JヨA
JAPAN BIOINDUSTRYASSOCIAT10N
2‐ 26‐

9,Hatchobo五 ,Chuo‐ にu,TOkyo 104‐ 0032,Japan TcL+81‐ 3‐ 5541‐ 2731 Fax:+81‐ 3‐ 5541‐ 2737

Solutね ns to Digital Sequence lnforIIlation llllder the Convention on Bね logical Diversity Must
Prottct Researcと ,Development,孤 ld ln■ ovatlon[SllIIlmtty]

Currently,there is an ongoing debate within the ConventiOn on Biological Diversity(CBD)onwhether the use of digital sequence information on genetic resources(DSI)should be subject tobeneflt‐ sharing. While there is no agreed deanition of DSI nor consensus on whether it iswithin the scope ofthe CBD,discussion on policy options for access and beneflt‐ sharing of DSI

is now underway.
Some ofthe prOposals under the(近 scussion could have serious negative impacts on accessingand using]DSI that is currently available without restriction and free of charge to researchers
around the world.This point has been clearly made within the current ttscussions and wereiterate this be10w. Howeveち JBA is alsO cOncerned that,glven how international databases
operate,if monetary beneflt‐ sharing were linked to the access and use ofindividual sequences,
there is a risk that copied and′ or fよ bricated"profltable]DSIW and fake data could be generated
which would proflt only the source ofthe infOrmation or circumvent beneflt‐ sharing.It is fearedthat spread of intentionally lnanipulated scientiflc data by(近 shonest individuals lnOtivated byflnancial incentives would underHline the credibility and utility of the entire scientiflc
infrastructure.

Biodiversity is one of the basis of scientiflc progress and innovation, and science andtechnology is essential for the conservation,restoration and sustainable use of biodiversity.
Recognizing the interttpendency ofthese factors,we need to seek solutions that will bring about
a win・ win situation rather than a trade‐ off between the two。
」BA agrees that a robust
flnancing strategy is needed for these purposes,howevet we should not let any mOtivation
corling from flnancial incentives into the ilnportant scientiflc infrastructure by placing
overblown expectations on ABS systeln as a prilnary 1lnancing lnechanism. A anal solution to
the DSIissuc lnust protect research and developmentincluding free and open access to sequence
data and the integrity of the international database system.

[BackgrOlllldl

Access to genetic resources(GR)and the fair and equitable sharing of beneflts arising fromtheir utilization(ABS)cOmplement the cOnservation and sustainable use ofbiodversity.
Recently,there is a concern that the ready availability of DSI will underHline ABS systems,
It is argued that free and unrestricted availability of DSI obviatts the need to access material
GR.It is further argued that advances in biotechnology make it possible to conduct researchand development using]DSI alone without accessing GR. In order to block this leakage fromthe systeHl",there is currently a proposal under the CBD to expand the scope ofABS to include
DSI.It is beheved that such a proposal would strengthen the lnobilization of resOurces(funds)
to the developing countries to fund the conservation and sustainable use ofbiodiversity. ThisissueisexpecttdtobeoneofthernttorpointsOfcontentiOnatthe 15thConferenceoftheParties(COP15)to the Convention on Biological Divorsity to bo held in China in 2022,along with tho
next 10・ year strategic plan,the Post‐ 2020 Global Biodiversity Fralxlework(GBF).

1lRe∞ nt Discussbn制

Negotiations on ABS related to DSI since COP14(2018)have been hampered by COVID 19.
The Open‐ enttd Working Group 3(OEWG‐ 3)Part l prOcess,held virtually in 202 1,produced
some documents for further discussions in Part 2 session to prepare draft recoHllnendations for
COP151,2.Many webinars and on‐ line discussions evaluated and led to several proposals foraccess and beneat‐ sharing mechanisms(policy options)for DSI.The co‐ chairs Of OEWG‐ 3drafted a report that categorized options using multiple criteria にffectiveness, ease ofimplementation,ease of comphance and legal certainty,etO to evaluate theIュ 112.ImpOrtandy
for JBA, 情。pen access to public databases"and"not to inhibit research and innovation"are
included,though,it is unclear hOw the weighting of these and Other factOrs will be handled inthe f■ lture.

[Our PreviOus ttws]
Regarding DSI,JBA earlier expressed the following views in coordination with other relatedorganizations3,4,● DSI is not directly subject to ABS,because it is informatiOn and is not material GR asdefェ ned by the CBDo Howeve4 beneit‐ sharing with respect tO those DSIs is not excluded
froIIl existing fralxlework of the CBD and the Nagoya Protocol,as the treatlrlent of DSIs
obtained through the utilizatiOn Of accessed(}Rs,including beneat‐ sharing,can be coveredby lnutually agreed terlns(MAT)between the prOvider and user Of genetic resources.
● DSIs are essential for modern litt science and biotechnology research and development,andinnovation in key areas ofour g10bal society Q.g.,health,foodノ agriculture,environment)is

supported by free and unrestricted access and use of DSI on the pubhc database of thelnternational Nucleotide Sequence Database Collaboration(INSDC)。
Any restrictions tofree and open access for the sake of beneflt‐ sharing would be detrilnental not only to theconservation of biodiversity and the sustainable use ofits components,but also tO humanwell‐ being.

[New∞ Ilcerns regarding recent discllssbns]
JBA has the f0110wing concerns underpinning the benefit‐ sharing(近 scussions on DSI.

(1)There is no common understanding or agreed definition of"DSItt or"open access"。

Our

discussion herein lilnits DSI to genetic sequence data froI1l genetic resources that are madeavailable in international databases. Given to extent to which DSI has been described andwide range oftechnical flelds aヨ るcted,the current discussbns on DSI are uninterpretable, Asa result,it is impossible to estilnate the cOst and benefits Of the Options under discussion.

l CBD/WG2020/3/5,ど 2翅 θイ T,θ ttИ

(Report of contact group b on digit工sequence iね formation on genetic resourceO,

htttSV′帝ww cbd.近 比んonferences/post2020/、 vg2020・ 03旭 0(瓶 ment辞

2 cBDか VG2020/3/1NF/8 (Co・ leads'report on the wo■ k Offhe Iュ」ormal Co‐ Chaェ rsI Advisory Group on dgttal sequence
inforination on genedc resOurces),ht′ tps7/www cbd htん onferences/geneva‐ 2022/wg2020・ 03旭 Ocuments非3 views OfJapan Bioindustty AssOciation(JBA)on the issues of Digital Sequence lnformation on Genetic Resources(8 Septehber2017), httpoV/www Obd ht/ab3/DSI・ 宙Ows/JBA・ DSI Pdf
4 Prom(lttg sustahable use and conservadon ofbiodversity tあビough Open exchange OfI)igital Seqと とence lnformation:

Joht statement by pubLc and private sector organisadons,acadeH■c alad scientific instェ tutions,data repositories and colledttOns
representtg a broad ral■ ge Of stakeholders(24ヽ[ay 2019),https:〃 www cbdint/abs/DSI・ views/2019/」 oht・ stakeholder‐ statement‐

DSI Pdf

2

(2)IInposing a payIIlent scheme for the accessing and using genetic sequence data in the INSDC
creates a inancial incentive for dishonest individuals to underHttne the integrity of thisinternationalinfOrmation exchange system.The extensive pubLc DSI database lnanaged by theINSDC provi(お s free and unrestricted access to sequences that researchers upload. The
process to upload sequence data assumes that the basic information is correctlv described.The
accession number(sequence identiflcatiOn number)assigned by the INSDC is required for
subHlitting papers to international scientiflc jOurnals, It is said that lnore than 900/O of hfe

science databases depend on the INSDC5, Developed to be a coェ Ylmon good,the INSDC does
not verify the authenticity of the data.Validatibn of the data and assessing its accuracy is leA

to the users(registrants).TherefOre,there is no guarantee that the sequences to bo registeredand their functiOns are correct. Furthermore,duphcate data registratiOn is possible。
(井 iventhis situation,there is a clear risk that tttshonest individuals could upload copied or fabricatedsequence data hoping to circumvent benerlt sharing obhgations and/or proflt from others
accessing and using the information.Once such intentionally lnanttpulated sequence data has
spread,it will be impossible to elilninate them fronl public databases because strict peer review
and/or Other costly】 neasures cannot be taken, Policy options that(近 rectly couple paymentswith access and usc of DSI pose real risks to the integrity and ut工 ity of the international
databases̀

[Conchsね nlJBA supports the need to fLlnd the Post 2020 Global Biottversity Framework. Howevett wehave serious reservations thatilnposing beneflt sharing obhgations on the access and use ofDSI

will achieve the conservation and sustainable use goals of the CBD. Instead,regulating DSI
poses a real threat tO scientiflc research,development,and innovation by thwarting the aow ofinformation and potentially aヨ るcting the integrity of critically ilnpOrtant international
databases.

ゝ 坊籾
Yoshiaki TSUKttMOTO
Executive Director
Japan Bioindustry Association

5 cBD狙 )S1/AHTEG/2020/1/4 (Co五 bhed study on(■ gltal sequence五 」賂rmation in pubLc a4d private databases alld
位aceabihty), httpS7/www cbd ht/docん /1lBf/d793/57cb■ 4ca40あ 6468f479584旭 si・ ahteg・ 2020・ 01‐ 04‐ en pdf

3