Emerging Challenge? Accessing Genetic Resources : the building blocks of new technologies Access and Benefits Sharing, an emerging issue transitioning from international regimes to national implementation Tom Nickson Monsanto Company

Background The Convention on Biological Diversity – Came into force in 1993; currently 193 Parties – 3 Objectives (foundational pillars): 1.conservation of biological diversity i.e., the variability among living organisms from all sources 2.sustainable use of its components 3.fair and equitable sharing of the benefits derived from the utilization of genetic resources (ABS) – A genetic resource is genetic material [functional unit(s) of heredity] of actual or potential value. – Access to genetic resources “shall be on mutually agreed terms” (MAT) and “subject to prior informed consent” (PIC) unless a Party decides otherwise. – These principles underpin the Berne Guidelines on ABS (2002), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA ) & the Nagoya Protocol (finalized in 2010, but not yet entered into force) 2

The Berne Declaration Non-binding, completed in 2002 and set the stage for the Nagoya Protocol Contains: 1.General provisions 2.Roles and responsibilities 3.Participation of stakeholders 4.Steps in the ABS process 5.Other provisions including monitoring Monitoring may include applications for intellectual property rights 6. Two appendices – suggested model contractual clauses and monetary and non-monetary benefits 3

Nagoya Protocol Will entered into force 90 days after deposit of the fiftieth instrument of ratification – finalized in 2010, currently 23 Parties Affirms national sovereignty over genetic materials/resources – to some, it puts private ownership in question Scope is very broad and may eventually include genetic resources for which PIC and MAT are not possible Prescribes bilateral agreements (PIC & MAT), checkpoint(s) and an internationally recognized certificate of compliance – Checkpoints “must be effective and should have functions relevant to implementation [of the monitoring provisions]” 4

ITPGRFA – FAO Entered into force 2004, 130 Parties Scope includes all plant genetic resources for food and agriculture (PGRFA), but – Prescribes a multilateral system (MLS) encompassing 64 crops and requiring the standard material transfer agreement (SMTA 2006) The SMTA imposes mandatory benefits sharing in cases where a patent “restricts” access to a PGRFA – Payments could be in perpetuity – Compliance with the SMTA would require monitoring every gene in perpetuity 5

How might implementation of ABS rules become barriers to the development and protection of new technologies? New disclosure requirements as conditions of obtaining a patent on biological materials (checkpoints) – Will implementation of the Nagoya Protocol establish checkpoint(s) in patent offices, how will they operate and what will be the impact? Procedural and legal uncertainties – What is the role of a statutory body, a National Focal Point or Competent Authority and internationally recognized certificates of compliance in obtaining patents? Disincentives to investment – Does the SMTA encourage avoiding MLS material (PGRFA), and if so, how will seed companies secure the legal certainty required under the Nagoya Protocol? 6