BIOPROSPECTING: ISSUES AND POLICY CONSIDERATIONS PETER G. PAN Researcher Report No. 1, 2006 Legislative Reference Bureau State Capitol Honolulu, Hawaii 96813 http://www.hawaii.gov/lrb/ This report has been cataloged as follows: Pan, Peter G. Bioprospecting: issues and policy considerations. Honolulu, HI: Legislative Reference Bureau, January 2006. 1. Germplasm resources. KFH421.5.L35 A25 06-1 FOREWORD This report was undertaken in response to House Concurrent Resolution No. 146, H.D. 1, 2005. The Bureau has been requested to "conduct a study on the fair and equitable sharing of benefits arising from research, indigenous knowledge, intellectual property, or application of biological resources that are public natural resources held in trust by the State for the benefit of the people." This study examines the nature of bioprospecting and certain problematic issues surrounding the use of biological resources. These include certain assumptions that may not necessarily be correct or relevant. The study further discusses the issue of the public land trust and benefit sharing with indigenous knowledge holders. We also examine several models of bioprospecting guidelines for the Legislature's consideration. Ken H. Takayama Acting Director January 2006 iii FACT SHEET Bioprospecting involves searching for, collecting, and deriving genetic material from samples of biodiversity that can be used in commercialized pharmaceutical, agricultural, industrial, or chemical processing end products. By the early 1990s, objections to uncompensated bioprospecting that does not share benefits with the source country became contentious. Since 1991, the Convention on Biological Diversity (CBD) has embodied the principles of compensated bioprospecting globally. Compensated bioprospecting involves obtaining prior informed consent from the source country, sharing benefits, and promoting sustainable use of biodiversity. Where indigenous knowledge holders are involved, efforts are made to recognize and protect their rights. Benefits can take various forms, from royalties to negotiated advance and milestone payments, capacity building, facilities and equipment transfer, personnel training, sharing of research, and other forms. The United States (and six other nations) are not parties to the CBD, which is an international protocol meant to apply to sovereign nations, not to individual cities, provinces, or states. The CBD encourages parties to enact national bioprospecting legislation. The United States has not done so. Neither has any individual state. Without participation in the CBD and in the absence of national and state laws, bioprospecting is not regulated in Hawaii. The CBD is difficult to enforce and relies on voluntary compliance. However, it provides guidelines for implementing the principles of prior informed consent, benefit sharing, and promotion of sustainable use of biodiversity. The Legislature is faced with the decision whether to regulate bioprospecting in Hawaii and who, including native Hawaiians, should share in the benefits. At present, it is the opinion of the Attorney General that the State does not automatically hold title to the genetic material derived from biodiversity taken from public lands. The Attorney General further opines that, at present, revenues from the sale of that genetic material do not qualify for transfer into the Ceded Lands Trust Account to be distributed by the Office of Hawaiian Affairs for the benefit of native Hawaiians. Thus, if the Legislature desires to regulate bioprospecting, it needs to ensure that the State retains title to share in benefits. It must also decide whether native Hawaiians should share in benefits, how, and how much. It does not make sense to implement actual bioprospecting regulation without first setting policy guidelines. It is important that all stakeholders have the opportunity to be heard and help shape policy through the political process. After the Legislature determines overall policy, the actual implementation of a regulatory framework may fall to a bioprospecting working group composed of representatives of stakeholder groups, including state agencies, to work out the details, guided by legislative policy. iv TABLE OF CONTENTS Page FOREWORD........................................................................................................................ iii FACT SHEET ...................................................................................................................... iv 1. INTRODUCTION.................................................................................................... 1 H.C.R. No. 146, H.D. 1.............................................................................................. 1 Organization of the Study .......................................................................................... 2 2. BIOPROSPECTING ISSUES................................................................................. 3 Bioprospecting ........................................................................................................... 3 Fear: Lack of Conservation Effort and Unsustainable Use of Biodiversity............................................................................................................. 4 Bioprospecting vs. Final Commercial Manufacture ......................................... 4 Bioprospecting Generally Requires Minimal Sample Quantities..................... 5 Distinction between Pharmaceutical Bioprospecting and Phytomedicine................................................................................................ 6 Bioprospecting Generally Focuses on Genetic Material .................................. 7 Fear: Bioprospecting is Unnatural ............................................................................ 8 Bioprospecting Does Not Equal Biotechnology............................................... 9 Fear: Lack of Compensation or Benefit Sharing ...................................................... 10 Evolution of Demand for Compensation .......................................................... 10 The Willow Bark and Aspirin........................................................................... 10 Why No Prior Demand for Sustainable Use..................................................... 11 Why Compensation Demanded ........................................................................ 11 Convention on Biological Diversity ................................................................. 12 Types of Benefits or Compensation.................................................................. 12 Negotiated Bioprospecting Agreements ........................................................... 14 Prior Informed Consent..................................................................................... 14 Milestone Payments.......................................................................................... 15 Bioprospecting Does Not Necessarily Achieve Large or Quick Profits............................................................................................................. 15 Capacity Building Supports Development........................................................ 16 Fear: Traditional Cultural Practices Threatened or Limited..................................... 17 Three Approaches to Bioprospecting................................................................ 17 Intellectual Property Rights .............................................................................. 18 National Pride at Stake............................................................................................... 21 v Page 3. MODELS AND GUIDELINES FOR REGULATION......................................... 23 Approaches to Bioprospecting Regulation ................................................................ 23 Convention on Biological Diversity .......................................................................... 23 Parties to the CBD ............................................................................................ 24 Objectives of the CBD...................................................................................... 24 Conservation and Sustainable Use of Biodiversity........................................... 25 Identification and Monitoring of Biodiversity.................................................. 25 In-Situ and Ex-Situ Conservation ..................................................................... 25 Sustainable Use................................................................................................. 27 Incentives, Training Programs, and Public Education...................................... 27 Exchange of Information .................................................................................. 27 Technical and Scientific Cooperation for Conservation and Sustainable Use.............................................................................................. 28 Regulation of Bioprospecting ........................................................................... 28 Environmental Impact Assessments ................................................................. 28 Sovereign Rights and National Legislation ...................................................... 28 Access to and Transfer of Technology ............................................................. 29 Patents and Intellectual Property Rights........................................................... 29 International Intellectual Property Rights Regime ..........................................