United Nations Development Programme Country: Panama PROJECT DOCUMENT1 Project Title: Promoting the application of the Nagoya Protocol on Access to Genetic Resources and Benefit Sharing in Panama UNDAF Outcome(s): 4.1 Panama has implemented development policies that promote the sustainable use of natural resources and recognize the economic and social value of environmental services and biodiversity conservation 4.2 Panama has implemented policies and programmes that with the participation of the private sector and civil society promote sustainable consumption and production, fomenting cleaner production, the use of renewable energies and the reduction of wastes and pollutants. 4.3 Panama has reduced vulnerability to climate change and natural threats, and is moving towards and economy with low levels of greenhouse gas emissions, through inter-sector actions at national and local levels for the efficient and sustainable use of natural resources. UNDP Strategic Plan Environment and Sustainable Development Primary Outcome: To integrate in general activities issues related to environment and energy UNDP Strategic Plan Secondary Outcome: To mobilize funding for the environment Expected CP Outcome: To elevate to the level of State policy the protection of the environment to strengthen economic growth, tourism development and wellbeing in general Expected CPAP Output (s): In process Executing Entity/Implementing Partner: UNDP Implementing Entity/Responsible Partners: ANAM, Panama International Cooperative Biodiversity Group Brief description Panama’s protected areas contain high levels of globally important biological and genetic diversity, which have major value as the source of nature-based products with the potential to contribute significantly to disease control and food supply worldwide. This project will create the levels of capacities and awareness that are required to scale up and consolidate this situation, allowing Panama to enjoy full control and ownership of these processes, and to generate benefits such as investment, employment and training that will motivate increased investment in the protection of PAs and their genetic resources. This will be achieved by: i) investing directly in bioprospecting and bioassays, in order to strengthen the long-term sustainability of Panama’s drug discovery program; ii) transferring technology and practices to increase the research capacity of Panamanian institutions and facilitate the discovery of active compounds and the sustainable use of biodiversity; iii) raising awareness among the Panamanian population of the benefits of biodiversity; and iv) increasing national capacities for ratifying the Nagoya Protocol on access and benefit sharing. A key problem that this project seeks to address is that at present, royalties are typically perceived as the only financial mechanism whereby developing nations such as Panama can receive benefits from the exploration and exploitation of their genetic resources for drugs and agrochemicals. Unfortunately, the proportion of the explored genetic resources that actually make it to market and generate royalties is relatively small. At the same time, spending worldwide on drug discovery research (amounting to tens of billions of dollars per year) is virtually all conducted in developed countries rather than the host countries where the biodiversity occurs naturally. As a result, the benefits that host countries receive from the exploration of their genetic resources are very limited, both in terms of financial income and trickle-down benefits such as training and employment. This in turn limits their motivations and abilities to invest in the conservation of biodiversity. Therefore, the long term solution to this problem, which will be pursued by this project, is the realization of the potential of genetic resources in Panama to generate tangible economic benefits to the country, in the form of business, technology transfer, employment and capacity building opportunities, through the discovery and development of new medicines or agrochemicals, thereby providing a rationale for the preservation of the biological resources that contain the genetic material. This will represent a paradigm shift from the situation described above, to one in which biodiversityrich nations such as Panama are fully and equitably involved in this lucrative research process. Through collaborations between Panamanian partners and academic and private sector actors abroad, the project will focus on the biodiscovery process, the enhancement of human and institutional capabilities in the country, and the transfer of equipment and expertise from the United States to Panama, in order to establish a state-of-the-art drug discovery program. In synthesis, the biodiscovery process facilitated by the GEF investment will build the capacity of Panamanian organizations through high-tech equipment and training (i.e., shortterm monetary benefits) and pave the way for the materialization of long-term monetary benefits for the country. 1 For UNDP supported GEF funded projects as this includes GEF-specific requirements UNDP Environmental Finance Services Page 1 Programme Period: _____________ Atlas Award ID: Project ID: PIMS # ______________ ______________ ______________ Start date: End Date ______________ ______________ Management Arrangements PAC Meeting Date ______________ ______________ Total resources required Total allocated resources: o GEF o Other In-kind contributions o National Institutes of Health o STRI o INDICASAT o UCSD o University of Utah o Eisai o Centauri o Dow AgroSciences 4,422,000 2,650,000 1,000,000 1,650,000 170,000 300,000 300,000 200,000 132,000 325,000 20,000 325,000 Agreed by (Government): Date/Month/Year Agreed by (Executing Entity/Implementing Partner): Date/Month/Year Agreed by (UNDP): Date/Month/Year UNDP Environmental Finance Services Page 2 SITUATION ANALYSIS ..................................................................................................... 5 Policy and Institutional Context .................................................................................................. 5 Biodiversity in Panama .............................................................................................................. 5 Threats .................................................................................................................................... 7 The long term solution ............................................................................................................... 8 Barriers.................................................................................................................................... 8 Stakeholder analysis .................................................................................................................. 9 Baseline analysis....................................................................................................................... 9 II. STRATEGY ..................................................................................................................... 10 Project rationale .......................................................................................................................10 Policy conformity ....................................................................................................................10 Country ownership: country eligibility and country drivenness .....................................................10 Design principles and strategic considerations .............................................................................11 Project objective, outcomes and outputs/activities ........................................................................13 Key indicators, risks and assumptions.........................................................................................19 Financial modality ...................................................................................................................20 Cost-effectiveness ....................................................................................................................20 Sustainability...........................................................................................................................20 Replicability ............................................................................................................................21 III. PROJECT RESULTS FRAMEWORK: ................................................................................ 22 IV. TOTAL BUDGET AND WORKPLAN ................................................................................ 24 Summary of GEF budget by Atlas code ......................................................................................25 Budget notes ...........................................................................................................................25 V. MANAGEMENT ARRANGEMENTS ................................................................................ 28 Implementation arrangements and responsibilities........................................................................28 Summary of the inputs to be provided by partners ........................................................................29 Audit arrangements ..................................................................................................................30 Agreement on intellectual property rights and use of logo on the project’s deliverables ....................30 VI. MONITORING FRAMEWORK AND EVALUATION ......................................................... 31 VII. LEGAL CONTEXT ........................................................................................................... 35 VIII. ANNEXES ....................................................................................................................... 36 Annex I. Terms of Reference: ...............................................................................................36 I. UNDP Environmental Finance Services Page 3 List of Abbreviations Abbreviation ABS ABWP ANAM APR CBD CO DIM GoP ICBG INDICASAT IR NBSAP NGO NIH NPC NPD PA PIR PIU QOR RCU STRI ToR TPC UNARGEN UNDP Meaning Access and Benefit Sharing Annual Budget and Work Plan National Environment Agency Annual Project Report Convention on Biological Diversity Country Office Direct Implementation Government of Panama Panama International Cooperative Biodiversity Group Institute of Advanced Scientific Investigations and High Technology Services Inception Report National Biodiversity Strategy and Action Plan Non-Governmental Organization National Institutes of Health National Project Coordinator National Project Director Protected area Project Implementation Review Project Implementation Unit Quarterly Operational Report Regional Coordination Unit Smithsonian Tropical Research Institute Terms of Reference Tripartite Committee Unit for Access to Genetic Resources United Nations Development Programme UNDP Environmental Finance Services Page 4 I. SITUATION ANALYSIS Policy and Institutional Context 1. The National Environment Agency (ANAM) is the lead governmental institution in the natural resources and environment sector in Panama and the national authority on ABS. ANAM is also responsible for administering the Panama National Protected Area System (SINAP), which includes 65 protected areas. While local research organizations such as INDICASAT and University of Panama have undertaken national efforts to investigate the uses of genetic resources, these initiatives have not shown similar potential to that of the Panama International Cooperative Biodiversity Group (ICBG). The Panama ICBG, with headquarters in the Republic of Panama, was established in 1998 and is comprised of the University of Panama, the Institute of Advanced Scientific Investigations and High Technology Services (INDICASAT-AIP, for its initials in Spanish), and the Smithsonian Tropical Research Institute (STRI). These institutions in turn have academic, non-profit and industrial collaborators at both the national and international level, which include the University of California, Oregon State University, Utah State University and University of Connecticut. 2. The project will contribute directly to a number of the Strategic Objectives of the country’s National Biodiversity Strategy and Action Plan (NBSAP) 20002, in particular the following: 3) Increase knowledge, information and citizen awareness regarding biodiversity, biotechnology, bioprospecting, biosecurity and access to genetic resources. 4) Generate policies, judicial instruments and methods for the valuation of biodiversity that motivate the sustainable use of biological resources. 5) Increase the participation of local and indigenous communities in the management, planning, administration and sustainable use of biodiversity 8) Strengthen the application of the General Environment Law for the promotion of conservation, sustainable use and distribution of the benefits of biodiversity, in accordance with the commitments acquired under the Convention on Biological Diversity. 9) Increase human capital and infrastructure for education and research on biodiversity. 11) Develop mechanisms for cooperation and finance aimed at the conservation and sustainable use of biodiversity, in accordance with national priorities. 12) Contribute to the conservation of global biological diversity. Biodiversity in Panama 3. As the southern-most portion of the Central American bridge between North and South America, Panama is a “biodiversity hotspot”, at the center of the region with the greatest concentration of terrestrial plant species in the world (>5,000 species/10,000km2; Barthlott et al. 1996, Myers et al. 2000). Such high diversity is due to extraordinary regional (beta) diversity, the result of an unusual mosaic of habitat types (D'Arcy 1987, Condit et al. 1996, Condit et al. 2002). Panama has over 13 life zones that host over 9,520 species of flowering plants (Tosí 1971, Correa et al. 2004). It is the northern-most extent for approximately 4,000 South American species, has about 5,000 Central American species, and endemic species account for 12% of its flora. Given that Panama is slightly smaller than South Carolina, this exceptional terrestrial diversity is highly accessible. 4. Panama's unique geographic position makes it a critical area for global conservation planning. Panama’s forests play an important role as migratory corridors between Central and South America (Coates and Obando 1996). Because Panama is only 100 km wide, the corridor is particularly vulnerable; 2 http://www.cbd.int/doc/world/pa/pa-nbsap-01-p1-es.pdf UNDP Environmental Finance Services Page 5 habitat destruction can easily disrupt this important link between the hemispheres (see AP5). As climate fluctuations become more severe, it will be increasingly important for species to migrate in response to global change. Hence, in recognition of the importance of the Panamanian corridor for the persistence of many species, seven Central American countries pledged to help preserve this forested ‘bridge’ and started the Mesoamerican Biological Corridor initiative (The Paseo Pantera Agenda, Illueca 1997). Figure 1. Forest cover in Panama . 5. With its 2,988km of coastline and 66,405km2 of coastal waters, the country has unparalleled access to the flora and fauna of three distinct water bodies: the Caribbean Sea, the Gulf of Chiriquí and the Gulf of Panama. The barrier posed by Panama has caused significant differences in ocean chemistry and climate between the Caribbean and Pacific. The SW-trending trade winds result in high evaporation and greater salinity (about 1 ppm) in the Caribbean than the Pacific. The trade winds cause upwelling of cool, nutrient-rich waters making the Pacific more turbid and slightly cooler, with more abundant nutrients and phytoplankton than the Caribbean (Haug et al. 2001). Within the Panamanian Pacific, there is a marked contrast between Gulf of Chriquí (in the southwest) and the Gulf of Panama (southeast) because a break in the mountains results in unimpeded passage of the trade winds to the Gulf of Panama. In western Panama, the cordillera blocks the flow of the trade winds. The result is colder (below 20 ºC), nutrientladen water in the Gulf of Panama relative to the Gulf of Chiriquí (Glynn and Maté 1997). The differing physical environments of the two oceans, as well as between the Gulfs of Panama and Chiriquí, are thought to be manifest in the high marine biodiversity observed in Panamanian waters. 6. Subtidal limestone platforms, sand and mud plains, diverse reefs, seagrass meadows and mangroves are typical of the Caribbean coastline, which has a minimal tidal flux (<0.5 m). In contrast, the Pacific coast experiences a tidal amplitude of up to 6 m and comprises rocky outcrops with numerous tide pools and diverse algal turfs. The more protected shorelines have extensive sand and mud flats and mangrove forests. Corals are present but rarely develop into elaborate reefs, with the exception of the 1.6 km2 reef of Maria Ensenada, next to Coiba Island in the Gulf of Chiriquí. While coral reefs constitute a comparatively trivial portion of coastal habitats in the eastern, more seasonal Pacific region of Panama (D’Croz and Robertson 1997), 91% of all genera of eastern Pacific reef-building corals occur in Panama (Glynn and Maté 1997). Many of these species are found in the very warm Gulf of Chiriquí. 7. The Panama Bight includes the islands and waters in the east-central Pacific off Ecuador, Colombia, Panama and Costa Rica. This ecoregion, which includes the Gulf of Chiriquí, is one of the most UNDP Environmental Finance Services Page 6 productive areas of the eastern tropical Pacific and one of the world’s most biologically diverse geographical provinces (Glynn and Maté 1997). In this area, where major ocean currents converge, there is a high degree of ecological interconnection, and complex oceanographic characteristics affect the migrations, movements and distribution of many species of regional and global significance (Glynn and Maté 1997, Wellington 1997). Threats 8. Panama is unique in Central America in having 45% of its land, 33,646 km2, still forested. Slightly more than one third of Panama’s land area is protected in the country’s 65 parks and reserves. However, deforestation continues at a rapid rate: 440 km2 per year. At this rate, Panamanian forests will disappear within approximately 80 years (FAO 2005). Several of Panama's ecosystems were recently acknowledged by the World Bank as being of global significance for conservation (Document of the World Bank, 1998). Due to Panama’s extraordinary yet threatened biodiversity, it is considered a “threatened biodiversity hotspot” (Myers et al. 2000). 9. It is estimated that 30% of Caribbean coral reef systems are at high risk from overfishing as well as siltation and pollution from inland and coastal activities. A further 30% are being significantly threatened by human activities (Burke 2001). Notable also are the oil spills along the Caribbean coast of Panama (such as the Galeta spill of 1986: Guzman 1991), which are a chronic source of coral reef deterioration (Ballou et al. 1989). In the last decades, coral reef habitats have additionally been endangered by escalating outbreaks of disease (Cervino et al. 2001) and by coral bleaching events caused by the El NiñoLa Niña effect, such as that affecting the western Pacific coast of Panama in 1997-98 (Goreau et al. 2000). Figure 2. New roads planned through fragile pristine coastal ecosystems to allow the development of international destination coastal resorts. The underlying problem 10. At present, royalties are typically perceived as the only financial mechanism whereby developing nations such as Panama can receive benefits from the exploration and exploitation of their genetic resources for drugs and agrochemicals. Unfortunately, the proportion of the explored genetic resources that actually make it to market and generate royalties, is relatively small. At the same time, spending worldwide on drug discovery research (amounting to tens of billions of dollars per year) is virtually all conducted in developed countries rather than the host countries where the biodiversity occurs naturally. As a result, the benefits that host countries receive from the exploration of their genetic resources are very UNDP Environmental Finance Services Page 7 limited, both in terms of financial income and trickle-down benefits such as training and employment: this in turn limits their motivations and abilities to invest in the conservation of biodiversity. The long term solution 11. The long term solution to this problem, which will be pursued by this project, is the realization of the potential of genetic resources in Panama to generate tangible economic benefits to the country, in the form of business, employment and capacity building opportunities, through the discovery and development of new medicines or agrochemicals, thereby providing a rationale for the preservation of the biological resources that contain the genetic material. This will represent a paradigm shift from the situation described above, to one in which biodiversity-rich nations such as Panama are fully and equitably involved in this lucrative research process. Through collaborations between Panamanian partners and academic and private sector actors abroad, the project will focus on the biodiscovery process, the enhancement of human and institutional capabilities in the country, and the transfer of equipment and expertise from the United States to Panama, in order to establish a state-of-the-art drug discovery program. Barriers 12. The achievement of the solution proposed above has to date been impeded by a number of factors. 13. 1. Limited technical capacities. Although since 1998 the Panama ICBG, with its partners STRI, INDICASAT and the University of Panama, has invested more than $7 million to date in carrying out a large number of explorations and bioassays, the limited levels of technical capacities in Panamanian institutions mean that it is currently not possible to scale these activities up to a level that would constitute a “critical mass” enabling the country fully to own and control exploration and bio-testing processes, and to establish a firm international reputation in this regard. Panama has an excellent resource of undergraduate and graduate scientists with the potential to staff and manage a national biodiversity exploration and testing programme; however, to date an insufficient number of these have been trained in the specific technical skills of relevance to these issues, to be able to make this programme an internationally-recognised success in the long term. Furthermore, to date these scientists have had limited exposure to the international scientific community apart from their contacts with the US-based partners of the Panama ICBG, and have had few opportunities to establish their international reputations by presenting their findings at international meetings or in peer-reviewed academic journals: this also has impeded the establishment to date of the credibility and reputation of Panama as a centre for biodiversity exploration and biotesting. 14. 2. Limited awareness of the existence, use and option values of biodiversity. At present, there are insufficient levels of awareness of the value of biodiversity and its genetic resources among decision- and policy-makers, and the constituents to whom they respond, to ensure political support for assigning the levels of resources that are required for its conservation. This is reflected by the slow pace followed by the legislative branch for the ratification of the Nagoya Protocol. 15. 3. Limited experience with ABS agreements. An agreement has been signed between the STRI and the ANAM of the Government of Panama, regarding the mechanisms and conditions governing the exploration and biotesting of the country’s biodiversity. This agreement is groundbreaking inasmuch as its simplicity promotes collaborative research, while providing equitable sharing of benefits among all the Panama ICBG institutions. The agreement states that STRI can sign agreements with other academic and private sector parties. These agreements state that collaborative research on uses of biodiversity should be facilitated. If discoveries reach the stage of potential commercialization that could lead to milestone or royalty payments, then they are renegotiated with explicit reference to how benefits will be shared. At this stage, both ANAM and the inventors have to agree before further research can take place. By having simple initial agreements that encourage research, Panama receives immediate benefits such as jobs and training, copies of publications, participation in research, and the probability that a commercial discovery UNDP Environmental Finance Services Page 8 may be made is higher. At present, however, it is doubtful whether all key national actors adequately understand the provisions and implications of the agreement, or the complex issues to which it refers, a situation which limits their ability to negotiate future benefit sharing agreements if products are derived from the biodiscovery process. Furthermore, there is room for improvement in the efficiency of the practical mechanisms associated with the agreement, such as the collecting, import and export permits issued by ANAM; this has potential implications for the efficient functioning and therefore profitability and attractiveness of bioexploration and testing initiatives. Finally, while the legal framework of ABS agreements between ANAM, STRI and private and academic partners is established and functioning well, mechanisms are yet to be developed and tested for the complementary, more specific agreements that will be required if new partners are added or if evidence of the commercial potential of products makes it necessary to clarify the details of benefit streams returning to Panama. Stakeholder analysis 16. The Smithsonian Tropical Research Institute, INDICASAT and the University of Panama are the research institutions in Panama involved in the nature-based product discovery investigations. These three institutions form the nexus of the program and are responsible for collection of microorganisms, bioassays and purification and structure elucidation of active compounds. 17. Foreign academic collaborators at the University of California, Oregon University, Utah State University and University of Connecticut are involved in natural products research. Some of these collaborators have carried out postdoctoral research in the Panamanian laboratories and now have their own faculty appointments in the US. All say that their experience in Panama was instrumental in helping them obtain faculty positions. All have maintained their links with Panama, returning for research and hosting Panamanian students and scientists in their US labs. A senior collaborator at the University of Arizona is a leading expert in the identification and taxonomy of endophytic fungi. 18. ANAM is the branch of the Panamanian government in charge of authorizing accesss to the country’s genetic resources and facilitating the negotiation of benefit sharing agreements. In addition, ANAM is in charge of 65 protected areas that include more than 15 marine or coastal areas. 19. The project will also engage the private sector. The Panama ICBG has two private sector collaborators who assist in bringing leads to the market, Dow AgroSciences and Eisai Research Institute. The Panama ICBG provides crude extracts and purified compounds for testing in their bioassays. In addition to the extensive resources involved in running these bioassays, they have provided supplies and technical know-how to Panama, and hosted Panamanian visitors to their labs. In Panama, the ICBG has worked with Centauri Technologies Corporation, a company specializing in information technology, and proposes to expand its collaboration with Centauri using GEF funding. Baseline analysis 20. The Panama International Cooperative Biodiversity Group (ICBG) has been operating in Panama since 1998 with the goals of natural products drug discovery from this rich biota, especially in the areas of antiparasitic and anticancer drug discovery as well as the finding of new agrochemicals. These therapeutic and agrochemical goals are of high relevance to the people of Panama and their needs. Moreover, these efforts are largely conducted in Panama, helping to develop scientific training and infrastructure, and leading to a generally enhanced valuation of biological diversity. As such, the Panama ICBG is a model of how to conduct such efforts, which simultaneously meet the goals and needs of both developed and developing countries. From progress made over the past 13 years by the Panama ICBG program, a fledgling scientific community has been created in Panama which integrates drug discovery from natural sources with ecosystem preservation and conservation activities. By conducting a majority of the research in country, there is growing recognition and appreciation by the government and populace of Panama of the value of biodiversity preservation and scientific capacity building. Beyond the specific accomplishments of this program in Panama, the experiences and practices developed within this model UNDP Environmental Finance Services Page 9 can be applied on a global level and guide parallel efforts in other biodiversity-rich but economicallydisadvantaged countries. 21. The project has been funded by the Fogarty International Center since 1998. The Fogarty is part of the US National Institutes of Health (NIH) and is dedicated to research and training for global health. During and prior to NIH funding, the Panama ICBG established productive collaborations and signed critical ABS agreements with the Panamanian government and the participating academic and private sector collaborators. The combined funding from the partners that can be used for co-financing of the GEF award is over $3 million. Thus substantial investments and extensive efforts have put this project in the unique and promising position of providing benefits for human health and economic benefits to Panama while protecting valuable biodiversity. II. STRATEGY Project rationale 22. Panama’s protected areas contain high levels of globally important biological and genetic diversity, the conservation of which depends on the assignment of adequate levels of financial resources and political support to PA management. In addition to its global existence value, these genetic resources have major option and use value as the source of nature-based products with the potential to contribute significantly to disease control and food supply worldwide. The Government of Panama and the Panama ICBG (a group of academic and private sector institutions from both Panama and the Unites States) have established a solid basis of experience and understanding for the exploration, testing and use of this biodiversity, based on the principles of equity enshrined in the Convention on Biological Diversity. The incremental support to be provided under the present project will create the additional levels of capacities and awareness that are required to scale up and consolidate this situation, allowing Panama to enjoy full control and ownership of these processes, which will in turn come to generate benefits for the country (in terms of investment and employment) that will motivate increased levels of investment in the protection of PAs and the biodiversity that they contain. Policy conformity 23. The project is fully in alignment with Article 5 of the Nagoya Protocol, which stipulates (in accordance with Article 15, paragraphs 3 and 7 of the CBD) that “benefits arising from the utilization of genetic resources as well as subsequent applications and commercialization shall be shared in a fair and equitable way with the Party providing such resources that is the country of origin of such resources…Such sharing shall be upon mutually agreed terms”, Article 6 which stipulates that “in the exercise of sovereign rights over natural resources, and subject to domestic access and benefit-sharing legislation or regulatory requirements, access to genetic resources for their utilization shall be subject to the prior informed consent of the Party providing such resources that is the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the Convention, unless otherwise determined by that Party” and Article 9, which stipulates that “The Parties shall encourage users and providers to direct benefits arising from the utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components”. Country ownership: country eligibility and country drivenness 24. Panama signed the Convention on Biological Diversity on 13th June 1992 and ratified it on 17th January 1995, and signed the Nagoya Protocol on 3rd May 2011. 25. Panama has a policy which facilitates access to genetic resources and distribution of the resulting benefits (Decree 25 of 29th Abril 2009) and is taking initiatives to discover genetic resources through the Panama ICBG. This proposal is consistent with Objective 5 of the National Biodiversity Policy of 2008, UNDP Environmental Finance Services Page 10 which proposes, within the context of national competitiveness, to develop new alternatives that contribute to promoting research into biodiversity, production systems, bioprospecting, biosecurity and access to genetic resources, thereby contributing to the creation of highly efficient and effective businesses in relation to the conservation and sustainable use of biological resources. Design principles and strategic considerations 26. The Panama ICBG Program has an overall focus on nature-based product discovery from the country’s diverse microbial life forms, both free-living such as marine cyanobacteria as well as those associated or symbiotic with macroscopic life forms, such as endophytic fungi. However, the Panama ICBG puts equal emphasis on biodiversity inventories and conservation, and believes there is a natural synergism between these pursuits. Its overarching rationale in this regard is that by attaching tangible value to biodiverse habitats, such as through the discovery and development of new medicines or agrochemicals from their inhabiting flora, fauna and microorganisms, it is providing one of the strongest rationales for their preservation and conservation; at the same time, it is generating global use benefits in terms of the availability of drugs and other chemicals (e.g., fungicides and pesticides) of utility in fields such as medicine and agriculture. 27. The systematic evaluation of natural products from diverse life forms to discover new drug leads has led to many of the most important pharmaceutical agents. For example, it has been estimated that 37% of total pharmaceutical sales, and 45% of today’s bestselling drugs, are from natural products and natural products-derived molecules (Frormann and Jas 2002). Another analysis reported that 8 of the top 25 top selling drugs worldwide derive from microorganisms (Chicarelli-Robinson et al. 1997). Approximately 60% of the agents in clinical trial for the treatment of cancer owe their origin to natural products (Cragg and Newman, 2000). These include many compounds from natural sources with potentially useful but imperfect medicinal properties which have become the ‘chemical idea’ around which synthetic analogs have been generated to create an effective pharmaceutical. From a very recent analysis by Newman and Cragg (2007), 47% of the anticancer agents are natural products, or are derived or inspired by natural products. Further, of 974 new small molecule chemical entities brought into the clinic between 1981 and 2006 in all therapeutic areas, 58 (6%) are unmodified natural products, 273 (28%) are modified natural products, and 282 (29%) are synthetic analogs. These last have a natural products “ancestry” and were patterned after features of the natural products. The remaining 360 (37%) are completely synthetic in origin. Hence, natural products have played a critical role in the development of 614 (63%) of the agents in use today. 28. A number of marine organisms contain secondary metabolites, used by the organisms as toxic defences that can be therapeutically useful for humans. The field of marine natural products is currently poised to make a major contribution to the arsenal of anticancer agents with 20 such substances in (or recently in) various phases of clinical trial. 29. In agriculture, natural products play important roles in the protection of crops against fungi, insects and other pests (Clardy and Walsh, 2004, Copping and Duke 2007). The fact that many modern pesticides pose serious risks to non-target animals and humans has led to considerable commercial interest in lowtoxicity forms of crop protection. Recent low-toxicity products with sales up to one billion dollars include strobilurin fungicides abamectin and spinosad. 30. At first glance, the original biological sources of these agents appear dispersed among microorganisms, especially the eubacteria, and macroorganisms, in particular the sponges and ascidians. However, it is becoming increasingly apparent that many of the organic molecules ascribed to “sponge” or “ascidian” metabolism is actually due to the metabolic activities of bacteria that live in association with these sessile invertebrates (Dunlap et al., 2007). While such speculations have been abundant in the literature for many years, largely based on structural relationships between the compounds isolated from sponges and those isolable from free living bacteria, especially the cyanobacteria, it has been remarkably difficult to obtain experimental proof of this phenomenon. In part the difficulty has resulted from the near UNDP Environmental Finance Services Page 11 absolute failure to culture the microorganisms found in symbiosis with invertebrates separately from their hosts, and thus, the chemical and biochemical relationships between hosts and symbionts remain vague and uncertain. Some partial success has been obtained through isolation of bacterial and eukaryotic host cells by cell separation techniques followed by chemical profiling of the resultant cell types (Unson & Faulkner, 1993). This approach, however, suffers the criticism that compounds could be excreted from one cell type and absorbed by another, resulting in misleading or conflicting results. Recently, the Panama ICBG used a powerful genetic basis, CARD-FISH analysis to a gene encoding a biosynthetic enzyme, to demonstrate unequivocally that a cyanobacterial symbiont, Oscillatoria spongeliae, is the site of biosynthesis of a series of unique chlorinated peptides that had previously been isolated from the host sponge Dysidea herbaceae. (Flatt et al., 2005). If one makes reasonable speculations based on distinctive chemical motifs in sponge and ascidian natural products and their relationship to microbial metabolites, then a majority of the marine anticancer agents in clinical trial today (or recently in trial) may derive from marine microorganisms. 31. There is much debate on how many species exist on the planet, largely because of uncertainty over the true extent of the microbial world; however, estimates as high as 30 million have been reported (Waterman 1998). Nevertheless, when one considers that for most species, and especially for microbes, each consists of multiple strains with their own unique metabolic profiles, the numbers of organisms to be examined for useful natural products is enormous. There is growing recognition that microorganisms have ‘core genomes’ which may accord to a species concept, but that each strain of a given ‘core genome’ can have significant genetic materials coding for distinctive adaptive and secondary metabolite features. In a few microorganisms wherein there has been significant and detailed annotation of the secondary metabolome as deduced by bioinformatics, as much as 10-15% of the genome is allocated to encoding the biosynthesis of natural products. Panama is a hotspot for terrestrial plants and the Indo-Pacific Regions and Caribbean-Pacific Juncture are two of the most highly biodiverse regions for marine organisms on the planet. Inherent to high biodiversity is high inter-species interaction. Competition among co-habitating species for limiting resources (e.g. space, nutrients - Reigosa et al. 1999, Gross 1999) and defence against predators and pathogens has been proposed as a key factor for why the percentage of species containing bioactive natural products is so high in biodiversity-rich areas, such as the tropics (Coley and Aide 1991, Coley and Barone 1996). As argued by Cragg and Newman (2002), in response to arguments put forth by Tulp and Bohlin (2002), chemical diversity is encountered as a function of biodiversity. Implicitly, the Panama and Indo-Pacific regions possess the greatest percentage and number of species which elaborate bioactive natural products. 32. Panama’s rich terrestrial and marine biota are unique in the world for their easy access. For example, within a 2 hour drive of Panama City, it is possible to sample sites from sea level to 1100 m, and lowland forests from “dry-deciduous” through “very wet-evergreen”. Similarly, it is possible to drive from the STRI headquarters to the Pacific and Caribbean coasts for a SCUBA diving day-trip to make marine cyanobacterial collections. More distant sites in the province of Bocas del Toro near Costa Rica and in the Darién province near Colombia can be reached by inexpensive daily flights of approximately one hour. Thus, the extraordinary accessibility of a diversity of intact forests make it possible to collect readily across large gradients in rainfall and altitude and across biomes with primarily Central or South American influences. The combination of extraordinarily high marine and terrestrial biodiversity over a small area, STRI field stations throughout the country, and accessibility, makes Panama an outstanding site for natural product drug discovery efforts. Collection site: Coiba National Park 33. This GEF funded project will facilitate collections in the Coiba National Park, a marine park located off the south coast of the country. The project will use a collection strategy that combines ecological and taxonomic information to maximize diversity and activity of endofungal collections. Building on past success of using basic ecological research to inform collections of terrestrial plants (Coley et al 2003, Kursar et al 2008), the project will include information on endophyte ecology. For example, it is UNDP Environmental Finance Services Page 12 predicted that endophytes inhabiting grasses, long-lived mature leaves and live and dead wood may yield particularly active compounds. In addition, endophytes with slow growth and ones that show activity in a pre-screen with an oomycete have greater bioactivity. Because many of the promising leads for medicine and agriculture are often not from the most abundant classes of endophytes, the project will use selective media, DNA sequencing and state of the art techniques for fungal identification to focus on poorly studied lineages and lineages with known activity. Finally, because so much of endophyte diversity is unexplored, the project will maximize sampling of taxonomic classes and life history traits of endophytes by collecting from a diversity of terrestrial plants and macroalgae. 34. Cyanobacteria proliferate in the shallow subtidal zone, often in protected bays where shallow reefs accommodate a diversity of microalgal species, and cyanobacteria are the primary nitrogen fixers. Alternatively, mangrove forests and sea grass communities provide sheltered habitats for cyanobacteria in locations with high light intensity and temperature as well as low wave action. These locations also provide refuge for fishes and marine invertebrates, and yet cyanobacterial species are conspicuously untouched by the myriad predators. Similarly, freshwater aquatic environments in Coiba National Park nurture many molluscs, crustacea and fishes which prey on microalgae, yet do not conspicuously feed on the many cyanobacteria of these habitats. Therefore, cyanobacterial species found in physical abundance will be collected preferentially on the premise that they rely on chemical rather than physical defenses (Hay 1996; Nagle & Paul, 1999). 35. Microbial communities in the open ocean reach densities up to 105 bacteria/ml; however, marine sediments and marine invertebrates contain densities up to 109 bacteria/ml. In these nutrient-limited environments competition for energy forms the basis for all species-species interactions. It is hypothesized that the capacity to produce bioactive metabolites provides producing organisms with a strong competitive advantage. Indeed, terrestrial microbial natural products chemistry has already proved unequivocally that 'chemical warfare' plays a central role in defining microbial community structure (Czárán et al, 2002). The project will therefore exploit this diversity by probing the microbiome of marine sediment and marine invertebrates. Project objective, outcomes and outputs/activities Objective: The discovery of nature-based products for the pharmaceutical and agrochemical industries and benefit sharing to promote the sustainable use of genetic resources in the Protected Areas System of Panama Component 1: Discovering active compounds for pharmaceutical and agrochemical uses from terrestrial and marine organisms in protected areas and improvement of the capacities of ANAM for their monitoring. 36. In order to develop the international credibility of Panama’s drug discovery program and to maximize awareness at national level of the significance and potential of the country’s biodiversity and the importance of conserving it, it is necessary to demonstrate the ability to purify and characterize compounds that are highly active in agrochemical and pharmaceutical bioassays. Activities under this component will focus on demonstrating the existence of these capacities, by supporting Panamanian institutions in carrying out drug discovery. This will involve three institutions in Panama (INDICASAT, STRI and the University of Panama) as well as academic and private sector partners. The drug discovery efforts of the Panama ICBG will continue to be focused on the unique endophytic fungi of tropical plants, freshwater and marine cyanobacteria, and marine bacteria associated with corals and sponges. Output 1.1 Over 2,500 extracts tested in cancer, tropical disease and agrochemical bioassays by the Panama ICBG partners. 37. Despite the enormous public health consequences of many tropical diseases, research has lagged, and many treatments were discovered over 50 years ago. Thus there is an enormous need for safer and more effective treatments. In Panama, GEF resources will be used to run bioassays for activity against bacterial infections (to find new antibiotics) and cancer as well as malaria, leishmaniasis and Chagas. UNDP Environmental Finance Services Page 13 GEF resources will be used to send samples to private sector partners: Eisai screens for anti-cancer activity and will help pursue promising leads, while Dow Agrosciences is screening extracts for agricultural pests. 38. Microbial collections will be made by the Panama ICBG team in terrestrial and marine protected areas throughout Panama. If the microbes are associated with hosts, such as plants or marine invertebrates, these hosts will be identified and vouchers stored. Microbes will be cultured by the Panama ICBG to obtain sufficient mass to make extracts that can be tested in the above-mentioned bioassays. If extracts show significant activity, they will be re-cultured in larger quantities to allow bioassay-guided fractionation, purification and structure elucidation of the active compound. It is expected that it will be possible to purify 50 active compounds. These will be evaluated and the best candidates for next stage leads will be identified. Criteria for identifying active compounds qualifying as next stage leads This decision will be based upon the criteria of selectivity, therapeutic window, properties associated with medicines (solubility, oral availability and others) and the novelty of the compound. Selectivity is measured by bioassay and refers to the ability of the compound to affect one or a few diseases in a dose that is low compared to the (higher) dose that is required to affect other kinds of cells. High selectivity is desirable. This criterion eliminates compounds that are broadly toxic. Therapeutic window or therapeutic index also is measured by bioassay. This is a quantitative measure of a drug’s selectivity for a disease target relative to normal cells as well as a measure of the safety factor for application of the drug. Compounds with a high therapeutic index are toxic to a disease but not to normal human cells. A high therapeutic index is desirable. The chemical properties that make the best medicines are those that can be taken orally (as opposed to intravenous injection) and that are stable at room temperature. Compounds that can be taken orally must be intermediate in their chemical polarity such that they are both soluble in water and able to cross biological membranes and must not have an excessively high molecular weight. Lastly novel structures provide a greater opportunity for the protection of intellectual property; this will be more important for anti-cancer leads and less important for neglected diseases such as Chagas’ disease and Leishmania. All of the active compounds will be evaluated using these criteria and the best candidates qualifying as next stage leads. Further work on the next stage leads will depend upon the availability of additional resources. Output 1.2 Fifty active compounds purified and their structures elucidated in facilities of private sector partners. 39. If extracts show significant activity, they will be re-cultured in larger quantities to allow bioassayguided fractionation, purification and structure elucidation of the active compound. It is expected that it will be possible to purify 50 active compounds. Output 1.3 Adjusted ABS agreements as a result of the biodiscovery process include royalty rates and milestone payments if the research process indicates that specific products will be developed 40. The legal framework of ABS agreements between ANAM, STRI and private and academic partners is established and functioning well. They typically follow a format worked out over years of discussion among the stakeholders, thus new agreements are easily understood by all parties. Should new partners be added, additional agreements will be drafted, following this simple and straightforward strategy. Additionally, the agreements all state that should there be commercial potential, then the bioprospecting initiative will negotiate a new agreement with ANAM specifying the details of the benefit stream returning to Panama. At the point when commercial potential becomes evident, all parties will have a clearer idea of the market potential of the discovery and negotiations can be specific. Panama will have the option of terminating the research or going forward with a new ABS agreement. UNDP Environmental Finance Services Page 14 Component 2: Transfer of technology and practices to facilitate the discovery of active compounds and the sustainable use of biodiversity 41. A major goal of GEF funding will be to enhance the capacity within Panama to conduct drug discovery research. GEF resources will be used to improve the infrastructure for finding active compounds from Panama’s biological diversity, using state of the art techniques for collection, bioassays and natural products’ chemistry. In addition to contributing to improving human health and agriculture, this will position Panama to take advantage of its remarkable biological diversity. The project will increase Panama’s international standing as a centre for the discovery of drugs from natural products through technology transfer and the training of young scientists. Output 2.1 Capacities for state of the art analytical chemical techniques for characterizing active compounds installed in Panamanian organizations. 42. Training of young Panamanian scientists as natural products chemists is a goal of the GEF-funded project and will occur at INDICASAT, the University of Panama and STRI. As part of their biodiscovery missions, these institutions have acquired sophisticated equipment, such as a Nuclear Magnetic Resonance (NMR) Spectrometer, several High Performance Liquid Chromatographs (HPLC) and two Liquid Chromatography-Mass Spectrometer (LC-MS) systems. The project will develop synergisms among the institutions to build a maximally effective team effort and to train additional young Panamanian scientists on the use of these powerful analytical instruments. The opportunity to do first class research with modern equipment has proved to be pivotal in making students competitive for funding and access to international graduate programs. This will continue to be a major emphasis. 43. A multi-institutional committee of scientists will be formed to oversee operational features of the NMR and LC-MS systems, and this will improve operation, repair and scheduling, in conjunction with training workshops. Training and instrument maintenance will improve the overall capacity for scientific research in Panama. Output 2.2 Updated methods for disease bioassays used for the identification of active compounds. 44. To screen effectively for tropical diseases, bioassays must be enhanced and new assays developed. Previously the Panama ICBG developed bioassays that did not use radioactive reagents and thus were feasible in developing nations. These techniques have since been transferred to countries in the North and South. The Panama ICBG continues to improve these bioassays, using different life stages of the parasites and different culturing conditions. At INDICASAT, the Panama ICBG will screen for malaria, leishmaniasis and Chagas disease, three diseases that are found in Panama and have been long-standing public health issues. The project will complement these with new mechanism-based bioassay methods, such as screens for inhibitors of proteases specific to parasites. These new bioassay methods should increase the throughput of extracts tested, and also provide insight into the mechanisms of action of the extracts, providing helpful information for prioritizing leads. 45. Bioassays are run by young technicians at the Panamanian institutions and provide invaluable training in science and technology. This opportunity will open the door for many young members of the project team allowing them to obtain graduate training abroad. 46. To enhance bioassay technology in Panama, it is anticipated that Panamanian scientists will visit appropriate laboratories abroad, including those of the private sector partners of the Panama ICBG, to learn new techniques that can be applied in their own laboratories in Panama. In addition, foreign experts will visit Panama to train technicians, run workshops, and consult with the Panama ICBG scientists. Output 2.3 Data handling system among Panamanian institutions harmonizes the transfer of information on samples collected and scientific results between national and international institutions. UNDP Environmental Finance Services Page 15 47. The Panama ICBG will also continue to improve its current database, which is web accessible to all scientists in the Panama ICBG and is used for sharing information on all microbes collected, including collection sites, DNA sequencing, bioassay activities and purified compounds. Output 2.4 Methodology and capacities for collection, culture and long-term storage of microbes developed for Panamanian institutions 48. The microbial collections made by the Panama ICBG are unique in the world, given the high levels of biodiversity in the marine environment of Panama, high levels of endemism, and their inclusion of endophytic fungi from terrestrial plants (an extremely diverse but poorly known group). The collection and preservation of these biota in Panama will be enhanced by GEF funds. 49. The quality of this collection will be maximized through emphasis on proper maintenance and curation. 8000 microbes will be stored permanently in liquid nitrogen cryostorage: this allows microbes to be regrown when necessary for bioassays, purification of active compounds and DNA sequencing. Duplicate samples will be stored in microbial banks at both INDICASAT and STRI to assure permanence and safety of the collection. A web-based catalog of these materials will be created in conjunction with the other Panama ICBG efforts involved in collections. Training and long term capacity building will be a secondary benefit of these activities. 50. To make these collections in an effective and safe manner requires specialized gear, equipment and personnel training. GEF funds will enable an expansion of this part of the program so that samples from additional locations in Panama can be obtained. This will involve the training of Panamanian undergraduate students and scientists in the techniques of marine and terrestrial collections and their ensuing maintenance as preserved specimens, extracts, and living cultures. Access to an increased biodiversity through these collections will enhance the Panama ICBG program as well as having long term value for the country of Panama. 51. The Panama ICBG currently has facilities for growing bacteria and fungi, but not for cyanobacteria, one of the most highly active groups of organisms. As large collections from nature are not always possible, it is necessary to rely on culturing. GEF funds will be used to establish a culturing facility for cyanobacteria in a Panamanian organization. 52. The establishment of a bank of microorganisms is a national need that has been identified by UNARGEN. In addition, this facility will facilitate compliance with Decree 43, Law 24 of 1995 on Wildlife in Panama and Decree 25 of 2008 on ABS, which require duplicates of samples collected to be deposited in the relevant reference collection. Output 2.5 Database on biodiversity and natural products installed in ANAM. 53. A sophisticated, relational database will secure and enhance the flow of information among multiple participants. This will store and permit full retrieval of information on collections of biodiversity, the activity of samples in bioassays and chemical analyses. A database will be created in collaboration with the Panamanian company Centauri. Such a database will have utility for ANAM as well as the Panama ICBG participants. Non-confidential collection, bioassay and chemical data will be available to ANAM and others. Young scientists will be trained in the design and use of the database. We envision that this will be a “legacy” database, improving the capacity for bioprospecting within Panama, allowing ‘data mining’ and having applications long after the data were initially collected and stored. Component 3: Benefits shared with national parks and the Panamanian population 54. The positive impacts of the project on the conservation status of Panama’s biodiversity depend largely on Government decision-makers and the public as a whole being aware of the magnitude of the country’s biodiversity and its potential to generate diverse and sustainable benefits for the country. The project will approach this on two levels: on one level it will contribute to converting the Coiba National UNDP Environmental Finance Services Page 16 Park into a nationally- and internationally-important resource for biodiversity exploration, biodiversity education and biodiversity-related tourism, and on another it will invest in awareness-raising and education on biodiversity nationwide. Output 3.1 Enhanced trail system within Coiba National Park for use by scientists and tourists. 55. The Project proposes to carry out and promote scientific research in the Coiba National Park. At present there is no information about trails in the Park, which makes a visit to the area and research very difficult. Additionally, there is almost no infrastructure and this highly limits research in the region. Therefore, the project will map and mark main at least 2 marine and/or terrestrial trails. Output 3.2 INDICASAT scientific station strengthened in Coiba to facilitate scientific research 56. INDICASAT has recently been authorized to construct a scientific research station in Coiba. The project will provide funds for the equipment of this station, in order to create conditions that allow national and international scientists to carry out bioprospecting work. This will be directly linked to the improvement of the marine trail system, which will be used by both scientists and tourists. Output 3.3 Biological inventory based on the collections carried out by Panama ICBG 57. In the course of the biodiversity explorations to be carried out by the Panama ICBG in Coiba National Park, duplicates of both flora and fauna will be collected and used as the basis for an inventory of the park’s biodiversity. Plant samples will be deposited in herbaria in Panama, and when available, duplicates will be sent to internationally recognized herbaria in the US and Europe. Microbial samples will be stored in the GEF funded microbial bank (output 2.4). Output 3.4 Public media campaign on the protection and uses of biodiversity and its genetic resources in Coiba. 58. This campaign will include information on the uses and protection of the biodiversity of Coiba, and will be conducted principally through the written media, radio and pamphlets. These materials will be developed by ANAM in consultation with other relevant actors. The effectiveness of this campaign will be measured through surveys of the attitudes and behaviour of visitors to Coiba at different moments in the life of the project, and the focus of the campaign and content of the materials will be adjusted accordingly, as necessary. Output 3.5 Outreach presentations and activities explain the uses of biodiversity and its genetic resources 59. The project will establish and implement an outreach program will provide talks for students of primary and secondary schools, tourist guides, business groups, and local communities, on the concept of bioprospecting, the importance of biodiversity and the potential that its sustainable use has to generate benefits for the country. As such these talks also will develop capacity of non-scientists, including those in local communities, to develop additional biodiscovery and conservation activities. Output 3.6 24 Panamanian scientists trained on biodiscovery techniques in national and international laboratories 60. The training of young Panamanian scientists will be one of the non-monetary benefits of the project with most significance in the long term, as it will help to establish the solid human resource basis that the country’s bioprospecting-related industries will require in order to grow and consolidate its international prestige. The project will directly support the training of young Panamanian scientists in biodiscovery techniques in Panamanian institutions as well as foreign laboratories. One measure of the growth in scientific capacity in the country will be the publication of scientific papers co-authored by Panamanians, reporting on this research, in internationally recognized journals: publishing in international journals is the benchmark for modern science and is essential for recognition as a serious drug discovery program; it also increases chances of attracting additional funding from national and international agencies. UNDP Environmental Finance Services Page 17 Component 4: Increase in national capacities on ABS Output 4.1 Increased knowledge in Panamanian legislature of the potential benefits for the country of prompt ratification of the Nagoya Protocol 61. Panama has yet to ratify the Nagoya Protocol, which is a key step for it to become a member of the instrument and to commit to the provisions which it makes in relation to ABS. To this end, the project will support the realization of two workshops and other meetings intended to inform members of parliament, the Minister of External Relations, the Minister of Economy and Finance, the Ministry of Commerce and Industry, and the aquatic resources authority and other relevant actors, of the potential benefits (monetary and non-monetary) which ratification of the Protocol could bring to the country. Output 4.2 Mechanisms and methodologies for ABS updated and in place clarifying rules and procedures for ANAM and genetic resource users 62. ANAM has developed application forms for scientific research permits, for use by anyone potentially utilizing genetic resources and their derivates for commercial or research purposes. These have been used in a relatively effective manner to date, however they lack several types of information which both ANAM and users need to be able to facilitate the processes of access and benefit distribution. For this reason, it is proposed to develop two procedural manuals. The first, for ANAM, will set out clearly the route taken by applications from the moment that they are presented until they are approved. The users’ manual will include not only an updated application form but also a list of the requirements for the application, an explanation of how to complete the application, the establishment of a system for tracking the chain of custody for samples and derivates, through bar codes or other relevant mechanisms, examples of framework agreements for benefit distribution, example of agreements for the transfer of materials and examples of commitment letters that provide for the delivery of a report at the end of the collection, research reports and other relevant aspects. 63. Article 17 of Executive Decree 25 provides for charges to be set for applications for access to genetic resources with the aim of covering costs and promoting orderly access to the resources, taking into account access with commercial, industrial and non-commercial ends, and in function of the quantity, endemism or rarity of the species to be affected by the research. Additionally, Article 33 of the same Executive Decree states that the charges for the provision or movement of genetic resources be set by administrative resolution of the ANAM, according to the category of conservation, and will be reviewed every two years or at the request of the Technical Advisory Group. This output will contribute to the development of a methodology and proposal for charges, with the aim of executing the above provisions of this decree. 64. Based on the experienced derived under the above output and other international bioprospecting initiatives, a proposal of norms for the monitoring of bioprospecting projects will be developed, including those with commercial aims as well as basic research initiatives of utility to UNARGEN. These norms will be of utility for the identification and monitoring of bioprospecting projects aimed at identifying products for the pharmaceutical, agricultural, food, agrochemical, textile, manufacturing and other related industries, which use genetic resources or their derivates for the development of products or commercial processes. The norms will take into account the different stages involved in the chain of custody of samples and the derivates of the research process, and the utilization of these derivates for commercial or research ends. Output 4.3 5 staff members of ANAM trained in different stages of bioprospecting processes and in negotiation of ABS agreements 65. The Unit for Access to Genetic Resources (UNARGEN) of ANAM is a pioneer in relation to the regulation of genetic resources and the distribution of the benefits gained from these; however it still requires additional experience with how to manage the different stages involved in the execution of a UNDP Environmental Finance Services Page 18 bioprospecting project. The Panama ICBG and ANAM will jointly define a plan of work under which at least three ANAM staff members will receive training on the phases related to the process of collecting field samples (including the need of new collections in the case that promising compounds are discovered), the realization of bioassays, the identification of active compounds as well as other relevant stages, in order to enable them to understand the complexity of the scientific research process. This training will include details related to the type of technology used at each step, and the chain of custody for the management of samples and products derived from the research process, which may involve both Panamanian and foreign institutions. 66. This output will contribute to the capacity of UNARGEN for the negotiation of agreements on the distribution of the benefits derived from the utilization of genetic resources. To this end, the project will support at least two staff members of ANAM in a training process which will involve a course and participation in a relevant international event developed by an organization with expertise in this subject. This course will be held in Panama and as a result will also benefit other relevant Panamanian actors in addition to the two ANAM staff members in question. Key indicators, risks and assumptions Risk Level Mitigation measures Uncertainty of being able to recollect organisms if greater quantities are required for pursuing active compounds. If a microbe provides levels of activity against disease targets, recollections may be necessary to confirm activity and pursue purification of the active compounds. Because of natural fluctuations in microbial populations, habitat destruction and climate change, microbes may ‘disappear’ from a site. Medium Researchers will continue to check sites across seasons, or to explore nearby sites in PAs. To date, there has been a high level of success in obtaining additional collections from the wild. In order to mitigate the risk of this not being possible, the project will establish a culturing facility so that once collected from the wild, cultures can be maintained in the laboratory, and sufficient quantities can be grown for follow-up analyses. Uncertainty of governmental changes in policies. In the 13 years that the Panama ICBG has been active in Panama, there have been a number of changes in the President, which is accompanied by changes to personnel in institutions directly involved with protected areas, permits and bioexploration. Most of the major changes to the law and its implementation regarding ABS have been installed, which will reduce the vulnerability of the project’s activities to political changes. Low Unforeseen changes in the levels and attractiveness of threats to biodiversity, reducing the effectiveness of ABS as a strategy for motivating conservation. Medium The project will raise awareness among decisionmakers of the full range and magnitude of the benefits that can be generated from the conservation and sustainable use of biodiversity, compared to alternative activities that imply its destruction, resulting in them allocating sufficient resources to PAs to enable them to be protected effectively against changing levels of threats. UNDP Environmental Finance Services To address these uncertainties, the project executors we will continue to communicate closely with ANAM and UNARGEN (the agencies in charge of protected areas and genetic resources) in order to maintain an excellent working relationship. Component 3 of the project will specifically contribute to awareness among decision makers (especially in Government) regarding the value of biodiversity and the importance of its conservation, and Component 4 will ensure that they are fully aware of and involved in the formal agreements on ABS. Page 19 Financial modality 67. The project will be jointly funded by the Government of Panama, the private sector (Panamanian and US-based bioprospecting and bioassay companies) and Panamanian and US academic institutions. The grant from the GEF Trust Fund will complement these investments in order to ensure the development of institutional capacities, an enabling framework of policies, agreements and administrative instruments and public awareness that will enable genetic resource-based businesses in Panama to be financially fully selfsustaining in the long term. Cost-effectiveness 68. The core aspect of the project’s cost-effectiveness strategy is its focus on promoting public/private sector partnerships, in the context of which the discovery process of nature-based products is considered as a viable business and therefore subject to private sector investment once GEF funds have been used to jump start the country’s to date limited biodiversity-based industry. 69. Alternative strategies considered but discarded on grounds of cost-effectiveness were as follows: 1) Emphasis on a “command and control” approach to biodiversity conservation. In the absence of the kinds of evidence of the full range of benefits than can potentially be generated from genetic resources, which the chosen approach will provide, continued efforts will be required to maintain political support for the ongoing funding of biodiversity and PA conservation; furthermore, conservation initiatives will lack public support at national and local level and will therefore require disproportionately high levels of funding in order to be effective. 2) Exclusive public sector involvement. The public sector has vital roles to play in terms of regulation and oversight, in order to ensure that bioprospecting and ABS agreements serve the country’s best interests. It does not, however, have the mission or the levels of installed technical facilities and marketing capacities that are required to realize the full potential benefits from access to genetic resources, in a cost-effective manner. Sustainability 70. Environmental sustainability will be ensured by the fact that the techniques to be used for collecting will have negligible impacts on the biodiversity itself and will be carried out in strict accordance with the stipulations of the permits issued by the ANAM. Furthermore, it is assumed, as a central tenet of the project, that the benefits to be generated from the collection and testing of biodiversity will have positive, albeit indirect, implications for the status of biodiversity by acting as motivations for increased governmental investment in its conservation. 71. Financial sustainability; the project will create capacities in Panama for the establishment of highly lucrative businesses based on the sustainable utilization of its genetic resources, the income from which will be many times larger than the relatively small initial investment proposed under this project. 72. Institutional sustainability: the project will be closely integrated with national institutions from the Government, academia and the private sector, who have been fully involved in the development of the initiative and whose roles are well defined and clearly set out in the formalised agreements governing ABS in the country. These will be regularly updated with support from the project in order to ensure their relevance; furthermore, under Component 1 the project will generate lasting capacities in ANAM to propose and negotiate any further modifications in these agreements the need for which may arise after the project has ended. 73. Social sustainability: the biodiscovery activities proposed within the framework of the project will be carried out in full compliance with the existing agreement and legislation in Panama regarding the equitable distribution of the resulting benefits, which will contribute to the generation of positive socioeconomic impacts for the country. The project will also support the development of capacities in the UNDP Environmental Finance Services Page 20 Government of Panama for the updating of ABS agreements as necessary, in order to ensure their continued relevance. Replicability 74. The ABS model which will be supported by this project, featuring host country empowerment, the generation of concrete and immediate benefits in the form of employment and investment (instead of a reliance on uncertain benefits through royalties) and public/private/academic sector partnerships that combine effective oversight with business efficiency and scientific credibility, has the potential to be replicated in numerous other biodiversity-rich developing countries. The model may need to be further developed and refined in locations where, unlike the Coiba National Park, there are local communities who own, use and/or depend on the genetic resources that are proposed to be subject to exploration and development. UNDP Environmental Finance Services Page 21 III. PROJECT RESULTS FRAMEWORK: This project will contribute to achieving the following Country Programme Outcome as defined in CPAP or CPD: To elevate to the level of State policy the protection of the environment to strengthen economic growth, tourism development and wellbeing in general Country Programme Outcome Indicators: % of watersheds with management plans in operation Primary applicable Key Environment and Sustainable Development Key Result Area (same as that on the cover page, circle one): 1. Mainstreaming environment and energy OR 2. Catalyzing environmental finance OR 3. Promote climate change adaptation OR 4. Expanding access to environmental and energy services for the poor. Applicable GEF Strategic Objective and Program: Objective 4: Build Capacity on Access to Genetic Resources and Benefit Sharing Applicable GEF Expected Outcomes: Outcome 4.1: Legal and regulatory frameworks, and administrative procedures established that enable access to genetic resources and benefit sharing in accordance with the CBD provisions Applicable GEF Outcome Indicators: Indicator 4.1: National ABS frameworks operational score as recorded by the GEF tracking tool (to be developed) Indicator Project Objective The discovery of naturebased products for the pharmaceutical and agrochemical industries and benefit sharing to promote the sustainable use of genetic resources in the Protected Areas System of Panama Outcome 1: Discovering active compounds for pharmaceutical and agrochemical uses from terrestrial and marine organisms in protected areas and improvement of the capacities of ANAM for their monitoring Outcome 2: Transfer of technology and practices to facilitate the discovery of active compounds and the sustainable use of Baseline Targets End of Project Source of verification Assumptions Number of lead compounds for agrochemical and pharmaceutical uses discovered during the project period 0 1 lead compound ICBG database Compounds discovered prove to show promise as lead compounds Number of highly active compounds for agrochemical and pharmaceutical uses discovered during the project period Number of extracts tested in cancer, tropical disease and agrochemical bioassays by the Panama ICBG and by private sector partners during the project period Number of active compounds purified and their structures and elucidated during the project period Existence of guidance for the monitoring of bioprospecting processes 0 10 highly active compounds ICBG database Compounds discovered include highly active compounds 0 2,500 extracted ICBG database 0 50 active compounds ICBG database No formalized guidance currently available ANAM is satisfied with agreements 1 guidance document produced on monitoring of bioprospecting processes ANAM is satisfied with agreements Document Existing facilities at STRI, INDICASAT and the University of Panama are limited, with microbes being Microbial bank and culturing facilities installed in a Panamanian institution Adequacy of baseline agreements in relation to results of project developments and the biodiscovery process Levels of installed capacities for collection, culture and long-term storage of microbes UNDP Environmental Finance Services Letter(s) of conformity from ANAM Inspection of microbial bank and culturing facilities Continued commitment and policy support in ANAM Page 25 Indicator biodiversity Outcome 3: Benefits shared with national parks and the Panamanian population Targets End of Project Source of verification Assumptions stored at room temperature Number of trails in Coiba National Park Numbers of species collected from Coiba National Park included in ICBG collection database Increase in awareness among the Panamanian population on the sustainable uses of biodiversity of Coiba Capacities among Panamanian scientists in relation to biodiscovery Outcome 4: Increased national capacity on ABS Baseline Level of knowledge in Panamanian legislature of the potential benefits for the country of prompt ratification of the Nagoya Protocol Capacity regarding bioprospecting processes in ANAM Level of capacity for negotiation of ABS agreements in ANAM Existence of guidance tools on ABS for ANAM and genetic resource users Existence of methodology for determining rates for permits for access to genetic resources UNDP Environmental Finance Services 0 2,000 species in 20082010 period Quantitative baseline to be determined at project start up based on surveys of visitors to Coiba 143 scientists have been trained to date No legislators are aware of the benefits and intend to support the ratification of the Nagoya Protocol No staff members have in-depth knowledge of bioprospecting processes in ANAM 0 ANAM staff members with in-depth familiarity with processes of ABS negotiation 0 Executive Decree 25 of April 2009 on ABS 2 500 additional species Quantitative targets for mid term and end of project to be determined at project start up based on surveys of visitors to Coiba - 20 additional young Panamanian scientists have been trained in biodiscovery - 4 additional Panamanian scientists have been trained in foreign laboratories on biodiscovery techniques 9 legislators are aware of the benefits and intend to support the ratification of the Nagoya Protocol Field inspection Review of database Surveys of visitors to Coiba Records of training events Availability of committed Panamanian scientists of high calibre Interviews with legislators Receptivity of legislators 3 ANAM staff members trained in different stages of bioprospecting processes ANAM records Continued commitment of ANAM 2 ANAM staff members trained in negotiation of ABS agreements ANAM records Continued commitment of ANAM Two manuals of procedures on ABS have been produced for ANAM and users (including proposals for framework contracts and formats for obtaining prior informed consent) Methodology has been defined for determining rates for permits for access to genetic resources Manuals Review of methodology document Continued commitment of ANAM Page 23 IV. TOTAL BUDGET AND WORKPLAN GEF Outcome/Atlas Activity Responsible party 1. Discovering active compounds for pharmaceutical and agrochemical uses from terrestrial and marine organisms in protected areas 2. Transfer of technology and practices to facilitate the discovery of active compounds and the sustainable use of biodiversity Source of funds GEF 3. Benefits shared with national parks and the Panamanian population 4. Increased national capacity on ABS GEF ERP/ATLAS Budget Description/ Input Local Consultants 71300 Cont. Serv. - Individ 71400 Supplies 72500 Prof. Services 74100 Total Outcome Cost Cont. Serv. - Individ 71400 Travel 71600 Cont. Serv. - Companies 72100 Equipment and Furniture 72200 Supplies 72500 Prof. Services 74100 Total Outcome Cost Cont. Serv. - Individ 71400 Travel 71600 Cont. Serv. - Companies 72100 Equipment and Furniture 72200 Prof. Services 74100 Total Outcome Cost International Consultants 71200 Travel 71600 Cont. Serv. - Companies 72100 Training 72700 Prof. Services 74100 Total Project Management GEF Total Totals by source Totals UNDP Environmental Finance Services GEF Year 1 Year 2 Year 3 Total Atlas Budgetary Account Code International Consultants Travel Cont. Serv. - Companies Equipment and Furniture Supplies Prof. Services 71200 71600 72100 72200 72500 74100 US$ 1,000 72,400 45,000 6,300 124,700 US$ 1,000 72,400 36,000 6,300 115,700 US$ 1,000 64,400 9,000 6,300 80,700 US$ 3,000 209,200 90,000 18,900 321,100 72,600 6,000 60,000 9,000 20,000 6,300 173,900 34,100 2,000 9,000 10,000 6,300 61,400 20,000 1,000 15,000 19,000 7,300 62,300 3,000 1,500 1,000 7,200 12,700 435,000 72,600 72,600 217,800 6,000 6,000 18,000 17,000 7,000 84,000 9,000 16,000 13,400 49,400 6,300 6,300 18,900 117,900 105,300 397,100 24,100 18,100 76,300 2,000 2,000 6,000 9,000 6,000 24,000 10,000 6,300 6,300 18,900 41,400 32,400 135,200 10,000 30,000 1,000 15,000 3,000 4,000 26,000 7,300 7,300 21,900 20,300 11,300 93,900 7,800 7,800 15,600 1,000 1,000 2,000 3,000 3,000 9,000 1,500 1,000 1,000 3,000 7,200 7,200 21,600 20,000 20,000 52,700 315,300 249,700 1,000,000 1,368,800 1,368,800 684,400 3,422,000 1,803,800 1,684,100 934,100 4,422,000 Page 24 Summary of GEF budget by Atlas code Atlas Budgetary Account Code International Consultants Local Consultants Contractual Services - Individ Travel Contractual Services-Companies Equipment and Furniture Supplies Training Professional Services ERP/ATLAS Budget Description/ Input 71200 71300 71400 71600 72100 72200 72500 72700 74100 Year 1 20,000 1,000 179,100 9,000 87,000 20,500 66,000 19,000 33,400 435,000 Year 2 17,800 1,000 169,100 9,000 29,000 53,000 3,000 33,400 315,300 Year 3 7,800 1,000 155,100 9,000 16,000 23,400 4,000 33,400 249,700 Total 45,600 3,000 503,300 27,000 132,000 20,500 142,400 26,000 100,200 1,000,000 Budget notes Component 1. Discovering active compounds for pharmaceutical and agrochemical uses from organisms in protected areas Atlas category Local consultants Contractual Services Individ Atlas code 71300 Amount 3,000 71400 32,000 36,300 72,600 32,000 36,300 2. Transfer of technology and practices to facilitate Supplies 72500 30,000 30,000 30,000 Professional Services Contractual Services Individ 74100 71400 18,900 72,600 72,600 UNDP Environmental Finance Services Explanation Specialist in ABS agreements to support review of ABS agreements: 6 days @ $500/day Salary of Director of INDICASAT for testing extracts in Panama: 32 months @ $1,000/month Salary of INDICASAT technican, 33 months @ $1,100 for testing extracts in Panama Salary of 2 STRI technicans, 33 months each @ $1,100 for making extracts in Panama Salary of Director of Natural Products Laboratory of the University of Panama for purifying active compounds and elucidating structure: 32 months @ $1,000/month Salary of University of Panama technican, 33 months @ $1,100 for for purifying active compounds and elucidating structure Supplies for INDICASAT for testing extracts in Panama Supplies for STRI for testing extracts in Panama Supplies for University of Panama for purifying active compounds and elucidating structure Part salary of project coordinator Salary of 2 University of Panama technican, 33 months each @ $1,100 Salary of 2 INDICASAT technicans, 33 months each @ $1,100 for disease bioassays Page 25 Component the discovery of active compounds and the sustainable use of biodiversity Atlas category Travel Contractual Services Companies Atlas code 71600 72100 Amount 72,600 18,000 40,000 35,000 9,000 3. Benefits shared with national parks and the Panamanian population 4. Increased national capacity on ABS Equipment and Furniture Supplies 72200 72500 Professional Services Contractual Services Individ 74100 71400 Travel Contractual Services Companies Equipment and Furniture 71600 72100 Professional Services International consultants 74100 71200 72200 9,000 24,000 25,400 18,900 5,000 5,000 36,300 30,000 6,000 15,000 9,000 5,000 5,000 18,900 10,000 10,000 10,000 Project management Travel Contractual Services Companies 71600 72100 1,000 5,000 Training 72700 10,000 10,000 Professional Services 74100 International consultants 71200 UNDP Environmental Finance Services 16,000 18,900 3,000 7,800 Explanation Salary of 2 STRI and INDICASAT technicans, 33 months each @ $1,100, for establishing and managing microbe bank Travel of Panamian students and scientists for overseas training Updating and maintenance of the Bruker Nuclear Magnetic Resonance Spectrophotometer, housed at STRI Data handling system among Panamanian institutions to harmonize information transfer between national and international institution Development of database on biodiversity and natural products database and installation in ANAM Cryostorage nitrogen tank for microbe bank Supplies for STRI for microbial curations in microbe bank Supplies for INDICASAT for microbial curations in microbe bank Part of salary of Project Coordinator Local labour for marine trails Local labour for scientific station Salary of STRI technician for maintenance of biological collection Salary for outreach specialist Travel to protected areas for biological inventory Development of production of materials for public media campaign Publication of scientific papers Building materials and equipment for marine trails Building materials and equipment for scientific station Part salary of project coordinator Specialist in monitoring of bio-prospecting for support to development of norms and guidance for the monitoring of bio-prospecting processes: 20 days @ $500/day Specialist in ABS procedures and processes for support to development of two manuals of procedures on ABS for ANAM and users Development of methodology for determining rates for permits for access to genetic resources International trainer for negotiation of ABS agreements Hire of meeting venues for raising awareness on ABS among members of legislature Hire of meeting venues and production of manuals on ABS procedures Training of staff members of ANAM in different stages of bio-prospecting processes Training of staff members of ANAM in negotiation of ABS agreement Part salary of project coordinator Part salary of administrative assistant External consultant for mid-term review Page 26 Component Atlas category Atlas code Travel 71600 Contractual Services Companies Equipment and Furniture Supplies Professional Services 72100 Amount 7,800 1,000 1,000 9,000 72200 72500 74100 1,500 3,000 21,600 UNDP Environmental Finance Services Explanation External consultant for final review International travel for mid-term review consultant International travel for final review consultant Audit costs ($3000/year) Computer and office equipment Office consumables Part salary of administrative assistant Page 27 V. MANAGEMENT ARRANGEMENTS Implementation arrangements and responsibilities 75. The project will be executed by UNDP through the Direct Implementation (DIM) modality. Key elements of the project implementation arrangements are as follows: Project Board 76. The duration of the project would be 3 years. Implementation of the project will be carried out under the general guidance of a Project Board (Steering Committee), specifically formed for this purpose. The composition, responsibilities and rules of operation of the Board will be confirmed during its first meeting. Subject to the decision of this meeting, it is proposed that the Board will be responsible for approving the operational plans and annual reports of the project as well as the terms of reference and appointments of key members of staff, and will be composed of representatives of the following: - ANAM, as GEF focal point, which will function as Executive (chair) of the board. - UNDP, as Senior Supplier, Implementing Agency and Executing Agency under the DIM modality, who will provide guidance regarding the technical feasibility of the project. - INDICASAT and STRI, as GoP and international members respectively of the Panama ICBG. 77. The Board will meet at least two times per year and in addition could be convened extraordinarily by the Chair, on the request of individual members. 78. The Project Board will be responsible for making executive decisions for the project, in particular when guidance is required by the Project Coordinator. The Project Board will play a critical role in facilitating inter-ministerial coordination, project monitoring and evaluations by quality assuring these processes and products, and using evaluations for performance improvement, accountability and learning. It will ensure that required resources are committed and will arbitrate on any conflicts within the project or negotiate a solution to any problems with external bodies. In addition, it will approve the appointment and responsibilities of the Project Manager and any delegation of its Project Assurance responsibilities. Based on the approved Annual Work Plan, the Project Board will also consider and approve the quarterly plans and will also approve any essential deviations from the original plans. 79. In order to ensure UNDP’s ultimate accountability for the project results, Project Board decisions will be made in accordance to standards that shall ensure management for development results, best value for money, fairness, integrity, transparency and effective international competition. In case consensus cannot be reached within the Board, the final decision shall rest with the UNDP. National Project Director (NPD) 80. The NPD, to whom the Project Coordinator will report, will be the Director of INDICASAT, an institution of the Government of Panama. The NPD will be responsible for orienting and advising the National Project Coordinator on Government policy and priorities, for maintaining regular communication with the lead institutions in relation to biodiversity in Panama, and ensuring that their interests are communicated effectively to the National Project Coordinator. Project Implementation Unit 81. Project implementation will be the responsibility in practice of a Project Implementation Unit (PIU), led by a National Project Coordinator. National Project Coordinator 82. The NPC will be responsible for implementing the project in operational, administrative and financial terms, subject to oversight and monitoring by UNDP, the National Project Director and the Project Board, and specifically the following (see Terms of Reference in Annex I): UNDP Environmental Finance Services Page 28 - The implementation of project activities in accordance with Annual Budgets and Workplans and Quarterly Plans, approved by UNDP and the Project Board as appropriate; The delivery of the project outputs foreseen in the Project Document; The achievement of project outcomes, in accordance with the indicator targets specified in the project Strategic Results Framework; The monitoring and evaluation of project impacts; The effective participation of project partners and other stakeholders in project implementation, in accordance with the project participation plan; The conformity of project activities with national policies and priorities; The effective, efficient and transparent use of project funds. 83. In addition to the specific positions underlined above, a series of sub-contracts will be necessary in order to ensure and complement the technical capacity of the members of the PIU. These contracts will be entered into in accordance with the guidelines of UNDP and terms of reference defined by the NPD, during the first month of the implementation phase or annually, in accordance with the project’s work plan. UNDP will provide GEF funds to the project partners for the purchase of goods and services. UNDP will contract with STRI the purchase of scientific supplies and equipment for the Panamanian partners. STRI will purchase and import the supplies and equipment using expedited procurement procedures at no cost for the project. UNDP 84. UNDP will provide Project Assurance, supporting the Project Board Executive by carrying out objective and independent project oversight and monitoring functions. Organizational structure of the project: Project Board Senior Supplier and Executing Agency (UNDP) Director/a Executive Chair General (ANAM) INDICASAT, STRI or University of Panama National Project Director (INDICASAT) National Project Coordinator (full time) Summary of the inputs to be provided by partners Partner ANAM INDICASAT Members of Panama ICBG (STRI, INDICASAT, University of Panama) UNDP Environmental Finance Services Inputs Provision of strategic orientation to project through participation in PSC Provision of strategic orientation to project through role of INDICASAT Director as NPD Responsible for technical aspects of project implementation subject to coordination by NPC Provision of strategic orientation to project through participation in Page 29 Partner Foreign academic collaborators (University of California, Utah State University and University of Connecticut) Private sector UNDP Inputs PSC Natural products research, hosting Panamanian students and scientists in US labs Realization of bioassays, marketing, provision of supplies and technical know-how to Panama, hosting of Panamanian visitors to their labs Implementing Agency, Executing Agency and Senior Supplier Audit arrangements 85. The Government will provide the Resident Representative with certified periodic financial statements, and with an annual audit of the financial statements relating to the status of UNDP (including GEF) funds according to the established procedures set out in the Programming and Finance manuals. The Audit will be conducted by a special and certified audit firm. UNDP will be responsible for making audit arrangements for the project in communication with the Project Implementing Partner. 86. UNDP and the project Implementing Partner will provide audit management responses and the Project Manager and project support team will address addit recommendatios. 87. As a part of its oversight function, UNDP will conduct audit spot checks at least two times a year. Agreement on intellectual property rights and use of logo on the project’s deliverables 88. In order to accord proper acknowledgement to GEF for providing funding, a GEF logo should appear on all relevant GEF project publications, including among others, project hardware and vehicles purchased with GEF funds. Any citation on publications regarding projects funded by GEF should also accord proper acknowledgment to GEF. UNDP Environmental Finance Services Page 30 VI. MONITORING FRAMEWORK AND EVALUATION 89. Project Monitoring and Evaluation (M&E) will be conducted in accordance with the established UNDP and GEF procedures and will be provided by the project team and the UNDP Country Office (UNDP-CO) with support from the UNDP/GEF Regional Coordination Unit (RCU) in Panama City. The Project Results Framework provides performance and impact indicators for project implementation along with their corresponding means of verification. The M&E plan includes an inception report, project implementation reviews, quarterly and annual review reports, and mid-term and final evaluations. The following sections outline the principle components of the M&E plan and indicative cost estimates related to M&E activities. The project’s M&E plan will be presented and finalized in the Project Inception Report following a collective fine-tuning of indicators, means of verification, and the full definition of project staff M&E responsibilities. Project Inception Phase 90. A Project Inception Workshop (IW) will be held within the first three (3) months of project startup with the full project team, relevant Government of Panama (GoP) counterparts, co-financing partners, the UNDP-CO and representation from the UNDP-GEF RCU, as well as UNDP-GEF headquarters (HQs) as appropriate. A fundamental objective of this IW will be to help the project team to understand and take ownership of the project’s goal and objectives, as well as finalize preparation of the project's first annual work plan on the basis of the project results framework. This will include reviewing the results framework (indicators, means of verification, and assumptions), imparting additional detail as needed, and on the basis of this exercise, drafting the Annual Work Plan (AWP) with precise and measurable performance indicators, and in a manner consistent with the expected outcomes for the project. Monitoring Responsibilities and Events 91. Day-to-day monitoring of implementation progress will be the responsibility of the Project Coordinator based on the project's AWPB and its indicators. The Project Coordinator will inform the UNDP-CO of any delays or difficulties faced during implementation so that the appropriate support or corrective measures can be adopted in a timely and remedial fashion. The Project Coordinator will finetune the progress and performance/impact indicators of the project in consultation with the full project team at the IW with support from UNDP-CO and assisted by the UNDP-GEF RCU. Specific targets for the first-year implementation progress indicators together with their means of verification will be developed at this workshop. These will be used to assess whether implementation is proceeding at the intended pace and in the right direction and will form part of the AWPB. Targets and indicators for subsequent years will be defined annually as part of the internal evaluation and planning processes undertaken by the project team. 92. Periodic monitoring of implementation progress will be undertaken by the UNDP CO through quarterly meetings with the project implementation team, or more frequently as deemed necessary. This will allow parties to take stock of and to troubleshoot any problems pertaining to the project in a timely fashion to ensure the timely implementation of project activities. The UNDP CO and UNDP-GEF RCU, as appropriate, will conduct yearly visits to the project’s field sites, or more often based on an agreed upon schedule to be detailed in the project's Inception Report/AWPB to assess first-hand project progress. Any other member of the Steering Committee can also take part in these trips, as decided by the Steering Committee. A Field Visit Report will be prepared by the UNDP CO and circulated no less than one month after the visit to the project team, all Steering Committee members, and UNDP-GEF. 93. Annual monitoring will occur through the Tripartite Committee (TPC) Reviews. This is the highest policy-level meeting of the parties directly involved in the implementation of the project. The project will be subject to TPC review at least once every year. The first such meeting will be held within the first twelve (12) months of the start of full implementation. The project proponent will prepare an Annual Project Report (APR) and submit it to UNDP CO and the UNDP-GEF regional office at least two weeks prior to the TPC for review and comments. 94. The Terminal TPC Review is held in the last month of project operations. The Project Coordinator is responsible for preparing the Terminal Report and submitting it to UNDP-CO and to UNDP-GEF RCU. It shall be prepared in draft at least two months in advance of the TPC meeting in order to allow review, and will serve as the basis for discussions in the TPC meeting. The terminal TPC review considers the implementation of the project as a whole, paying particular attention to whether the project has achieved its stated objectives and contributed to the broader environmental objective. It decides whether any actions are still necessary, particularly in relation to sustainability of project results, and acts as a vehicle through which lessons learned can be captured to feed into other projects being implemented. Project Monitoring Reporting 95. The Project Coordinator, in conjunction with the UNDP-GEF extended team, will be responsible for the preparation and submission of the following reports that form part of the monitoring process and that are mandatory. A Project Inception Report (IR), which will be prepared immediately following the IW. It will include a detailed First Year/AWP divided in quarterly timeframes detailing the activities and progress indicators that will guide implementation during the first year of the project. The Annual Project Report (APR) is a UNDP requirement and part of UNDP CO central oversight, monitoring, and project management. An APR will be prepared on an annual basis prior to the TPC Review, to reflect progress achieved in meeting the project's AWP and assess performance of the project in contributing to intended outcomes through outputs and partnership work. The Project Implementation Review (PIR) is an annual monitoring process mandated by the GEF. It has become an essential management and monitoring tool for project managers and offers the main vehicle for extracting lessons from ongoing projects. The PIR can be prepared any time during the year and ideally prior to the TPC review. Quarterly Progress Reports outlining main updates in project progress will be provided quarterly to the local UNDP CO and the UNDP-GEF RCU by the project team. Progress made shall be monitored in the UNDP Enhanced Results Based Management Platform and the risk log should be regularly updated in ATLAS based on the initial risk analysis included in the Project Document. 96. A Project Terminal Report will be prepared by the project team during the last three months of the project. This comprehensive report will summarize all activities, achievements, and outputs of the project; lessons learned; objectives met or not achieved; structures and systems implemented, etc.; and will be the definitive statement of the project’s activities during its lifetime. It will also lay out recommendations for any further steps that may need to be taken to ensure sustainability and replicability of the project’s activities. Reporting may also include Independent Evaluation 97. An independent Mid-Term Evaluation will be undertaken at exactly the mid-point of the project lifetime. The Mid-Term Evaluation will determine progress being made towards the achievement of outcomes and will identify course correction if needed. It will focus on the effectiveness, efficiency, and timeliness of project implementation; will highlight issues requiring decisions and actions; and will present initial lessons learned about project design, implementation, and management. Findings of this review will be incorporated as recommendations for enhanced implementation during the final half of the project’s term. The organization, ToRs, and timing of the mid-term evaluation will be decided after consultation between the parties to the project document. The ToRs for this Mid-Term Evaluation will be prepared by the UNDP-CO based on guidance from the UNDP-GEF RCU. The management response of the evaluation will be uploaded to the UNDP corporate systems, in particular the UNDP Evaluation Office Evaluation Resource Center (ERC). 98. An independent Final Evaluation will take place three months prior to the terminal Steering Committee meeting, and will focus on the same issues as the Mid-Term Evaluation. The Final Evaluation will also look at impact and sustainability of results, including the contribution to capacity development and the achievement of global environmental goals. The Final Evaluation should also provide recommendations for follow-up activities and requires a management response which should be uploaded to PIMS and to the UNDP Evaluation Office Evaluation Resource Center (ERC). The ToRs for this evaluation will be prepared by the UNDP-CO based on guidance from the UNDP-GEF RCU. 99. The indicative M&E work plan and budget is as follows: Type of M&E activity Inception Workshop Inception Report Measurement of Means of Verification of project results Measurement of Means of Verification for Project Progress and Performance (measured on an annual basis) ARR and PIR Tripartite Committee Reviews and Reports Steering Committee Meetings Responsible Parties Project Coordinator UNDP CO UNDP GEF Project Team UNDP CO UNDP GEF Regional Technical Advisor/Project Coordinator will oversee the hiring of specific studies and institutions, and delegate responsibilities to relevant team members Oversight by Project Coordinator Project Team Project Coordinator and Team UNDP-CO UNDP-GEF GoP counterparts UNDP CO UNDP GEF RCU Project Coordinator UNCP-CO GoP representatives Budget US$* 3,000 CF None Time frame Within first two months of project start-up Immediately following IW To be determined during the initial phase of implementation of the project and the IW. Start, mid-point, and end of project No separate M&E cost: to be absorbed within salary and travel costs of project staff Annually prior to ARR/PIR and to the definition of annual work plans None Annually None Annually, upon receipt of APR Two times per year Quarterly progress reports Project Coordinator and Team None Quarterly Technical reports Project Coordinator and Team None To be determined by Project Team and UNDP-CO Terminal Report Project Coordinator and Team UNDP- CO UNDP-GEF RCU External Consultants (i.e., evaluation team) Project Coordinator and Team UNDP- CO UNDP-GEF RCU External Consultants (i.e. evaluation team) Project Team UNDP-CO Lessons learned Project Coordinator and Team Mid-term Evaluation Final Evaluation International consultant 7,800 Travel 1,000 International consultant 7,800 Travel 1,000 None At the mid-point of project implementation At least three months before the end of project implementation At least three months before the end of the project Yearly Audit Visits to field sites UNDP-GEF RCU (suggested formats for documenting best practices, etc) UNDP-CO Project Coordinator and Team UNDP-CO UNDP-GEF RCU (as appropriate) GoP representatives TOTAL INDICATIVE COST (*Excluding project team staff time and UNDP staff and travel expenses) 9,000 No separate M&E cost: paid from IA fees and operational budget GEF 26,600 CoF 3,000 29,600 Total Yearly Yearly VII. LEGAL CONTEXT 100. This document together with the CPAP signed by the Government and UNDP which is incorporated by reference constitute together a Project Document as referred to in the SBAA [or other appropriate governing agreement] and all CPAP provisions apply to this document. 101. Consistent with the Article III of the Standard Basic Assistance Agreement, the responsibility for the safety and security of the implementing partner and its personnel and property, and of UNDP’s property in the implementing partner’s custody, rests with the implementing partner. 102. The implementing partner shall: put in place an appropriate security plan and maintain the security plan, taking into account the security situation in the country where the project is being carried; b) assume all risks and liabilities related to the implementing partner’s security, and the full implementation of the security plan. 103. UNDP reserves the right to verify whether such a plan is in place, and to suggest modifications to the plan when necessary. Failure to maintain and implement an appropriate security plan as required hereunder shall be deemed a breach of this agreement. a) 104. The implementing partner agrees to undertake all reasonable efforts to ensure that none of the UNDP funds received pursuant to the Project Document are used to provide support to individuals or entities associated with terrorism and that the recipients of any amounts provided by UNDP hereunder do not appear on the list maintained by the Security Council Committee established pursuant to resolution 1267 (1999). The list can be accessed via http://www.un.org/Docs/sc/committees/1267/1267ListEng.htm. This provision must be included in all sub-contracts or sub-agreements entered into under this Project Document. VIII. ANNEXES Annex I. Terms of Reference: 1) National Project Coordinator - - - Coordination of Project activities in accordance with Annual Work Plans and Budgets (AWPBs). Supervision of the activities of the technical personnel of the project, thereby guaranteeing their relevance, effectiveness and efficiency Preparation of terms of reference for external consultants contracted by the project, the supervision and coordination of their work and the review and approval of their products. Ensure that the project is executed with the full participation of local actors and that mechanisms exist to ensure that their interests are taken into account, communicated and reflected in the implementation of the project. Promote the coordinated participation of Government institutions and key partners, at national and local levels, in the implementation of the project. Continuous and periodic monitoring of the impacts of the project, in relation to the advances foreseen in the AWPBs and the impacts foreseen in the project results framework. In communication with the NPD, ensure that the Project is executed in accordance with the policies and plans of the ANAM In communication with the Programme Office of UNDP, ensure that the project is executed in accordance with the United Nations Development Assistance Framework (UNDAF) in Panama. Identification and promotion of opportunities for actions of other agencies of the United Nations system. Ensure the incorporation of a cross-cutting gender focus in the actions of the project. Together with UNDP, prepare Project Implementation Reviews (PIRs) detailing the progress of the project, to be presented to GEF. Together with UNDP and the project team, and in discussion with local stakeholders, prepare AWPBs for approval by the NSC and the GEF. With the support of the administrative team of the project, ensure the efficient and transparent execution of financial and physical resources, in conformity with the norms of the Government, GEF and UNDP. Design and implementation of plans of professional development for the members of the Project Implementation Unit. Identification of the risks that could affect the achievement of the impacts foreseen by the project, and the definition and application of corresponding mitigation strategies. Support to the functioning of the PSC, through the provision of advice and logistics. Preparation and supervision of the application of operations manuals for the implementation of the Project. Organization and support of external evaluations of the project. Preparation of quarterly reports (QORs) in English, of no more than 150 words, on the progress of the project Any other tasks that may be assigned to him/her and are compatible with the nature or his/her post. 2) Administrative Assistant - Manage the economic and financial resources assigned to the project, under the direction of the Project Coordinator, in close coordination with the ANAM and UNDP Assist the Coordinator in the different activities involved in the implementation of the project. - Support the monitoring and evaluation of the implementation of the project. Provide logistic support for the execution of activities. Facilitate coordination with UN agencies and participating national institutions Provide administrative support to the contracting of personnel for the Project, as required Assist in the process of procurement of goods and services within the framework of the project Assist in the presentation of financial, administrative, audit and other reports, as necessary Generate a database of contacts, providers, personnel and documentation.