BOOK REVIEW
THE
REGULATORY CHALLENGE OF BIOTECHNOLOGY:
HUMAN
GENETICS, FOOD AND PATENTS
By Han Somsen (Editor), Edward Elgar Publishing Limited, 2007, 265pp.,
£75.00, ISBN 978-1-84542-489-3.
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| DOI: 10.2966/scrip.040407.478 | ||
If the success of a skilful editor is measured by
his or her bringing together some of the key thinkers in a field and
facilitating the elucidation of their ideas then Somsen succeeds
magnificently in this edited collection
which examines the regulation of biotechnology. To a researcher
working in this field the book comes as a welcome treat. There is an
impressive line-up of contributors which is noteworthy for its
academic pedigree and includes inter alia; Roger Brownsword, Colin
Scott, Neil Gunningham and Graeme Laurie. Overall Somsen’s
book offers a sophisticated introduction to the regulatory challenges
in the sphere of biotechnology. This book both fills a more than a
small gap in the current literature and will additionally succeed in
stimulating debate which will doubtless lead to research spin-offs.
The book opens with two very insightful
chapters which set out some general perspectives and themes on the
regulation of biotechnology. These chapters are provided by Neil
Gunningham and Colin Scott, who in line with a number of academics in
this field have worked extensively in the area of environmental law
and policy. Indeed it is to environmental law that Gunningham turns
to examine whether the regulators of biotechnology can learn from
past experiences of environmental regulation. Learning from past
experience is a central theme running through a number of the
chapters and is extended to include the area of nuclear technology by
Scott. Gunningham presents a variety of regulatory options for
biotechnology which include: smart regulation, reflexive and meta
regulation. He then proceeds to assess the potential of each in its
application to biotechnology. This provides the reader with a useful
framework for the subsequent chapters.
The second ‘setting the scene’ chapter
comes from Colin Scott who contests that
biotechnology has not yet adequately matured to be classified as a
discrete area of public policy. Scott’s chapter is a real tour
de force, he argues very convincingly that the state has been
over-active in establishing ‘standard setting processes’
to the extent that it has inhibited the capacities of businesses and
civil society to participate in or determine the standards. This, he
argues, has meant that the opportunity to promote ‘ownership’
of regulatory norms is being missed.
Following the opening chapters, the book is
divided into three distinct parts: human
genetics, GMOs and agricultural biotechnology and the regulation of
biotechnology through the patent system. In terms of the structure,
the book is disappointingly biased against human genetics. In fact,
a dissection of the book shows that for the five papers relating to
GMOs and agricultural biotechnology, there are only two on human
genetics. Somsen mentions that this is the first book in a series so
maybe this imbalance is intentional and will be rectified in the next
volume. My second comment on structure also pertains to substance:
on a personal note I would like edited collections to aim for greater
cohesiveness of purpose. While there is the implicit assumption that
all the authors are working from the same hymn sheet, it is more
often the case that they are post hoc adapting conference papers to
fall under an umbrella of shared subject matter. To this end, a
greater coherence would have been achieved if the authors could have
referred to the ideas set out in the opening two chapters. While as
stand-alone papers the chapters work wonderfully and meet their
author’s own aims, there should be a little more emphasis paid
to the fact that they form part of a whole. To this end, personally
I would have extended Somsen’s foreword into a short chapter
which outlined the aims and purpose of the book as a whole and set
out the regulatory challenges in very clear terms. It would be more
reader-friendly to make explicit the common goals of the book and a
more tightly drawn out set of aims would push the authors on to
express in greater clarity the potential solutions they are offering
to the challenges faced by biotechnology.
Biotechnology is riddled with ethical issues that
have the potential to inculcate public concern, be the concerns
based upon perceived or actual risks. The predominant challenges
range from issues such as the different reactions to the technology
across legal jurisdictions which make harmonisation or the
establishment of regulatory norms difficult. The central issues,
both ethical and risk-based, lead regulators and academics to
question whether the adaptation of existing regulation is appropriate
or whether it is necessary to develop novel regulatory frameworks to
deal with them. There is generally a lack of consensus within and
across states as to the regulatory goals in this area. There are
currently many different ways that the regulation can develop and
direct, shape and govern the technologies. Although it is critical
to bear in mind, as Dutfield comments that other forms of control
exist outside of regulation and equally that regulation is not an
absolute force of control.
In relation to the questions and challenges
raised by the regulation of biotechnology, Brownsword draws up a four
dimensional framework comprising of regulatory phasing, pitch, mode
and range. He utilises this successfully to scope out the regulatory
options available. Additionally, Brownsword provides a novel angle
to the study of regulation of human genetics in that he suggests we
look at human genetics less as a regulatory target and more as a
regulatory tool. This chapter is one of the most stimulating in the
collection terms of the issues that surround the regulation of
genomics and leaves the reader wanting to extend the discussion of
techno-regulation (technology that assists regulation) further. The
second chapter on human genetics comes from Burley who adopts a very
abstract approach in her discussion of the moral and ethical
considerations in human genetics. She presents the reader with a
hypothetical, fantasy world in which genetic technologies have
advanced significantly and where she can play with regulatory and
policy directions. Burley’s motivations for such a method are
the failure of regulators to adopt abstract reasoning and this proves
to be a useful device in the unpacking of the moral dilemmas posed
and the remedies available to regulators.
Of the five chapters on
red biotechnology, one is an account of the regulation of GM foods by
Van der Meulen who presents a concise overview of the approval,
handling and labelling of GM foods under European law. Van der
Meulen makes a strong case that the regulation is creating too great
a burden upon the food industry and that a more effective regime
should be designed. This balancing of technological developments
against the protection of the environment from risk is the subject of
Paul Street’s chapter. Street has produced a convincing
argument for the necessity of a more inclusive approach in regulatory
decision-making as a means to examine the various and often
conflicting perceptions of risk in the area of biotechnology. The
centrality of the public in the regulation of biotechnology is
examined further by van den Daele in his chapter on the precautionary
principle and risk perception in the regulation of new technologies.
Van den Daele examines the gap between the political and regulatory
handling of biotechnology in which the political battles relate to
the process of modernisation and the democratic control over forces
of social change whereas the issue at the heart of the regulation is
the containment of risk. Van den Daele argues that ‘the
procedures designed to resolve conflicts over new technology hence
fail to address the major themes that drive these conflicts’
(van den Daele; 118).
The
remaining two chapters in this section come from Sara Poli who writes
about coexistence of EU and domestic law in the case of GMOs and Mary
Footer who offers a chapter on plant genetic resources and trade
reform. Poli’s chapter picks up one of the central problems
with multi-national regulation of biotechnology, the lack of
agreement across the states. The case of the cultivation of GMOs
brings to the fore very clearly the different wishes of European
publics.
The third section of the
book centres on the role of patenting within the regulatory system in
the promotion of inventive activity which benefits the public. There
is very clearly a greater unity across the chapters under this
umbrella and they work exceptionally well together. These chapters
are provided by Graham Dutfield, Graeme Laurie and Geertrui Van
Overwalle. Dutfield focuses upon terminator technologies and
examines the scope the patent system, most specifically the
applicability of the ordre public, in the prevention of legal
protection for applications on moral grounds. The pros and cons of
terminator technology are fleshed out concisely. A pertinent point
raised by Dutfield is that the very denial of the patent may actually
lead to a greater adoption of the technology. This highlights very
forcefully the limitations of patent law and as Laurie reiterates the
need for it to be seen as a part of the wider social systems in which
is exists.
Laurie has produced a beautifully eloquent
analysis of informed consent in patent law, or more specifically the
consent to patent an individual’s biological material. A
central theme of the chapters on patent law is the
extent of the reach of patent law into the regulation of
biotechnology as a whole. Laurie draws out the important point that
to view the patent system as being in isolation ‘driven only by
its own internal dynamics and unencumbered by broader social agenda’
is an attitude that is changing and the nature of the relationship of
the patent system with other social systems is being explored. In
his analysis he clearly illustrates the limitations of the patent
system in terms of its role in the regulation of science and
scientific conduct. The contribution of the patent system argues
Laurie is ‘not in the realm of direct regulation, but in
incentivization or perhaps more accurately, disincentivization’
(Laurie; 226).
The final chapter of the book is left to Van
Overwalle who sets out the primary objections of the public to the
patenting of biological material. These objections raise the
dominant issue of the role of patenting as a control or influence in
the shaping of the moral and ethical dimensions arising from the
application of genetic technologies. Van Overwalle comments on how
the debate over the ethical reach of patenting has moved from an
inner circle of lawyers, experts and courts to a wider circle
encompassing interest groups, consumer associations and the public
(Van Overwalle:242). Pivotal to the current politics of regulation
of biotechnology is the inclusion of civil society in this debate.
In terms of readership, I would recommend Somsen’s
book to researchers in the field of biotechnology and additionally in
keeping with Somsen’s comment that ‘while the technology
may be novel, many of the regulatory issues posed have been seen
before’, the book will be an interesting and stimulating read
for those interested in areas of regulation beyond biotechnology.
The book is divided into sector specific parts because as argued by
the authors, biotechnology is deemed too diverse to be analysed in
general terms. However, a creative approach may reap greater rewards
and I would thus suggest sub-division of the field on the grounds of
regulatory themes or public attitudes rather than as has been done
here in relation to the application of the technology to either human
or agricultural genetics. Indeed the chapters on patent law are the
most cohesive and hold together most successfully. These comments
are essentially a minor diversion though as in terms of substance,
Somsen’s collection maintains a high level of critical thinking
which is derived from robust research.
Kate Getliffe
MSc, LLM,
Egenis,
University of Exeter
© Kate Getliffe 2007.
This work is licenced under a
Creative Commons Licence.