Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions
Chris Rudge, Narcyz Ghinea, Megan Munsie, Cameron Stewart
Australian Health Review | CSIRO PUBLISHING | Published : 2021
ObjectiveThis paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018.MethodsThe paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all 'biologicals', including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence re..View full abstract
Awarded by Australian Research Council of Australia
This work was supported by the Australian Research Council of Australia (Linkage Project LP150100739).