EU Regulation of GMOs

EU Regulation of GMOs

Law and Decision Making for a New Technology

Biotechnology Regulation series

Maria Lee

This book explores the EU’s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts.

Series editor's preface

Maria Lee

Subjects: environment, biotechnology, environmental law, law - academic, biotechnology and pharmaceutical law, environmental law, european law, regulation and governance

Extract

Series editor’s preface Advances in biotechnology raise regulatory issues that both quantitatively and qualitatively differ from anything that regulators have had to deal with in the past. The Regulatory Challenge of Biotechology, the first book in this series, explored some of the most pressing of these challenges in agricultural and medical biotechnologies. The title of this monograph, EU Regulation of GMOs, might suggest that this second volume in the series represents a highly specialised account of the regulation of genetically modified organisms in the European Union. Indeed, GMO regulation, especially within the foggy institutional context of the European Union, is spectacularly technical and complex, and hence to some extent invites such a specialised account. However, one major argument that Maria Lee forcefully articulates in this volume, is precisely that stalemates in the regulation of GMOs in part are the inevitable result of exclusive reliance on different kinds of specialisation such as scientific risk assessment and patent law, and on European technocracy more generally. It is thefore particularly important that this book, apart from containing a strong argument in favour of public involvement at various stages of the regulatory process, amounts to the kind of accessible and holistic account of current EU policy as regards GMOs that is needed to facilitate such public participation. Although this volume concerns EU law pertaining to GMOs, each chapter is doing justice to the reality that its proper understanding necessitates an appreciation of the institutional and political context from which those legal provisions arise. This...