European genome editing regulations: threats to the European bioeconomy and unfit for purpose

Abstract

Summary: The European Court of Justice has ruled that products developed by gene editing and other new genetic technologies must be subject to GMO regulations. This is having profound detrimental effects on the European Bioeconomy as the current GMO regulation is not fit for purpose. We review how this ruling is jeopardising competition, disinsentivising small and medium sized enterprises, exporting employment overseas, and increasing costs to European Society and the environment. Furthermore, the current regulations are scientifically flawed in that identical genetic changes can occur spontaneously or be introduced by new gene technologies, yet the European Commission requires methods to be available to determine how the genetic change occurred. This is impossible. We argue that while the safety of a product is of paramount importance, the technology used to develop it is irrelevant. A successful European Bioeconomy will require continued constructive discussion of how to base European regulations on best available scientific evidence.