An Industry Perspective on Access Benefit Sharing

An Industry Perspective on Access & Benefit Sharing Tom Jacob, Senior Advisor - Global Affairs, Du. Pont Chair, ICC Task Force on ABS tom. jacob@usa. dupont. com WTO 26 May 2004

The CBD Context F CBD is dealing with legitimate issues – But range of potential issues is vast F Those issues go well beyond environmental concerns – But, as MEA, many countries delegate to environment ministries F Role of indigenous/local communities is huge – But very ill-defined F Broad support among nations – But non-environment matters deliberated by environment-focused delegates creates potential for “venue shopping”

ABS From Our Perspective… F There is reason to hope for sustainable development benefits – Direct linkage of resources to in-country stakeholders, with expectation of benefits – Recognition of the linkages of development ecological and social/cultural impacts F Nowhere are the agendas more complex – New obligations for countries --> new for industry – We’re all trying to figure this out F to obligations We need time and country-level experience to find the right balance – Few countries with experience with ABS PIC regulations or

A New CBD ABS Negotiation Should be encouraging new regimes and experience, using Bonn Guidelines, but… F We now have new, broad negotiating mandate F – Everything is on the table – Lock-in decisions with limited experience? F Danger to parallel processes – FAO International Treaty – WIPO Committee – WTO TRIPS Council

Conceptual Model of CBD ABS Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT

Complication: No National Regime Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting ? Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product ? Sharing or Proceeds per MAT

Complication: Pre-CBD Extraction Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting ? Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product ? Sharing or Proceeds per MAT

Complication: Pre-CBD w. “Country of Origin” Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting ? Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT

Complications: Non-Patent GR Use – Patent-Linked System Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting ? Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product ? Sharing or Proceeds per MAT

Complications: Burden of Transaction Costs Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting Expected Value of GR Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT

Complications: Lower Expected Value Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting Expected Value of GR Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT

Differing Perceptions of Value? F Reference case for many is “blockbuster” drug discovery from natural GR – Dependence of pharma on natural GR F Increased reliance upon new technologies for “drug design” – Less dependence upon natural GRs – Many major pharma firms reducing or eliminating natural product research F Remaining industries less likely to “blockbuster” yields – Plant breeding, agrochemicals, flavours & fragrances, industrial enzymes, herbals, etc. have

Challenges Shaping ABS Evolution F Country ABS regimes – Bonn Guidelines + learn from our experience F FAO Standardized MTA – A useful model? F Disclosure of PIC/Origin proposals – Limited coverage and legal complications F Certificate of Origin/Source/Legal Provinance proposals – Workable or will it collapse of own weight?

Challenges Shaping ABS Evolution F Traditional Knowledge and Indigenous & Local Communities obligations – TK very complex IPR challenge – Countries must sort this out consultative relations F Codes of Conduct among Commercial, Public and Non-Profit Institutions – Important, but too few as yet

Bye, Now. . .

Negotiating Boundary Conditions F Trading system – Evolved over hundreds of years F “Environmental” system – Evolved in past several decades – Not yet institutionalized – Quite undisciplined

Convention on Biological Diversity (CBD) F An environmental treaty… – Biological diversity, ecosystem integrity F But also an economic/social treaty – rights to genetic resources and traditional knowledge – rights of indigenous and local communities – equity concerns, and sharing of benefits F There is reason to hope for sustainable development benefits – Direct linkage of resources to in-country stakeholders, with expectation of benefits – Recognition of the linkages of development ecological and social/cultural impacts to

Bonn Guidelines -- A Major Step F A broad “inventory” of potential measures and ideas – Workable if used selectively F Needed: Countries to gain experience implementing regimes – Few countries with experience with ABS PIC regulations – Need experience to learn implications of potential elements of ABS regimes F Should be encouraging new regimes and experience, using Bonn Guidelines or

Complication: Exemption for Academic Research Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT

Complication: Exemption for Academic Research Products Pursuant to National Regime Consultation w. Sovereign State Consultation w. Indigenous/Local Communities In-situ Resource Bioprospecting Mutually Agreed Terms/PIC Ex-situ R&D Development of Commercial Product Patenting of Commercial Product Sharing or Proceeds per MAT