Industry opinions on the TGA restrictions to cosmetic injectables advertising

The TGA’s updated guidance on general terms such as ‘anti-wrinkle injections’, ‘wrinkle-reducing injection’ and ‘dermal fillers’ is the latest in a sweep of reforms to the cosmetic surgery sector in Australia. AMP asked practitioners across the country to share their opinions on the new advertising restrictions and what the new guidelines mean for the industry at large.

The negotiated terms the profession has previously been able to use were negotiated with the TGA to avoid the use of scheduled medication brand names, which at the time was an influx, particularly influenced by American advertising and our fledging internet access.

The general public will adapt to the new terminology. The new terminology, however, can be just as easily exploited as the more simple descriptive wording.

In terms of the new regulations affecting my advertising strategy, my brand has been established for a long time – I am a geriatric member of the profession! Our strategy has not changed, as most new patients to our practice avail themselves to other services in the practice or are referred by word of mouth, GP or specialist referral.

Regarding the financial challenges as a consequence of the restrictions, I think all businesses in Australia are stressed, and that has a flow-on effect into any area which avails itself to disposal income. The medical profession as a whole has struggled with the pandemic period, and now in the post-pandemic period there has been a myriad of regulation and legislative changes.

This has created a lot of IT work, and is changing the way clinics project themselves.

My concern for patients, remembering this is an adult choice, is they will begin to rely on overseas information which may highlight products and provide inaccurate/incorrect information not relevant to Australia.

As a result of the dovetailed changes to a number of guidelines, I think the consultation process is a better format. I confess I am rather conservative when it comes to patient care and support the concept of responsibility and obligation to the patient by the treating doctor; all patients should be able to identify their treating doctor.

And I definitely agree with any individual working in this medical sector to be appropriately trained and to be able to demonstrate annual CPD. Better still, to be interested enough in their craft enough to gain a fellowship in aesthetic medicine, as you would strive to in other areas of medicine.

I think the new advertising guidelines are a result of previous ‘extreme’ advertising, cosmetic and operation ‘porn’ and flaunting of the TGA rules.

My concern for the patient is how they can find information about any potential treatment they wish to undertake. They are left to consulting international sites and forums. Restricting information about procedures which are openly discussed on the internet, TV and forums such as YouTube I don’t believe will decrease requests, but how patients locate where they can receive treatment due to these restrictions may lead to unintended consequences, such as non-legitimate ‘backyard’ services or, worse still, patients illegally importing and self-injecting medications by purchase from the internet.

These days, everyone makes a more-significant outlay when they start practising and wants to recoup that more quickly. Patients search for information before seeking advice from professionals and often will come to see us with a pre-conceived idea, rightly or wrongly, before they even enter a practice.

Patients have become used to looking things up to gain information and then asking professionals who can then clarify, redirect or correct what they have learned. I suppose that is still the case, but we have to be a lot more vague about what we say. We can put far less educational content on our websites or any other medium we might use.

I believe we can say ‘contouring treatments’. This could refer to any number of things, including cosmetic injections, but also some of our energy-based device treatments. We could also refer to ‘treatments for reducing wrinkles and smoothing the texture of the skin’. Because we are having to be more vague, possibly referring to multiple types of treatments, we can also not be precise about duration of action, course after treatment and realistic expectations.

I am fortunate to be in an established practice that doesn’t rely heavily on advertising, anyway. It will likely be harder for newer practices and those that rely on marketing.

I spent some hours going through my website to change wording – hopefully I caught it all – and my wonderful practice manager is able to change things herself. There will be those who will need to spend money to get others to do that – and hope that they understand the brief and the repercussions if they get it wrong.

I always say that it’s easy to regulate people who are already doing the right thing. It’s much harder to regulate people who are not.

We all know that there are lots of practices that weren’t following the prior guidelines and were reaping benefits from that. I imagine that those will be the same ones who don’t follow the new guidelines and will, potentially, attract the less-discerning patient who follows a hit from a search.

It may also mean that others who are searching online for information will gather their information from overseas sites, which may or may not be accurate for Australia, and might potentially attract more patients to do these treatments overseas where regulations about safety of substances and treatment standards may be lower, potentially resulting in complications having to be treated here, when those patients return.

The TGA has said they are wanting to bring the cosmetic services in line with other medical fields, however, its statement about not referring to any S4 substance really means that we can’t even say that we inject a local anaesthetic for a treatment, whether it be an injectable or energy-based treatment. I certainly feel that this is detrimental to medicine, as a whole. I believe that all surgeons and doctors would like to be able to advise in their educational content that a treatment is performed after giving a local, or general, anaesthetic! I have removed such references from my site, but don’t believe it is a beneficial move.

They will just find other ways of getting patients through the door. It may actually assist in reducing patient protections. Consider that one regulation is about not being able to provide ‘inducements’ for cosmetic services, but the new regulation now prohibits any description of what that cosmetic service may be and so inducements can be freely offered because the ‘service’ being provided is not being categorised or described.

The reasoning behind the new restrictions I have been told is that use of the term ‘dermal filler’ will ‘turn the patient’s mind’ to thoughts of restricted products. This is a very long bow and is akin to saying that ‘abdominoplasty’ will ‘turn the patient’s mind’’ to thoughts of anaesthesia which involves the use of restricted S4 and S8 products.

The new regulations will require more thought on how to advertise cosmetic services in a way which is informative and educational for patients while trying to observe the regulations. I suspect that advertising will become more creative. In many ways the new regulations open the way for less ethical advertising.

In my own case, I think the best strategy is to offer a professional consultation to discuss options for patients.

In essence, I don’t think there will be any better protection to patients and indeed I fear it will make things worse.

It is difficult to adequately explain what we offer with these new guidelines in place and to fulfil the Ahpra guidelines requiring transparency and clarity. I think what we can do is portray an ethos of treatment excellence and patient-centric importance. We are displaying best practice in what we do, however I feel we are doing our patients a disservice by not informing them adequately.

Regarding the financial challenges for clinic owners, it will be incredibly difficult to put your business out there and be relevant to your prospective patient without being able to say what you do. Our businesses will be drowned out by similar and less regulated businesses outside of Australia. This is unsafe for patients, particularly those willing to sell Schedule 4 drugs to patients directly. I am incredibly fortunate to have a busy, well-established practice, but I am passionate about education. I think patients have a right to the truth.

For the most part, I do not think these new advertising regulations provide additional protection to patients – as patients are ordering product online and injecting themselves and becoming injured. Patients that are receiving no education have no comparisons to make and therefore cannot adequately educate themselves on brand differences or clinic ethos differences.

Most clinicians in the aesthetics industry have patient safety as their highest priority and are wanting to do everything they can to provide a positive, natural-looking clinical outcome and safe experience.

On the other hand, whether banning the use of these terms would protect patients from dodgy practitioners remains to be seen.

My practice relies more on word-of-mouth referrals and patient retention than it does on advertising. The impact of the TGA requirements will not greatly affect my advertising strategy and will have little effect on my ‘brand’. Furthermore, my practice provides many non- injectable treatments. Businesses that rely on advertising to attract new patients for injectables are likely to be affected to a greater extent. In my opinion, it is likely to affect new businesses and those that rely on ‘volume throughput’ to a greater extent than it will affect established or bespoke clinics.

There are a number of financial challenges that may affect clinics and business owners as a consequence of these restrictions. I do not think that this change will necessarily result in a reduction in the total number of people looking to have injectable cosmetic treatments, but it may lead to a redistribution of where they go to have their treatment performed. This may well favour established clinics. Whilst some people respond to advertising, many talk with their friends about where they should go to have a treatment.

In my opinion, the biggest financial challenges for clinics will be in the changes required to their websites and social media, including upcoming advertising campaigns.

Australia has tough restrictions on the advertising of cosmetic injectables. There are clear guidelines from Ahpra about how non-surgical cosmetic procedures should be performed, but these should not be seen as restrictions. In essence, they are requirements to ensure that practitioners are suitably qualified, screen for contraindications to treatment, obtain informed consent from the patient and provide clear instructions for follow-up care. The goal of these requirements is to improve quality of care and patient safety.

It is debatable as to whether the updated position by the TGA on the advertising of cosmetic injectables will improve patient safety. The TGA letter dated 15th January 2024 does not claim to provide additional protection to patients. It states that its intent is to ‘detect and disrupt unlawful advertising’ and ‘support consistent application of legislation related to the advertising of therapeutic goods across all industry sectors’. If the TGA polices the regulations, it is likely to achieve its stated goal.

In essence, the updated position by the TGA on the advertising of cosmetic injectables will greatly impact many businesses through the need to update websites, social media posts and alter upcoming advertising campaigns. According to the Therapeutic Goods Act, scheduled substances (cosmetic injectables) cannot be advertised. This has caused frustration as previous guidance provided by the TGA had approved the use of the terms ‘anti-wrinkle injections’ and ‘dermal fillers’. Disallowing the use of these terms makes it impossible for Australian businesses to provide specific education or information about these products outside of a consultation setting. This information is however freely available from non-Australian sources and, interestingly, the media in general.

There remains confusion at present. The TGA has stated the term ‘anti-wrinkle injections’ is disallowed, however this does not, regarding cosmetic surgical and non-surgical procedures, advertising of cosmetic surgical procedures, telehealth services and the current draft guidelines for healthcare practitioners who perform and advertise non-surgical cosmetic procedures. It is important to look at the new information from the TGA in the context of all these changes, which have been driven by recent events. These have been extensively covered by the media and have led to the coining of the term ‘Cosmetic Cowboys’.

The changes in regulations and guidelines have occurred under the auspices of making the industry ‘safer’ as breaches in advertising cosmetic services has been commonplace by some providers, either intentionally or through lack of awareness of Ahpra guidelines and TGA regulations. Unfortunately, the resulting changes will affect everyone, including those that have been compliant.

Most advertising is now electronic, either through websites or social media, and whilst Australian practitioners will not be allowed to use certain terms that were previously allowed, overseas providers can, including the use of drug trade names. In other words, consumers will still have access to the same information as they previously have, just not from local providers. The TGA rationale is that the advertising of schedule 3, 4 and 8 substances is in breach of the Therapeutic Goods Act (1989) and information regarding scheduled substances is done best in a consultation with the practitioner.

Ultimately, for a patient to make an informed decision, they should have a discussion with the practitioner about their proposed treatment and the options available to them in order to be able to give informed consent as required by Ahpra and the various Board guidelines. In other words, the in my opinion, refer necessarily to treatment with a scheduled substance but may in fact refer to treatment with a fractionated laser, HIFU or RF microneedling.

Lastly, there is an appetite amongst industry bodies to form a group to reach a consensus opinion regarding the updated position by the TGA on the advertising of cosmetic injectables in order to make an industry- based representation to them. If any groups are interested in being involved in such an initiative, they may contact me at drkosenko@cpca.net.au.

For those of us with a lot of online content we will have to hire staff to edit previous online content for compliance and/or reproduce content on many platforms. This is a huge financial challenge for businesses, especially in the current climate.

I think the new regulations will be harmful to patients rather than protect them. Patients want to research procedures and their risks, etc, using accurate online information. Patients want to research the products they are considering putting in their bodies. The information Australian doctors are able to provide online is vague and unhelpful. An important part of our job is to inform patients, but we are prevented from doing this adequately online.

In Australia, cosmetic patients will have to get their information from non-medical sources, e.g., influencers or non-medical content creators, which seems so ridiculous.

It’s disappointing that Australian doctors are prevented from providing world-class patient education due to our regulators. Australian patients are the losers.

The crackdown will affect the ability of ethical registered health professionals to more broadly educate their patients about the nature of treatments that implement S4 drugs, benefits, risks, possible complications and the likelihood of adverse outcomes. This is a lost opportunity.

Nurses have a clear directive on what is acceptable practice and what is not thanks to the Nursing and Midwifery Board of Australia (NMBA). Professional standards such as the Code of Conduct for Nurses, Standards for Practice and the Code of Ethics are all directly able to be translated into a cosmetic context. Furthermore, their new position statement on nurses and cosmetic medical procedures provides further guidance on acceptable practice.

Using these resources along with the TGA advice will help them align their advertising and branding strategies. For example, advertising that contains false and misleading information may compromise health care choices and is not in the public interest. So advertising something like ‘Look five years younger’ does not comply with already established principles. Branding your cosmetic injectables business as ‘The Tox Fox’, for example, would also be in breach.

In the short term, there is a scramble to ensure that there is compliance. This is a time drain on small- to medium-sized business owners. They may have to reallocate their current staff to complete compliance work, hire a consultant or possibly seek legal advice.

This is an additional stress for business owners who may already be under financial duress from a depressed economy, rising costs and the challenges of recruiting and maintaining adequate staffing levels. Some practitioners are sole operators and this has placed an additional burden on them.

I’m unsure whether there is an undertaking from the NMBA or Medical Board of Australia to do a comparison of patient complaints comparing and contrasting pre-TGA recommendations and post. What I do know is that both boards have been buckling under the volume of patient and practitioner complaints (some vexatious, some genuine) and these organisations might need additional resources and stronger powers as we move forward.

I’m all for raising the standards of health care and want to suggest to my colleagues that when they are advertising their services and branding their businesses to consider that if they were a chronic pain or incontinence service, would they be doing it similarly? The principles and framework are the same.

There is a fine and delicate balance between protecting consumers from unethical advertising practices in the scheduled medicine and cosmetic injectables industry and ensuring that patients have access to transparent information to make informed decisions about their treatment choice. If consumers are not aware of the medicines being prescribed, there is a risk that they could be susceptible to dangerous practices and vulnerable to being provided counterfeit products potentially endangering their health and wellbeing.

A nuanced approach should allow for transparent and educational advertising coupled with robust regulatory oversight to empower patients to make informed decisions while still safeguarding them from deceptive practices.

When viewed in isolation, the recent TGA decision appears to be a rigid interpretation of the law that limits decision-making by consumers due to lack of transparent information. However, once the new Ahpra guidelines on cosmetic procedures comes out in 2024, it might provide not only the context but the much-needed clarity to the TGA’s recent decision. The TGA has also proposed a cosmetic injectable webinar soon. The TGA events page will have updates: tga.gov.au/resources/event The revised guidelines should be viewed by the industry as an opportunity to revisit their patient education and advertising which will be subject to intense regulatory oversight in the immediate future.

When you practice within a regulatory framework governed by law, new laws and updated guidelines are a natural part of the market in which you operate.

In order to comply with the new guidelines, you will have to completely restructure the way you communicate to patients and advertise your services. This is disruptive and will cost you time, money and significant resources.

My practice had to make extensive changes to all advertising, communications and marketing to ensure compliance with the cosmetic surgery and cosmetic procedure regulations that came out in 2023. This cost us a lot of time, money and resources and impacted my website traffic and clinic enquiries.

Luckily my practice has robust systems and we focus on providing patient-focussed care. This has helped us weather the downturn. Because most of the compliance was achieved last year, this year will be less.

I do believe these new advertising regulations will provide additional protection to patients. This has been the experience following introduction of the 2023 Ahpra guidelines on cosmetic surgery. The regulator scrutinised advertising and strictly enforced compliance. In addition, the regulator activated a ‘Cosmetic Complaints hotline’ that provided real-time data on poor professional standards and poor patient outcomes. The regulator followed this up with robust regulatory action to reduce false and misleading advertising – thereby enhancing patient safety in cosmetic surgery.

It would be reasonable to expect more of the same in the cosmetic procedure industry in 2024.

My final thoughts? In 2024, expect your advertising to come under intense scrutiny whether it is your website, Instagram post from 2024 or Instagram post from 2018. Complying with the advertising guidelines should be your number-one priority. This will be the challenge because currently no one is clear on what is allowed and what is not.

For most clinicians and business owners, there remains cause for hope and optimism despite the perceived challenges that lay ahead. Firstly, the playing field is levelled, and the same rules and regulations will apply to all across the industry, from specialist plastic surgeons to dermatologists, cosmetic physicians, dentists, nurse injectors and so forth. Secondly, out of every crisis there exist opportunities for those who can pivot and adapt. Ultimately, the changes will favour those who adapt and make necessary changes to their business model and advertising to be compliant.

For most of us, the first step in this endeavour is to obtain the right information and right advice. At the NSS 2024 (nonsurgical.org.au) we have a 90-minute masterclass on ethical cosmetic advertising run by experts in the field to help you with the right information and advice. This is based on our learnings from the cosmetic surgery guidelines of 2023. The aim is to ensure we navigate the changes well while continuing to focus on growth and success. AMP