Recent writing: ‘SBVs’ and ‘GMOs’

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 difficulties associated with regulating health practitioners who commit what we call SBVs; indeed, particular difficulties beset regulators in Australia, where AHPRA and the health professional boards (as well as the co-regulatory Councils in New South Wales, and the Health Ombudsman in Queensland) have been unable to stem the tide of increasing notifications of boundary crossing from patients. We also briefly engage with the proposed reforms (see here) being considered by Australian health ministers — reforms designed to discourage SBVs across health practice. Our conclusion is that more data are needed, and that more must be done to educate and train practitioners at the earliest stages of training: eg, medical school.

The second article is sole-authored and titled ‘Challenging Pandemic Law: From Vaccine Mandates to Judicial Review of Vaccine Approvals’ (see PMID 38963244). This article represents my attempt to clarify aspects of the polycentric (multi-centered) regulation of therapeutic goods, gene technology and health practice in Australia. It is particularly concerned to clarify the interaction of the Gene Technology Act 2000 (Cth) (GT Act) and the Therapeutic Goods Act 1989 (Cth) in light of claims that the so-called mRNA vaccines for SARS-CoV-2 (eg, Pfizer and Moderna) should have been subject to the licensing regime set out in the GT Act.

Following the Federal Court of Australia’s holding in Fidge v Pfizer Australia Pty Ltd & Anor [2024] FCA 161 (Rofe J), the article underscores the purposive approach courts are required to take in interpreting co-operative and interacting statutory regimes; indeed, as Rofe J observed in Fidge (at [66]), the GT Act (Cth) was intended to regulate ‘GM products (non-live or non-viable products) [only] where they are not regulated by an existing regulatory scheme.’

The article also undertakes a serious analysis of the law of standing as it relates to proceedings brought by self-identifying ‘aggrieved’ parties in respect of therapeutic goods and gene technology law. Notably, the article was written and published before the recent US Supreme Court decision on expanded access to the abortion drug mifepristone: Food And Drug Administration et al v. Alliance For Hippocratic Medicine et al 602 US 367 (2024). However, that US apex decision only reinforces the impediments faced by medical practitioners and special interest groups involving doctors when it comes to seeking court orders or relief relating to administrative decisions by drug regulators. No doubt FDA v Alliance will inspire a great many debates in relation to standing and challenging regulatory decision-making. Of course, the apparent demise of Chevron in the US may have other interesting impacts on these matters too.

‘Challenging Pandemic Law’ is also the first scholarly article I’m aware of that discusses the first ‘partially successful’ COVID-19 mandate litigation: Johnston & Ors v Carroll (Commissioner of the Queensland Police Service) & Anor [2024] QSC 2. No doubt many other articles will analyse this case.