Responsive to Whom? A Critical Analysis of Risk-Based and Responsive Regulation and its Application to Australian Pharmaceutical Industry

Miss Rhiannon Bandiera1
1Flinders University, Adelaide, Australia

For close to two decades, prescription and non-prescription medicine regulation in Australia has encompassed elements of both risk-based and responsive regulation. These theories have been pivotal to the formation of a regulatory regime, as well as an entire field of academic scholarship, which has emphasised working cooperatively with regulated entities when non-compliance occurs, and using deterrents only as a last resort when cooperation fails. However, data indicates that rates of non-compliance among Australian prescription and non-prescription medicines industry are greatest in those aspects of the regime which are most reliant on persuasive techniques. In the complementary medicines sector, which largely operates under a self-regulatory arrangement, as many as 90% of products have been found to contain quality, safety, and efficacy issues. This finding led the Australian National Audit Office (2011, p. 17) to conclude that regulation in this space ‘has been of limited effectiveness’.

This paper argues that an emphasis on compliance-based regulatory techniques, like risk-based and responsive regulation, has contributed to the formation of a regulatory regime congruent with neoliberal rationalities of government that aim to limit forms of market intervention by non-market forces contrary to the interests of capital. This paper finds that the limited capacity of the regulator to act on non-compliance, and lack of opportunities for meaningful democratic participation within the regulatory regime by other non-market players, is a direct consequence of this hybrid regulatory framework, which not only suffers from issues of incompatibility, but renders non-market forces less able to intervene in the regime.


Rhiannon Bandiera is an emerging early career researcher in Criminology at Flinders University, South Australia. Rhiannon’s research concerns the latest emerging issues within the fields of organised and white-collar crime. She is a specialist in legal prescription and non-prescription drug crime, from pharmaceutical diversion and counterfeiting, to manufacturer and consumer fraud. She has authored publications in the Australian and New Zealand Journal of Criminology and Australia’s leading criminology textbook Crime and Justice: A Guide to Criminology. She has First Class Honours, a Chancellor’s Letter of Commendation and three Dean’s Certificates from Flinders University. She was also the runner-up in the 2011 ANZSOC Student Essay Prize.



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