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Radio interview about cosmetic surgery regulation

I was interviewed alongside two leading voices in plastic and cosmetic surgery on 2SER

I recently was interviewed by 2SER’s The Wire (‘New Endorsement Model for Cosmetic Surgeons in Australia‘) in a program covering the newly proposed regulation of cosmetic surgeons through an endorsement model. The recent acceptance by the Health Ministers of the proposed endorsement model follows the production of an independent report commissioned by AHPRA and the Medical Board of Australia last year, which recommended the same.

However, another reform was also proposed and accepted — as a separate matter — in a decision of the Health Ministers in Febrary (effectively the Ministerial Council for the purposes of the relevant Health Practitioner Regulation National Law (NSW) (‘National Law‘)). That was a proposed reform to make the title ‘surgeon’ a protected title.

Adobe Stock under a University of Sydney licence.

Though details of the relevant Bill, titled the Health Practitioner Regulation National Law (Surgeons) Amendment Bill 2023, are not yet published, the effect of this reform would be, I presume, to add the title surgeon to the list of protected titles that currently appears in a Table (see below) under section 113 of the National Law.

At the moment, there are a number of titles protected under this section 113 Table for each of the 15 health professions. However, only ‘medical practitioner’ appears as a protected title within the category of medical practitioners. Presumably, the title ‘surgeon’ would be added here. (Interestingly, the term ‘dental surgeon’ is also not specified in this statutory table next to dentists; although certain restricted dental acts are specified under section 121.) The table appears in the National Law as below:

Given that the titles in the above table require a parliamentary amendment to change, they may be regarded as a ‘durable’ list of titles that strictly cannot be used without the relevant legal authorisation: namely, registration from AHPRA and the relevant health practitioner board.

Below this level of ‘strict’ or ‘durable’ regulation, however, there are a number of ‘specialist registrations’ that various health professionals may qualify to hold, including in medicine, dentistry, and even surgery. These specialist titles for surgery are also currently restricted — even though the general term ‘surgery’ is not. And you need to hold a ‘specialist registration’ to use them. And so, through this regulatory arrangement, a registered medical practioner with simply a general registration can currently call themselves a ‘surgeon’; however, that practitioner will need a specialist registration (with special training) to call themselves a ‘specialist orthopaedic surgeon’ or ‘specialist plastic surgeon.’

In terms of regulatory reform, however, it could be said that these specialist titles in surgery — just like all the specialist titles — are a bit less durable, or alternatively more agile, than those named in the primary Act. That’s because you do not need to change the primary law by amendment to change these. They can be changed when AHPRA recommends that a specialty should be recognised to the Health Ministers and the Health Ministers agrees.

And it would arguably be quite burdensome for Parliament to have to amend the National Law (namely, the table under section 113) every time the Health Ministers decided that a new specialist registration should be recognised and its use, as a title, restricted. Thus, the currently restricted specialist titles are not housed in the primary Act but are instead identified by the Medical Board of Australia here. The relevant part of this list for surgeons is reproduced below:

Importantly, however, the Health Ministers, or the Ministerial Council, is the body that approves what new specialist registrations are possible under the relevant sections of the National Law: namely, section 13(2) of the National Law. Once the specialist registration is approved, the Australian Medical Council (the practitioner training accreditor) and the Medical Board of Australia (the regulator of medical practitioners) then use guidelines (published in 2018) to ensure that anyone who seeks and holds such a specialist registration has undergone the relevant accredited course of training.

Notably, when the title ‘surgeon’ is protected, this appears to create protection for a more capacious or extensive rage of practitioners than ‘cosmetic surgeons.’ Indeed, the term ‘cosmetic surgeon’ will not be a specialist registration for a surgeon, and so it will not be protected. Rather, the more general term ‘surgeon’ appears to be proposed as the one that will be protected, and this may have strange ramifications for those who are practising cosmetic surgery. Presumably, there will be an exception that says ‘cosmetic surgeons are able to use the title ‘surgeon” when it is used in the full title ‘cosmetic surgeon.’

However, to make this make sense, the so-called ‘endorsement’ model will have to be created so that ‘endorsed’ cosmetic surgeons will be able to use the title in this way (as an exception) only. If any medical practitioner who performs cosmetic surgery is able to use the title surgeon as they describe themselves as a ‘cosmetic surgeon’ — even if they do not have an endorsement — then the title protection will be otiose.

This takes me to the first point I raise in this interview: namely, whether the ‘endorsement’ model will require registered medical practitioners who perform cosmetic surgery to be endorsed, or whether it will simply be a ‘nice to have’ — so that health consumers can feel better guided by the accreditation standard signalled by their chosen practitioner’s endorsement in the area of cosmetic surgery. I think this gets addressed in my analysis above. What I suspect will happen is that ‘endorsed’ cosmetic surgeons will have an entitlement to call themselves ‘surgeons’ without liability of penalty. The current example of this is the case of acupuncturists, which also have an endorsement model.

Under section 114 of the National Law, there is a carve out for acupuncturists that permits them to use the title without any liability:

As can be seen in the provision above, the acupuncturist can only call themselves an acupuncturist if they have an endorsement under section 97 of the National Law, as follows:

I suspect we will see similar provisions inserted into the National Law for cosmetic surgeons, although it could be that cosmetic surgeons are covered by the catch-all provision for certain areas of practice under section 98 (‘Endorsement for approved area of practice’) and regulations take care of clarifying that a cosmetic surgeon is an approved area of practice. However, in my view, the legislature should mirror the acupuncturist provisions to make the reform abundantly clear and durable.

The other point I make at the end of the interview related to the resolution of the so-called turf war that has been long running between ‘untrained’ cosmetic surgeons and those who have significant training — the plastic surgeons and others who are fellows of the Royal Australasian College of Surgeons.

Obviously, I am relatively neutral in this debate, not being from either camp. However, I was sandwiched, as it were, between the leading voices from each camp in this interview, which made it an interesting result, given that I had no idea that these other interviewees would be taking part. Luckily, I did not take sides inadvertently, and, perhaps as some kid of reward, was gifted a few minutes’ exclusive commentary at the end of the report.

Please let me know if you have any feedback on my take below or on Twitter.

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Doctors may soon get official ‘endorsements’ to practise cosmetic surgery – but will that protect patients?

This article was originally published in The Conversation here.

Image: Adobe Stock under a University of Sydney licence.

Disturbing reports about botched cosmetic surgeries and injuries in Australia – from breast augmentations causing chronic pain to liposuction leaving patients with lifelong injuries – have sparked concerns in recent years. Several high-profile cosmetic surgeons alleged to have fallen short of expected professional standards have been disciplined.

Last year, a class action was commenced against one clinic in the Victorian Supreme Court.

People who are interested in exploring whether cosmetic surgery is appropriate for them are right to feel wary and confused. Now, the introduction of a scheme to officially endorse doctors who practise in the area of cosmetic surgery promises to allay patients’ doubts. But the idea remains contentious for those in the field.

The story so far

In the wake of cosmetic surgery controversies, two significant but separate responses have been adopted by medical regulators. First, the country’s health ministers began a consultation to decide whether to stop doctors promoting themselves as “surgeons”.

The consultation acknowledged a gap or “loophole” that allows any registered medical practitioner to call themselves a surgeon in Australia, even with no specialist training beyond their medical degree.

The second response was initiated in December 2021, by AHPRA, which accredits and registers doctors, and the Medical Board of Australia, which regulates the practices of registered medical practitioners. Together, they commissioned an independent review into the regulation of medical practitioners who perform cosmetic surgery in Australia.

Although informed by each other, these separate initiatives wrought distinct solutions. While one has been embraced, the other remains controversial.

Image: Adobe Stock under a University of Sydney licence.

Ministerial reforms

After nearly two years of consultation, the health ministers decided last December to restrict the use of the title “surgeon”. Soon, only medical practitioners holding a specialist registration, such as ophthalmology, will be permitted to use the title.

In a meeting late last month, health ministers approved a draft bill to give effect to this decision. While the draft remains unpublished, no stakeholders in the health sector appear to have criticised the change.

But the health ministers approved another, more controversial, reform as well. They welcomed a new model of accrediting cosmetic surgery practitioners known as an “endorsement of registration”. This proposal came from the AHPRA and Medical Board review.

AHPRA and the Medical Board’s ‘endorsement model’

Among its 16 recommendations (all of them accepted by AHPRA and the Medical Board), the independent review’s first and most significant reform proposal was to establish an “area of practice endorsement” for cosmetic surgery.

The technical language of “endorsement” comes from consistent national laws enacted, with minor variations, in each state and territory.

In a nutshell, “area of practice endorsement” would introduce new minimum standards for the education, training and qualification of Australian medical practitioners seeking to practise as cosmetic surgeons.

Currently, the Medical Board uses codes of conduct and guidelines to regulate most doctors’ practices.

But these “soft law” instruments permit doctors to decide for themselves whether they are competent enough to perform procedures like brow lifts or tummy tucks.

The new endorsement model would require doctors to apply to the Medical Board to qualify to practice in the area of cosmetic surgery. To be approved, the doctor-applicant would need to furnish evidence of their qualifications. Such an endorsement arrangement already exists for acupuncture.

Together with restricting the title “surgeon” and some other reforms (such as improved information campaigns), it is now hoped the endorsement model would manage risky cosmetic surgeries by requiring practitioners to be endorsed by the Medical Board. But not everyone thinks it’s the way to go.

Read more: Who’s the best doctor for a tummy tuck or eyelid surgery? The latest review doesn’t actually say

What’s the problem with endorsement?

Fresh forms of old tensions have arisen, based on how endorsement will be designed. At the core of these tensions is a debate about how the Australian Medical Council, which is responsible for setting the accreditation, training and education standards for the medical profession, will determine the curriculum and assessment regimes for cosmetic surgery study programs.

What was once a debate about an unregulated area of practice is now about what kind of training cosmetic surgeons should have before wielding their instruments.

Some experts suggest defining cosmetic surgery could help regulation and safety discussions. Meanwhile, the Royal Australasian College of Surgeons says it will oppose any study program of a lesser standard than that required of specialist surgeons.

Although the Australian Medical Council has not yet published its education standards for cosmetic surgery, it has proposed six draft qualification standards and is consulting with the profession.

What this could mean for patient safety

On the one hand, the proposed changes are a continuation of a long-running turf war. On one side are the surgeons with special accreditation, approved by the Royal Australasian College of Surgeons and typically engaged in reconstructive plastic surgeries. On the other, stand the so-called “non-surgeons” or “wannabees”.

The debate is also about protecting patients and legislative reform.

It is too early to determine whether the Australian Medical Council’s endorsement standards will improve patient safety. But the slow process of reforming the cosmetic surgery “industry” – in the face of explosive increases in demand, fuelled in part by seductive social media claims – illustrates how complex medical regulation is in Australia. With so many regulatory actors involved in our polycentric system, feuds over governance are unsurprising.

Today, the cosmetic surgery industry is estimated to be worth more than one billion dollars a year. It is crucial regulators ensure the public is protected from unscrupulous – or unqualified – operators.

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Podcast interview: ‘Learn Me Right in Health Law and Bioethics’

Learn Me Right in Health Law and Bioethics is a podcast produced by QUT’s Australian Centre for Health Law Research. I was fortunate to be invited to join the podcast by its scholar producers, Sinead Prince and Ruthie Jeanneret, and to discuss my work on somatic cell genome editing.

One thing that I probably failed to do was to distinguish somatic cell genome editing (perhaps more helpfully described as non-heritable adult genome editing) from another type of therapy involving genes, which is known simply as ‘gene therapy.’ I failed to make this distinction, even though, on listening back, Sinead prompted me to do so when asking about whether gene treatments are a once-and-for-all cure. I should have understood this question to have probably been directed towards some of the gene therapies that are currently on the market, such as Luxturna, Yescarta, Zolgensma, Kymriah (tisagenlecleucel) or Hemgenix. Many of these therapies are a one-time treatment, and most of them are incredibly expensive. Hemgenix, for instance, which is a treatment for Hemophilia B, costs about 3.5 million US dollars. Isn’t that a remarkably expensive form of medicine?

The important distinction between gene therapies and adult genome editing is as follows. In a book chapter soon to be published authored by me and Dianne Nicol, we state the following:

Although there are various forms of genome editing, their key features are ‘programmable nucleases’ designed to create precise breaks in both strands of the DNA molecule (double strand breaks). Thus, somatic cell genome editing is usually distinguished from ‘traditional’ somatic cell gene therapy (SCGT) (World Health Organization 2021a)—or simply ‘gene therapy’—because the latter employs random insertion methods, including by using adenovirus-associated viral vectors (AVVs) or other delivery tools, to replace mutated genes or add new ones. The former, by contrast, seeks to alter existing nucleotides (Chang et al., 2018).

See Rudge and Nicol, “Bioethical decision-making about somatic cell genome editing: Sickle-cell disease as a case study” in Erick Valdés Meza et al, eds. Springer Handbook of Bioethical Decisions (Springer, forthcoming; contracted in 2022).

So, in short, gene therapies like those named above involve inserting new genes into the cellular DNA, including by replacing mutated genes with new genes (non-faulty genes) not associated with dysfunction. These new genes are ‘inserted’ through AAVs, which are versatile viral vectors that can be engineered for specific functions and are used as vectors through which new DNA can be delivered to target cells. It is important that these AAVs lack any viral genes but instead contain the ‘good’ replacement DNA sequences for the relevant therapeutic application.

In contrast, as can be heard in the podcast, non-heritable genome editing involves removing cells from a patient, usually hematopoietic stem cells, then editing those cells, and then reinfusing those edited cells back into the patient’s body. Those edited cells are usually edited with a CRISPR-Cas9 endonuclease, which may make targted breaks and then repair (using an RNA-guided nuclease) those double strand breaks (DSBs) in the human cellular DNA in a programmed way, so that, when the DSB is repaired, it is repaired in such a way that the cells are no longer pathogenic.

I should note that nuclease-mediated SCGE may occur either outside the body (ex vivo), as I discuss in the podcast, or inside the body itself (in vivo). I am unfamiliar with much of the latter actually going on. A third route, in which edited somatic cells may be administered to fetuses (in utero), is also under investigation.

In terms of the process that I am describing — which is an ex vivo application — when the extracted cells are taken from the patient’s body, they are separated from the so-called vascular fraction (heterogenous extraction of cells) so that enriched hematopoietic stem cells (CD34+ cells) can be isolated.

Following this ‘enrichment’ process, the cells are then edited by means on instrument called an electroporator. This instrument delivers a precise electrical pulse to the enriched cells in a protective medium that contains the CRISPR-Cas9–guide RNA complex. The electroporation increases the permeability of the cell membranes, allowing the RNA-guided nuclease to be introduced (or electrotransferred) into the cell. Another way in which cells are edited is through as process called nucleofection.

A description of both methods is given in Synthego’s guide to using CRISPR, in its chapter on transfection protocols, as follows:

Traditional electroporation and nucleofection are based on the same overall methodology. Cells are first mixed with an electroporation or nucleofection reagent, and then added to CRISPR components (shown here as RNPs). The cell-RNP mix is then put into a Nucleocuvette (for nucleofection) or Neon pipette tip (for electroporation) and inserted into a Nucleofector or electroporator. Once in the machine, an electric pulse is applied to the cells. The electric field temporarily causes pores to form in the plasma membrane, enabling RNPs to enter the cells. Nucleofection also enables nuclear entry of RNPs. Once the electric field is removed, the plasma membrane is repaired.

See How To Use CRISPR: Your Guide to Successful Genome Engineering, chapter 6.
nucleofection.svg
Source: Synthego, How To Use CRISPR: Your Guide to Successful Genome Engineering, chapter 6.

Following this process, the cells are left to recover, during which the editing, as it were, occurs. After some time, the cells are then cryopreserved to facilitate manufacturing quality analysis before being thawed. These edited cells are then reinfused in the patient.

Although I do not go into this kind of detail in the podcast, I do describe the manner in which one new somatic cell genome therapy for sickle-cell disease has been described in the provisional ‘proof of principle’ studies. That description is based on exa-cel (formerly CTX-001) — a genome editing therapy currently undergoing the regulatory submission provess in the US.