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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 While the draft remains unpublished, no stakeholders in the health sector appear to have criticised the change.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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On Dobbs v. Jackson Women’s Health Organization

I have submitted the abstract below to an upcoming conference. I welcome good-faith comments and feedback.

I’m very disapointed that a majority of SCOTUS has seen fit to identify its commitment to stare decisis as lower now than that which was observed in Casey. I also disagree with the use of William Blackstone and Matthew Hale in the opinion, who because they sometimes dropped the word ‘quickening’ from their discussions (perhaps elliptically), are thought to have been prohibitive of all abortions.

I also did not think it was in line with the concept of legal liberty (all that is not explicitly banned is permitted: see Glanville Williams), which is obviously why so many trigger laws are raring to go. And I am not sure the same approach would be adopted here or in the UK had such an implied right been recognised in those jurisdictions. (Perhaps one of the rare ocassions where not having a be-all-and-end-all Rights Bill in Australia might suddenly seem preferable.) Dismaying, really.

Kudos to Justices Breyer, Sotomayor and Kagan who honoured Casey’s commitment to stare decisis. As they wrote:

An abortion restriction, the majority holds, is permissible whenever rational, the lowest level of scrutiny known to the law. And because, as the Court has often stated, protecting fetal life is rational, States will feel free to enact all manner of restrictions.

Some of those restrictions already slated or even already enacted, however, are in my view not rational: for example, abortion could be restricted when the mother’s life is at significant risk. How is that rational? Obviously the kinds of conficts of interest that doctors will have to deal with will also be intractable and unbearable.

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Mitochondrial donation law reform

Recently, a new Bill on mitochondrial donation, the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, was tabled in the federal Parliament. Although a vote was scheduled for last June, circumstances conspired against the parliamentary agenda, and it has been held over until later in the year.

The Bill proposes to introduce mitochondrial donation — and to legalise the intervention, which would be unlawful under current law — into the Australian health system. One of the reasons the Bill was needed is that, under current law, an act that alters a human genome is unlawful in Australia and will result in a penalty of 15 years imprisonment — one of the strictest penalties for genome alteration in the world.

That penalty is set out in section 15 of the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) (the ‘PHCR Act’). That provision has remained unchanged since 2002, despite huge advancements in science, including the invention and discovery of several completely new forms of editing and altering human genomes. One such advancement was the discovery of a way of editing the human genome with great precision; this was the CRISPR Cas-9 (and related) techniques, and the discoverers won joint Nobel prizes for chemistry in 2020 for their achievements.

How Mitochondrial Donation Works

Mitochondrial donation involves taking healthy mitochondria from the egg of a donor and transferring that healthy mitochondria into the egg of a mother who has defective or diseased mitochondria. Replacing the defective mitochondria in the mother’s egg with healthy mitochondria from another woman’s healthy egg means that the child who will issue from the mother will not have mitochondrial disease or any other disease associated with defective mitochondria (such as Leigh syndrome). Where the procedure is not undertaken, a child born of a mother with defective mitochondria is virtually guaranteed to inherit mitochondrial disease or a related condition. Most of these conditions are not well treatable, and certainly not curable. After all, imagine if every cell (or most cells) in your body had a defect! The health implications of any mitochondrial defect are serious indeed.

Figure 1: Here is a diagram of mitochondrial donation.

This figure is taken from this article, pulished in Harvard University’s Science in the News website (CC BY 4.0). The figure is by Rebecca Clements.

As may be seen in figure 1, mitochondrial donation involes a few steps. First, a medical practitioner will remove the nuclear DNA from the donor egg, leaving an ’empty egg’ (an egg sans nucleus) containing healthy mitochondria (purple). Second, the medical practitioner will then remove the defective mitochondrial DNA from the birth mother’s nuclear DNA (teal). This creates a healthy nucleus with all of the defective mitochondrial material removed. Then, the altered nuclear DNA from the mother is transferred into the empty donor egg that is free of any defective mitochondria. The result is a newly engineered egg comprising the donor’s mitochondrial DNA and the mother’s nuclear DNA. This new egg is then fertilised by the father’s sperm outside of the body (ex vivo) and, once fertilised, implanted into the mother’s womb.

Once this transfer, fertilisation, and implantation process has taken place, the mother will possess a new egg. As noted, this will be an engineered egg — a product of the mother, the father, and the donor. Inside that egg, an embryo will develop that will now possess (1) nuclear DNA from the mother, (2) nuclear DNA from the father, as well as (3) the donated mitochondrial DNA from the donor’s egg. The defective mitochondrial DNA has been removed and in its place we have only healthy mitochondrial DNA.

The reason this is possible is because, fascinatingly, mitochondria have their own chromosomes and their own DNA. This DNA is separate from the DNA that we find in the nucleus of cells (the nuclear DNA). As such, it is possible to swap out the mitochondrial DNA in an egg without disturbing the nuclear DNA.

Since the nuclear DNA is the trait-giving DNA (that is, the DNA of primary genetic inheritance, imparting such things as eye colour, height, bone density, etc.), the child’s primary genetic inheritance will remain undisturbed by the addition of the donated mitochondrial DNA from the donor. In fact, the mitochondrial DNA is just that: DNA that relates only to the mitochondria in the cells. The anatomy of a cell is visible in figure 2, below. As we can see, the nuclear DNA and mitochondrial DNA are separated and rarely interdigitate. But while the mitochondrial genome is separate from the nuclear genome, its volume is much lower. The mitochondrial genome is built of 16,569 DNA base pairs, while the nuclear genome is made up of some 3.3 billion DNA base pairs.

Figure 2. The image above shows where mitochondria and nuclear DNA are distinct; it also shows the number of genes contained in the cell nucleus compared to the number of genes in the mitochondria, which sits outside the cell nucleus.

This figure is taken from this article, pulished in Harvard University’s Science in the News website (CC BY 4.0). The figure is by Rebecca Clements.

Hang on — what are mitochondria?

Mitochondria are known as the ‘energy powerhouses’ of our cells. They are membrane-bound organelles within our cells that generate enough energy to facilitate cellular activity. Mitochondria also contain their own chromosomes. They are essential in converting the energy we receive from exogenous sources (such as food and sunlight) into energy that the cell can use in the tissues or organs. Mitochondria create energy by storing it chemically in the form of adenosine triphosphate (ATP).

Different tissue and organ cells have varying numbers of mitochondria. A mature red blood cells or erythrocyte may have no mitochondria; by contrast, liver cells (hepatocytes) can have more than 2,000 mitochondria in a single cell. Mitochondria even exist in collagen-producing cells like fibroblasts (see figure 3, below).

Figure 3. Fluorescent microscopy image of the mitochondria (red) and cell nucleus (blue) of two mouse embryo fibroblast cells.

Image taken by the Institute of Molecular Medicine I, University of Düsseldorf (CC BY 4.0) and obtained here via this Wikimedia Commons page.

What does the Maeve’s Law Bill do?

Among other things, the Maeve’s Law Bill amends section 15 of the PHCR Act to carve out an exception for mitochondrial donation, essentially decriminalising the procedure. Recall that altering the human genome is unlawful, and that mitochondrial donation would have to be deemed an unlawful alteration of the human genome under the existing law. This is because, when a mitochondrial donation intervention takes place, the medical practitioner will be altering the human genome by transferring the DNA contained in the mitochondria into a new egg that will ultimately be implanted into a mother. Precisely how and when the alteration occurs (for instance, is it unlawful to alter the genome ex vivo?) is probably not worth considering. The provision seems broad enough to capture almost any kind of alteration, at least potentially. So, without the amendment in the Bill to make an exception for mitochondrial donation (and the Bill proposes to makes a huge number of amendments across three separate Acts), a practitioner who administers the treatment would be liable for up to 15 years imprisonment.

The question I have is as follows: Is the Maeve’s Law Bill a sign of things to come? Could we see further carve outs for CRISPR-style interventions in the near future? While interesting to contemplate, I do not think we shall see any such change. The reason is that we are still too far away from wielding CRISPR (or other genome editing techniques) in ways that would be safe and effective. Somatic cell genome editing, however: that may be a different matter. But I digress. Somatic cell editing is a different case altogether.

Federalism and Mitochondrial Donation

Despite many good aspects, the Maeve’s Law Bill does have some issues. Some of those relate to the ways in which the treatment is to be made available across the state and federal levels of government. As always in health, the dualism of our federal republic — and the indelible separation of the state and federal tiers on matters of health — threaten to complicate the roll out of any medical treatment.

On my analysis, it is quite possible that certain states, for whatever reason (perhaps ethical ones), may in the future enshrine a law prohibiting mitochondrial donation in that state, despite a Commonwealth laws that permits the intervention (Maeve’s Law). In such an instance, the current Bill is powerless to overcome that issue. Of course, it is arguable that federalism would require that to be just so, since the Commonwealth lacks a power to legislate on health. However, I wonder whether a National Cabinet memorandum of understanding could not be reached, and whether the states and territories could not refer their powers to legislate on this narrow area of health law to the Commonwealth under s 51 (xxxvii) of the Constitution.

Submission to Senate Inquiry

I and my colleague Professor Ainsley Newson set out some of our perceptions of the Bill in our submission to the Legislation Committee of the Senate Standing Committee on Community Affairs. Our submission is available here; it is submission number 49.