Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies

Abstract

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. © 2019 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Potential, Challenges, and Threats for the Application of New Breeding Techniques by the Private Plant Breeding Sector in the EU

“…Given the highly competitive market for strategic agricultural and food investments, the level of uncertainty that exists within the EU has the potential to divert potential research and development investments away from the EU to markets with more science-based, risk-proportionate, and innovation-supporting regulations (Lassoued et al, 2018). Uncertainty and irreversibility have a strong effect on postponing investment in R&D with NBTs (Purnhagen and Wesseler, 2019).…”

Getting an Imported GM Crop Approved in China

“…to commercialization is regulatory delay [8,9]. China, in common with many other countries in the world, experiences this delay, most particularly since 2010 when biosafety certificates for GM rice were issued by MARA.…”

The Economics of Regulating New Plant Breeding Technologies - Implications for the Bioeconomy Illustrated by a Survey Among Dutch Plant Breeders

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