A LEGAL UPDATE By: Ben Hemmelgarn

Introduction  Personal Introduction  Coordination with Governments  Convention on Biological Diversity  Nagoya Protocol  Access and Benefit Sharing  DNA Import/Export  Future Intellectual Property Issues  Future Genetic Privacy Issues

Personal Introduction

Convention on Biological Diversity  Earth Day in Rio de Janeiro  Effective December 29, 1993  196 Parties  Help develop national strategies for conservation and sustainable use of biological diversity

Convention on Biological Diversity Cartagena Protocol on Biosafety  Effective September 11, 2003  170 Parties  Primarily focused on safe handling, transport, and use of living modified organisms. Nagoya Protocol  Effective October 12, 2014  73 Parties  Implementation of CBD goal for fair and equitable sharing of benefits from genetic resources.

Nagoya Protocol  Croatia  Egypt  European Union  Germany  India  Mexico  Norway  South Africa  Spain  Switzerland  United Kingdom  Uruguay  MetaSUB countries that are a party to the Nagoya Protocol

Nagoya Protocol  Access  Prior Informed Consent  From a Competent National Authority  Benefit Sharing  Utilization of Genetic Resources Includes research and development Includes subsequent commercialization  Benefits can be Monetary Non-Monetary Training Sharing results

ABS Clearing House

 County Profiles

MetaSUB and Access  Different regimes encountered  No Prior Informed Consent (PIC) required. Portugal, Germany, Norway, UK, Sweden  PIC from transit authority New Zealand, Japan  PIC from state-level government Colombia, Australia  PIC from national government (environmental agency) Brasil, Argentina, Singapore, Italy, India, Qatar

MetaSUB and Benefit Sharing  Model Agreement (MetroRio in Rio de Janeiro)  Public Domain  Proprietary

DNA Export Laws  Prohibited Goods  Not allowed to leave the country  Restricted Goods  Exportation is regulated  South Africa Example DNA is regulated under the Non-Proliferation of Weapons of Mass Destruction Act 87 of 1993 Need to Contact the Non-Proliferation Office Need to fill out a Material Safety Data Sheet

DNA Export Laws  Material Safety Data Sheet  Isolated DNA in suspension  DNA Swabs

Future Intellectual Property Issues  Synthesis from DNA collected  Small molecules  Drugs  Full organisms  Data sharing  Subsequent negotiations with provider states

Future Genetic Privacy Issues  Reasonable Expectation of Privacy

Questions  Contact Info  Ben Hemmelgarn  