Extracellular vesicles are generating excitement as tools for regenerative medicine and drug delivery — but no EV-based therapeutic has received market approval anywhere in the world. In a new Perspective article, we argue the barriers are not solely technical. They are also regulatory.

How a long-forgotten episode involving the wrongful conviction of 15,000 Australians for unproven welfare offences prompted the creation of the Robodebt scheme

Recent legislative reforms to abortion law in New South Wales gave rise to vigorous public and media discourse. This post seeks to provide some clarifications across several related but legally and ethically distinct domains in health law.

I was recently asked to answer a few questions about the effects of the Abortion Law Reform Amendment (Health Care Access) Bill 2025 (NSW), which was recently introduced by Greens Member of Parliament Dr Amanda Cohn, MLC.

Recently, the defence of sexsomnia — a subcategory of the so-called ‘sane automatism’ defence — has been a source of disquiet and concern in the UK and now Australia. The defence rests on the ancient criminal law doctrine that only voluntary acts will give rise to criminal liability and involuntary acts are excused. But what reform, if any, could appropriately address the concerns of victim survivors and other advocates?

Can an employer be liable for causing psychiatric injuries to an employee if they terminate them in a manner that amounts to a breach of contract? A majority of the High Court has confirmed that, if certain criteria are met, contract law will aid the plaintiff.

What are the implications of the TGA’s stricter approach to cosmetic treatment promotions? And how might the TGA’s regulatory approach interact with the law of negligence that requires practitioners to warn patients of inherent material risks?

Income apportionment and the FTXB test case With lead author Dr Darren O’Donovan (senior lecturer in administrative law at La Trobe), I have authored a blog post on a significant test case recently heard by the President of the Administrative Appeals Tribunal, Justice Kyrou, and two senior members, called FTXB; Secretary, Department of Social Services […]

Today I’ve written a short reflection on AHPRA and the Medical Board of Australia’s (MBA) proposed options to reform the regulation of ‘late-career medical practitioners’ — ie, doctors over 70 years old — by requiring them to undergo regular health assessments. I will mostly let my short analysis published in the Conversation, speak for itself. […]

The most recent two issues of the Journal of Law and Medicine carry articles authored or co-authored by me. The first is lead-authored by Mike O’Connor (with me and Cameron Stewart) and is titled ‘Sexual Boundary Violations by Doctors – Context, Regulatory Consequences and Preventive Strategies’ (see PMID 38761390). In that paper, we discuss the […]

A genome-edited pig kidney I was pleased to be invited to reflect on the future of xenotransplantation and human genome editing recently in an interview on ABC’s The World with Beverley O’Connor. The interview was broadcast following news of the unfortunate passing of Richard “Rick” Slayman — the first human to have received a genome-edited […]

The Therapeutic Goods Administration (TGA) has updated its guidance on advertising cosmetic injectables. What are the implications?

Last week, the biotech firm eGenesis supplied a donor kidney sourced from a genome-edited pig to a surgical team at Massachusetts General Hospital (MGH) in the US. The donated kidney was transplanted into a patient with end-stage renal disease whose existing kidney transplant (‘allotransplanted’ from a human) was wearing out. The FDA had granted an […]

Today on Welfare Law in Australia, Darren O’ Donovan analyses an internal document released under the Freedom of Information Act 1982 (Cth) just a few days ago. That document reveals the inner working of Services Australia as it continues in its efforts to remediate a multi-decade calculation blunder likely affecting more than 100,000 people. What […]

Last Wednesday (8 March 2024) I was featured on the ABC News Daily podcast, thanks to researcher Bridget Fitzgerald and host Sam Hawley. We discuss the crackdown on botox and cosmetic procedures in Australia and what it will mean for patients. The episode is available here.

Fidge v Pfizer is notable for making several provisional holdings. Among those was Rofe J’s holding that it is not a ‘necessary incident of medical practice’ for doctors to challenge government decisions based on alleged breaches of legislation, even when done in a purported attempt to protect patients’ health.

On BioEdge, Dr Patrick Foong and I quickly run through the bioethical perturbations that have come with the relatively rapid approval of Casgevy, the first-ever approved genome-editing therapy that utilises CRISPR/Cas 9. In some ways, it could be said that Casgevy is the first-ever approved genome therapy ‘full-stop’, because other categories of gene therapy have […]

On our welfare law substack Welfare Law in Australia, Dr Darren O’Donovan writes about the saddening fact that some one million Centrelink claims are at the moment awaiting assessment and determination. O’Donovan analyses the causes of this unsustainable backlog and the way it might be solved.

This post is a brief discussion of three media contributions I have made in the last few months.

I recently spoke on a panel of three at the second annual Australian Progressive Legal Studies Conference. The theme of the conference was ‘Law and Class in the 21st Century: Australia and Beyond.’
The roundtable comprised Scarlet Wilcock (University of Sydney Law School), Asher Wolf (independent activist) and me. It was focused on robodebt. The text of my address is below.

In late November, I presented a paper via video link to the Australasian Association of Bioethics and Heath Law (AABHL) on ‘risk-based regulation.’ The abstract for that paper was as follows: What risk? A critical analysis of risk-based regulation of therapeutic goods, from stem cell medicine to osseointegration devices Therapeutic goods (medicines, biologicals and devices) […]

The chimeric monkey experiment I was quoted in this article today regarding a newly published study in Cell that demonstrates, in the author’s words, that ‘mammalian pluripotent stem cells possess preimplantation embryonic cell-like (naive) pluripotency.’ As the summary notes, this discovery about embryonic stem cells can now be said to have been demonstrated experimentally through […]

Exa-cel and the FDA review Just last week, on 31 October, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee met to discuss Vertex Pharma’s Biologics License Application for Exagamglogene autotemcel (or exa-cel, and formerly known as CTX-001) — a cell-based gene therapy designed to treat sickle-cell diseases. I have written about exa-cel many times […]

This month has been a busy month for my semi-scholarly work. At the start of the month, I wrote this piece for the Conversation about the so-called crackdown on the cosmetics procedures sector announced by AHPRA around 7 September 2023. Following the publication of that piece, I was lucky to be asked to appear on […]

Legal errors impacting those entitled to social security benefits continue to arise in Australia

On 2 August 2023, the Commonwealth Ombudsman published a terse report outlining its findings after an investigation into the lawfulness of ‘income apportioning’ — a method of debt calculation used by Australian welfare agencies DHS and DSS since at least 2003 (ie, for more than 17 years). As the Report states, this process, as it […]

After several years of controversy, and both praise and blame for his willingness to perform high-risk surgeries, neurosurgeon Charlie Teo has been subject to practice restrictions by a special committee established under health practitioner law. So how does the process of restricting doctors’ medical practice work? And what did this mean for Teo? How are […]

The following post explores the relative egregiousness of the robodebt scandal, the Royal Commission report’s structure and contents, and the earliest stage at which the capability of creating something like robodebt arose. It also considers automated decision-making and the extent to which the Commission omits to consider the actual technical workings of robodebt.

The post goes on to consider the problem of subject matter experts, as well as the problem of the ‘proof point’ solution for robodebt, both of which are not considered in the Commission’s report. Next, the post notes the way in which the Commission’s report does not take a strict or legalistic approach to the unlawfulness of robodebts — at least not beyond anything already said in the Federal Court of Australia.

Finally, the post briefly touches on the AAT firing scandals that the Report essentially omits. Despite all this, the article concludes with some compliments for what is obviously an exceptional output from this Royal Commission — one that chronicles an unprecedented Australian governance failure and recommends 57 ways it might be redressed.

After a long journey that should have been no surprise whatsoever (not when one looks at the scale and size of this volume), a book chapter I authored with Emeritus Distinguished Prof Dianne Nicol from the University of Tasmania’s Centre for Law and Genetics, way back in 2021, has now been published. The chapter deals […]

Yesterday I delivered a presentation on the regulation of stem cell-based interventions in Australia, focusing on the theory and practice of risk-based regulation and on some new developments in this regulatory environment. The talk was a part of the Cellular Horizons research grant that has been awarded to a team of scholars of which I […]

The proposed ACT approval model Recently, I was interviewed by the young journalistic team at SIX News Australia about a Bill that the ACT Government introduced into its single-house Parliament in late March 2023. As I see it, the proposed Bill, if passed, will be transformative. And in a good way. It will require interventions […]

My submission to the Inquiry into Constitution Alteration (Aboriginal and Torres Strait Islander Voice) 2023 Bill may be found here.

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

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 […]

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. Gene therapy and genome editing One […]

I recently published an article in the Conversation on proposed changes to the regulation of cosmetic surgery in Australia here. In essence, the state and territory Health Ministers have decided, after three years of consultation, to make the title ‘surgeon,’ as well as ‘cosmetic surgeon,’ a protected title. This will mean that cosmetic surgeons will […]

Cellular Horizons is a Medical Research Future Fund project investigating how consumers (and health practitioners) can improve decisions about accessing cellular therapies.

In November I delivered two conference papers. I summarise them below.

If you’re thinking about a tummy tuck, breast implants or eyelid surgery, you might be looking for reassurance your chosen doctor is qualified and has the right skills for the job. Today’s release of the much anticipated review of how cosmetic surgery is regulated in Australia goes partway to achieving that. The review makes several sensible […]

Mainstream critical legal education in Australia gives little attention to enactments and case law regulating the Commonwealth’s constitutional power to appropriate (s 81) and spend money (s 83). This neglect has several causes, including a shallow knowledge base. Few legal scholars have engaged with reforms aimed at increasing the public administration of government spending, much […]

This post is a provisional opinion, expressed in a moment in time. It does not represent the view of my employer. Nor is it legal advice. It is also not offered as a scholarly contribution. Recently, Bernie Fraser has said he’d prefer the ACTU Secretary Sally McManus be appointed to review the RBA over an […]

Overruling Roe and Casey I’m very disappointed by the result of Dobbs v Jackson Women’s Health Organization. The majority holding of the SCOTUS opinion (authored by Justice Alito) is summarised in the headnote as follows: The Constitution does not confer a right to abortion; Roe and Casey are overruled; and the authority to regulate abortion […]

In short, because the texts don’t constitute ‘advertising.’

Recently, a new Bill to allow mitochondrial donation was tabled in the federal Parliament. Will it achieve all that it promises?

I’ve begun a substack blog titled Welfare Law in Australia. The purpose of the blog is to write and compile a bunch of informal notes about welfare law in Australia, primarily in the Administrative Appeals Tribunals, as I develop my interest in this field. Please visit the substack at https://welfare.substack.com/ Although my primary interest remains […]

Australia’s Therapeutic Goods Administration has been more vigilant in policing advertisements for unproven COVID-19 ‘treatments’. But have some slipped through the cracks?

It’s been a long time since my last update, but I just wanted to note below a few recent papers I have co-authored with my Australian health law colleagues. More to come! Christopher Rudge and Megan Munsie, ‘The Promise of Stem Cell Treatments: What are They and How Are they Regulated Down Under?’ (2020) 156 […]

Philament is a peer-reviewed, open-access journal that publishes scholarship by postgraduates and early-career academics on literature, cultural studies, and the arts. I have been managing editor of the journal since 2016, so it’s a thrill to publish the journal’s 25th volume and at the same time launch a new website at www.philamentjournal.com. Both the volume […]

I’m writing this quick update simply to share my recent movements and my goings-on in the coming months. One success story of last year was finishing the final version of my major report for the Medical Council of NSW, titled “Regulating Medical Practitioners in the Public Interest: A Qualitative Review of Public Interest-based Decisions of the […]

The Vaporfly study and the four per cent claim In November 2017, Wouter Hoogkamer and colleagues published the study that underlies Nike’s claim that its new shoe — the Zoom Vaporfly 4% (VF4%) — improves one’s running by around 4%. Hoogkamer, a research associate at the University of Colorado, published the study in the journal […]

The following is an abstract recently submitted to the organisers of a neuroscience and society conference in Sydney. It combines two projects that I’m currently working on: the first, a paper on “the public interest” under the Health Practitioner Regulation National Law (NSW); and the second, a paper on the Chelmsford scandal from the perspective of the legislative and regulatory history of psychiatry and medicine in NSW in the 1960s through to the 1990s.

Well, it’s certainly been a long time since I’ve written anything here — almost 8 months. For that reason, I thought I’d better put together a quick update on my goings on. I am currently working on a report on the meaning of “public interest” as that expression appears in a state statute for a […]

Measuring emotion at the Burghölzli In July, 1907, the Swiss psychiatrist Carl Gustav Jung and American neurologist Frederick Peterson published the results of their investigations into the galvanometer and the pneumograph in BRAIN, the journal of neurology. The pair had subjected various people to these instruments—people they had identified as “normal” and “insane”—in an attempt […]

In the late nineteenth century, Sigmund Freud’s colleague Wilhelm Fleiss successfully diagnosed an illness in one of Freud’s relatives, without even having met them. Freud was so impressed by Fleiss’s “diagnostic acumen” that he went on to advocate the method in certain circumstances. Freud would write that diagnosing someone without personally examining them was acceptable […]

I recently submitted the following abstract to Neuroscience and Society: Ethical, Legal and Clinical Implications of Neuroscience Research — a conference scheduled for mid-September, 2017. Please do not use or reproduce this work without attribution.

Below is a paper I delivered in April, 2017, at the Sixth International Aldous Huxley Symposium. Held at the University of Almería, the symposium was organised by Bernfried Nugel and the Aldous Huxley Society. There I met and became friends with a number of the scholars I cite in the paper, including Sam Deese and Jerome Meckier. Running for three days, it was a wonderful event, and I am grateful to the Aldous Huxley Society for inviting me to attend.

Please do not use or reproduce this work without my express consent or permission. If you wish to cite this work, please specify that it was originally delivered as a conference paper and give details of this website. I also prepared a presentation, which is accessible here.

Freud, Fliess and the clinical consultation At the turn of the twentieth century, Sigmund Freud and his otolaryngologist friend Wilhelm Fleiss parted ways in bitter disagreement. The men’s vexation arose before a lethiferous background of cocaine use and abuse, and was ultimately ended by that same route, with the pair discovering they had developed a difference […]

Fisher’s critique of capitalist realism Although a few books, numerous essays, an art movement, a literary tradition, and an ideology have all been given the title “Capitalist Realism,” it is likely that what first springs to mind when a cultural studies scholar hears those two words is a small book published in 2009. More than six years since its publication, that […]

Models of scholarly success I assume that, on occasion, many early-career researchers are tempted, as I am, to reach for those kinds of books that offer a system or model for publishing success. After all, what better way to reassure oneself that an academic career is feasible than to learn about others’ achievements? Dean A. Shepherd’s The Aspiring […]

Academic blogging and the value of work Busywork, or work that keeps one busy but serves no value in and of itself, is variously familiar to us all. But busywork seems just as likely to affect the lives of researchers, of “knowledge workers,” as it is to bear upon those of other professionals—if not more likely. Indeed, […]

Reading Goodrich’s “Proboscations” Just a short note to recommend Peter Goodrich’s remarkable new article, “Proboscations: Excavations in Comedy and Law,” published in the Winter 2017 issue of Critical Inquiry (volume 43, issue 2), “Comedy: An Issue,” edited by Lauren Berlant and Sianne Ngai. I’m sure that there are many fantastic pieces to be discovered in this installment […]

This year I’ll commence a short-term “project-to-publication” fellowship with the Australian Research Council Centre of Excellence for the History of Emotions. It will transpire only for a short 6 months, so I’ll have to make the most of it. One of the things that the Centre encourages its researchers to do is regularly blog about […]

I’ve been working as editor of the postgraduate journal Philament for around two years now. It has not always been an easy endeavour. For one thing, I am not paid to undertake the huge task of editing and producing the journal, a fact that certainly makes the work difficult to justify. But, despite the many […]

This paper was presented at a conference held on 20–21 February 2012 at The University of Sydney. More details about the event are below.