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 5: Living with GMOs (2): Ownership

Maria Lee

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


INTRODUCTION The ‘regulation’ of agricultural biotechnology is frequently presumed to begin and end with the procedure for the authorisation of a product or process, generally now through a risk-focused framework.1 The dominance of this risk paradigm can, however, distract attention from other significant issues, and, more realistically, regulation stretches both forwards and backwards from authorisation. The central contention of this chapter is that the regulation of GMOs is intimately connected with the rights, interests and liabilities awarded and arbitrated through intellectual property law. Intellectual property rights contribute to the shaping of the relationship between the biotechnology industry and those it affects, including farmers, potential consumers, and broader publics, both locally and globally. As such, intellectual property demands the close attention of those interested in the regulation of agricultural biotechnology. Whilst it tends not to be cast directly in a regulatory role by patent lawyers, it is conventional to see patent law discussed in terms of influencing behaviour,2 and indeed the economy. In particular, the importance of patent rights in stimulating research and development of new technologies, in turn crucial for a prosperous economy, is a widespread and deep-seated belief in EU policy and law.3 Holding patents is seen as a measure of success, for countries4 and regions as well as for companies, and there is clearly a perception, at least on the part of the European Commission, that the EU has lagged behind its 1 Most obviously the legislation discussed in Chapter 3. Elizabeth Fisher, ‘Risk and Environmental Law:...

You are not authenticated to view the full text of this chapter or article.

Elgaronline requires a subscription or purchase to access the full text of books or journals. Please login through your library system or with your personal username and password on the homepage.

Non-subscribers can freely search the site, view abstracts/ extracts and download selected front matter and introductory chapters for personal use.

Your library may not have purchased all subject areas. If you are authenticated and think you should have access to this title, please contact your librarian.

Further information