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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
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Emerging Challenge?Accessing Genetic Resources: the building blocks of new technologiesAccess 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): • conservation of biological diversity i.e., the variability among living organisms from all sources • sustainable use of its components • 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 - 2004) & the Nagoya Protocol (finalized in 2010, but not yet entered into force)
The Berne Declaration • Non-binding, completed in 2002 and set the stage for the Nagoya Protocol • Contains: • General provisions • Roles and responsibilities • Participation of stakeholders • Steps in the ABS process • 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
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]”
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
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?
