November–December 2023 updates: AABHL presentation; thalidomide apology; unlawful welfare convictions

Just a quick blog post to note a few news items

  • In late November, I presented the following presentation remotely at the Australasian Association of Bioethics and Heath Law (AABHL) on ‘risk-based regulation.’ My abstract 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) are regulated both in Australia and globally via ‘risk-based regulation’ (RBR). Recently, the OECD has described RBR as rules that are ‘science-based, targeted, effective and efficient,’ invoking the paradigmatic ‘risk-benefit analysis.’ But, as this paper contends, this description is misleading. In essence, RBR is neither health-focused nor harm-minimising but about ‘less-is-more’ governance. As with other neoliberal creations, RBR’s aim has been to prioritise private sector remediation (eg, civil litigation) and self-regulation over centralised governmental control. While the impact of RBR in the financial sector has been studied in detail, scarce legal scholarship has examined the state’s devolution of responsibility and control over therapeutic goods law to private individuals and organisations, such as hospitals or private practitioners.

As this paper will illustrate, while therapeutic goods legislation does control risk and experimentation (‘innovation’), it does so only for high-risk therapies: ie, those ‘worth’ regulating. Two examples are on point: the practice of stem-cell medicine and the use of osseointegration devices. In pursuit of efficiency, RBR eschews ‘overregulation’ and avoids duplication of oversight and enforcement. In concert with the Australian Civil Liability Acts, RBR has arguably achieved its implicit goal of ‘deresponsibilisation.’ However, a regulatory vacuum for unregulated or unapproved experimentation, creating confusion among practitioners and leaving regulators open to accusations of arbitrary decision-making. While better ‘upfront’ guidance for practitioners may assist, I contend that better-publicised reasons by regulators will enhance standard-setting.

A video recording of the presentation is below:

  • On 7 December, I was quoted in the Guardian in a story written by Paul Karp about two people remain in jail for welfare fraud offences based on defective and unlawful evidence. That defectiveness and unlawfulness has been recognised by the Ombudsman and the welfare agencies, and even, seemingly, the Cth Director of Public Prosecutions. I make the point that more should be done to facilitate the review of these cases. The CDPP have disclosure obligations, but it appears to me that the nature of the disclosures may be narrow (notifying of a potential problem) or broad (giving detail as to the nature of the evidentiary issues). The story is here.

Chelmsford’s Legacy: Regulating Experimental Brain Interventions in the Public Interest (Abstract)

The former Chelmsford Private Hospital (this photograph from 1990). Source: The Daily Telegraph.

I paste below an abstract, with the above title, that I’ve 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 ’60s through to the ’90s.

Barbiturate-induced deep sleep therapy (DST), electroconvulsive therapy, and cingulotractotomies to lesion the brain’s cingulate gyrus were among the many controversial brain interventions used, often in combination, by psychiatrist Harry Bailey and colleagues in Sydney’s Chelmsford Private Hospital from 1963 until the 1980s. Prompted by the Church of Scientology’s Citizen Commission on Human Rights, and later the NSW-based Public Interest Advocacy Centre, a Royal Commission into Bailey’s use of DST was established in 1988. Although Bailey committed suicide before giving evidence at the Commission, the resultant report found that the psychiatrist had been responsible for the deaths of more than 24 patients at Chelmsford, together with the suicides of another 19 previously under his care.

In this paper, I will briefly trace Bailey’s unethical misuse of various neuroscientific theories of the mind and brain he had learnt from, among others, Manfred Bleuler, the son of pioneering schizophrenia nosologist Eugen Bleuler, before detailing, in clear terms, the momentous regulatory changes that occurred in NSW after Chelmsford.

When reports of Bailey’s conduct reached authorities in the 1970s, the NSW regulator took no disciplinary action against the psychiatrist, finding that while the Medical Act 1938 proscribed “infamous conduct,” it did not allow interim orders against doctors for poor performance. Subsequent regulatory changes would transform the state’s approach to regulating health practitioners, leading to a new Medical Practice Act in 1992. Drawing on research recently commissioned by the NSW Medical Council on the public interest, this paper will show how regulatory reform after Chelmsford continues to shape health regulation today, including through public interest-based amendments recently made to the 2009 Health Practitioner Regulation National Law across all Commonwealth jurisdictions. Citing hypothetical and real examples, I will also explain what these important reforms mean for practising brain specialists who use or abuse novel experimental brain interventions, such as deep brain stimulation.