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.

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.

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?

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 […]

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.

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

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) […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]