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.

Chapter 3: GMOs and Risk Regulation in the EU

Maria Lee

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


INTRODUCTION An economic understanding of biotechnology pervades the EU’s Life Sciences Strategy, pointing towards the advantages of speedy commercialisation of GMOs.1 This perspective is if anything increasingly emphasised in the ongoing annual reviews of the Strategy: the overriding objective seems to be ‘to improve the situation for European biotechnology’.2 Whilst the contribution of biotechnology to economic development tends to be presented as objective fact, a necessity to which we must adapt, these conclusions are profoundly value laden. One of the important implications of conceptualising biotechnology as an economic question is to put biotechnology into terms of competition with the US (for example). This contributes to the presentation of biotechnology as a European problem, which should be solved for a European public.3 It is important to remember that it is not just the opponents of agricultural biotechnology who have social and ethical commitments on the topic. The social and ethical commitments of the policy framework are often silently taken for granted. 1 European Commission, Life Sciences and Biotechnology – A Strategy for Europe COM (2002) 27 final (the Life Sciences Strategy), p. 7. The Strategy was drafted by the Commission and ‘welcomed’ by the Council; see Council Conclusions and Roadmap of 26 November 2002 for a Strategy on Life Sciences and Biotechnology [2003] OJ C 39/9. Other arguments in favour of pursuing agricultural biotechnology are also part of EU policy; see Chapter 2. 2 COM (2004) 250 final, p. 2. The Life Sciences Strategy has been subject to annual ‘progress reports’; see...

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