"Foreword" [2007] ELECD 111; in Somsen, Han (ed), "The Regulatory Challenge of Biotechnology" (Edward Elgar Publishing, 2007)

Book Title: The Regulatory Challenge of Biotechnology

Editor(s): Somsen, Han

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781845424893

Section Title: Foreword

Number of pages: 9

Extract:

Foreword
This book is the first in a series focussing on the regulation of biotechnol-
ogy. The event of modern biotechnology has given rise to a plethora of
regulatory challenges. Whereas modern biotechnology is a relatively new
phenomenon, many of these are familiar to regulatory theorists and regu-
lators. Precautionary risk regulation, for instance, was pioneered in
European environmental regulation, years before it came to form the back-
bone of the regulation of GMOs within the EU. Issues of privacy and
autonomy that arise in the sphere of human genetics are nothing new to the
medical lawyer either.
In all these instances, those faced with responsibilities to regulate
biotechnology would do well to investigate if lessons can be learned from
previous experience. To be sure, even the search for useful existing models
for the regulation of a new technology is a challenging and time-consum-
ing intellectual exercise, as it requires awareness of legal domains that may
have little prima facie significance for the problem at hand. For example,
researchers struggling with the implications of the emergence of bio-banks
for the continued viability of requiring prior bilateral informed consent
could possibly find some answers to their questions if they appreciated that
prior informed consent, a regulatory communicative instrument, was first
developed in medical law as a bilateral tool, but later evolved into a multi-
lateral instrument in environmental law.
But the intellectual investment needed to identify and then usefully apply
existing regulatory instruments to the new regulatory context of ...