Modernising Australia’s Gene Technology Scheme

    25 May 2021

    Following the Third Review of the National Gene Technology Scheme, the Federal Department of Health is seeking to modernise and futureproof Australia’s National Gene Technology Scheme. This presents an opportunity for Australia to remain a world-leader in biotechnology regulation.

    In 2018 the Legislative and Governance Forum on Gene Technology declared that products created through the gene-editing technique SDN-1 would be exempt from regulation given the outcomes were indistinguishable from products created through conventional methods. With biotechnology making huge leaps in the areas of agricultural and medical research, the regulatory system must keep pace. Now is the time to go further and de-regulate gene-editing techniques like SDN-2 and Oligo-Directed Mutagenesis (ODM), the products of which could quite literally save lives.

    These types of techniques were used in the new cancer treatment known as CAR T-cell therapy, via the product Kymriah® (tisagenlecleucel), which was approved by the Therapeutic Goods Administration of Australia in early 2021. It is used for the treatment of leukaemia and lymphoma in patients where alternative treatment options have been exhausted.

    CAR T-Cell therapy is a once-off, individualised treatment that uses gene-editing techniques beyond the capability of SDN-1 to reprogram the patient’s own T-cells to fight cancer.

    Prior to approval, Australians receiving immunotherapy were required to have blood collected and sent overseas to undergo the reprogramming process before the cells could be returned and used for treatment.

    Enabling Australia’s first onshore commercial manufacture of the therapy substantially reduced patient treatment time. Government approval also led to subsidised access to the treatment, providing eligible patients with new hope and the prospect for improved quality of life.

    Due to this approval, institutions such as the Peter MacCallum Cancer Centre can continue to explore the technology and expand possibilities for the treatment of other cancers.

    Interest in agricultural applications for these techniques is also growing. In late 2020, a Japanese start-up was granted approval by Japanese regulators for the commercial release of a new tomato variety with enhanced nutritional properties. The tomato was gene-edited to increase the accumulation of the naturally occurring amino acid, gamma-aminobutryric Acid (GABA). It has nutritional benefits for treating metabolic disorders and reducing blood pressure and stress.

    Set for release in May 2021, the Sicilian Rouge High GABA tomato will be the world’s first direct consumption gene-edited tomato.

    Widespread government-led marketing campaigns in Japan to educate consumers about the difference between genetically modified organisms (GMOs) and gene-edited crops, means there is a higher level of understanding and acceptance of these products than in other parts of the world.

    The Sicilian Rouge High GABA tomato took over 15 years to produce. Commercialisation was only viable because unnecessary regulation was removed providing clarity on gene-edited plants and their products where they are developed comparably to natural processes of genetic mutation.

    Many applications of SDN-2 and ODM use site-specific guides and repair templates that allow for highly specified changes and predictable outcomes in comparison to randomly induced mutations when using SDN-1 techniques. This increased specificity not only accelerates product development but allows for greater predictability and increased success of the desired alteration.

    Continuing to regulate techniques such as SDN-2 and ODM which have a history of safe use as genetic modification will hamper the development of critical technologies in medicine and new nutritious produce choices.