Gene editing promises revolutionary medical advances. To date, 38 clinical trials involving somatic cell gene editing are listed on www.clinicaltrials.gov, 18 of which are recruiting or currently active. Although no such trials appear to have commenced in Australia, it is likely only a matter of time. Robust safety reviews of gene editing trials will be essential. However, complexities and gaps in the Australian regulatory system raise questions about which bodies will provide such review and their capacity to do so.
- The Office of the Gene Technology Regulator reviews trials involving genetically modified organisms. However, reviews expressly delegate consideration of risks to participants to the Therapeutic Goods Administration (TGA) and Human Research Ethics Committees (HRECs) to avoid potential regulatory duplication.
- The TGA administers the Australian therapeutic goods legislation, including prohibitions on the supply of unapproved therapeutic goods. However, the Administration only assesses product safety directly for trials conducted under the Clinical Trials Exemption (CTX) scheme, as compared with the far more common Clinical Trials Notification (CTN) scheme. The CTX scheme is only mandatory for certain high risk biologicals, which may not include all gene editing products.
- HRECs review all Australian clinical trials, including the trial’s risk-benefit profile, but not all will have the necessary expertise to assess highly innovative trial products such as gene editing constructs and vectors.
- Institutional Biosafety Committees ensure the safe, compliant and appropriate use of biologically hazardous materials. However, this review addresses only a small portion of the risks that might arise from gene editing trials.