HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Saturday, June 25, 2022

Uniformity, Experimentalism, and the Unfulfilled Promise of Differentiated Integration in EU Regulation of GMOs: Which Way Forward?

Patrycja Dabrowska-Klosinska (Independent), Uniformity, Experimentalism, and the Unfulfilled Promise of Differentiated Integration in EU Regulation of GMOs: Which Way Forward?, SSRN (2021):

EU governance in the field of agricultural biotechnology, especially authorizations for commercial use and cultivation of genetically modified organisms (GMOs), has always been an exemplary field of intense policy controversies leading to regulatory impasses. Notwithstanding repeated attempts to improve the functioning of the regime, the longstanding problems with insufficient democratic legitimacy of EU-level GM product approvals in comitology decision making have persisted, affecting the overall profile of the policy. This paper appraises the most recent reform of the GMO regime through a case study of the implementation of the Opt-out Directive 2015/412, which returned powers over GMO cultivation to the national level, from the perspective of differentiated integration (DI) in relation to other regulatory approaches, namely experimentalist governance (XG) and uniform regulation (UI). In order to do so, the paper addresses the conceptualization of the GMO regime, its successes and pitfalls, the origins of the DI reform, and national implementation in six Member States. The regulatory appraisal of the impact of the reform on the accommodation of diversity within the EU is carried out through the lens of the functioning of the Internal Market and GMO approvals through the comitology voting system. The paper establishes that the DI approach introduced by the 2015 Opt-out Directive failed to effectively foster accommodation of diversity in the GMO regime. It argues that this was due to the atypical mode of DI which was introduced in the system, and lack of exploitation of the opportunities offered by XG within the GMO regime. The paper shows that the reform reinforced asymmetries between Member States and did not fully address key problems of the GMO regime, including effective deliberation in comitology committees, pertinent national-level issues, and the need to revise the regulation in view of development of New Plant Breeding Techniques (NPBTs). Finally, the paper outlines three possible scenarios in the present situation. It argues that the most promising scenario would involve a combination of more radical DI and more extensive use of XG, including a complete return of decision-making powers over cultivation to the Member States and opening up debates about GMO authorizations to socio-economic and ethical-cultural factors beyond scientific risk assessment.

https://lawprofessors.typepad.com/healthlawprof_blog/2022/06/uniformity-experimentalism-and-the-unfulfilled-promise-of-differentiated-integration-in-eu-regulatio.html

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