Ms Megan Moss1
1Monash University
In February 2021, the Australian government enacted an amendment to the Therapeutic Goods Act 1989, to categorise bioprinting applications as a cell/device combination, class III medical device with a biological component. I argue the inclusion of bioprinting applications in this regulatory framework does not adequately address the technology’s disruption to the conceptual distinction between research and treatment. In this presentation, I will use the concept of liminality to frame my argument that bioprinting will challenge and disrupt the traditional distinction between the domains of research and treatment. I will discuss Australia’s risk-based approach to regulation, and its implications for the degree of robust evidence required for the clinical approval of bioprinting applications. I will then explore the traditional phased approach to research, and how the patient-specific design of bioprinting will impact the production of evidence. I demonstrate the limitation of conventional research methodologies to produce generalisable knowledge, specifically population-based evidence derived from Randomised Clinical Trials (RCT), due to the inherent variations of bioprinting applications. The significance of this argument will be to demonstrate the disruption of bioprinting applications and how the amended Australian regulation is not fit-for-purpose.
Biography:
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