Regulatory Pipelines for Gene Editing

Genome editing represents a highly specific and efficient tool for plant and animal improvement with the potential to rapidly generate useful novel phenotypes/traits or correct known defects within elite genetic resources. The approach is more precise, targeted and expeditious than traditional breeding and transgenic approaches. As such, advances in genome editing and its application to plant and animal improvement programs is outpacing the ability of society to adequately process potential ethical and biosafety implications.

Many current regulatory frameworks lack the clarity on whether genome editing should or could be regulated. This is, in part, due to the range of potential products that could be generated, from the insertion of whole genes to single base changes that already exist in nature and that are indistinguishable from a ‘natural’ mutation. In the absence of these frameworks, and by default, genome editing techniques are often grouped with existing precautionary biotechnology/biosafety regulatory approaches.

Further, many existing biosafety regulatory systems focus on the assessment of the process (e.g. European and Australian systems) rather than a phenotype or product based assessment (e.g. Canadian regulatory system). The lack of regulatory harmonisation and certainty results in neither regulatory agencies nor regulated proponents knowing what information needs to be generated in order to adequately map a clear pathway to market for new products developed from the use of genome editing.

This presentation will explore the challenges faced by regulators in managing the expectations of consumer safety and discuss strategies for proponents in navigating a pathway to market under an environment of uncertainty.