AUTHOR=O’Sullivan Gabrielle M. , Philips Joshua G. , Mitchell Heidi J. , Dornbusch Michael , Rasko John E. J. 

TITLE=20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

JOURNAL=Frontiers in Medicine

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.883434

DOI=10.3389/fmed.2022.883434

ISSN=2296-858X

ABSTRACT=<p><list list-type="simple"><list-item><label>•</label><p>In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.</p></list-item><list-item><label>•</label><p>The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.</p></list-item><list-item><label>•</label><p>It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.</p></list-item><list-item><label>•</label><p>Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.</p></list-item></list></p>