Many nurse-led clinics in Queensland have been alarmed to learn they are potentially operating illegally, following publication of a factsheet from the state’s Medicines Approvals And Regulation Unit (MARU). It has triggered passionate debate regarding the regulatory implications for all Australian states.
The formal statement from Queensland Health’s MARU of the current law relating to ‘authorisations for prescribing and administering Schedule 4 cosmetic injectables’ emphasised:
- only doctors or nurse practitioners (APHRA endorsed with cosmetic S4 prescribing rights) can buy and/or store the injectables;
- doctors and nurse practitioners cannot buy stock for a place that they do not practice from, which includes locations for which telehealth is provided.
The strict wording of the five-page MARU notice – relating to substances classified as Schedule 2, 3 and 4 prescription-only – meant hundreds of nurse-operated beauty clinics and day spas have been operating in breach of the law for several years.
In addition, the notice jeopardised the legality of the nurse-led business models: many don’t have ‘on-site’ doctors and rely on partnerships with companies providing cosmetic telehealth services to prescribe and supply the drugs for their clients.
Amid significant industry confusion, several operators told The Australian they had been unable to gain clarification about the ‘discrepancy between the guidance and current practices’ from Queensland Health.
But a spokesperson for Queensland Health said the information in the guidance was not new and emphasised that the fact sheet ‘was produced to support the beauty industry to better understand existing legislative requirements.
‘Queensland Health has received enquiries from clinic owners and will continue to work closely with them. While many non-surgical cosmetic businesses are already compliant with the legislation, our focus is on supporting all businesses to achieve full compliance.’
The Australian commented: ‘However, that raises significant questions about how hundreds of clinics have been able to operate for years without being shut down if they do require an on-site doctor or nurse practitioner to be compliant with legislation.’
Upon seeking further clarification from Queensland Health Minister Tim Nicholls, The Australian reported it ‘understands Nicholls, who was appointed to the portfolio in November, has requested a brief on the issue’.
To ensure clarity surrounding the current legislative requirements, the MARU notice included separate sections detailing the specific legal requirements relating to:
- Authorisations for prescribing and administering S4 cosmetic injectables
- Standing orders
- Buying S4 cosmetic injectables
- Supplying S4 cosmetic injectables
- Storage of S4 medicines, including cosmetic injectables
- Advertising of S4 cosmetic injectables
- Buying and administering S2 and S3 medicines
- Infection control requirements.
With nurse-run cosmetic injectables clinics now widespread across Australia, speculation has become intense whether other state jurisdictions will follow the Queensland lead.
Questions arise whether insurance companies will change or update their requirements – potentially declining insurance if clinics don’t formally meet these specific criteria and guidelines.
What’s for certain is that the Queensland fact sheet has caused confusion, most notably as it threatens to disrupt the legality of the corporate clinic model, requiring only doctors and nurse practitioners who physically work at the clinic to buy and store injectables.
Massive ‘non-compliance’
Michael Fraser, co-director of patient advocacy group Operation Redress, told The Australian: ‘This (the Queensland Fact Sheet) appears to be designed to protect the public, which is important. Stronger government initiatives and advice around regulating injectables is crucial given the industry has significant social media influence, encouraging unnecessary medical procedures as if they are life-changing and risk-free beauty treatments.’
He added: ‘We are seeing mass non-compliance in the cosmetic procedure industry to both TGA and Ahpra guidelines, especially around advertising. While we don’t believe the industry should be shut down, we do believe stronger regulation and enforcement is warranted given self-regulation and voluntary compliance are not keeping the public safe.
‘Unfortunately there is real harm which has come from the cosmetic injectables industry. This harm is often shared to us in confidence by both patients and practitioners, but due to fear of retaliation or non-disclosure agreements many are afraid to speak out.’
Dr Toni Connor confirmed: ‘There are a lot of clinics out there doing the wrong thing, which is really sad… There are also dodgy (non-TGA approved) products out there that people are buying on overseas websites or whatever. And they’re buying the products because they’re much cheaper, and they are using them.’
‘Attack on female- dominated profession’
Elizabeth Jarrett, a nurse who runs a clinic in Toowoomba, told The Australian: ‘I was beyond devastated after reading Queensland Health’s guidelines regarding the apparent processes of nurses working in the cosmetic industry. It feels like a complete attack against a female- dominated profession.’
Christina Hill, a registered nurse operating a clinic north of Brisbane, added: ‘Instead of imposing financially devastating measures, policymakers should work with practitioners to develop equitable, evidence-based pathways into aesthetics, such as hospital experience, postgraduate studies and supervised training.
‘This would protect patients and preserve the integrity of the industry without unfairly crippling its most dedicated professionals.’
Lisa Lovell, a registered nurse operating a facility in Bribie Island said: ‘As an experienced RN with extensive training, I’ve worked in both hospitals and the cosmetic field, including training other healthcare professionals. It’s concerning that Queensland now deems me unqualified to store or handle S3 and S4 medications, despite my qualifications and compliance with national nursing standards. This inconsistency is stark when compared to endorsed assistants in nursing administering medications in aged care.’
Dr Toni Connor, a director of Allure Pacific Aesthetics, an online wholesale, training and telehealth prescribing service to about 450 cosmetic clinics across Australia (at least 100 in Queensland) noted: ‘What’s weird and what’s thrown a lot of people now is that not only has there been no commonwealth update, there’s also been no state-based update, just a fact sheet.’ But she ‘suspects other jurisdictions will follow the Queensland lead’.
NSW Health clarification sought
Dr Tom Parmakellis, owner of LookFresh Cosmetic Medicine, sought written clarification on NSW’s regulations regarding the prescribing and administering of cosmetic injectables.
On 25 January 2025, he wrote to the NSW Ministry of Health: ‘I would like clarification of a statement in your document Cosmetic treatment by unauthorised persons (8 April 2024): “Substances such as botulinum toxin, hyaluronic acid dermal fillers, injections or local anaesthetics, and other prescription-only medications can only be administered by a medical or nurse practitioner, or by a nurse under the direct supervision of these practitioners.”
‘Does a telehealth consultation with my registered nurse off-site fulfil the definition of direct supervision? Or do I need to be on-site where my nurse administers a Schedule 4 (S4) cosmetic injectable drug?’
On 5 February, David Ng, Director, NSW Ministry of Health, Pharmaceutical Services Unit, Legal and Regulatory, responded: ‘That statement is probably not correct – I have asked for it to be updated. The relevant requirement is that it is administered “under the direction of a medical practitioner…”, which is specified in the Regulations under Sections 68C–68F)…’
Dr Parmakellis followed up, citing inconsistencies in the legislation: ‘The direction given to the nurse can be via audio-video link or verbally if the doctor or nurse practitioner is present and instructs the nurse in person. However, the legislation also states that the direction to inject an S4 drug can be valid for up to 6 months at intervals deemed necessary by the prescriber.
‘This suggests to me that I can provide my nurse with a video consultation and instruct her to inject my patient (eg, botulinum toxin at 3-monthly intervals at dose X to area Y) over 6 months without seeing the patient again, allowing the nurse to administer independently at subsequent visits.
‘However, the Medical Board’s guidelines state that a doctor must see a patient at every consultation, preferably in person, before delegating the injection of an S4 drug.
Does NSW legislation mean that the doctor does not need to see the patient each time within the 6-month period?
Or does it mean the prescription is valid for 6 months but requires a new patient consultation before each administration?’
Ng replied: ‘The legal requirements are separate from the professional standards set by the Medical Board, Colleges or the Medical Council.
‘Under the Regulations, the written direction must be valid for 6 months from the date of the original patient review – this can be interpreted as the validity of the prescription. However, you must still comply with professional requirements and best practice standards, which require a patient review before subsequent injections.’
Latest update from Ahpra
Dr Parmakellis sought further clarification from Ahpra on whether a doctor or nurse practitioner must consult with the patient each time an S4 cosmetic injectable is administered or only when prescribing. On 5 March, Ahpra’s Sarah Harper, Policy Manager – Medical, confirmed:
‘The guidelines say there must be a consultation with the patient for each time they prescribe cosmetic injectables.
‘We know that each prescription may result in more than one administration of cosmetic injectables. A consultation is required each time they are prescribed, not each time they are administered, unless indicated.
‘The prescribing medical practitioner retains overall responsibility for the patient including when another health practitioner administers a previously prescribed injectable.
‘In relation to the number of repeats permitted or how long a prescription is valid for – this is determined by state and territory drugs and poisons legislation.’
Key takeaway
A doctor consultation is required when prescribing and delegating cosmetic injectables but not for subsequent injections by a registered nurse during the prescription’s validity (up to six months in NSW), unless indicated. The meaning of ‘unless indicated’ warrants further exploration and remains open to interpretation.
NSW, VIC ‘public health alert’
NSW Health issued a ‘Public Health Alert’ on 24 January warning: ‘Likely case of botulism linked to unregulated anti-wrinkle injections.’ It followed a suspected case of botulism in a woman in Sydney, which is believed to be linked to an unregulated anti- wrinkle injection she received at a residential premises.
NSW Health’s Executive Director of Health Protection Dr Jeremy McAnulty said the case was ‘a reminder of the potential side effects of unregulated cosmetic injections’ and patients needed ‘to be sure to receive cosmetic injections by authorised practitioners’.
A week later on the morning of 31 January, ABC News revealed ‘a suspected case of botulism linked to cosmetic injections occurred in Victoria last year, but was not publicly announced’.
The ABC reported NSW health authorities were ‘investigating whether recent cases of suspected botulism caused by unregulated anti-wrinkle products, and injected in an unlicensed premises, were linked to another case in Victoria last year’.
Later that day, both the NSW Health Care Complaints Commission (HCCC) and Victorian Health Complaints Commissioner issued Public Warnings about ‘Ms Norsafiza Binti Zakaria, Cosmetic Injector’. The NSW HCCC warned: ‘Ms Zakaria is a non-registered health practitioner and is not permitted to perform medical procedures in NSW. Despite this, the Commission is investigating allegations that Ms Zakaria has been illegally administering botulinum toxin (Botox) and other injectable substances without medical supervision.’
NSW HCCC Commissioner John Tansey told The Sun-Herald the cases were ‘a stark reminder’ of the danger posed by unqualified people performing cosmetic injections. He said: ‘The Commission has zero tolerance for unregistered practitioners who put lives at risk by performing cosmetic procedures without the proper qualifications, training or medical oversight. These unlawful practices can have devastating consequences, and we are taking firm action to protect the public.’
The TGA told the ABC it was ‘aware of the cases in NSW, plus one other in the last 12 months, and was liaising with state authorities and other regulators’. The TGA also said ‘detecting and disrupting unlawful supply and advertising of unapproved and high-risk medicines and medical devices, including cosmetic injectables’ was a priority.
Meanwhile Federal Health Minister Mark Butler said state and federal authorities were alive to the risks of unregulated products and practitioners. Following the NSW/Victorian warnings, he told reporters: ‘We’re deeply concerned about the potential in this market of cosmetic surgery and injectables that some Australians are vulnerable to poor quality products and practitioners who might not be properly qualified to deliver them.’
‘Doctor on site’ for buying and storing debate
The ‘doctor on site’ for purchase and storage issue was debated on the ‘Inside Aesthetics’ podcast, where Dr Jake Sloane (from Sydney’s Infinity Skin Clinics) and David Segal (former Laser Clinics Australia franchisee) interviewed industry veteran and former Australasian College of Aesthetic Medicine (ACAM) president Dr Gabi Caswell.
Dr Caswell said doctors and nurses ‘work under a regulatory framework which prioritises patient safety’. But some script prescribers ‘are not cosmetically trained’. The Medical Board ‘has guidelines for surgery and cosmetic medicine. And in practice your insurance, not the Board, dictates an individual’s “scope of practice”; they are risk managers, and the premium you pay is set against the risk relating to your group.’ Hence basic nursing insurance ‘is much less, because under our system, all responsibility and obligation is tied to the prescriber’.
Dr Sloane noted the potentially massive implications of a strict interpretation of the ‘doctor on site’ regulation: ‘These procedures are now hugely popular. I estimate 90% of this industry’s non-surgical procedures are done by nurses.’
Dr Caswell said: ‘The regulations require that you demonstrate appropriate continuing professional development (CPD) for your ‘scope of practice’. You have to evaluate your skills base and ask: Are you up to date? Do you have the necessary CPD certificates? In practice, for a doctor your registration is effectively now tied to your CPD.’
She emphasised: ‘The landscape has changed. A big question is: are the people running the clinics ‘purely as a business’ good for our craft?’
She added: ‘How do we move forward? Patient safety must be the priority. When you apply the McDonald’s model to medicine, there are always issues. Each participant needs to decide: how do you wish to practice?’
Dr Caswell summarised the clinic-regulator conundrum: ‘The crux of the current problem our industry now needs to face is this: we were given privileges we didn’t appreciate. We were given lots of leeway and didn’t behave ourselves. We need to understand that, from the regulators’ point of view, the Board’s job is to protect the public.’
She stressed: ‘The current situation is factually simple: the rules have not changed. We bent the rules. The regulators are now taking us back to the rules.
‘Requirements dealing with S4 drugs have never changed. We were given some liberties, and people have convinced themselves to believe what they wanted to believe. But just because it hasn’t been stopped to date, doesn’t mean it was legally allowed.
‘So the result is that the necessity to have a ‘doctor on site’ for handling S4 drugs means many current clinic business models are not sustainable.’
Dr Sloane replied: ‘Then a major decision is needed to decide: either shut down the industry or make our injectors better by having prerequisite training for this type of medicine, because this is a speciality – or should be.’
Dr Caswell suggested: ‘If you want to move forward, and you want to stay in the profession, then look at your skills base – and make sure they’re gold plated.’
She added: ‘The practical reality is that over-turning regulations is very difficult and it’s low on the medical priority ladder. Ideology will rule: they are the regulations, make your business fully compliant with them.’
Dr Sloane declared: ‘My issue is: does having a doctor ‘on site’ really change anything in practice?’
To which Dr Caswell answered: ‘The doctor is responsible. The Board mantra is ‘patient safety’. The Board wants to be able to clearly identify: who is responsible? Who is the prescriber?
‘There is an integrated regulatory plan for how the Board views we should operate. If we fail to regulate ourselves, we will be formally regulated from above.’
Fresh owners met QLD Health re Fact Sheet
Following the release by Queensland Health’s Medicines Approvals and Regulation Unit (MARU) of its 5-page Fact Sheet relating to ‘authorisations for prescribing and administering
S4 cosmetic injectables’, Fresh Clinics founders Dr John Holbrook and Dr John Delaney and their lawyers had an urgent zoom meeting with relevant officials from Queensland Health.
The same afternoon they addressed 330 clinic staff across Australia, with a background screen noting: ‘Key points taken from our meeting with Queensland Health’:
- Queensland Health are hearing a range of views
- ‘Exploring & Listening’
- They want to work collaboratively with the industry
- Priority is education.
Dr Delaney noted: ‘They were quite surprised at the impact of their Fact Sheet. They explained it was simply issued in the ordinary course of business.
‘They significantly underestimated how many people were in this industry, and they misunderstood what standard operating procedures look like in this industry.
‘Our lawyers have had an ongoing back-and-forth with them. Our position is that they can enforce the legislation, but the specific words ‘physical presence’ and ‘physically practising from’ are not in the legislation anywhere – and they can’t insert things into the legislation that aren’t there.
‘We emphasised we want to be compliant. So we need to match the regulatory requirements.’
He told his audience: ‘On the call with the doctor, you need to be very specific about precisely what you want to do. And our digital drug book entries are very important
to accurately record things. The
S4 drug is still the medical legal possession and responsibility of the prescribing doctor.
‘Queensland Health emphasised they don’t like cases where someone buys from both company A and company B, but then scripts it all from company A.’
Dr Delaney relayed to his staff that ‘their focus is on education and prioritising that people currently in the industry can stay at work.
‘So we’re in a bit of a holding pattern at the moment, providing you are operating within the guidelines – that is, as long as you’re operating withing the clinical standards of Fresh.’
Dr Delaney conceded that ‘a certain level of risk has always been there. So you’ve got to do your own assessment.
‘Meanwhile there will be another round of discussions and feedback with Queensland Health. So we hope we will have answers to the more nuanced legal questions soon. But we’re happy to keep operating, based on the legal advice we have.
‘We will be having further meetings with Queensland Health in coming weeks and we anticipate an update on their Fact Sheet will be coming.’
To assist in gathering industry feedback, the meeting was then shown QR codes for two surveys being arranged by Fresh. Dr Delaney explained that ‘what to do next’ involved:
- A survey of ‘Queensland Health responses from the Fresh community’; and
- A ‘state of aesthetics 2025 survey’.
Dr Delaney emphasised such surveys would enable Fresh operatives to ‘speak with numbers and with a voice’.
Dr Holbrook reassured the Fresh audience: ‘I’m confident that we have been doing the right thing’ and added ‘I think that if changes are required, we will be able to work with them’.
Dr Delaney said Fresh’s team had argued in that morning’s meeting with regulators that their announced definition of the words ‘practising from’, if pursued, ‘will be affecting tens of thousands of people.
‘But definitions and clarity help us. Ambiguity is the problem. So we said: ‘Tell us what you want’. In the end it may just require changes to the contract.’
Dr Holbrook summarised: ‘The scripting and buying needs to be within the same process. There may need to be some minor changes that need to be implemented.’
Dr Delaney concluded with a positive statement: ‘I wouldn’t read too much into the Fact Sheet – as long as we don’t give the legislators reasons to change the law.’
He ended with the request: ‘Fill in the surveys. If they get 1,000 responses, our voices count. Solidarity matters. It helps us to put out the ‘Patients Are Happy’ message.’
In a subsequent interview, Dr Delaney told Aesthetic Medical Practitioner magazine: ‘Remote supervision is extremely efficient, and it ensures demand is met in a safe environment.
‘But if the number of doctors involved in the process is radically limited, industry oversight will be severely reduced because many ethical doctors will leave while unethical practitioners will continue to operate in the shadows.
‘To meet the huge public demand, clinics like ours with our strict formal processes represent the best tool to ensure self- regulation in an environment that prioritises patient safety.
‘We must be clear about our ability to self-regulate via our strict protocols emphasising patient safety. We want to be at the forefront of productive conversations with the regulators.’
Corporate race to sign nurses
Meanwhile the ‘race is on’ among the corporate chains to sign up new nurses.
Corporate clinic chains have mushroomed across Australia in the last decade – and currently they’re jockeying among themselves to sign up nurses for their business model.
This leads to a bigger philosophic issue in the cosmetic injectable debate and begs the question: Should corporates be allowed to dictate how the delivery of Schedule 4 medicines is regulated?
ACAM support for QLD Fact Sheet
The Australasian College of Aesthetic Medicine (ACAM) released a statement regarding the Queensland Health Fact Sheet: ‘[ACAM] supports and encourages safe and ethical medical practice to be available to all Australians and recognises the pivotal role that both doctors and nurses play in providing this. Regulation is a critical tool to guide clinical practice and ensure positive outcomes for patients. Medical practice is governed by Acts of Parliament as well as Ahpra and Board guidelines (Medical, Dental and Nursing).
President Dr Matthew Holman commented: ‘ACAM’s understanding of the clarification within this Fact Sheet of the supervision guidelines is that it reflects the TGA Act (Federal) with regards to the purchasing, distribution, stocktaking and administration of scheduled medication. It is similar to the NSW Medicines, Poisons and Therapeutic Goods Act and ‘scripting’ law, with regards to obligation and responsibility to patients’.
Dr Holman added: ‘This is very well established (in the way that Australia practices medicine) and this Fact Sheet does not reflect any change to the current law.’
ACAM noted: ‘It is also consistent with the updated Medical Board of Australia’s ‘Guidelines For Registered Medical Practitioners Who Perform Cosmetic Medical And Surgical Procedures and Good Medical Practice: A code of conduct for doctors in Australia’ 2022.’
Debate continues on LinkedIn
Numerous industry figures have debated both sides of the ‘doctor on-site’ regulation on digital media.
Dr Jonathan Hopkirk, from Sydney’s Refine Cosmetic Clinic and co-founder of Levels Of You, posted on LinkedIn: ‘I empathise with all the nurse injectors in Queensland following the weekend’s announcements.
‘This situation exemplifies regulator overreach at its finest. I hope that the path forward is much smoother than it currently appears.
‘In my view, this is a case of taking action without a true understanding of the impact it will have on the lives of business owners. While patient safety is paramount, there is concern that these measures may further frustrate patients and actually lead to an increase in backyard and black market operations, as seen in the UK.
‘It would be more beneficial to address the entry criteria for cosmetic injectables for professionals and implement improved mandatory training standards through Registered Training Organisations (RTOs), similar to those in most fields of medicine and nursing. This would ensure that patients receive a higher level of care and elevate the minimum standards across the board.
‘I find it baffling that the same nurses who are trusted by health boards and regulators to take phone orders for Schedule 8 medications and administer them in hospitals are not afforded the same trust with the less risky Schedule 4 drugs in private practice.
‘I genuinely hope this situation resolves with a better outcome than the current outlook. Stay strong.’
But Dr Tom Parmakellis replied: ‘With all due respect, I believe there may be a misunderstanding. It seems incongruous to suggest that a nurse taking a phone order for a Schedule 8 narcotic – prescribed by a medical practitioner who has thoroughly assessed a patient in need of pain relief – poses greater risk than injecting a hyaluronic acid filler into a patient’s face.
‘The latter carries significant potential complications, including vascular necrosis, which could lead to blindness or severe disfigurement.
‘Consider this: a registered nurse, having completed a three-year degree, can attend a weekend course, open a clinic, and begin injecting fillers into patients’ faces.
‘This is often done under the ‘supervision’ of a doctor conducting video consultations – doctors who, in many cases, have no experience or training in the aesthetic field.
‘This process enables the prescription of Schedule 4 hyaluronic acid implants for relatively inexperienced nurses to inject, exposing patients to potentially devastating outcomes.
‘The notion that injecting a so- called ‘safer’ Schedule 4 drug into a young person’s face – with the possibility of dire consequences – is currently permissible under law is, frankly, alarming.
‘The system is flawed, and meaningful change is desperately needed.’ AMP
