AusBiotech is seeking feedback from Members on proposed changes to the Gene Technology Scheme (the Scheme) that may impact companies and early research working with GMOs. While the Scheme has previously focused on biotech’s agricultural application, attention is now turning to managing risk in emerging technologies, such as gene therapies, with proposed changes related to definitions, risk-proportionate regulation, and streamlining regulation.
The Office of the Gene Technology Regulator has recognised three policy problems that have the potential to unnecessarily slow down the progression of a medical product on the path to market, which is detrimental to industry and its international competitiveness.
The proposed changes seek to: update existing definitions in the Gene Technology (GT) Act to clarify the scope of regulation in light of on-going technological advances; introduce a new risk-tiering framework that ensures regulation remains commensurate with risk; and reduce regulatory burden through streamlining processes and current regulatory requirements, where appropriate.
More recently, different types of GMOs are being developed for medical and industrial purposes, and these do not necessarily fit into a system that was originally designed for GMO plants. There is a growing trend that licences under the GT Act are being granted for medical and other uses, with 92 per cent of licences granted in 2019–20 related to medical uses. This trend is expected to continue into the future, as the Australian government recognises and is investing in promoting Australia as a leader in clinical trials and medical research.
Therefore, it is important that the proposed changes are effective and do not present unnecessary barriers for the progress of biotech research and development, including clinical trials, which contribute to the wellbeing of the community and the environment.
The consultation offers three regulatory reform options: no change; a risk-tiering model, where dealings with GMOs would be categorised according to their indicative risk; or a matrix model, where the nature of the dealing with the GMO would be the determinative factor for categorisation.
Twenty years of experience in regulating trials and commercial releases of GM crops and GM therapeutics supports the creation of new streamlined authorisation pathways for dealings that are low risk and where effective management conditions are known. This would reduce the cost of regulation and enhance the competitiveness of the Australian biotech industry, without compromising the object of the GT Act.