access and benefit sharing (abs) in bio prospecting

Access and Benefit Sharing (ABS) in BioProspecting

27 May, 2010

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CBD 　 Convention on Biological Diversity

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193 countries in CBD (2010)

• Conservation• Sustainable Use• Benefit Sharing (incl. capacity building)

• Resource country’s right

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Bioprospecting

Bioprospecting is an effort to find academic or commercial values from biological diversity

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Biopiracy

Bio prospecting activities without Prior Informed Consent (PIC)

– From authority or community, if necessary– Should include benefit sharing scheme

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Are you from local institute?

Are you from public sector ？

You have proper permission?

Are you from public sector ？

You have proper permission?

You have proper permission?

You have proper permission?

Yes

Yes

Authorised bioprospector

Bio Pirates

No, we are foreigner

No we are from private 　 Yes

NO !YES !

No we are from private

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Keys for good ABS practice

Nimura Principles

1. Keep Biological Resources in Resource Countries2. Practical Technology Transfer3. Sharing Intellectual Properties (IP) with Resource Countries

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Value of Resources: Expectation Gap between owners and users

Med

icin

al V

alu

e of

B

iolo

gica

l Res

ourc

es Expectation of Resource Countries

Expectation of Resource Countries

Reality in User

Countries

Reality in User

Countries

soil samples

isolated

micr

obes

extracts

leads

patent

medici

nes

pre-cli

nical

clinica

l

purified

hit

compoundhit e

xtracts

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Access to resources should be this?

Ideal to user country

Ideal to resource country

Low high

1. From collection to Drug development

in resource country

1. From collection to Drug development

in resource country

2. User establish itslaboratory in

resource country

2. User establish itslaboratory in

resource country

3. Research as much as possible in

resource country

3. Research as much as possible in

resource country

4. Free supply ofBiological material

4. Free supply ofBiological material

Possibility to be accepted by user country

Governmental partners in Malaysia 　

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Universiti Malaysia SabahUniversiti Malaysia Sabah

Governmental partners in Bhutan

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Royal government of BhutanMinistry of Agriculture and forestryNational Biodiversity Centre

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Resource　country NGSNGS client

ABS　scheme

•　 IPR　(co-own　among　3　parties)•　 Client　has　no　direct　negotiation•　 Technology　transfer　is　carried　out　through　NGS•　 Biological　Resources　will　not　go　out　of　Resource　country,　unless　any　process　is　impossible　to　carry　out　in　Resource　country.

AgreementRoyalty　+　Mileston

To　NGS

Agreement

Research Result example 1

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CH3

O

O

O

H3C H3C HO

O

OO CH3

CH3

OR1

H3C

R3HOOH

H3CO

CH3CH3OH

O

O O

CH3

OHOH

CH3H3C

R2O

Malaysian application2006/05　

PCT application2007/05Japan, US, EU

Novel anti-biotics (Bispolides)

Microbispora sp

Research Result example 2New invention on non-pharmaceuticals

Application of New Firefly Luciferase to Patent Registration officein Malaysia on 25th of Feburary, 2010

Applicant:Olympus CorporationNimura Genetic Solutions Co., Ltd.Perak State Development Corporation

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NGS model

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ResourceCountry　X,Y,Z…

ResourceCountry　X,Y,Z…BhutanBhutan

MalaysiaMalaysia

NGS(J)SBCSBC

FRIMFRIM

UMSUMS

NGS(M)

ClientsClientsNGS　Group

ClientsClients

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Approved and similar

Under negotiation

Future target

Future expanding plan

Conclusion

Bioprospecting is one of most important method of Sustainable Use of Biodiversity

Proper ABS scheme is required Resource Countries’ demands should be

entertained Resource Countries’ support is also

important

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Thank you for your attention

Bioprospecting activity: Bioprospecting activity: Misconstrued for BiopiracyMisconstrued for Biopiracy

Bioprospecting activity: Bioprospecting activity: Misconstrued for BiopiracyMisconstrued for Biopiracy

Chairman 　 NIMURA　Satoshi

＜ National　Conference　on　Agrobiodiversity ＞

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Contents

1. What is Bioprospecting?• pre CBD and post CBD• Operation example

2 ． What is Biopiracy?• Definition

3. How do we do in CBD era?• Expectation gap between resource countries

and user countries• Operation examples

4. Conclusion: For reasonable ABS.

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What is Bioprospecting ？

It was called “Plant Hunting”

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History of Bioprospecting （ PreCBD）

Bioprospecting was a respected adventure as well as a part of expanding policy

European big countries competed for bioresources.

Their quest for spices. Captain Cook

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History of Bioprospecting （ PreCBD）

Big names in plant-hunting

　　　　　Sir Joseph BanksMost famous British plant hunter in 18 C.

As a Director General of Royal Kew Garden, organized plant hunters to overseas. with Navy assist.

Rosa banksiae was named after his wife.

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History of Bioprospecting （ PreCBD）

Big names in plant-hunting

Philipp Franz von Siebold

Charles 　 R. 　 DarwinDutch biologist stayed in Japan. Introduced Many Japanese indigenousPlant to Europe.

His theory comeThrough his experienceAs onboard biologist.

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Big names in plant-hunting　 Alfred ・ R. Wallace and Wallace line

History of Bioprospecting （ PreCBD ）

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History of Bioprospecting （ PreCBD）

Famous incident　　 Mutiny on the Bounty

The Bounty had a mission to deliver seedlings

Of Bread fruit from Tahiti to East Indies.

No.2 kicked out Captain from the Bounty.

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History of Bioprospecting （ PreCBD）

FAO’s statement （ 1983 ）　　「 International Undertaking on Plant Genetic

Resources 」　　　　

“Biological Resources belong to all mankind.” 　“ common treasure” 　

　　　Still dominant idea for many scientists.

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History of Bioprospecting （ PreCBD ）

As a Strategic Resources

　　 Merck & Costa Rica

Access right to bio resources

in Costa Rica(1991)

First Exclusive Access

agreement of its kind

This agreement indicates biological access could be

Strategic resources to fight for, as petroleum.

Costa Rica 　 INBio

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Heat-up discussionsSouthern counters against Northern globalization.Resource countries consider it as great advantage

for protecting their right.

Domestic regulationsPhilippines' president order 247India’s biodiversity lawetc.

CBD　arrived

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Definition of Bioprospecting

Bioprospecting is an effort to find academic or commercial values from biological diversity

Common image of prospecting

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Bioprospecting (NGS’s case)

Collection trip

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Bioprospecting (NGS’s case)

Soil collection isolation

collectionCharacterization Genetic analysisfermentation

Extraction Assays

HIT

Structure elucidation

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NGS company profile

Company Neural Genetic Solutions Co., Ltd.Established 　　　 26 June, 2000Address 　 2nd Floor, 1-19-10, Osaki, Shinagawa-ku, Tokyo, 141-0032Management Chairman Satoshi Nimura

　 President Keiichi KiyotaCapital 　　 410,000,000 yen (about US$3.8 mil)Staff 　　 15 （ 7 PhD. 3 Master, as of Nov. 2006 ）Company Nimura Genetic Solutions (M) Sdn. Bhd

Established 　　 Dec 2000 　（ Oct 2002 Lab start operation ）Capital 　　　 RM 2,030,000 (about US$550,000)Staff 　 28 （ 1 PhD. 7 Master, 10 Bachelor as of Nov. 2006 ）Address 　 Third floor, Chemistry Building,

Forest Research Institute Malaysia (FRIM)

Kepong 52109, Kuala Lumpur, Malaysia

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Biopiracy: definition

Bio prospecting activities without Prior Informed Consent (PIC)

– From authority or community, if necessary– Should include benefit sharing scheme

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Difference between Bioprospecting and Biopiracy

BioprospectingBioprospectingLegal

Bioprospecting

Legal Bioprospecting

Illegal Bioprospecting

Illegal Bioprospecting

Foreigner’s Bioprospecting

Domestic Bioprospecting

academic

academic

CommercialCommercial

Commercial Commercial

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How do we do in CBD era?

Foreign company has to cope with 　 these.

1. Discussion for agreement

2. Operation of collaboration

3. Avoid Speculations

4. Handling of

Intellectual property

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Value of Resources: Expectation Gap between owners and users

Med

icin

al V

alu

e of

B

iolo

gica

l Res

ourc

es Expectation of Resource Countries

Expectation of Resource Countries

Reality in User

Countries

Reality in User

Countries

isolates

identifi

ed st

rains

active i

solateslea

ds

patent

medici

nes

pre-cli

nical

clinica

l

hit extra

cts

purified

hits

extracts

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Access to resources should be this?

Ideal to user country

Ideal to resource country

Low high

1. From collection to Drug development

in resource country

1. From collection to Drug development

in resource country

2. User establish itslaboratory in

resource country

2. User establish itslaboratory in

resource country

3. Research as much as possible in

resource country

3. Research as much as possible in

resource country

4. Free supply ofBiological material

4. Free supply ofBiological material

Possibility to be accepted by user country

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Business Scheme 1

Extract supply scheme• Controllable• Not beneficial

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Business Scheme 2

Screening contract scheme• improvement• client satisfaction is a problem

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Business Scheme 3

Client visit scheme• more commitment from client• better improvement

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Real Biopiracy or not?

Speculation can kill the company. Rootless rumor is an offence.

Big established companies have proper internal regulation for not committing Biopiracy.

Through our practical observation, academic fields commit more Biopiracy, unconsciously.

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Conclusion

Bioprospecting is not Biopiracy at all, If proper process is taken.

Biopiracy is not always carried out by foreigners and commercial people, by domestic and academic people as well.

Prevent rootless negative speculation or misuse of the word “Biopiracy” is essential for foreign investment into Malaysia.