Institutional Drift in International Biotechnology Regulation
| Date | 01 May 2019 |
| Published date | 01 May 2019 |
| DOI | http://doi.org/10.1111/1758-5899.12652 |
Institutional Drift in International Biotechnology
Regulation
Florian Rabitz
Research Group Civil Society and Sustainability, Kaunas University of Technology
Abstract
Digitalization, genome editing and synthetic biology are presently leading to fundamental changes in the field of biotechnol-
ogy. At the same time, international regulatory institutions have largely failed to adapt to those changes. This text evaluates
the role of interests, knowledge and institutional factors for explaining nonadaptation, or ‘institutional drift’. Focusing on the
domains of biosafety, biosecurity and genetic resources, the analysis highlights the explanatory power of knowledge and, to a
lesser extent, interests, with institutional factors playing only a minor role. With global governance having to cope with pro-
found changes in various technological fields, the text thus shows the broader importance of understanding the conditions
under which international institutions do, or do not, adapt.
Policy Implications
•Biotechnological innovation increasingly generates regulatory gaps that international institutions have so far failed to
close.
•Insufficient knowledge constitutes a major explanation for institutional drift. The scaling-up and centralization of scientific
assessment processes would thus facilitate adaptation.
•International biosafety regulation requires minimum biocontainment standards and multilateral procedures for the poten-
tial release of gene drive organisms.
•In biosecurity, greater emphasis must be placed on bioweapons programs at the level of states relative to nonstate actors.
•Instruments that address the commercial and scientific utilization of genetic resources must reconcile the principle of fair
and equitable benefit-sharing with the new technological environment while avoiding regulatory overreach.
International institutions are often ill-equipped to deal with
technological change, leading to gains that would be avail-
able from international cooperation not being realized. The
failure to adapt to changing technological environments
that promise new types of benefits or hold new types of risk
is a theoretical puzzle. Even more puzzling is the variegation
in institutional responses to technological change. Why is
there no international treaty on nanotechnology but several
on nuclear power? Why are lethal autonomous weapons sys-
tems being addressed under the Convention on Certain
Conventional Weapons while the overarching issue of Artifi-
cial Intelligence is largely unregulated? Why have no inter-
national rules been adopted for technologies that aim to
manipulate the global climate through the modification of
planetary albedo while ocean-based technologies for the
large-scale removal of atmospheric greenhouse gases are
being addressed under the London Dumping Convention
and its protocol?
This text attempts to explain the limited institutional
responses to changes in biotechnology. The scale of biotech-
nological innovation has been nothing short of dramatic over
the last decade or two. Advances in bioinformatics and
sequencing technology enable the rapid and cheap digitaliza-
tion, distribution and mining of genomic data (Mardis, 2017).
Innovation in genome editing allows the manipulation of
genetic sequences with an unprecedented degree of preci-
sion (Doudna and Sternberg, 2017). The term synthetic biol-
ogy captures a range of crosscutting applications that enable
the synthesis of entire genomes, the manipulation of the
information flow from nucleotides to proteins, the engineer-
ing of metabolic pathways in cells, or the construction of
genes based on nucleotides that do not exist in nature (CBD,
2015). Technological change progresses faster than institu-
tional change. While numerous international institutions dedi-
cated to various aspects of biotechnology emerged in recent
decades (Andersen, 2008; Fidler, 2010; Oberth€
ur and Gehring,
2006; Pollack and Shaffer, 2009), their practical relevance is
increasingly being undermined through novel products and
processes that are either entering the markets or are at differ-
ent stages of R&D. Despite differences between institutions
and policy fields, crosscutting changes in biotechnology are
leading to similar outcomes: the failure of international insti-
tutions to adapt to technological change.
Section 1 develops the theoretical framework based on
two key concepts. Regulatory gaps are insufficiencies in the
scope and depth of international institutions. Thus, gains
that are in principle available from cooperation are not
being realized. Regulatory gaps create demand for
Global Policy (2019) 10:2 doi: 10.1111/1758-5899.12652 ©2019 University of Durham and John Wiley & Sons, Ltd.
Global Policy Volume 10 . Issue 2 . May 2019 227
Research Article
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