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.
This latest review seeks to clarify whether organisms developed using newly developed technologies should be regulated as genetically modified organisms (GMOs) to ensure that new technologies are regulated in a manner commensurate with the risks they pose, and importantly, to ensure the Gene Technology Regulations reflect the current state of technology and scientific knowledge. Among the “new” technologies noted in the Regulator’s discussion paper as being relevant to the present technical review are agroinfiltation, grafting, RNA interference (RNAi) and, of course, genome editing.
Under the terms of the Gene Technology Act 2000 (Gene Technology Act), “dealings” with organisms that meet the definition of “genetically modified organism” (GMO) – being an organism that has been modified by gene technology or an organism that has inherited particular traits that has occurred because of gene technology – are tightly regulated, and generally prohibited unless authorized by a GMO licence or otherwise may be characterised as “low risk”, “exempt” or specifically included in the GMO Register. While these restrictions on dealings with GMOs are aimed at minimising the risks posed by GMOs to people and the environment, it is clear that the definition of “GMO” was intentionally cast broadly to ensure that it could be adapted to new technology as it develops.
The Gene Technology Regulations currently exclude a number of techniques from the definition of gene technology (including somatic cell nuclear transfer, protoplast fusion and various forms of induced mutagenesis) and a number of organisms from the definition of GMOs. However, the applicability of those exclusions has become less clear with the fast development of new technologies. A major focus of the technical review will therefore be to clarify what is excluded from the definition of “gene technology” and “GMO”.
The Technical Review
The Regulator seeks submissions from interested stakeholders, offering the following four options for the regulation of new technologies:
- no amendment to the Gene Technology Regulations
- regulate certain new technologies
- regulate some new technologies based on the process used
- exclude certain new technologies from regulation on the basis of the outcome they produce.
Option 1 is self-explanatory. Option 2 proposes to amend the Gene Technology Regulations so that dealings with all organisms developed using oligo- and site-directed nuclease techniques are regulated under the Gene Technology Act. Under option 3, techniques which use a nucleic acid as a guide for directing DNA repair would result in a GMO, whereas certain techniques which do not involve the application of a nucleic acid guide would not result in a GMO. Option 2 and, to a lesser extent, option 3, would appear to have the effect of regulating organisms that are indistinguishable from those that are presently excluded from the definition of GMO, such as organisms brought about by natural, chemical or radiation mutagenesis. Option 4 proposes to exclude organisms from regulation as GMOs if the genetic changes they harbour are similar to, or indistinguishable from, those brought about by “conventional” breeding (including radiation and chemical mutagenesis).
A number of other issues will also be examined as part of the technical review including issues surrounding gene driven research and the applications of RNA interference. Stakeholders are asked to provide answers to eight consultation questions which are focused on these issues. The discussion paper also foreshadows the possibility of amending the Gene Technology Regulations to clarify the meaning of certain terms which have become increasingly ambiguous in light of technological developments such as “mutational event”, “introduction”, “foreign nucleic acid” and “non-homologous”.
The technical review must maintain the current policy settings and so cannot alter the definition of “GMO” in the Gene Technology Act. However, it is within the scope of the technical review to add to the list of techniques that are not “gene technology” and to the list of organisms that are not “GMOs”. In the event that amendments to the Gene Technology Regulations are deemed necessary, the Regulator will conduct another public consultation on any proposed amendments.
The discussion paper is available here. The initial deadline of 2 December 2016 for lodging a submission to the review has been extended to 16 December 2016.