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 3 December 2023, I was quoted in a news story on the thalidomide apology, which the Commonwealth government issued following a Senate Inquiry into support for thalidomide survivors. The new story is here.
- 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.