An Industry Perspective on Access & Benefit Sharing

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

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

ABS From Our Perspective… • 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 to ecological and social/cultural impacts • Nowhere are the agendas more complex • New obligations for countries --> new obligations for industry • We’re all trying to figure this out • We need time and country-level experience to find the right balance • Few countries with experience with ABS or PIC regulations

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

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

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

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

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

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

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

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

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

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

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

Bye, Now...

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

Convention on Biological Diversity (CBD) • An environmental treaty… • Biological diversity, ecosystem integrity • 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 • 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 to ecological and social/cultural impacts

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

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

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

An Industry Perspective on Access & Benefit Sharing