UPDATE: OGTR Releases Guidelines on Organisms Containing “Gene Drives”
The deadline for submissions on the discussion paper prepared by the Office of the Australian Gene Technology Regulator (OGTR) concerning its review of the Gene Technology Regulations closed on 16 December 2016, and submissions received by the Regulator have yet to be made publicly available.
However, the OGTR has now issued guidelines for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’ following the discussion paper consultation which revealed that some stakeholders were not aware organisms genetically modified to contain ‘gene drives’ are GMOs. The guidelines reflect the current requirements under the Gene Technology Act 2000 (Act) and will be amended to reflect any changes that are ultimately made.
As Australia faces the challenges that come with the end of the resources boom and a shift away from many traditional manufacturing industries, the biotechnology industry represents an important opportunity for economic growth. With an increase in the demand for biotech products comes the potential for Australia’s biotechnology sector to offer substantial growth and investment opportunities if supported by the right policy settings. It was recently reported that the sector is expected to grow at a rate of 4.4% a year until 2021, bringing AUD8,675M of revenue to industry.
Further, last year alone, more than 630 biotechnology patent applications including claims referring to “nucleic acids” were filed with the Australian Patents Office – many claiming subject matter that no doubt will test the boundaries of what constitutes patentable subject matter.
In an industry that has undergone rapid technological advancement since the Regulator last conducted a technical review (which resulted in amendments being made to the Gene Technology Regulations 2001 (Gene Technology Regulations) in 2011), it is timely that the Australian Gene Technology Regulator (Regulator) has initiated a technical review of the Gene Technology Regulations.