Dr Christopher Rudge1
1Sydney Law School, Sydney, Australia
Biography:
Dr Christopher Rudge is a lecturer in Sydney Law School. His research focuses on human health and welfare law, with concentrations in therapeutic goods regulation, health practitioner regulation, social security law, mental health law and health information and data rights.
Abstract:
Many new therapeutic treatments promise unprecedented health benefits. But many also pose uncertain risks to human health. Administrative drug regulators, such as the FDA and TGA, operate within a dualistic framework to manage these risks. On the one side, the regulators take responsive risk-based action at the ‘street level’ (eg, Braithwaite’s pyramid of escalating enforcement). Less commonly acknowledged is that these agencies also operate at a lawmaking level. Legal staff help to craft ‘static’ risk-based rules that influence regulatory operations and limit the scope of the agencies' responsibilities (eg, responsibility for a certain 'low-risk' drug may be delegated to another agency or to treating health practitioners through a legislative exception).
During COVID-19, criticisms about drug regulators’ approaches to new treatments have surged. Several legal challenges were also brought against the agencies' administrative decisions. However, the bulk of these criticisms and challenges show a deep misunderstanding about the principles underlying the risk regulation of therapeutic goods, particularly the 'delegation' function noted above. Many seem to think that drug regulators exist to prevent all possible harms.
This paper aims to redress this misconception by comparing the agencies' administrative or 'institutional' approach to risk with approaches adopted in other areas of health decision-making. I claim that the risk governance of therapeutic goods must be distinguished from risk-benefit (actuarial) analysis, the precautionary principle, and the ‘primum non nocere’ (first do no harm) principle. The central mistake critics make is to assume that uncertainty is or should be eschewed by the regulatory regime. In reality, the regime tolerates and even embraces degrees of uncertainty.
To illustrate the practical reality of risk governance, the paper will provides several examples from the regulation of stem cell medicine. This work arises out of a broad team project on cellular therapy regulation in Australia.