|Title||Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies|
|Author(s)||Purnhagen, Kai P.; Wesseler, Justus H.H.|
|Source||Pest Management Science 75 (2019)9. - ISSN 1526-498X - p. 2310 - 2315.|
Law and Governance
Agricultural Economics and Rural Policy
|Publication type||Refereed Article in a scientific journal|
|Keyword(s)||approval costs - European Union - ex-ante regulation - ex-post liability - gene editing - investment - maximum harmonization - minimum harmonization - new plant breeding technologies - real options - regulation|
New plant-breeding technologies (NPBTs), including gene editing, are widely used and drive the development of new crops. However, these new technologies are disputed, creating uncertainty in how their application for agricultural and food uses will be regulated. While in North America regulatory systems respond with a differentiated approach to NPBTs, the Court of Justice of the European Union (EU) has in effect made most if not all NPBT subject to the same regulatory regime as genetically modified organisms (GMOs). This paper discusses from a law and economics point of view different options that are available for the EU's multi-level legal order. Using an ex-ante regulation versus ex-post liability framework allows the economic implications of different options to be addressed. The results show that under current conditions, some options are more expensive than others. The least costly option encompasses regulating new crops derived from NPBTs similar to those used in ‘conventional’ breeding. The current regulatory situation in the EU, namely making the use of NPBTs subject to the same conditions as GMOs, is the most costly option.