Promoting the application of the Nagoya Protocol in the Philippines Response to Check list for NPIF projects 1. Is the proposed project eligible under the Nagoya Protocol and NPIF? Our project collects mollusks and archives mollusk specimens. Bacteria are isolated from the mollusks and archived. The bacteria are extracted and the extracts are assayed and active compounds/enzymes isolated and identified. Our chemical screening areas are central nervous system, antimicrobial and anticancer. In the enzyme arena we seek enzymes that break down cellulose to sugar, which can be converted to ethanol for fuels. We use a unique information-rich CNS assay, particularly useful for identifying anti-pain agents, pioneered at the University of Utah, the dorsal root ganglion assay. This assay has led to a number of novel active compounds that have been published 1 and two pending patent applications. Materials that have been transferred from the host country to the partner laboratories in the US at Oregon Health & Science University, University of Utah, Academy of Natural Science, Philadelphia and Ocean Genome Legacy under our agreements include bacterial strains, tissue samples, nucleic acids, organic extracts and pure compounds. In addition, some bacterial strains and extracts have also been transferred from US partner laboratories to the Marine Science Institute of the University of the Philippines, Diliman. We have isolated nearly two thousand bacterial strains from Philippine samples and identified over 100 compounds, more than 40 of them new to science, and identified several gene clusters encoding compounds and enzymes. Thus, under our agreements, we have transferred/exchanged genetic materials and sources of genetic material (strains and tissues) and have added value by discovery of novel compounds, many of them with significant bioactivity. Eisai, Inc. has expressed interest in our compounds, especially the neuroactive class. If you would like to examine the unpublished compounds identified, we can prepare a confidentiality agreement. 2. What are the objectives of the project? The objectives of the project are discovery of drugs and enzymes for anticancer, antimicrobial central nervous system and biofuels applications from Philippine biodiversity of mollusks and their bacterial symbionts, training and research capacity building in the Philippines and documentation of this biodiversity. The project serves as a test case for devising and using agreements for access and benefits sharing in the context of biodiversity-based discovery. The activities include collection, documentation and archiving as well as discovery and training. If the GEF funds become available, we will accelerate and expand our efforts, investigating more samples, isolating more bioactive compounds and the genes encoding them, chemically synthesizing compounds to move them to the next level of bioactivity testing, thus increasing our chances of commercially relevant discoveries. 3. Is there a “baseline project” on ABS (including an existing consortium or joint-venture in place), or is the NPIF funding going to support a start-up operation? The proposed project is based on the Philippine Mollusk Symbiont ICBG (PMS-ICBG, NIH 1U01TW00816301 “Diverse drug lead compounds from bacterial symbionts in tropical marine mollusks”). The partner organizations are University of the Philippines Diliman, Oregon Health & Science University, University of Utah, Academy of Natural Sciences, Philadelphia, and Ocean Genome Legacy. We are negotiating an agreement with Eisai, Inc. to develop drugs based on our discoveries and extracts. The project has been underway for four years. Is the project leading to the revision of a baseline ABS Agreement or the developing of new ABS agreements between users and providers? 4. 1 Lin, Z. et al., 2011. Nobilamides A–H, Long-Acting Transient Receptor Potential Vanilloid-1 (TRPV1) Antagonists from Mollusk-Associated Bacteria. Journal of medicinal chemistry, 54(11), pp.3746–3755. Lin, Z. et al., 2010. Pulicatins A-E, neuroactive thiazoline metabolites from cone snail-associated bacteria. Journal of Natural Products, 73(11), pp.1922–1926. Lin, Z. et al., 2012. Totopotensamides, Polyketide–Cyclic Peptide Hybrids from a Mollusk-Associated Bacterium Streptomyces sp. Journal of Natural Products, 75(4), pp.644–649. Promoting the application of the Nagoya Protocol in the Philippines We have baseline ABS agreements with the Philippine government Department of Agriculture and among the five partner universities/institutions that have governed our success so far. During the term of the GEF funding these would be renewed and revised. The agreements are not in the public domain. There are provisions for sharing confidential information with the agreement of all parties. This would go through the UP System Legal Office. It would likely be approved for this purpose. 5. Is there basic legislation that can be used to frame the proposed activities of the GEF funded project? We have a foundation for our existing agreements that has allowed us to work successfully. The following agreements and permits govern our collections, research, training, intellectual property, ABS, etc.: Memorandum of Understanding for the Conduct of Academic Research (MOU-CAR) with the Philippine Department of Agriculture, inter-institutional Memorandum of Agreement, Prior Informed Consent (PIC) Certificates, Gratuitous Permits, Material Transfer Agreements. We have documented our activities to the government and renewed our collecting permits three times during two presidential administrations. Our host country research partner, the Marine Science Institute of the University of the Philippines Diliman (UP-MSI) is a leader in developing best practices for prior informed consent of local communities, and consequently our activities are respected. The Philippine legal foundation is the Republic Act 9147, colloquially known as the Wildlife Act, passed in 2001. I’ve sent you a copy. Section 15 governs our agreement, but we follow the terms of section 14 (i.e. prior informed consent, local institution involvement) also). RA 9147 was drafted prior to the Nagoya Protocol. 6. Is the private sector engaged in the development and implementation of the project? Yes, negotiations are underway with Eisai, Inc. Eisai is interested in anticancer and central nervous system applications, two of our four areas. We anticipate that Eisai will contribute an annual cash payment. In addition they will screen our extracts and pure compounds in their assays and share the results with us, a major in-kind contribution. Compounds that fit their development criteria will enter their development pipeline. We are seeking additional partners in the antimicrobial and biofuels areas. For example, we are meeting with one of the largest pharmaceutical companies in the Philippines, Pascual Laboratories. 7. Is there technology transfer between users (private sector or partners in developing countries) and providers of genetic resources (Government and research institutions in country providing genetic resources)? Our project has supplied equipment, software and training to our host country research partner, the Marine Science Institute of the University of the Philippines Diliman (UP-MSI). We have provided over 100,000 USD of equipment and several thousand USD of software. We contribute substantial user fees for using, maintaining and repairing major existing equipment and facilities in UP. We have provided longterm training for 20 UP-MSI researchers, including 11 extended training visits to the US. We believe Eisai, Inc. will participate in technology transfer. 8. What are the monetary and non- monetary benefits to be gained by both users and providers? (Note: User-provider terminology is not ideal for our project, since UP-MSI is a full partner in the research and discovery.) UP-MSI, the host country research institution, benefits by improved research capacity and infrastructure. Host country researchers benefit from opportunities and training. The host country benefits from access to biodiversity documentation. Local communities benefit by employment of local fishers as expert collectors, and infusion of funds in to local economies during collecting activities. Local communities are provided information about our project and how to value and conserve the surrounding marine environment and biodiversity. US researchers benefit from research opportunities and collaborators. Our industrial partner, Eisai, Inc. benefits from access to rare biodiversity for discovery. Humans in general will benefit from biomedical and bioenergy discoveries. Monetary benefits from royalties and licensing for all parties are spelled out in our inter-institutional agreement. These benefits flow to institutions, researchers, the Philippine government and local communities. 9. Can the partnership bring together co-financing (cash or in-kind) at a ratio of 1:2 or 1:3 (GEF-Partnership)? Promoting the application of the Nagoya Protocol in the Philippines Yes, we can provide a combination of cash and in-kind support from our US research funding agencies and industrial partner, Eisai, Inc. 10. Are the GEF eligible countries planning on using this project to review and upgrade their capacities and needs on ABS, with focus on the provisions of existing policies, laws, and regulations on genetic resources? We plan to use a portion of the GEF funding to improve engagement (dissemination and education about our project results, discoveries and the benefits to the Philippine government, the University of the Philippines, the Philippine research community, local communities, etc.) and improve our renewed agreements. We believe the Government of the Philippines will join us as a true and honest partner. The University of the Philippines is the national university of the Philippines is thus part of the Phil. Government. In the UP Charter of 2008, UP is mandated to become a true research university. UP presently receiving major support from the Phil. Gov’t Department of Science and Technology, Department of Budget and Management, etc. and indications are that the support will grow. Commercialization of research and technology and revenue generation are a high priority of the Phil. Government and of UP. The Philippines is welcoming foreign investments, particularly from/through the US. GEF funding to UP would be perceived as compatible with Philippine interests. Bilateral agreements between the US and Phil. are being strengthened. Margo G. Haygood, Oregon Health and Science University Gisela P. Concepcion, University of the Philippines, Diliman