Law and Decision Making for a New Technology
Biotechnology Regulation series
Chapter 5: Living with GMOs (2): Ownership
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:...
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