How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

 How gene regulation is changing in Australia (from Frontiers in Medicine, see title link for pdf))

Summary

• 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.
• The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.
• It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.
• 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.

Keywords: gene technology, gene therapy, clinical medicine, gene technology regulation, risk management, technological and regulatory advances, ethics and law

Citation

O’Sullivan GM, Philips JG, Mitchell HJ, Dornbusch M, Rasko JEJ. 20 Years of Legislation – How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic. Front Med (Lausanne). 2022 May 10;9:883434. doi: 10.3389/fmed.2022.883434. PMID: 35620726; PMCID: PMC9127347.