EOAR SEMINAR, MAY 2023

Dr Christopher Rudge (Sydney Law School, The University of Sydney)

 

This presentation will introduce the way in which biologicals, and specifically stem cell-based therapies, are regulated in Australia. It will show that the manner of regulation is risk-based regulation, which involves placing different potential dangers or harms into different categories and requiring ‘sponsors’ (organisations who are applying for their stem cell treatment to be approved) to provide clinical evidence in accordance with those perceived dangers. Risk-based regulation relies on a general theory, which is that more attention should be paid by regulators to more dangerous things (and less to less dangerous things). However, in the case of stem cell-based treatments, it also relies on a special theory: namely, that unmanipulated cells that function in the way they did before they were extracted, are safe. This presentation will explore this special theory. Finally, the paper will also look at some new developments in the regulation of biologicals in Australia, and how all of the above might impact on consumer decision-making.

 

When: Wednesday, 31st May 2023, 1-2 PM (ACST)

Where: Online. Please RSVP to openstemcells@adelaide.edu.au

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Dr Christopher Rudge is a lecturer in private law at Sydney Law School and a member of Sydney Health Law at the University of Sydney. He has a broad network of research collaborators in the sciences and social sciences across the world, and focuses on legal issues relevant to the regulation of innovative medical technologies, including genome editing (somatic and germline cells; CRISPR, TALENs and ZFN-based systems), stem cell-based interventions (including extracellular vesicles) and other innovative medical treatments in Australia.