Gene drives and the international biodiversity regime

Published date01 November 2019
AuthorFlorian Rabitz
Date01 November 2019
DOIhttp://doi.org/10.1111/reel.12289
RECIEL. 2019;28:339–348.    
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1 | INTRODUCTION
Enabled by recent advances in genome editing, gene drive organisms
(GDOs) are currently being proposed as a potential measure for the
rapid genetic manipulation of entire populations of insects and other
species.1 GDOs potentially offer an efficient way to combat plant pests
or disease vectors. As they are designed to diffuse widely in the envi
ronment, their release also poses numerous risks that go beyond those
of ordinary living modified organisms (LMOs) such as transgenic crops.2
Research and development (R&D) efforts are presently intensifying to
the point that open field trials may be merely a few years away.
No dedicated international rules regulating the release of GDOs
exist as of presen t. The Conventio n on Biological D iversity (CBD)
provides rules regarding the conservation and sustainable use of bi
ological diversity.3 Its Car tagena Protocol o n Biosafety4 an d the
Nagoya–Kuala Lumpur S upplementa ry Protocol on L iability and
Redress5 cover the transfe r, handling and use of LMO s that cause
adverse effe cts on biological dive rsity or likely have the potent ial to
do so. Those inst ruments bear dir ect relevance for GD O governance.
However, all of them had bee n negotiated for oth er purposes an d,
indeed, befor e recent development s in biotechnology m ade the con‐
structio n of gene drive systems an (at leas t theoretical) possibi lity.
Research on gene d rives is rapidly p rogressing towa rds initial
field trials . At the same time, r egulatory re sponses unde r the CBD
and its protocol s have largely been limited to ge neral affirmatio ns of
the applicab ility of the pre cautionar y principle to G DOs. With the
next biennial m eeting of the gover ning bodies of the C BD and its
protocols sched uled for late 2020, it is likely that r esearch, develop‐
ment and field t rials will outpace the abil ity of international lawm ak‐
ers to provide a res ponse. Agai nst the backdrop of i nstitutiona l
inertia and rapid technological change,6 this article assesses regula
tory gaps and i nconsistencie s under the CBD an d its Cart agena
Protocol. As th e existing lega l framework wil l stay in place for t he
1 ABurt,‘Si te‐specif icSelfishG enesasToolsforth eControlandG eneticEngi neeringof
Natural Pop ulations’ (20 03) 270 Proceedin gs of the Royal Soci ety B 921.
2 KOyeetal,‘Regu latingGen eDrives.Reg ulatoryGa psMustbeFill edBeforeGe ne
Drives Coul d be Used in the Wil d’ (2014) 345 Science 626 .
3 ConventiononB iologica lDiversit y(adopted5Jun e1992,enteredin toforce29
December 1993) 1760 U NTS 79 (CBD). The CBD e njoys close‐to‐u niversal mem bership,
with the nota ble exception of t he United State s.
4 Cartage naProtocolonB iosafetytot heConventio nonBiologic alDiversit y(adopted29
January20 00,enter edintoforce11Sep tember20 03)2226UNTS20 8(Cartag ena
Protocol). Th e Cartagen a Protocol prese ntly has 171 contrac ting partie s, excluding la rge
LMO export ers such as Arge ntina, Canad a and the United St ates.
5 Nagoya–KualaLu mpurSuppl ementar yProtocolonLi abilityan dRedresstothe
Cartage na Protocol on Bio safety (adopt ed 15 October 2010 , entered into forc e 5 March
2018) UN Doc UNEP/CBD/BS/CO P‐MOP/5/17 (Nagoya–Kuala Lump ur Supplemen tary
Protocol). Th e Supplement ary Protocol p resently has 4 3 contractin g parties, ch iefly from
the European and African regions.
6 FRabitz,‘I nstitutio nalDrifti nInternatio nalBiotechn ologyRegu lation’(2019,fc)Glo bal
Policy, 1, ht tps ://doi.org/10.1111/1758‐5899.12652.
Received:8Sept ember2018 
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  Revised:19March2019 
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  Accepted:26Marc h2019
DOI: 10 .1111/reel .12289
ORIGINAL ARTICLE
Gene drives and the international biodiversity regime
Florian Rabitz
©2019JohnWiley&Son sLtd,9600Gar singtonRoa d,OxfordOX42DQ ,UKand350MainSt reet,Malde n,MA02148,USA .
Correspondence
Email:florian.rabitz@ktu.lt Gene drives are genetic m odifications designed fo r rapidly diffusing tr aits throughout
a target populatio n. They are currentl y being proposed as bio logical control agent s
to combat, for insta nce, invasive alien specie s and disease vector s. They also raise
concerns regarding t heir potential advers e effects on b iological diversi ty. This text
assesses gene drive gover nance under the Convention on Biological D iversity (CBD)
and its Car tagena Protocol on Bios afety. While gene drives are di rectly relevant fo r
the objectives of bot h agreements, t heir regulatory f rameworks have not kept up
with the pace of technol ogical change. The fo cus of this article is o n the analysis of
gaps and inconsisten cies within both agreements . It highlights numerous element s of
the CBD and the Car tagena Protocol that raise chall enges for gene drive governance,
such as matters relate d to regulatory scop e, transbounda ry movements, p recaution
and invasive alien species.

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