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From concept product

  1. 1. FROM CONCEPT TO PRODUCT: An Examination of Issues Related to the Commercialization of Biotech CropsPresented at the XI International Rice Conference for Latin America and the Caribbean Cali, Cali Colombia Sept. 21-24, 2010 Dr. Judith Chambers Director, Program for Biosafety Systems International Food Research Institute
  2. 2. A FEW POINTS TO KEEP IN MINDTrends and the continuing need for innovationRole of Biotechnology Product development issues Evolving market forces and demographics – local, regional, and global Controversy, politics, policy and regulation Complex and diverse institutional playersWhen considering where we are forcommercialization of biotech crops, there is a need i li i f bi h h i dto consider historical context and role ofintegration
  3. 3. THE GLOBAL CHALLENGEIncreased demand for Food, Feed, Fiber and Fuel • World population will grow from current 6.5B to 8B by 2025 and 9.2B by 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 biofuel consumption Source: Leaver, 2008; FAO, 2009
  4. 4. THE GLOBAL CHALLENGE – CLIMATE CHANGEBy 2050, climate changes will reduce Asian irrigated rice production by 27% 2050
  5. 5. TECHNOLOGY HAS BEEN AN IMPORTANT TOOL TO INCREASE AGRICULTURAL PRODUCTIVITYFor 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 yields • Conventional breeding C ti lb di • Biotechnology traits Fertilizer Crop protection Efficient machinery Supportive government policy pp g p yAnd, globally, new innovations in biotechnologyhave delivered yield increases from 9 to 31% pesticide application decreases from 39 to 60% income increases from $117 to $250 per acre
  6. 6. GLOBAL AREA OF BIOTECH CROPS 1996 to 2008 By Crop (mil ha) Source: James 2009 Page 12
  7. 7. EXPERIENCE WITH GM CROPS IN THE DEVELOPING WORLD Global Area of Biotech Crops, 1996 to 2008:Industrial and Developing Countries (million ha) Source: James 2009
  9. 9. INDIA: BT COTTON --A SUCCESS STORY --Acontributed to doubling of yields in 5 years Source: Cotton Advisory Board
  10. 10. IMPACTIndia emerged as 2nd largest exporter of cotton g g p Source: Cotton Advisory Board 2009
  11. 11. IMPACT AT THE FARM LEVELAverage effects of Bt cotton vs. non-Bt in India non- Based on peer-reviewed published studies Yield Increase 39%* Reduction in insecticide 33%* sprays Profit Increase/ha 70.9%* * Significantly different from zero at 5% level Source: Gruere, Mehta-Bhatt and Sengupta 2008 Page 11
  12. 12. DEVELOPING COUNTRY CROPS IN THE PIPELINEInsect resistant cowpea – Africa pVirus resistant cassava – AfricaVirus resistant papayaNutrient enhanced cassava, rice,banana and sorghumWater efficient maize ffRice - salt tolerant, disease & insect resistant, enhanced resistant nutritionWater and fertilizer efficient maize
  13. 13. BIOTECHNOLOGY BENEFITS AND IMPACT• Economic Benefits >>>productivity>>>>income leading to <<<$food• Protection of biodiversity• Protection of Natural Resources and climate change conservation tillage/carbon sequestration ti till / b t ti reduced pesticide load reduced time to breed adaptive varieties• Poverty alleviation for ~13 million small scale farmers Social b S i l benefits fit gender positive impacts more disposable income for health care, education nutritionally enhanced crops Source : ISAAA
  14. 14. AND YET…….The 8 years preceding adoption in India were characterized by: major public controversy burning of field trials accusations of multi-national domination continuing regulatory uncertaintyWhile today, most developing countries, esp. in sub-Saharan Africa, are non- adopters and not commercially growing biotech crops
  15. 15. It’s not just about the science ! Markets/Policy Political/Socio M k t /P li -P liti l/S i -cultural Markets/Policy-Political/Socio- lt lProduct development considerationsLinks to markets – local, regional and globalTrade competition and retaliation pEnabling policy/regulatory climateComplex and diverse institutional pplayersTechnological gaps & science literacyConcerns about food systemcontrol, risk, consumer rights t l i k i ht
  17. 17. Unique to or greater emphasis for biotech cropsStakeholder outreach Stewardship Regulatory throughout and Variety value chain Certification
  18. 18. GENE DISCOVERYIdentification of gene/construct with marketable orbeneficial traitSmall scale transformation, evaluate researchplants in greenhouse (containment)Prescreen research events and produce seed forfurther evaluationBegin stakeholder analysis at product concept
  19. 19. PLANT AND SEED PRODUCTIONRegulatory trials in target countriesContinued variety developmentContinued seed productionFurther development of validated detectionmethods (marker) for commercial qualitycontrolSta e o de dialogue a p gStakeholder d a ogue ramping upMarketing and technical support intensified
  20. 20. PLANT AND SEED PRODUCTION cont.Quality Management SystemImplement or adapt QMS to maintain plant product integrity and quality segregation of plant material in storage accurate tracking of all planted and harvested plant material prevent the inadvertent during planting or harvest previous and subsequent land use maintain plant product integrity in the fi ld i i l d i i i h field equipment is cleaned and any harvested plant materials are used and/or disposed of appropriately
  21. 21. PLANT AND SEED PRODUCTION cont.Licensing/Contract Production:appropriate steward ship requirements – awareness, pp p p q ,training, verificationRegulatory Compliance: Compliance with regulationsincluding transport, production, treatment, and storage ofplant materialsProduct Launch: regulatory approvals required (as opposedto simply plant variety certification)
  22. 22. CROP PRODUCTION AND UTILIZATIONCommercialization requires  management across value chain Commercialization requires management across value chain
  23. 23. VALUE CHAIN DISTRIBUTION AND MARKETINGProduct launch: develop and implement planDistribution of product through a supply chain tocustomers. All necessary regulatory authorizations required.Quality management maintain and document plant product integrity, inventory control and product trace back and recoveryRegulatory compliance conditions of authorization monitoring import/export phytosanitary
  24. 24. VALUE CHAIN DISTRIBUTION AND MARKETING cont MARKETING, cont.Stewardship education educate the distribution, value chain and stakeholders on proper use enables them to define practices for appropriate product useProduct withdrawal (?) controlling materials in supply chains, recalling and controlling material in commercial distribution h i di t ib ti chains (?) communication
  25. 25. PRODUCT DISCONTINUATIONCommercialization may be abandoned or products withdrawn due to: Issues with regulatory registration Market licensing agreements Trade issues Resistance or pressure by stakeholders in the value chain Public relations considerations
  26. 26. Successful Technology Adoption and the Product Development Lifecycle 1 2 3 4 5 6Product Discovery Early Product Integratio Product Market PostConcept Testing & n& Ramp Up Introduction Market Development Product Activities Selection Field Trials/Testing 1 – 3 years 1 – 3 years 1 – 3 years Stakeholder Engagement Intensity
  27. 27. Successful Commercialization Involves Diverse Players a d Pathways e se aye s and at ays Research & Ext Service Government Go ernment Policy Agriculture EnvironmentMarket/Consumer FARMERS Donors & NGO’sFinance Bank Distribution st but o Multinationals Commitment, Government, Partnerships
  28. 28. Public vs. Private Sector Contrasting Impacts on Commercialization STEP IN CYCLE PUBLIC SECTOR PRIVATE SECTORProduct Concept May not be supported by market Market primary consideration realitiesConstruct Constructs – varied owners, IPR; Cross Licensing, IPR may be legal capacity may be an issue more straightforward; resident legal capacityTransformation/ and Scale, capacity Sophisticated capacity, able to handle large numbersexperimental validationRegulatory review Limited capacity and resources – Well resourced for larger private human, financial; lack of sector companies; longer term framework i target countries f k in t t ti commitment than conventional it t th ti l cropsDelivery, Distribution, Absent, weak, informal Products usually have an integrated “fit”Value ChainStakeholder Outreach and More credibility but resource Requiring more resources, intensive expertise; devoted PR andCommunication communications efforts; less credibility with some stakeholdersProduct Withdrawal, Limited capacity to manage or Capacity exists but liability pay regimes may prevent productLiability entry
  29. 29. IFPRI PROGRAM FOR BIOSAFETY Mission St t Mi i StatementtEmpowers partner countries to build and implement functional regulatory systems by providing:1. Independent expertise – science and policy2. Capacity building p y g3. Credible information to policy makers, stakeholders, end users and key opinion leaders for informed decision making g4. Experts are regulators from govt. and industry, scientists, lawyers and economists
  30. 30. CURRENT PARTNER COUNTRIES PHILIPPINES NIGERIA KENYA UGANDA MALAWI East Africa: Kenya, Uganda, Ethiopia, COMESA West Africa: Nigeria Southern Africa: Malawi, Mozambique SE Asia: Philippines, Vietnam, IndonesiaAffiliations: IFPRI, Danforth Center, Center for Science in the PublicInterest, ISAAA, Calvin College, U. Minn., Iowa State/BIGMAP
  31. 31. RECENT PBS ACHIEVEMENTSKENYA Stakeholder outreach for passage of Biosafety Bill in 2009 draft implementing regulations and training lawyers and regulatorsUGANDA CFTs (cotton, cassava, banana), regulatory policy, commercialization strategy and handbook gyMALAWI submission of 1st field trial application pendingNIGERIA technical input to law public communication and stakeholder outreach support passage of biosafety bill through House of pp p g y g RepresentativesPHILIPPINES extensive capacity building specific regulatory issues – IRM, stacked traitsVIETNAM facilitated first CFT
  32. 32. Biosafety Policy - Developing Country Experiences Program For Biosafety Systems – Lessons Learned Balance Science is NOT static Transparent, predictable science based fle ible Transparent predictable, science-based, flexible Product Evolution Regulations reflect product development stage Investment Regulatory system should promote internal and external investment, trade Local Test Can local organizations/ private companies comply with and afford the y system? Other Reconciliation with other applicable laws – seed laws, plant variety protection, food safety laws Resources Implementation and capacity building
  33. 33. SUMMARY OF CONSTRAINTS TO GLOBAL BIOTECH COMMERCIALIZATIONLIMITED PROFIT OPPORTUNITIES – for private sector incentivesDONOR RELUCTANCE - t fito finance long term, expensive, l t icontroversial researchINSTITUTIONAL CHALLENGES - in working across/with diverseorganizations – no vertical integration; capacityMARKETS - Weak markets, delivery systems, product stewardshipand managementINTELLECTUAL PROPERTY - may limit access esp. for orphan y p pcropsREGULATORY – capacity, cost, tradeCOMMUNICATION – consumer resistance, limited stakeholderoutreach at early stages, systematic approach needed
  34. 34. WHAT IS NEEDED TO INCREASE COMMERCIALIZATION OF BENEFICIAL PRODUCTS, ESP. FOR THE DEVELOPING WORLD Less polarized debate: A recognition by industry, govts., NGOs that there is not a “one size fits all” and that choice is important – (biotech, nanotech, conventional, organic, etc.) A rationalized regulatory dialogue; harmonization Adoption in the context of market and cultural realities; communication is key! Capacity building for developing world “players” – for R&D, regulatory review, stakeholder outreach and risk communication General market development for agriculture with supporting infrastructure Additional compelling products More incentives for technology donation and public/private cooperation
  35. 35. ACKNOWLEDGEMENTS Colleagues at IFPRI Drs. Mark Rosegrant Guillaume Gruere Jose Falck Zepeda Donald Danforth Plant Science Center Dr. Hector Quemada Donna Ramaeker Zahn, consultant ISAAA Margaret Karembu