FROM CONCEPT TO PRODUCT:An Examination of Issues Related to the

FROM CONCEPT TO PRODUCT:An Examination of Issues Related to theAn Examination of Issues Related to the

Commercialization of Biotech CropsAn Examination of Issues Related to the

Commercialization of Biotech Crops

Presented at the XI International Rice Conference for Latin America and the Caribbean

Cali Colombia

Presented at the XI International Rice Conference for Latin America and the Caribbean

Cali ColombiaCali, ColombiaSept. 21-24, 2010

Dr. Judith Chambers

Cali, ColombiaSept. 21-24, 2010

Dr. Judith ChambersDirector, Program for Biosafety Systems

International Food Research InstituteDirector, Program for Biosafety Systems

International Food Research Institute

A FEW POINTS TO KEEP IN MINDA FEW POINTS TO KEEP IN MINDTrends and the continuing need for innovationRole of BiotechnologyRole of Biotechnology

Product development issuesEvolving market forces and demographics – local,Evolving market forces and demographics local,regional, and globalControversy, politics, policy and regulationComplex and diverse institutional players

When considering where we are for i li i f bi h h i dcommercialization of biotech crops, there is a need

to consider historical context and role of integrationintegration

THE GLOBAL CHALLENGE

Increased demand for Food, Feed, Fiber and Fuel• World population will grow from current 6.5B to 8B by 2025 and 9.2B by 2050by 2050

• Affluence in emerging economies will drive meat, cereals, edible oil consumption up

• Climate change will alter land, water availability and quality; introduce new pests

Increase in biof el cons mption• Increase in biofuel consumption

Source: Leaver, 2008; FAO, 2009

THE GLOBAL CHALLENGE – CLIMATE CHANGEBy 2050 climate changes will reduce Asian irrigated rice production by 27%By 2050, climate changes will reduce Asian irrigated rice production by 27%

TECHNOLOGY HAS BEEN AN IMPORTANT TOOL TO INCREASE AGRICULTURAL PRODUCTIVITY

For example: At the turn of the century, the U.S. farmer fed 7 people.p pToday, the U.S. farmer feeds 96 people, due to:

New seed = increased yieldsC ti l b diC ti l b di•• Conventional breedingConventional breeding

•• Biotechnology traitsBiotechnology traitsFertilizerCrop protectionEfficient machinerySupportive government policypp g p y

And, globally, new innovations in biotechnology have delivered

yield increases from 9 to 31%yield increases from 9 to 31%pesticide application decreases from 39 to 60%income increases from $117 to $250 per acre

GLOBAL AREA OF BIOTECH CROPSGLOBAL AREA OF BIOTECH CROPS1996 to 20081996 to 2008

By Crop (mil ha)By Crop (mil ha)

Source: James 2009Page 12

EXPERIENCE WITH GM CROPS IN EXPERIENCE WITH GM CROPS IN THE DEVELOPING WORLDTHE DEVELOPING WORLDTHE DEVELOPING WORLDTHE DEVELOPING WORLD

Global Area of Biotech Crops, 1996 to 2008:Global Area of Biotech Crops, 1996 to 2008:Industrial and Developing Countries (million ha)Industrial and Developing Countries (million ha)

Source: James 2009

TTHE GLOBAL COMMERCIALIZATION PICTUREHE GLOBAL COMMERCIALIZATION PICTURE

INDIA: BT COTTON INDIA: BT COTTON ----A SUCCESS STORYA SUCCESS STORYcontributed to doubling of yields in 5 yearscontributed to doubling of yields in 5 years

Source: Cotton Advisory Board

IMPACTIMPACTIndia emerged as 2India emerged as 2ndnd largest exporter of cottonlargest exporter of cottongg g pg p

Source: Cotton Advisory Board 2009

IMPACT AT THE FARM LEVELIMPACT AT THE FARM LEVELAverage effects of Bt cotton vs. nonAverage effects of Bt cotton vs. non--Bt in IndiaBt in India

Based on peer-reviewed published studies

Yield Increase 39%*

Reduction in insecticide sprays

33%*

Profit Increase/ha 70.9%** Significantly different from zero at 5% level

Source: Gruere, Mehta-Bhatt and Sengupta 2008

Page 11

DEVELOPING COUNTRY CROPS IN THE DEVELOPING COUNTRY CROPS IN THE PIPELINEPIPELINEPIPELINEPIPELINE

Insect resistant cowpea – AfricapVirus resistant cassava – Africa Virus resistant papayaNutrient enhanced cassava, rice, banana and sorghum

ffWater efficient maizeRice - salt tolerant, disease &insect resistant enhancedinsect resistant, enhancednutritionWater and fertilizer efficientWater and fertilizer efficientmaize

BIOTECHNOLOGY BENEFITS AND IMPACT•• Economic BenefitsEconomic Benefits

>>>productivity>>>>income leading to <<<$food•• Protection of biodiversityProtection of biodiversity•• Protection of Natural Resources and climate changeProtection of Natural Resources and climate change

ti till / b t ticonservation tillage/carbon sequestrationreduced pesticide loadreduced time to breed adaptive varieties

•• Poverty alleviationPoverty alleviationfor ~13 million small scale farmers

S i l b fitS i l b fitSocial benefitsSocial benefitsgender positive impacts more disposable income for health care, educationnutritionally enhanced crops

Source : ISAAA

AND YET…….The 8 years preceding adoption in India

were characterized by:major public controversyburning of field trialsaccusations of multi-national dominationcontinuing regulatory uncertaintycontinuing regulatory uncertainty

While today, most developing countries,While today, most developing countries, esp. in sub-Saharan Africa, are non-adopters and not commercially growing biotech crops

It’s not just about the science !It’s not just about the science !M k t /P liM k t /P li P liti l/S iP liti l/S i lt llt lMarkets/PolicyMarkets/Policy--Political/SocioPolitical/Socio--culturalcultural

Product development considerationsProduct development considerationsLinks to markets – local, regional and globalTrade competition and retaliationpEnabling policy/regulatory climateComplex and diverse institutional pplayers Technological gaps & science literacy

Concerns about food system t l i k i htcontrol, risk, consumer rights

INTEGRATION OF FACTORS AFFECTING PRODUCT DEVELOPMENTPRODUCT DEVELOPMENT

Source: ABSP-II, Cornell University

Unique to or greater emphasis for biotech cropsfor biotech crops

Stakeholder outreach Stewardshipoutreach

Regulatory and Variety Certification

Stewardship throughout value chain

GENE DISCOVERY

Identification of gene/construct with marketable or beneficial traitbeneficial trait

Small scale transformation, evaluate research plants in greenhouse (containment)

Prescreen research events and produce seed forPrescreen research events and produce seed for further evaluation

Begin stakeholder analysis at product concept

PLANT AND SEED PRODUCTION

Regulatory trials in target countriesRegulatory trials in target countriesContinued variety developmentContinued seed productionContinued seed productionFurther development of validated detection methods (marker) for commercial qualitymethods (marker) for commercial quality controlStakeholder dialogue ramping upSta e o de d a ogue a p g upMarketing and technical support intensified

PLANT AND SEED PRODUCTION cont.

Quality Management SystemImplement or adapt QMS to maintain plant product integrityImplement or adapt QMS to maintain plant product integrity

and quality

segregation of plant material in storageaccurate tracking of all planted and harvested plant materialprevent the inadvertent during planting or harvestprevent the inadvertent during planting or harvestprevious and subsequent land use

i i l d i i i h fi ldmaintain plant product integrity in the fieldequipment is cleaned and any harvested plant materials are used and/or disposed of appropriately

PLANT AND SEED PRODUCTION cont.

Licensing/Contract Production: appropriate steward ship requirements – awareness, pp p p q ,training, verification

Regulatory Compliance: Compliance with regulations including transport, production, treatment, and storage of plant materialsplant materials

Product Launch: regulatory approvals required (as opposed to simply plant variety certification)

CROP PRODUCTION AND UTILIZATIONCommercialization requires management across value chainCommercialization requires  management across value chain 

VALUE CHAIN DISTRIBUTION AND MARKETING

Product launch: develop and implement planDistribution of product through a supply chain toDistribution of product through a supply chain to customers.

All necessary regulatory authorizations required.Quality management

maintain and document plant product integrity, inventory control and product trace back and recoveryinventory control and product trace back and recovery

Regulatory complianceconditions of authorizationconditions of authorization monitoringimport/exportphytosanitary

VALUE CHAIN DISTRIBUTION AND MARKETING contAND MARKETING, cont.

Stewardship educationeducate the distribution, value chain and stakeholders on proper use enables them to define practices for appropriate productenables them to define practices for appropriate product use

Product withdrawal (?)controlling materials in supply chains,recalling and controlling material in commercial di t ib ti h i (?)distribution chains (?)communication

PRODUCT DISCONTINUATION

Commercialization may be abandoned or products withdrawn due to:Issues with regulatory registration Market licensing agreementsTrade issuesTrade issuesResistance or pressure by stakeholders in the value chain Public relations considerations

Successful Technology Adoption and the Product Development Lifecycle

1 2 3 4 5 6

Product Discovery Early Product Integratio Product Market Post

1 2 3 4 5 6

Concept Testing & Development

n & Product Selection

Ramp Up Introduction Market Activities

1 – 3 years 1 – 3 years 1 – 3 yearsField Trials/Testing

Stakeholder Engagement Intensity

Successful Commercialization Involves Diverse Players and Pathways e se aye s a d at ays

Go ernmentResearch & Ext Service

PolicyAgricultureEnvironment

GovernmentExt Service

Environment

FARMERS Donors & NGO’sMarket/Consumer

Distribution MultinationalsFinance Bank

Commitment, Government, Partnerships

st but o Multinationals

Public vs. Private Sector Contrasting Impacts on Commercialization

STEP IN CYCLE PUBLIC SECTOR PRIVATE SECTORSTEP IN CYCLE PUBLIC SECTOR PRIVATE SECTORProduct Concept May not be supported by market

realitiesMarket primary consideration

Construct Constructs – varied owners, IPR; legal capacity may be an issue

Cross Licensing, IPR may be more straightforward; resident legal capacity

Transformation/ and Scale, capacity Sophisticated capacity, able toTransformation/ and experimental validation

Scale, capacity Sophisticated capacity, able to handle large numbers

Regulatory review Limited capacity and resources –human, financial; lack of f k i t t t i

Well resourced for larger private sector companies; longer term

it t th ti lframework in target countries commitment than conventional crops

Delivery, Distribution,Value Chain

Absent, weak, informal Products usually have an integrated “fit”

Stakeholder Outreach and Communication

More credibility but resource intensive

Requiring more resources, expertise; devoted PR and communications efforts; less credibility with some stakeholders

Product Withdrawal, Liability

Limited capacity to manage or pay

Capacity exists but liability regimes may prevent product entry

IFPRI PROGRAM FOR BIOSAFETYMi i St t tMission Statement

Empowers partner countries to build andEmpowers partner countries to build and implement functional regulatory systems by providing:

1. Independent expertise – science and policy2. Capacity buildingp y g3. Credible information to policy makers, stakeholders,

end users and key opinion leaders for informed decision makingg

4. Experts are regulators from govt. and industry, scientists, lawyers and economists

CURRENT PARTNER COUNTRIES

PHILIPPINES

KENYA

NIGERIA

UGANDA

KENYA

MALAWI

East Africa: Kenya, Uganda, Ethiopia, COMESAWest Africa: NigeriaSouthern Africa: Malawi, MozambiqueSE Asia: Philippines, Vietnam, Indonesia

Affiliations: IFPRI, Danforth Center, Center for Science in the Public Interest, ISAAA, Calvin College, U. Minn., Iowa State/BIGMAP

RECENT PBS ACHIEVEMENTSKENYAKENYA

Stakeholder outreach for passage of Biosafety Bill in 2009draft implementing regulations and training lawyers and regulatorsregulators

UGANDACFTs (cotton, cassava, banana), regulatory policy, commercialization strategy and handbookgy

MALAWIsubmission of 1st field trial application pending

NIGERIAtechnical input to lawpublic communication and stakeholder outreachsupport passage of biosafety bill through House of pp p g y gRepresentatives

PHILIPPINESextensive capacity buildingspecific regulatory issues – IRM, stacked traits

VIETNAMfacilitated first CFT

Biosafety Policy Biosafety Policy -- Developing Country ExperiencesDeveloping Country ExperiencesProgram For Biosafety Systems – Lessons Learned

BalanceScience is NOT staticTransparent predictable science based fle ibleTransparent, predictable, science-based, flexibleProduct EvolutionRegulations reflect product development stageRegulations reflect product development stageInvestmentRegulatory system should promote internal and external investment, Regulatory system should promote internal and external investment, tradetradeLocal TestCan local organizations/ private companies comply with and afford the Can local organizations/ private companies comply with and afford the system?system?yyOther Reconciliation with other applicable laws Reconciliation with other applicable laws –– seed laws, plant variety protection, seed laws, plant variety protection, food safety lawsfood safety lawsfood safety lawsfood safety lawsResourcesImplementation and capacity building

SUMMARY OF CONSTRAINTS TO GLOBAL BIOTECH COMMERCIALIZATION

LIMITED PROFIT OPPORTUNITIES – for private sector incentives

DONOR RELUCTANCE t fi l t iDONOR RELUCTANCE - to finance long term, expensive, controversial research

INSTITUTIONAL CHALLENGES in working across/with diverseINSTITUTIONAL CHALLENGES - in working across/with diverse organizations – no vertical integration; capacity

MARKETS - Weak markets, delivery systems, product stewardshipMARKETS Weak markets, delivery systems, product stewardship and management

INTELLECTUAL PROPERTY - may limit access esp. for orphan y p pcrops

REGULATORY – capacity, cost, trade

COMMUNICATION – consumer resistance, limited stakeholder outreach at early stages, systematic approach needed

WHAT IS NEEDED TO INCREASE COMMERCIALIZATION OF WHAT IS NEEDED TO INCREASE COMMERCIALIZATION OF BENEFICIAL PRODUCTS, ESP. FOR THE DEVELOPING BENEFICIAL PRODUCTS, ESP. FOR THE DEVELOPING

WORLDWORLDWORLDWORLDLess polarized debate: Less polarized debate: A recognition by industry, govts., NGOs that A recognition by industry, govts., NGOs that there is not a “one size fits all” and that choice is important there is not a “one size fits all” and that choice is important –– (biotech, (biotech, nanotech, conventional, organic, etc.)nanotech, conventional, organic, etc.)

A rationalized regulatory dialogue; harmonizationA rationalized regulatory dialogue; harmonization

Adoption in the context of market and cultural realities; communication is Adoption in the context of market and cultural realities; communication is key!key!

Capacity building for developing world “players” Capacity building for developing world “players” –– for R&D, regulatory for R&D, regulatory review, stakeholder outreach and risk communication review, stakeholder outreach and risk communication

General market development for agriculture with supporting infrastructureGeneral market development for agriculture with supporting infrastructure

Additional compelling productsAdditional compelling productsAdditional compelling productsAdditional compelling products

More incentives for technology donation and public/private cooperationMore incentives for technology donation and public/private cooperation

ACKNOWLEDGEMENTSColleagues at IFPRI Drs. Mark RosegrantGuillaume GruereJose Falck ZepedaDonald Danforth Plant Science CenterDr. Hector QuemadaDonna Ramaeker Zahn, consultantISAAAISAAAMargaret Karembu