What risk? A critical analysis of the risk-based regulation of therapeutic goods, from stem cell medicine to osseointegration devices (V)
Christopher Rudge1, University Of Sydney Law School Sydney 1University Of Sydney Law School, Sydney, New South Wales, Australia
Abstract
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 paradigm of the ‘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 aims 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 for 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 in concert with the Australian Civil Liability Acts, RBR has arguably achieved its goal of ‘deresponsibilisation.’ However, as I argue, the result has been a regulatory vacuum for unregulated or unapproved experimentation, creating confusion among practitioners and leading to accusations of arbitrary decision-making. While better ‘upfront’ guidance for practitioners may assist, better-publicised reasons by regulators for decisions is more likely to enhance standard-setting.
Biography
Dr Christopher Rudge is a health law scholar and teacher at Sydney Law School. His abiding research interests fasten on the law of therapeutic goods, mental ill-health and welfare. Christopher’s research speciality over the last five years has been the intersection of ‘cells and statues.’