Documenting Traditional Medical Knowledge Prepared by Ryan Abbott, M.D., J.D., M.T.O.M. March 2014 © World Intellectual Property Organization, 2014. Certain rights reserved. WIPO authorizes the partial reproduction, translation and dissemination of this publication for non-commercial and non-profit scientific, educational or research purposes, provided that WIPO, the publication and the author are properly identified and acknowledged. Permission to substantially reproduce, disseminate and/or translate this publication, or compile or create derivative works therefrom, in any form, whether for commercial/for profit or nonprofit purposes, must be requested in writing. For this purpose, WIPO may be contacted at www.wipo.int under “Contact us”. Disclaimer: This publication was prepared by Dr. Ryan Abbott. It does not necessarily represent the views of WIPO or any of its Member States. This publication is not a substitute for legal advice. Its purpose is limited to providing basic information. Readers are invited to consult also the Consultation Draft of the World Intellectual Property Organization Traditional Knowledge Documentation Toolkit, available at: http://www.wipo.int/export/sites/www/tk/en/resources/pdf/tk_toolkit_draft.pdf, and the Background Briefs prepared by the WIPO Secretariat, available at: http://www.wipo.int/tk/en/resources/publications.html. ii CONTENTS Executive Summary ............................................................................................................... 1 List of Abbreviations ............................................................................................................. 2 I. Introduction to Traditional Medical Knowledge ......................................................... 3 1. Traditional Knowledge ....................................................................................................................... 3 2. Traditional Medicine .......................................................................................................................... 3 Traditional Chinese Medicine (TCM) ............................................................................................... 4 3. Complementary and Alternative Medicine ..................................................................................... 4 4. Characteristics of Traditional Medicine .......................................................................................... 4 5. Importance of Traditional Medicine for Indigenous Peoples and Local Communities ............ 5 CordyCeps Sinesis in Tibet .............................................................................................................. 5 Magic and Medicine in Zimbabwe ................................................................................................... 6 II. Traditional Medicine Use ................................................................................................. 7 1. Traditional Medicine Worldwide ....................................................................................................... 7 2. Safety Issues ...................................................................................................................................... 7 Good Manufacturing Practices ......................................................................................................... 8 Misuse of Ephedra Sinica in the United States of America ......................................................... 9 3. Big Business and New Drug Development .................................................................................... 9 Malaria and Herbal Medicine .......................................................................................................... 10 4. Exporting Traditional Medicine ...................................................................................................... 11 5. Misappropriation............................................................................................................................... 12 Turmeric in the United States of America ..................................................................................... 12 III. National and International Policies on Traditional Medicine .............................. 13 1. Beijing Declaration ........................................................................................................................... 13 Excerpts from the Beijing Declaration ........................................................................................... 13 2. National Policies on Traditional Medicine .................................................................................... 14 3. Cultural Polices and Human Rights .............................................................................................. 14 Excerpts from the United Nations Declaration on the Rights of Indigenous Peoples ............ 15 IV. Regulation of Traditional Medicine ........................................................................... 16 1. Data Exclusivity ................................................................................................................................ 16 2. Regulation in the United States of America ................................................................................. 16 Fusing Science and Tradition ......................................................................................................... 18 3. Regulation in the European Community ...................................................................................... 18 4. Regulation in China ......................................................................................................................... 20 iii 5. Regulation in India ........................................................................................................................... 21 6. Regulation in Brazil .......................................................................................................................... 21 7. Traditional Systems of Regulation ................................................................................................ 22 V. Intellectual Property and Traditional Medicine ....................................................... 23 1. Intellectual Property Rights ............................................................................................................ 23 “Hot Yoga” Controversy ................................................................................................................... 24 2. Obstacles to Protecting Traditional Medicine .............................................................................. 25 3. Evolution of Intellectual Property Protection ................................................................................ 26 4. Sui Generis Regimes ...................................................................................................................... 27 5. The Public Domain .......................................................................................................................... 28 Kava ................................................................................................................................................... 29 6. Ownership of Intellectual Property Rights .................................................................................... 29 Mijikenda Ownership of Traditional Knowledge........................................................................... 30 VI. Considerations for Documenting Traditional Medicine ....................................... 32 1. Benefits and Risks of Documentation ........................................................................................... 32 The Traditional Knowledge Digital Library (TKDL) ...................................................................... 33 2. Additional Considerations for Documentation ............................................................................. 33 3. Traditional Knowledge Databases ................................................................................................ 35 4. External Collaborations ................................................................................................................... 36 University of Illinois at Chicago Benefit-Sharing Policy .............................................................. 37 Controversial Collaborations .......................................................................................................... 38 VII. Practical Strategies for Documentation .................................................................. 39 1. Before Documentation .................................................................................................................... 39 Lost Opportunities in Brazil ............................................................................................................. 40 Pre-Documentation Checklist ......................................................................................................... 43 2. During Documentation .................................................................................................................... 43 During documentation Checklist .................................................................................................... 44 3. After Documentation ........................................................................................................................ 45 First Nations Confidentiality Management ...................................................................................