Abstract
This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.
Highlights
This article gives a brief overview of what kinds of problems the European Union’s (EU) regulatory framework for genetically modified organisms (GMOs) faces in the wake of the ECJ judgment Confédération paysanne a.o. on directed mutagenesis (ECJ, 2018)
The ruling reflects the fundamental problem of European GMO law: Long before the request for a preliminary ruling had been addressed to the ECJ, the legislator failed to acknowledge and incorporate decades of technologic development, especially the capacity of new techniques to alter the genetic material of organisms to a result that is indistinguishable from conventional breeding or natural variation
An additional option for lowering the regulatory burden for innovators bringing genome edited organism” (GEO) to market is an update to technical progress to Annexes II, III, VI, and VII of the GMO Directive, which is provided for by statute with recourse to a Committee Procedure that has to be initiated by the European Commission
Summary
This article gives a brief overview (section The ECJ Judgment and Its Ramifications) of what kinds of problems the European Union’s (EU) regulatory framework for genetically modified organisms (GMOs) faces in the wake of the ECJ judgment Confédération paysanne a.o. on directed mutagenesis (ECJ, 2018). The ruling reflects the fundamental problem of European GMO law: Long before the request for a preliminary ruling had been addressed to the ECJ, the legislator failed to acknowledge and incorporate decades of technologic development, especially the capacity of new techniques to alter the genetic material of organisms to a result that is indistinguishable from conventional breeding or natural variation.
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