sets out requirements for substances and goods used for cosmetic and other purposes, including ‘botulinum toxins’ under s 18C(a). Contravening the requirements may result in a civil or criminal penalty under s 18D(2)(a) and (b).

These requirements are specified in the Poisons and Therapeutic Goods Regulation 2008 (NSW). For instance, reg 68B prescribes a few substances in addition to botulinum toxins to which the requirements in the Act apply. These include calcium hydroxylapatite, collagen, deoxycholic acid, polyacrylamide, polycaprolactone and polylactic acid when any of these substances are used in preparations for injection or implantation for tissue augmentation or cosmetic use. This regulation (and others) was introduced in an amendment of 2021; the purpose of the amendments were to set additional requirements relating to the administration, storage, and record keeping of medicine.

Another new regulation introduced in the 2021 reforms was reg 68C. It prohibits persons other than a nurse acting in accordance with a direction of a medical practitioner or nurse practitioner from administering the prescribed injectables. Nurse practitioners and medical practitioners are permitted to administer the injectables by themselves. In short, all patients receiving injectables must at least be overseen and personally reviewed (including by audiovisual link: see reg 68D(1)) the patient.

Can nursing practitioners or medical practitioners prescribe injectables via audiovisual link in New South Wales?

On these regulations alone, it would seem that a nursing practitioner (who must be endorsed by the Nursing and Midwifery Board of Australia (NMBA) and is not an enrolled or registered practitioner) or medical practitioner could consult a patient via audiovisual link (online) and then delegate the administration of an injectable to an registered or enrolled nurse (discussed below) under their direction. Interestingly, however, there is reason to doubt whether this is good or even permitted practice. In 2014, the Medical Board of Australia released a Public Consultation Paper titled Consultation – Registered medical practitioners who provide cosmetic medical and surgical procedures. Section 7.2 of the proposed guidelines at that time provided that

7.2 Medical practitioners must not prescribe schedule 4 (prescription only) cosmetic injectables unless they have had a face-to-face consultation with the patient. A face-to-face consultation is required for each course of injections. Remote prescribing (for example, by phone, email, or video conferencing) of cosmetic injectables is not appropriate.

To be sure, these proposed new guidelines apply only to medical practitioners. Still, several objections (see here and here, for instance) were made by nurse practitioners to the proposed guidelines. These objections were made not only because it was felt that face-to-face consultation might be an overreach, but because, as one submission explained, prescriptions can last 12 months. Accordingly, as that submitted wrote, there is

difficulty in interpreting the intention of the phrase ‘course of injections.’ Given that a medical practitioners prescription for S4s (in our company being for either a series of HA dermal filler injections, or a series of BTXA Injections) is valid for 12 months, we inferred that a ‘course’ of injections means the prescribed course or series during that 12 month period.

There is no medical need for the medical practitioner to examine a patient at every single appointment prior to receiving a single treatment of cosmetic injections if (a) the patient has had a full medical consultation with the medical practitioner; (b) the patient has been deemed a suitable candidate for a series of cosmetic injections and received a prescription from the medical practitioner, valid for 12 months; [and] (c) The patient was fully informed regarding the procedure upon the initial consultation with the medical practitioner.

As it happens, the question of a course of injections appears not to have been addressed directly since. Ultimately, however, it appears that the requirement for face-to-face consultations was abandoned: the 2016 Guidelines for registered medical practitioners who provide cosmetic medical and surgical procedures did not ultimately contain such a requirement. Similarly, the updated version of these guidelines, effective 1 July 2023, now specify at 3.1 that ‘Medical practitioners must have a consultation with the patient, either in person or by video, each time they prescribe them schedule 4 (prescription only) cosmetic injectables.’ Contrast this with the stricter rule for cosmetic surgery, which requires two consultations, including one in person:

3.1 A patient seeking cosmetic surgery must have at least two pre-operative consultations.

3.2 The patient’s first consultation must be with the medical practitioner who will perform the surgery or another registered health practitioner who works with the medical practitioner who will perform the surgery (not a patient advisor or an agent).

3.3 At least one of the two consultations must be in person with the medical practitioner who will perform the surgery.

3.4 Other consultation(s) can be in person or by video.

That there is no strict need for in-person consultations between nurses and patients seems to have been confirmed by the Nursing and Midwifery Board of Australia (NMBA) and AHPRA, which published a detailed policy on injectables called Position statement: Nurses and cosmetic medical procedures (Position statement) in June 2023. The Position Statement contains a great deal of information, including the scope of practice for enrolled nurses (ENs), registered nurses (RNs) and nurse practitioners (NPs).

Since cosmetic injectables are commonly prescribed and administered by these different categories of nurses, it is worth noting their different registrations. In Australia, a nurse practitioner is a registered nurse who has been endorsed as a nurse practitioner by the NMBA. Prescribing injectables is within an NP’s scope of practice. By contrast, an RN is a registered health practitioner who has completed a 3-year Bachelor of Nursing degree (or an equivalent approved qualification, such as a Master of Nursing degree) through a university course; and an EN is a registered nursing professional who has completed an approved diploma of nursing. As the Position statement clarifies, ‘RNs and ENs cannot prescribe Schedule 4 cosmetic injections.’ Thus, only NPs are entitled to prescribe injectables.

The NMBA’s Position Statement also clarifies that in-person consultations are not required for NPs to prescribe injectable drugs. However, the relevant authorised prescriber must be able to see the patient via video; it is not enough for them to communicate with the patient by phone or email:

NPs must not prescribe Schedule 4 cosmetic injections unless they have a consultation with the person receiving the cosmetic injection either in person or via video conferencing. Remote prescribing of cosmetic injections by phone or email (or equivalent) is not acceptable.

Though the health practitioner guidances and law is not the focus of this post, I will return to discussion of the regulatory framework for health practitioners in the final section. After all, it is interesting and necessary to understand how the therapeutic goods law and the regulation of practitioners interacts. Indeed, in one case discussed below, the Federal Court of Australia had to determine what was a suitable form of consultation for the purposes of the prescription of sch 4 drugs. While that analysis was undertaken pursuant to the therapeutic goods law on advertising provisions, it overlapped with the above-described concepts in the regulation of health practitioner law.

To wrap up discussion of the Poisons and Therapeutic Goods Regulation 2008 (NSW), it is notable that any supervised nurse (typically ENs) must not administer these substances unless emergency medical equipment is readily available. Supervised nurses must also record various details upon using injectables, including their name, the date of the injection, the batch number of the injectable product and the patient’s details too, among other things (see reg 68E). The bottom line is that these medicines have to be administered by or under the supervision of a registered medical or nurse practitioner in NSW; and other states have similar regulations.

Notably, in 2022, the Medicines, Poisons and Therapeutic Goods Act 2022 No 73 (NSW) was enacted; however, that Act has not yet commenced. Some Acts commence on specified dates specified in the commencement section, while others commence on a day after the date of assent appointed by a proclamation of the Governor. This Act, under s 2, is one of the latter kind: it will commence by way of proclamation. So, once this Act does commence, it will repeal and replace the 1966 Act discussed above. At that time, a new regulation — the Medicines, Poisons and Therapeutic Goods Regulation 2023 (NSW), which is currently in draft form and appears to still be in the process of consultation — will come into force too. In December 2023, a so-called RIS (or regulatory impact statement) was produced by strategy firm ACIL ALLEN. It outlines many of the changes to be introduced by the new Act and Regulations.

Queensland’s poisons and therapeutic goods framework

The same kind of ‘streamlined efficiencies’ that the new (but not yet operative) New South Wales poisons and therapeutic framework promises to bring have already been rolled out in Queensland. Before 2019, poisons (excluding pesticides and veterinary products) were regulated under the Health Act 1937 (Qld) and the Health (Drugs and Poisons) Regulation 1996 (Qld) and Health Regulation 1996 (Qld). Following a review, the Queensland parliament (a unicameral parliament) passed the Medicines and Poisons Act 2019 (Qld) to streamline the regulation of poisons and prohibited substances. Regulations supporting this primary Act include the Medicines and Poisons (Medicines) Regulation 2021 (Qld) and the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (Qld). It is this latter regulation that applies the Poisons Standard (discussed below).

Section 9 of the Medicines and Poisons Act 2019 (Qld) sets out the relationship between that Act and the Poisons Standard, noting, for instance, at s 9(1) that words in both Acts generally mean the same thing and at s 9(2) that an interpretation applying to the Poisons Standard will apply to the Queensland Act. However, there are many bespoke provisions for poisons regulation in the Queensland law, both in the primary Act and the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (Qld). Section 34(1) of the Medicines and Poisons Act 2019 (Qld) , for instance, makes it an offence for a person to by or possess a schedule 4 medicine (and this would include botox) unless authorised to do so or with a reasonable excuse. Exceptions are made in s 34(2) for therapeutic uses; however, this would mean that persons who buy botox without an authorisation would be subject to prosecution under the Queensland law for doing so.

If advertising injectables has always been prohibited, why is the TGA clamping down now?

The TGA’s announcement openly states that it has previously taken a permissive approach to enforcing the ban on advertising injectables. In the last few decades, it has allowed clinics and practitioners to promote these prescription drugs indirectly:

Historically, the TGA has allowed indirect references to prescription medicines to be referenced in advertisements related to cosmetic health services. This was allowed only in the context of promoting the service and only by using generic non-product specific terms such as ‘wrinkle reducing injections.’ Express references to products or ingredients themselves, such as ‘Botox’ or ‘botulinum toxin’, were not permitted. The TGA considered this a pragmatic approach which would allow cosmetic clinics who offered these services to differentiate themselves from those that did not.

The wording of the announcement — specifically the TGA’s reference to its past practice — is questionable. Has the TGA really distinguished between advertisers who used direct versus indirect references to injectables in the past? Or has it simply let the industry remain unpoliced? Because exactly how — and how often — the TGA has actually prosecuted practitioners who might have made ‘express references to products or ingredients’ such as ‘Botox’ is now virtually impossible to ascertain.

The TGA’s responsive, dialogical and risk-based enforcement approach to unlawful advertising means that practitioners who may have been subject to low-level enforcement action (such as a letter of caution) do not appear in the published datasets. As with all responsive or risk-based regulatory regimes, the totality of the enforcement activity of the agency — in this case the TGA — can be something of a black box.

To be fair, the TGA reports its advertising compliance activities on its Advertising and Compliance Investigations Outcomes webpage. And that page does include activity reports about those who have been subject to low-level intervention, such as cautionary letters. However, none of these activity reports identifies what kind of product was being unlawfully advertised, nor what part or section of the TGA’s advertising laws the advertiser had breached. In short, it is hard to say just how strictly the TGA has pursued breaches of advertising for injectable advertisements in the past.

Like much in the history of medical regulation, the TGA likely had little reason to police the industry in circumstances where few public scandals had arisen — or where those issues that had arisen were not widely known. But this was probably not sustainable due to ‘spillover’ from two other developments: some other new prescription drugs had emerged that needed action, and a cosmetic surgery review had also drawn attention to the cosmetic sector more generally.

Other modern drugs moved the dial on injectables

Recently, clinics and health services offering other prescription medicines – weight-loss injections (Ozempic), vaping products and medicinal cannabis — have begun their own direct-to-consumer advertising of their products. This has troubled the TGA. Its announcement observes that these other industry advertisements usually promote these products using a mixed service-product advertisement — ‘by referring to a class of goods (for example ‘weight loss injections’, ‘medicinal cannabis’ or ‘nicotine vaping products’)’ rather than a specific brand name or modality of treatment. As the announcement states, ‘the TGA has interpreted that promoting a health service in this way is also an advertisement for a therapeutic good that refers to prescription medicines, which is unlawful.’

Given this assessment, ithe TGA acknowledges that an inconsistent and exceptional policy position for injectables would have been quizzical:

To resolve any inconsistency in interpretation across industry areas, the TGA no longer permits references to terms such as ‘wrinkle reducing injections’ where those terms would result in a reasonable consumer understanding the intention of the content is to promote the use or supply of a prescription medicine.

But inconsistency in regulation is not bad per se. Risk-based regulation typically embraces inconsistency, but it does so in a controlled way. It identifies high risks medicines and exerts more regulatory control over them, while relinquishing control over low-risk medicines. It does this precisely to exert the appropriate level of oversight over different products. So if the TGA were really inclined to think of cosmetic injectables as substances distinguishable from other sch 4 prescription drugs, such as vaping and Ozempic, then an exception could have been carved out for these substances that permitted them to be advertised in the same way the TGA had permitted them to be promoted in the past (albeit now with the support of express textual exemptions).

However, in the wider circumstances of AHPRA’s cosmetic surgery review, which was published in 2022, and the extension of that review into non-surgical cosmetic procedures (in large part about injectables), such a course of action would not have been justifiable. In reality, it is probably not inconsistency that underlies the policy change but a recognition that injectables are not low-risk products — even if they were rated as such previously.

Scandal creep

In regulation, reform often begets more reform, just as complaints about misconduct often beget more complaints about related categories of misconduct. Such was the case in this instance, where AHPRA’s review of the cosmetic surgery sector, triggered by scandals in Victoria and elsewhere, ended up ‘widening to introduce stronger safeguards for the booming non-surgical cosmetic procedures sector, including new guidelines for registered practitioners performing and advertising aesthetic treatments.’ As AHPRA noted, the ‘number of reported complaints of serious harm from cosmetic surgery has grown significantly since attention was focussed on the sector over the past 18 months’ and ‘the more frequent use of non-surgical cosmetic procedures, and the expanded range of practitioners who provide them, creates the potential to put a larger section of the community at risk of some harm.’

AHRPA, of course, is not able to reveal the names and stories of patients who have been harmed and complained about cosmetic procedures. But in its announcement, it illustrated with several pseudonymous examples that cosmetic injectables are by no means ‘safer’ than either the cosmetic surgery industry or, more relevantly, comparable prescription drug industries (such as the medicinal cannabis industry). For instance, AHPRA provided four semi-fictional examples of the harm caused by cosmetic treatments. Here are just two:

• Yasmin is a patient with a history of mental illness who disclosed her history of body image issues and expressed dissatisfaction with the results of 10 previous non-surgical cosmetic procedures. Despite this history, a doctor administered a series of filler injections.
• Jennifer was treated with dermal fillers by a registered nurse, despite having several known skin conditions that made the treatments inappropriate and dangerous. Following treatment, Jennifer had an adverse reaction which required the fillers to be dissolved and steroid treatment to address the reaction.

The character of ‘Yasmin’ clearly illustrates the emerging but probably long-underestimated risk that cosmetic procedures will not always be a suitable treatment option for people with mental health issues associated with body dysmorphia — especially where those issues already stem from prior non-surgical cosmetic procedures, such as injectables.

But why is prescription medicine advertising banned in the first place?

The policy basis for the ban on DTCA-PM in Australia is said to follow a ‘simple logic.’ Because ‘advertising stimulates a perceived need for a drug‘ and leads patients to compel practitioners to prescribe them the drug, this in turn is thought to lead to more widespread demand and supply of the drug. Increased expenditure on prescription medicines across the country leads to bigger government outlays within the Pharmaceutical Benefits Scheme (PBS) (and in other related areas), which ultimately increases the cost of Australia’s public healthcare system overall. Setting aside the merits of this macroeconomic policy explanation, it becomes clear on review of the experience of the two jurisdictions that permit DTCA-PM — the Unted State and New Zealand — that permitting DTCA-PM may create social problems too. Indeed, of all the jurisdictions in the world, only the United States and New Zealand permit the DTCA-PM.

DTCA-PM in the United States

In the United States, this permissive approach is often associated with (or even blamed for) for the proverbial epidemic of prescription drug dependence afflicting modern America. Because addictive and powerful prescription medicines such as oxycodone are advertised directly to consumers, they have become part of the visual and cognitive landscape of the nation. No doubt the omnipresence of such advertisements, including in various online and private social media contexts, would make it far more difficult for a person adversely dependent on the drug to divert from a harmful pattern of use.

One historically prominent defender of DTCA-PM in the United States — the psychiatrist Arthur Sackler, who ran a public relations firm called the William Douglas McAdams
company — also helped revolutionise drug marketing in America. Indeed, in the United States, there is even a Medical Advertising Hall of Fame. In 1998, that institution declared
that

No single individual did more to shape the character of medical advertising than the multi-talented Dr. Arthur Sackler. His seminal contribution was bringing the full power of advertising and promotion to pharmaceutical marketing.

In 1957, Sackler’s defence of medical marketing was based on information dissemination and education. Speaking of pharmaceutical marketing generally, Sackler claimed as follows:

Pharmaceutical advertising has made one of the major contributions in the rapid dissemination of new therapeutic information. There are fascinating case histories of wonderful medications inadequately used and only applied to a small percentage of those patients who require them.

It is difficult to contend now, some 70 years later, that this information-based (or education) argument remains tenable — not just as it pertains to DTCA-PM but to marketing aimed at physicians and clinics. The information ecology has radically transformed since the 1950s due both to the great expansion of human knowledge about medicine and the emergence of the Internet. Additionally, the world of advertising has grown tremendously. One comprehensive study of spending on DTCA-PM in the United States between 1997 and 2016 show advertisements to be ever increasing:

DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million.

Still, DTCA-PM in the United States is not a free for all. Advertisements are regulated by the Federal Drug Administration, and its Office of Prescription Drug Promotion (OPDP). Section 502(n) of the Food, Drug, and Cosmetic Act (codified in Title 21, ch 9 of the United States Code) requires that advertisers of prescription drugs and biologics include ‘‘a true statement’’ of certain information including ‘‘information in brief summary relating to side effects, contraindications, and effectiveness’’ as required by regulations issued by FDA.

While many contend that the overall impact of DTCA-PM in the United States threatens the ‘public’s health and the quality of health care‘ by ‘ promoting ‘drugs over healthy alternatives,’ proponents often hold fast to the educative arguments enunciated by Sackler in the 1950s. Paradoxically, one study has shown that DTCA-PM about psychiatric medications can result in patient non-adherence. As the study notes, patients who learnt of adverse event (and other) information through the information that pharmaceutical companies are required to provide in all advertisements were dissuaded from taking those medications by those warnings. Of course, the inclusion of this information is not the purpose of the advertisements, but a condition of their distribution.

DTCA-PM in New Zealand

While New Zealand appears to have fared better in terms of its overall culture of prescription drug use, proposals to prohibit DTCA-PM have been on the agenda for more than 10 years. Last year, the Council of Medical Colleges in New Zealand (CMC) wrote an open letter to Health Minister Ayesha Verrall to ban direct-to-consumer advertising of prescription medicines (DTCA-PM). The authors of the letters noted that DTCA-PM presents a ‘biased, overly optimistic picture of advertised medicines and prompts patients to request treatments they do not need.’ The authors also enumerate 10 reasons why the CMC recommends legal amendments to prohibit DTCA-PM, including because it:

1. is prohibited almost everywhere else in the OECD;
2. is inconsistent with efforts to improve New Zealanders’ health literacy;
3. targets the most vulnerable;
4. leads to increased costs for the health system;
5. leads to inappropriate prescribing and overtreatment;
6. leads to iatrogenic harm;
7. puts the doctor–patient relationship at risk;
8. cannot be subject to regulation other than prohibition, because those options are flawed [my paraphrase];
9. does not provide patients with useful information; and
10. perpetuates power imbalances in pharmaceutical companies’ favour.

The same ten reasons were also included in a submission the CMC made on a proposed Bill in New Zealand — the Therapeutic Products Bill 2023 — which, based on its timing and subject matter, was well-placed to implement a prohibition on DTCA-PM. However, in the third reading of that Bill, on 18 July 2023, the Health Minister explained that no ban on DTCA-PM would be adopted:

I acknowledge that there is concern about the harms caused by direct-to-consumer advertising. Currently in New Zealand, medicines can be advertised direct to consumers under some controls. Officials have looked at the evidence around direct-to-consumer advertising of prescription medicine, and they did not find sufficient evidence to justify a ban. However, changes made to the bill strengthen the controls that can be placed on advertising and include the opportunity for prohibition, should sufficient work be done to justify that in light of some of the New Zealand Bill of Rights Act concerns and that we work through the potential for unintended consequences there.

As a doctor, I am extremely attentive to the views of medical practitioners and advocates who have been in touch to ask for direct-to-consumer advertising to be banned. We do all want the very best for our patients and the public, but as a legislator, I take my role extremely seriously and want to ensure that we do not make legislation about such important matters in haste. I want to be careful that there are no unintended consequences for making decisions without due consideration.

One ‘Viewpoint’ study published in the New Zealand Medical Journal, written in advance of the debate on the Bill, drew on evidence that DTC advertisements were ‘commonly misinterpreted’ by patients ‘as trusted public health messages.’ The article found that DTC advertisements were therefore ‘more likely to affect vulnerable subgroups’ (ie, those who are at-risk’) by persuading those groups they were in need of a drug they did not need. Despite this, more evidence appears to be needed to shift the policymaking appetite in New Zealand.

Issues arising from TGA’s clampdown

A few interesting questions have arisen in the context of these changes. Many practitioners — registered nurses and their supervised staff — have expressed objections to the TGA’s new enforcement posture. In some recent reports (in which I am quoted), it has been said that greater enforcement on DTCA-PM for injectables will lead to an information-scarce environment and that this may in turn lead to medical tourism. However, to my mind, discussion about the likelihood of medical tourism arising as a result of these changes seems to be unsupported by compelling reasoning. Before addressing that, it may be useful to describe the effects of the new posture.

It is likely that some health consumers seeking botox or dermal fillers will feel less well-informed when they begin their search for those products. That is because the effect of the new position of the TGA regarding the DTCA-PM ban in Australia will mean, in effect, that clinics and practitioners will no longer be permitted to disclose information about the products they offer in any material they create and disseminate to the public. This would include on social media and even outside the clinical consultation. It is likely to mean that even in the context of a waiting area of a clinic, such information will be prohibited.

Even before-and-after images are likely to be prohibited (on social media as well as in clinics outside the consultation setting) where those before-and-after images make apparent to the consumer, even indirectly, that a particular sch 4 prescription drug has been used to achieve the result. This kind of material would be prohibited because it would likely constitute an indirect advertisement of the sch 4 prescription medicine.

Given the scope of the restrictions on almost all forms of advertising of injectables, it is clear that consumers will ultimately be required to schedule and pay for a consultation with a registered health practitioner to confirm that a specific product — eg, the desired injectable — is available to them. This would depend not just on the availability of that product in the clinic, but on whether the practitioner agreed it was a suitable course of treatment for the patient for the purposes of writing a prescription.

In terms of the legislation, the reason that a clinician is able to promote a product in the context of a one-to-one consultation is because s 42AA(4) of the TG Act disapplies pt 5-1 of the TG Act (‘Advertising and Generic Information’) for those kinds of consultations, as follows:

This Part does not apply to advice or information given directly to a patient by a person referred to in paragraph (1)(a), (aa) or (c) or subsection (2) in the course of treatment of that patient.

So, while some consumers may be irritated that they cannot see before-and-after images from clinics, those images would likely be permitted to be perused and discussed in the context of a consultation, where s 42AA(4) would apply. Similarly, while consumers may be disappointed not to be in a position to confirm that a clinic provides botox, for example, before they schedule a consultation, such information would be available in the consultation setting.

Of course, s 42AA(4) does not specify that the ‘information given directly to a patient’ must be given in a consultation setting. The reality of health practice, however, is that information given directly by practitioner to patient can rarely occur outside such a setting. Recent reports, of course, indicate that this does happen all the time — and those reports refer to the problem as one to be addressed by AHPRA. However, it may well be addressed by the TGA too. After all, as I will discuss below, the exception in s 42AA(4) that allows a practitioner to give information to a patient has been understood by the Federal Court of Australia as requiring the information to be passed only where the relationship between the relevant information-sharing practitioner and the specific patient possesses four elemental features, including that a patient consultation and clinical examination has been performed.

Medical tourism? Highly unlikely

It is doubtful that health consumers will find this situation so difficult as to be prompted to fly overseas to access botox from a clinic. It does not seem likely that, simply because a consumer is not immediately able to ascertain from an Australian clinic that they will be able to receive an injectable from that practice, they will book a flight to a jurisdiction in which other clinics advertise the availability of that drug. While in my view far-fetched, in such a hypothetical scenario, the advertisement of the injectable would presumably be visible in the overseas jurisdiction because DTCA-PM was permitted — or not well enforced — in that country. However, as noted above, few countries permit DTCA-PM. Ironically, of all the places in the world, Australian consumers would perhaps seek to fly to New Zealand if they were to do so, given that New Zealand does not prohibit DTCA-PM and would permit practitioners to advertise injectables on social media and websites.

Even still, however, it is much more expensive to fly to another country than to book a consultation with a practitioner at the risk of being advised not to undergo a cosmetic treatment. On that basis, it seems most unlikely that the new enforcement posture of the TGA will plausibly lead to medical tourism. This is not to detract from the fact that these same advertising restriction with respect to cosmetic surgeries may well lead to medical tourism, as has been observed here and here.

Word of mouth? Consider the model of psychiatry

Though perhaps not likely to lead to increased medical tourism, the TGA’s changed approach may lead consumers to share and rely on word-of-mouth information more than before. Online reviews and forums have been recognised as a considerable source of ‘online psychoeducation’ for people living with bipolar disorder and other psychiatric illnesses. On the other hand, some psychiatric forums do not allow discussion of specific drugs because such information may be misunderstood outside the context of a clinical consultation.

Many forums devoted to psychiatric health services feature discussion of which practitioner is likely to prescribe which particular medication. Such forums are sometimes regarded as facilitating ‘doctor shopping’: a means by which patients can find a practitioner who will prescribe them a medication with minimal clinical objections. But other issues may arise. It is possible to imagine that clinicians unable to advertise may pose as anonymous consumers on such forums to confirm the fact that they will offer certain sch 4 drugs. For critics, this circumstance may seem undesirable because the quality of the information in these contexts might be viewed as less reliable and, in some cases, in need of correction or clarification.

But such online information environments are normative in many areas of health practice today. Various internet forums are devoted to discussing and rating medical practitioners. Theorists who might defend the permissive approach of the United States on the basis that the requisite disclaimers in medicines advertising about adverse events gives patients high-quality information they might otherwise not see on internet forums may have a point. However, it is not clear whether such critics would also seek to ban poor information online. This is a complex issue. Indeed, it is arguable that where patients rely on ‘reliable’ disclaimers over ‘unreliable’ online forums, the importance of the practitioner consultation is diminished rather than enhanced.

All laws lead to the clinic: the consultation remains paramount

Developments across many vectors of medical law — therapeutic goods law, health practitioner law, consumer law, and the common law — seem to indicate that, in the last 50 years, legal protections for health consumers have been thought to be best facilitated in and by the clinical consultation. As I have suggested already, the advertising restrictions in Australia seem ultimately to have the effect of directing a consumer to the clinical consultation, where all the obligations of care and skill between the practitioners to patient can be discharged.

Of course, although the clinical consultation may itself not be a panacea, the law of informed consent in Australia, which was revolutionised by the decision of the unanimous High Court in Rogers v Whitaker (1992) 175 CLR 479, lays down robust protections for patients. In theory, these protections ensure practitioners give consumers high-quality and personalised information, warnings and advice about any ‘material risks inherent in [a] proposed treatment.’ But what is the ambit of this regime?

The first step is to consider inherent risks. The term ‘inherent risk’ can be difficult to define. Leeming JA provided a detailed analysis of that term’s meaning in Paul v Cooke (2013) 85 NSWLR 167 — albeit an analysis focused on its meaning within s 5I of the Civil Liability Act 2022 (NSW). Ultimately, his Honour indicated that any analysis of an inherent risk ‘requires an analysis of the position before it materialised’ (182 [65]) so that ‘a risk of something occurring in the future, if it cannot be avoided by the exercise of reasonable care and skill, is an ‘inherent risk”‘ (182 [66]). In the context of injectables, it would appear that the risk of infection, localised pain, and ecchymosis or bruising could be understood as inherent risks. As such, a practitioner would hold a duty to warn of such inherent risks according to the ratio of Rogers v Whitaker, so long as they were also ‘material’ risks.

In Jiang v BCDS International Pty Ltd t/a/ Serendipity Miss Beauty [2019] NSWDC 578, the plaintiff underwent a non-invasive cosmetic facial treatment called a ‘3D Skin Lifting by Ultrasound’ in a clinic in Sydney; however, the plaintiff developed facial redness, burning, blistering, lumpiness and depigmentation to parts of her face that caused distress and embarrassment. In addition to claiming the treatment was administered negligently, the plaintiff contended that she had not been appropriately informed by the relevant practitioner of the nature and extent of a risks associated with that treatment.

These facts led Levy SC to consider the meaning of inherent risk within the meaning of s 5I of the Civil Liability Act 2002 (NSW) on the basis that, following Paul v Cooke (discussed above), if s 5I applied then it would extinguish the liability of the defendant-practitioner. However, the analysis in this decision is of limited usefulness because it is focused on the ‘inherent risk’ defence rather than the duty to warn of material risks inherent in the treatment. Nevertheless, in short, the ‘inherent risk’ defence did not apply here because: the patient had no knowledge of the risks the cosmetic procedure carried [79]; the patient had been assured it was ‘very safe’ [109] and had not been made aware of any risks; and a signed consultation form, on which the defendant relied as proof of disclosure of information, had not been provided to the patient in full (only the signature page had been provided) [107]. Although of limited authority for failure to warn cases, the decision indicates the likelihood of an ‘inherent risk’ defence failing where substantive warnings are not provided.

So what, then, are material risks — the other kinds of risks described in Rogers v Whitaker? The test in Rogers is often said to comprise two limbs — an objective and a subjective limb. According to the Review of the Law of Negligence (the Ipp Review), the duty to warn of material risks is both ‘proactive and reactive.’ In any event, it was parsed by the High Court (at 490) as follows:

a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it.

In either case of the subjective and objective — or the proactive and reactive — test, the duty inexorably falls on the practitioner to identify whether risks are material. The patient themselves does not hold a duty to inform themselves.

Two vectors of materiality are often raised in relation to medical procedures: severity (or gravity) of the risk and likelihood (or probability) of the risk. It is of course logical that a risk of severe or grave injuries that is statically probable would be material, because, as Rogers dictates, a ‘a reasonable person in the patient’s position, if warned of [such a] risk, would be likely to attach significance to it.’ Sometimes probability is also discussed in terms of rarity. And, as Bismark and colleagues note, ‘It is reasonable to think of rarity and severity as considerations that operate in tandem, on a sliding scale.’

In essence, if a risk is either severe or likely, it is likely to be material. It is only where the risk is neither of these things that it might be immaterial. As Bismark et al write, ‘Small risks of catastrophic outcomes usually warrant emphasis, as do high risks of relatively minor adverse outcomes, but not low risks of minor outcomes.’ In terms of cosmetic injectables, then, it might be said that, on one view, the risk of bruising is a material one — not because it is severe, but because it is likely.

Of course, the practitioner’s determination of materiality may well be reconfigured by the patient’s requests for information: hence the ‘subjective’ or ‘reactive’ limb of the test, which requires practitioners to pay attention to what the ‘particular patient’ in a clinical consultation says or does. As Bismark and colleagues note, ‘Distinctive characteristics of individual patients may also dictate the breadth and depth of discussion about certain risks.’ In terms of cosmetic injectables, then, it should be clear that a patient who expresses concern that an injection may cause infection or bruising should be warned of that risk, even where that risk would not otherwise be regarded as material.

However, in any discussion of the duty to warn of material risks inherent in a proposed treatment that has been the law of Australia since Rogers v Whitaker, it is probably important to disentangle the policy of this law from the more general legal concept and understanding of informed concept. In the NSW Court of Appeal in Wallace v Kam [2012], Allsop P observed that

The duty and the rule of responsibility are not to protect the patient from the risk of an uninformed decision; they are not to protect the integrity of the decision: Rosenberg at 456 [61] and Rogers v Whitaker at 489-490. They are to protect the patient from harm from material inherent risks that are unacceptable to him or her.

As Allsop P’s observation indicates, the duty centres on preventing a patient from hazarding a risk that would be, if they were warned about it, unacceptable to them. Thus, the law of negligence will not aid a patient who is aggrieved that they were uninformed of a risk that was innocuous or acceptable to them. The majority (French CJ, Crennan, Kiefel, Gageler and Keane JJ) of the High Court, in the appeal to that forum in Wallace v Kam (2013) CLR 375 (at 389 — 390 [36]) said much the same thing; however, the High Court put it in different terms, distinguishing the ‘single comprehensive duty’ to provide advice and treatment from the ‘component of that single comprehensive duty’ known as the duty to warn:

The duty of a medical practitioner to warn the patient of material risks inherent in a proposed treatment is imposed by reference to the underlying common law right of the patient to choose whether or not to undergo a proposed treatment. However, the policy that underlies requiring the exercise of reasonable care and skill in the giving of that warning is neither to protect that right to choose nor to protect the patient from exposure to all unacceptable risks. The underlying policy is rather to protect the patient from the occurrence of physical injury the risk of which is unacceptable to the patient.

In practice, it can be said that a practitioner administering injectables has a duty to warn the patient of risks inherent to that treatment that the patient would not accept. It follows that it is the practitioner’s responsibility to determine what inherent risks a patient would not accept in order to then warn them about those risks.

As they relate to cosmetic surgery, these precise issues were considered in a review of the area as long ago as 1999, when the NSW Minister for Health commissioned the Cosmetic Surgery Report (October 1999). That was, of course, before the CLAs were enacted and before cases such as Wallace v Kam were heard. However, a notable point made in that report asserted that

The courts regard the duty to warn as more onerous in cosmetic surgery because patients have a choice about whether to have the procedure. If there is a perceived level of inducement to have a procedure, coupled with failure to warn of risks, the doctor has a greater burden to demonstrate that the patient was properly informed

Unfortunately, however, no citations are given as authority for this principle in that Report; and there appears to be very few cases to support it. Granted, a ‘greater duty to warn of risks’ in cosmetic surgery was discussed in the Lancet in December 1988 as it was said to have been recognised in an (uncited) case involving a patient who unsuccessfully sued a surgeon, Mr Cochrane, for not warning of the risks of breast implants.

However, as the author of that short article notes, this authority is in conflict with the ruling of the UK Court of Appeal in Gold v Haringey Health Authority 1987 [1988] QB 481, CA, in which Lloyd LJ (Watkins and Stephen brown LJJ agreeing) (at 489) rejected the distinction between therapeutic and non-therapeutic treatments (including ‘a face-lift’) as ‘elusive,’ and said that distinguishing between advice given in ‘a therapeutic content and advice given in a non-therapeutic context’ would be contrary to established principle (namely, the principle enunciated in Bolam, which is not relevant to the failure to warn in Australia, it having been displaced by Rogers v Whitaker). Without clear authority on the point, there seems no clear reason to assume that the courts will regard the duty on practitioners administering injectables as more onerous than that imposed on practitioners performing so-called therapeutic treatments.

Conclusion: What if practitioners breach the prohibition on advertising injectables under the TG Act?

In 2018, amendments were made to the TG Act to introduce a new ‘tiered’ offence regime for advertising offences. This regime includes serious and ordinary criminal offences, as well as civil offences. The amendments make it a serious offence to advertise goods to a person who, in reliance on that advertisement, is or would be likely to be harmed or injured through the use, or potential use, of the goods. Serious offences must infringe certain ‘contravening provisions’ identified in the primary legislation; these include the civil prohibition on advertising prescription medicines under s 42DLB(7), as well as the criminal offence of doing the same thing under s 42DL(10).

As at 14 March 2024, a maximum of AUD $1,252,000 (1.252m) or 5 years’ imprisonment (or both) applies to the criminal offences. Civil penalties corresponding to the criminal offences (where no intention is needed to be proved) would involve fines of up to AUD $1,565,000 ($1.565m) for an individual and AUD $15.56 million for a body corporate.

In 2019, in Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Peptide Clinics), Jagot J in the the Federal Court of Australia (FCA) ordered that a penalty of $10 million dollars be imposed on Peptide Clinics Australia Pty Ltd (PCA) for contraventions of various advertising provisions under the TG Act. In its written submissions, the Secretary of the TGA alleged that PCA had advertised on its website, Facebook and Instagram in a ways prohibited under section 42DLB(7) of the TG Act. In analysing the operation of the TG Act, Jagot J said as follows:

[Peptide Clinics] had advertised therapeutic goods in a way proscribed by s 42DLB(7) of the TG Act. For a period of approximately 8 months, PCA advertised peptides – on its websites, Facebook and Instagram – and peptides are included in sch 4 of the Poisons Standard; additionally, for a period of about 14 days, PCA had also used the word ‘peptides’ in these advertisements.

Any practitioner or clinic advertising injectables in sch 4 of the Poisons standard in the same way that PCA did may be subject to the same kind of prosecution as PCA.

However, there is more to say about Peptide Clinics related to the information that it was alleged to have given to its patients in contravention of the TG Act (as outlined above). As already discussed, advice or information given directly to a patient by a specified health professionals under s 42AA(4) of the TG Act will not be a civil or criminal breach. Accordingly, the question that arose in Peptide Clinics was whether the process PCA had designed to give information to patients (probably to avoid the advertising ban) was exempt from the advertising prohibition under s 42AA(4). The process involved 5 steps, as follows:

• Prospective patients filled out an online questionnaire;
• the form was then sent to the clinic, which prompted a person — an unknown medical practitioner — to approve the form and then allow the patient to access the ‘back end’ of the PCA website;
• the back end of the website then advertised to the patient the various peptide drugs (sch 4 prescription medicines) they could purchase sale through PCA;
• the patient then purchased the drugs through this back-end of the website.

In her Honour’s analysis of the way the ‘back end’ of the PCA website delivered this ‘information’ to the patients, Jagot J found (at 21) that these were in reality advertisements that were not exempt under s 42AA(4). That was because, in these circumstances,

(1) the customer does not know the identity of the medical practitioner; (2) the medical practitioner has not satisfied the minimum requirements for conducting a patient consultation and a clinical examination of the customer or the patient; and (3) the medical practitioner has not treated the customer, including because the medical practitioner has not advised the customer of the risks associated with treatment involving the use of the Advertised Products.

As Jagot J further found, the exempting provision could not apply because the advice or information given could not ‘be said to have been in the course of treatment of the patient.’ That was so because

the medical practitioners involved, according to the evidence… (1) do not take a fully informed medical history from the customers; (2) do not provide the customers with all current treatment options available for managing their condition; (3) do not inform the customers of the risks and benefits of each treatment option; (4) do not follow-up the management process of the customer’s condition; and, (5) generally fall well short of the minimum standards expected of a doctor when treating a “patient” in respect of a medical condition.

All of this illustrates the paramount importance of the clinical consultation for the purposes of the TG Act’s exemption for the provision of information about prescription medicines. Practitioners should be aware that all of the above elements should be a part of the consultation process to ensure that any advice or information they give is regarded as non-promotional for the purposes of s 42AA(4) of the TG Act.

Post-script: Other legal sources of advertising restrictions for injectables

Several other legal restrictions on advertising injectables exist in Australia beyond those laid down in the therapeutic goods law. Advertising that is false, misleading or deceptive, for instance, will be contrary to several provisions of the Australian Consumer Law, contained in sch 2 of the Competition and Consumer Act 2010 (Cth).

More directly, the Australian Health Practitioner Regulation Agency (AHPRA) publishes several guidelines that deal with advertising, including most relevantly its Guideline for advertising regulated health service (December 2020). The so-called advertising guideline is made pursuant to the ‘codes and guidelines’ provision at s 39 of the Health Practitioner Regulation National Law (National Law), as well as by reference to the advertising provision under s 133 of the National Law. Notably, s 133 sets out some general prohibition on advertising health services, including the use of health service testimonials, which is banned under s 133(c).

But more guidelines are coming specifically for non-surgical cosmetic procedures. Beginning 27 November 2023, the Nursing and Midwifery Board of Australia (NMBA) and AHPRA opened consultation to the public on a proposal titled the Regulation of health practitioners who perform and who advertise non-surgical cosmetic procedures (the proposal document is available here (pdf)). That proposal contains three draft guidelines:

• Draft Guidelines for nurses who perform non-surgical cosmetic procedures
• Draft Guidelines for registered health practitioners who perform non-surgical cosmetic procedures
• Draft Guidelines for registered health practitioners who advertise non-surgical cosmetic procedures

Needless to say, the last proposed guideline (cosmetics advertising guidelines) is the most relevant to advertising injectables. Though the consultation period ended on 2 February 2024, the guidelines remain in draft form.

But these cosmetic advertising guidelines are comprehensive. They note that the National Boards of AHPRA (and the co-regulators in co-regulatory states, such as the Councils in NSW or the Health Ombudsman in Queensland), may seek to admit the guideline into evidence in any proceedings instituted under the National Law (under s 41 of that National Law) and use it as evidence of what constitutes appropriate professional conduct or practice for the profession. In other words, the guidelines will become a source of law (as a piece of extrinsic material or soft law) in any disciplinary or professional proceedings under the National Law, including in proceedings for suspension or deregistration or a prohibition order for unsatisfactory professional conduct (s 139B) or professional misconduct (s 139E).

The guidelines themselves are made up of ten sections, titled as follows:

1. Practitioner responsibility
2. Titles and claims about training, qualifications, registration, experience and competence
3. Financial and other incentives
4. Testimonials
5. Social media influencers and ambassadors
6. Use of images including ‘before and after images
7. Risk, recovery, and idealising non-surgical cosmetic procedures
8. Body image and promotion for wellbeing and improved mental health
9. Realistic expectations of outcomes
10. Targeting people potentially at risk

Each of the sections above houses several subsections composing various rules laid down in strong prohibitive language. Under 9.1, the guidelines states “Non-surgical cosmetic procedures must not be advertised in a way that creates unrealistic expectations of outcomes”; and under 9.2, it is said that “Advertising of non-surgical cosmetic procedures must not make claims about psychological or social benefit or similar claims that cannot be supported by acceptable evidence.” While a detailed analysis is not to the point of this blog post, the guidelines are, as noted, quite comprehensive; indeed, they mirror the restrictions on advertising sch 4 substances under the TG Act and echo the common law of informed consent (discussed below).

The draft guidelines are also themselves quite strict and will supplement (when a version of them commences) the strict approach the TGA will now take to enforce prohibited advertising of injectables. However, rather than being fined under the TG Act, any practitioner subject to disciplinary action by reference to the National Law and this guideline will be subject to orders affecting their registration or practice.

Of course, many such orders have already been made against practitioners, such as enrolled nurses, for cosmetic treatment-related professional conduct issues. In Health Care Complaints Commission v Bechara [2020] NSWCATOD 140, an enrolled nurse who owned and operated a cosmetics clinic in Canterbury (NSW) and who had previously been permitted to continue to practise subject to several conditions imposed on her registration, was prosecuted by the Health Care Complaints Commission (HCCC) on the basis of several complaints. Those complaints alleged the practitioner had:

• breached a previously imposed condition by practising without on-site supervision of a registered nurse;
• provided false information to the Nursing and Midwifery Council of NSW;
• performing cosmetic injections when her registration as an enrolled nurse had been suspended;
• held herself out as being entitled to practice as an enrolled nurse including by displaying business cards at her practice with the title cosmetic nurse; and
• held herself out as being a registered nurse.

In its reasons, a four-member panel of the NSW Civil and Administrative Tribunal (Occupational Division) (Tribunal) found that practitioner guilty of unsatisfactory professional conduct and professional misconduct under the National Law and accordingly, cancelled the practitioner’s registration as an enrolled nurse under s 149C(1)(b) of the National Law.

The Tribunal also made orders under s 149C(7) of the National Law debarring the practitioner from applying for review of the cancellation for 18 months. Pursuant to s 149C(5) of the National Law, the Tribunal also declared that the practitioner was prohibited from providing health services as defined in s 4 of the Health Care Complaints Act 1993 (NSW), including offering cosmetic or other forms of injectable treatments, other than as authorised by and in accordance with the requirements of her registration as a student nurse undertaking the Bachelor of Nursing course, or until such time as the practitioner was re-registered as an enrolled nurse. The practitioner applied for reinstatement of the 2020 decision in 2022 but that application was dismissed: see Bechara v Health Care Complaints Commission [2023] NSWCATOD 62.