- Gijs A. Kleter (1)
- Harry A. Kuiper (1)
- Dennis Eriksson (1)
- Richard G.F. Visser (1)
- Justus H.H. Wesseler (1)
- Wendy Harwood (1)
- Per Hofvander (1)
- Esther J. Kok (1)
- Huw Jones (1)
- Kai P. Purnhagen (1)
- Peter Rogowsky (1)
- Eva Stöger (1)
Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies
Purnhagen, Kai P. ; Wesseler, Justus H.H. - \ 2019
Pest Management Science 75 (2019)9. - ISSN 1526-498X - p. 2310 - 2315.
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.
Gene-Edited Crops : Towards a Harmonized Safety Assessment
Kleter, Gijs A. ; Kuiper, Harry A. ; Kok, Esther J. - \ 2019
Trends in Biotechnology 37 (2019)5. - ISSN 0167-7799 - p. 443 - 447.
crop biotechnology - gene editing - genetically modified crops - international harmonization - novel plant breeding techniques - regulation - risk assessment - safety assessment
Gene editing and other innovative plant breeding techniques are transforming the field of crop biotechnology. Divergent national regulatory regimes worldwide apply to crops bred with these techniques. A plea is made for international harmonization of the premarket assessment of their safety. Such harmonization has previously been achieved for genetically modified (GM) crops.
A Welcome Proposal to Amend the GMO Legislation of the EU
Eriksson, Dennis ; Harwood, Wendy ; Hofvander, Per ; Jones, Huw ; Rogowsky, Peter ; Stöger, Eva ; Visser, Richard G.F. - \ 2018
Trends in Biotechnology 36 (2018)11. - ISSN 0167-7799 - p. 1100 - 1103.
EU Directive - gene editing - GMO - new plant breeding techniques
Is the European Union (EU) regulatory framework for genetically modified organisms (GMOs) adequate for emerging techniques, such as genome editing? This has been discussed extensively for more than 10 years. A recent proposal from The Netherlands offers a way to break the deadlock. Here, we discuss how the proposal would affect examples from public plant research.