Project title: Sustainable, Accessible and Innovative Use of Biodiversity Resources and Associated Traditional Knowledge in Promising Phytotherapic Value Chains in Brazil
Country: Brazil
Management Arrangements: Direct Implementation Modality (DIM)
UNDAF/Country Program Outcome: Outcome 3: Institutional capacities strengthened to promote public policies, their coherence and implementation, for the sustainable management of natural resources and ecosystem services and for the fight against climate change and its adverse effects.
UNDP Strategic Plan Output (2018-2021 UNDP Strategic Plan):
Output 1.4.1: Solutions scaled up for sustainable management of natural resources, including sustainable commodities and green and inclusive value chains
Output 2.4.1: Gender-responsive legal and regulatory frameworks, policies and institutions strengthened, and solutions adopted, to address conservation, sustainable use and equitable benefit sharing of natural resources, in line with international conventions and national legislation.
UNDP Social and Environmental Screening Category:
Medium risk
UNDP-GEF PIMS ID number: 5792
GEF ID number: 9449
Brief project description:
Brazil’s rich floral diversity is under threat in various parts of the country as a result of deforestation and degradation, driven primarily by agriculture, in particular, cattle ranching and perennial crops (such as soybean and sugarcane), but also by logging, forest fires, slash-and-burn agriculture, and other factors. The production and commercialization of plant material for the herbal medicinal plant (HMP) sector may provide an economic incentive to for biodiversity conservation instead of land use change. This requires, however, that sourcing of these materials be based on sustainable plant extractivism or that the cultivation of medicinal plants takes place in already established agricultural zones (rather than resulting in the clearing of new areas) or in degraded areas. If not, plant production or extraction in the HMP sector could result in direct threats to biodiversity due to overharvesting and could reduce the gene pool. There are three overarching barriers that stand in the way of advancing the long-term solution of promoting the conservation of native Brazilian biodiversity through strong phytotherapic value chains that are environmentally sustainable and ABS compliant and that promote socio-economic co-benefits. These include: 1) Phytotherapic value chains based on native Brazilian species are still underdeveloped and do not contribute sufficiently to biodiversity conservation and socio-economic development. 2) Insufficient partnerships between indigenous and local communities (ILCs), science and industry to promote ABS-compliant R&D on herbal medicinal products and increase the level of scientific knowledge on native medicinal plants and their products; 3) Regulatory and institutional challenges limit the registry, notification and commercialization of herbal medicinal products based on native Brazilian species and traditional knowledge in the Unified Public Health System (SUS), with opportunities lost for wider benefit sharing with ILCs.
The project’s Objective is to enhance global biodiversity benefits, as well as multiple national and local co-benefits, arising from the sustainable, accessible, and innovative use of medicinal plants in Brazilian ecosystems. It will do so by strengthening promising phytotherapic value chains, based on indigenous and local communities’ traditional knowledge, in compliance with the applicable ABS regime, and while adhering to ecological sustainability criteria. The project will be implemented through the following four Outcomes: Outcome 1: Sustainable phytotherapic value chains established in indigenous and local communities (ILCs) within Local Productive Arrangements (LPAs); Outcome 2: Public and private R&D for the development of native Brazilian herbal medicinal products accelerated through strategic support for more equitable partnerships, ensuring the full engagement of ILCs and ABS compliance; Outcome 3: Simplified and ABS-compliant regulations mainstreamed in the national public health system to increase the demand for, and provide broader access to, herbal medicinal products based on native plants; and Outcome 4: Knowledge management, monitoring and evaluation carried out to disseminate information on ABS-compliant and environmentally sustainable phytotherapic value chains and to promote upscaling.
Financing Plan
USD 5,722,770
Parallel co-financing
USD 16,727,195
USD 350,000
USD 371,517.03
USD 33,448,965
Date:
Signature:
Date:
Contents II. Development Challenge 5 III. Strategy 15 IV. Results and Partnerships 20 V. Project Management 44 VI. Project Results Framework 46 VII. Monitoring and Evaluation (M&E) Plan 54 VIII. Governance and Management Arrangements 60 IX. Financial Planning and Management 67 X. Total Budget and Workplan 70 XI. Legal Context 78 XII. Risk Management 80 XIII. Mandatory Annexes 83 ANNEX A: Multi-Year Workplan 84 ANNEX B: Tracking tools at baseline- see attached Excel files 93 ANNEX C: Overview of Technical Consultancies 94 ANNEX D: Terms of Reference for Project Board, Project Manager, National Project Technical Advisor, and Administrative/ Financial Assistant 101 ANNEX E: Social and Environmental Screening Procedure 108 ANNEX F: Stakeholder Engagement Plan 123 ANNEX G. Gender Analysis and Action Plan 140 ANNEX H: UNDP Risk Log 146 ANNEX I: Co-financing letters, DEX letter - see separate attachments 166 ANNEX J: UNDP Project Quality Assurance Report 167 ANNEX K: Stakeholder consultations during the PPG phase 168 ANNEX L: Project´s Target Biomes 174 ANNEX M: State of Value Chains of four species 179 ANNEX N: Species hotlist 181 ANNEX O. References 185
List of Abbreviations
ABS
Access and Benefit Sharing (derived from the use of genetic resources)
ANVISA
FPIC
National Benefit Sharing Fund (Fundo Nacional de Repartição de Benefícios)
FSP
ILCs
LPA
NIT
NGO
Non-Government Organization
National Policy and Program on Medicinal Plants and Phytotherapic Products (Política e Programa Nacional de Plantas Medicinais e Fitoterápicos)
PPG
PPP
RENISUS
National List of Medicinal Plants of Interest for the SUS (Relação Nacional de Plantas Medicinais de Interesse ao SUS)
SDG
TE
UNDP
Environmental Context
1. With a varied topography across a land area of 8.5 million km2, Brazil displays a wide range of climatic zones and its biogeography produces environments ranging from equatorial rainforests in the north and semiarid deserts in the northeast, to temperate coniferous forests in the south and tropical savannas in central Brazil. From an evolutionary point of view, the combination of these elements created ideal conditions for the diversification of species and habitats, placing Brazil among the 17 megadiverse countries in the world. Brazil’s biodiversity is significant by any relevant measure, including the extension and importance of its terrestrial biomes (tallying six, including two biodiversity hotspots), the diversity of vegetation types, large marine ecosystems, marine eco-regions and major river basins.[footnoteRef:2] [2: Refer to the 2016 NBSAP. The six terrestrial biomes are: Amazon, Atlantic Forest, Caatinga, Cerrado, Pampa and Pantanal. https://www.cbd.int/doc/world/br/br-nbsap-v3-en.pdf]
2. Brazil is often considered the most biologically diverse country in the world. According to the 2016 NPSAP, “Brazil has the largest number of plant (more than half endemic), amphibian and primate species. It is the second country in the world with the highest number of species of mammals and reptiles; and the third in birds. Brazil is also the sixth country in terms of vertebrate endemism, with the highest rates for reptiles, with 37% of endemism, and 57% for amphibians. According to estimates, the country is home to about 20% of the planet's total biodiversity.” Brazil has an estimated 55,000-60,000 plant species, 1700 species of birds, 695 amphibians, 578 mammals and 651 reptiles that have been identified[footnoteRef:3]. However, it is believed that there are many more species that are not yet known to science. Its biodiversity has always been the object of scientific curiosity and it constitutes an essential resource for the Brazilian people. This is not only due to the environmental services that the biodiversity provides, but also due to the development opportunities that Brazil’s diverse habitats and the rich genetic heritage represent, including in the sustainable use of herbal medicinal plants (also called phytotherapics). In this sense, the vast genetic resources of potential value in the treatment of disease and illness remain largely unexplored. [3: Butler, 2014. Mongabay, Brazil.]
3. Brazil’s biological diversity also has a parallel in the country’s diverse cultural heritage and contrasting social fabric. An essential part of this heritage is linked to the bio-cultural knowledge held by Brazil’s indigenous peoples and local communities (ILCs). Brazil holds significant socio-diversity found in all Brazilian biomes. Over 300 indigenous ethnic groups live in at least 700 Indigenous Lands[footnoteRef:4] (13.3% of Brazilian territory) and speak approximately 180 different languages. In 2010, 817,963 people self-declared as indigenous in the census[footnoteRef:5]. There are 241 quilombola communities, with recognized territories, totaling 1,046,300 hectares (only 0.14% of Brazilian territory) in which over 16,000 families live. The traditional peoples and communities mentioned in the composition of the National Council of Traditional Peoples and Communities (CNPCT), are: indigenous peoples, quilombola people, terreiro peoples and communities/peoples and communities of african origin, gypsy peoples , artisanal fishermen and women, extractive workers, coastal and marine extractive workers, caiçaras, faxinalenses, benzedeiras (healers), ilhéus, raizeiras, geraizeiros, caatingueiros, vazanteiros, veredeiros, collectors of herbaceous ornamental flowers, pantaneiros, morroquianos, pomerano people, mangaba collectors, babassu nut crackers, araguaia migrants, back-pasture communities, riverside communities, cipozeiros, andirobeiros and caboclos. Some of these live on sustainable use conservation units, including extractivism reserves and sustainable development reserves. According to the Dynamic Information Panel[footnoteRef:6] of the Chico Mendes Institute for Biodiversity Conservation (ICMBio), 52,104 families are beneficiaries of sustainable use protected areas. [4: ISA. Instituto Socioambiental. População indígena no Brasil [Indigenous populations in Brazil]. Accessed on: 01 Feb 2017.] [5: https://biblioteca.ibge.gov.br/visualizacao/periodicos/93/cd_2010_caracteristicas_populacao_domicilios.pdf] [6: http://qv.icmbio.gov.br/QvAJAXZfc/opendoc2.htm?document=painel_corporativo_6476.qvw&host=Local&anonymous=true ]
4. Approximately 59% of Brazil´s land area is made up of forests. The country contains approximately one-third of the world's remaining rainforests[footnoteRef:7], including the largest proportion of the Amazon rainforest (3,331,065 km2 in 2015). According to FAO, approximately 519,522,000 ha of Brazil was under forest cover in 2010. Besides the importance of these forests in terms of the biodiversity they contain, they also represent a vital carbon sink. [7: Butler, 2014. Mongabay: Brazil.]
Socio-economic and Political Context
5. The development challenge for this project is set against the backdrop of a country that holds great potential, but which is currently recovering from a complex political, fiscal and economic crisis. The economy has been in recession since 2013and the impact of four to five years of negative per capita growth on unemployment and on the income of the lower classes has been significant. Government investments at all levels (federal, state and municipal) have been severely affected.
6. Brazil´s Human Development Index (HDI) is 0.754 (currently ranked 79 out of 188 countries). Other key socio-economic indicators corroborate the analysis of an emerging economy in crisis, with deep-seated social inequalities: (i) unemployment remains high, affecting 11.5% of the total labor force in 2016 ; (ii) the poverty ratio has increased since 2014, after being on a free-fall trend since the early 2000s; and last but not least (iii) despite recent efforts to address gender inequality, gender-based discrimination still persists, as demonstrated, for example, by a gender pay gap of 15% and a comparatively low proportion of female decision-makers.
7. In spite of recent socio-economic setbacks, Brazil is still the largest market in Latin America and its economy is the eighth-largest in the world. It is also quite diversified and active in the agricultural, mining, manufacturing and service sectors – not least by generating wealth on the basis of its abundant natural resources. Brazil is an important commodity exporter, and maintains a varied export portfolio.
8. There has been increased emphasis in recent years in building Brazil´s economy in a sustainable way based on its biological and natural resources. The phytotherapic or herbal medicinal sector represents one sector that can contribute to the country´s socio-economic development by taking advantage of the country´s rich biodiversity sustainably.
The Phytotherapic Sector
9. Herbal Medicine Products (HMPs), or phytotherapics as they are called in Brazil refer to medicines obtained from plants, as well as fungal or algae sources as active raw materials, except for isolated substances, for prophylactic, curative or palliative purposes[footnoteRef:8]. HMPs can be separated into two categories, both of which will be included in this project: herbal medicines (HM), which are licensed by demonstrating safety and efficacy through non-clinical and clinical trials, and traditional herbal products (THP), which are licensed based on the traditionality of use. Products are classified as traditional if there is evidence of continued use for at least 30 years and no known evidence of risk to the health of users, among other factors[footnoteRef:9]. The production of herbal medicinal products follows agro-industrial processes that rely on plant-based raw materials as the main ingredients in finished products. The industry is required by the health surveillance system to follows strict standards of product standardization and quality control. In addition, because HMP value chains are R&D based and they are built on the back of diverse genetic resources, sectoral players are also required by environmental authorities to comply with national legislation on access and benefit sharing (ABS). [8: Carvalho et al. (2018).] [9: These other factors include: if they can be used without the supervision of a doctor for diagnostic, prescriptive or monitoring purposes; if they do not involve an injectable or ophthalmic route of administration; if they do not refer to clinical parameters and broad actions; if they are consistent with traditional use; if they do not contain known hazardous chemical groups in concentrations above safe limits (Bezerra Carvalho et al., 2018).]
10. In order to be authorized for manufacturing and commercialization, herbal medicines (HM) must be registered with ANVISA, the Brazilian Health Surveillance Agency. Traditional herbal products (THP) can be registered or notified. Notification is a simpler process as long as the production adheres to certain technical criteria and companies comply with good manufacturing processes. THPs can fall in the notification category if they are included in the Brazilian Herbal Formulary (FFFB) and if the herbal preparation has a monograph of quality control in the Brazilian Pharmacopoeia. However, there are currently no THPs that are notified in ANVISA´s system.[footnoteRef:10] Overall, in the 2017 National List of Essential Medicines (RENAME), as published by the Ministry of Health (MS), there were 869 items in the 2017 edition, of which only 12 items would qualify as herbal medicines (phytotherapic). [10: Carvalho et al., 2018.]
11. In spite of the reality of unrealized potential, the HMP industry in Brazil has also been showing positive trends in recent times, with an average expansion in market value of 5% per year. The growth in the phytotherapic sector in terms of market values is reflected in the fact that it had an estimated worth of at least $200 million in 2014, mobilizing 4% of the overall pharmaceutical market in Brazil.[footnoteRef:11] Another positive trend relates to signs that stakeholders linked to the HMP sector in both corporate or public innovation and R&D nodes may already prefer native Brazilian plants, rather than exotic ones; when surveyed in a recent study, 54% of companies reported utilizing native Brazilian biodiversity in their R&D activities[footnoteRef:12]. At the same time, the number of products and producing companies have decreased and production is concentrated in the Southeast and Southern regions of Brazil. [11: Hasenclever, L., J. Paranhos, C. Reis Costa, G. Cunha and D. Vieira. The Brazilian phytotherapics industry: challenges and opportunities. 2009. Ciéncia & Saúde Coletiva. 22(8): 2559-2569, 2017.] [12: Hanenclever et al., 2017.]
12. Non-native medicinal plant species prevail in products’ composition. Paradoxically, in spite of Brazil’s impressive biological diversity, only 27 out of 101 species of plant used in HMPs licensed by ANVISA in 2017 were native to Brazil.[footnoteRef:13] Furthermore, of the ten top-selling herbal medicinal products sold in the retail market in Brazil in 2014, a total of 13 species were present in either single or combination HMPs, and of these, only two species were native to Brazil (Erythrina mulungu and Passiflora alata).[footnoteRef:14] In the National List of Medicinal Plants of Interest to United Health System (RENISUS), an initiative aimed at advancing the incorporation of phytotherapy and HMPs in the SUS, 71 species were listed, of which only 22 (or 31%) are native to Brazil. Considering the high number of native plant species in Brazil, the country is clearly underutilizing its genetic resources within the HMP segment and foregoing many opportunities of “transforming its flora into medicine”.[footnoteRef:15] This is in part due to a lack of data on safety, quality and operational protocols for native species, lack of clinical trials, and the rules in place regulating access to biodiversity for research, among other factors[footnoteRef:16]. Despite the low number of licensed products with native species, it should be noted that there is a large number of products in the informal market that rely on native biodiversity. However, these have not been evaluated for quality, safety and efficacy before their being commercialized. [footnoteRef:17] [13: According to Carvalho et al. (2018), which used the following typology for classifying species: EN - Endemic native, n=8 (7.9%); and “NEN - Non-endemic native”, n=19 (18.8%). This typology is different from the categorization used in the 2015 ABS Law, which additionally considers the following as part of the ‘Brazilian genetic heritage’ if they have developed distinctive characteristics in Brazil: “N – Naturalized”, n=6 (5.9%) and “C – Cultivated”, n=6 (5.9%). However,, this project will target only native species (endemic and non-endemic). ] [14: Rech et al. (2017). ] [15: Folha de São Paulo, (2010): “País deixa de gerar US$ 5 bi por ano com fitoterápicos”, published on 07 Jun 2010: ] [16: Carvalho et al. (2018).] [17: Similar to the HMP segment, the informal production of plant-based remedies also relies on plant raw material, and where the active ingredient is an expression of the plant’s genetic resources. The informal sector builds on popular wisdom (builds on traditional knowledge), simple techniques and it is widely disseminated throughout Brazil.]
13. The number of licensed HMP is small when compared to other countries. Brazil has a very small share of the global market[footnoteRef:18] for herbal medicinal products (less than 1%)[footnoteRef:19], and is missing out on the potential contribution of the sector to strengthening livelihoods and to economic growth. Within the pharmaceutical sector in general—to which the HMP segment belongs—Brazil is a net importer of goods[footnoteRef:20], to the point that the mainstream pharmaceutical industry, which based on synthetic active ingredients, is highly dependent on imports. [18: 83 billion in 2008 for the more broadly defined ‘traditional and natural products and it will likely be worth $115 billion in 2020 for the more specific HMPs] [19: Carvalho et al, (2018), Hasenclever et al. (2009), Torres, K. R. (2015) and Global Industry Analysts (2016).] [20: Source: The Atlas of Economic Complexity, Harvard’s Center for International Development (Link), accessed on 29 Jan 2018. According to the source, Brazil’s gross imports of ‘Medicinal and pharmaceutical products’ (SITC Code = 54) in 2016 reached $6.9billion in 2016, representing almost 5% of total imports.]
14. One of the motivations of the federal government for supporting the HMP segment is the possibility of reducing the costs of making safe and effective medicine that is made available to the population through the Unified (Public) Health System (SUS). Additionally, by developing integrated value chains, the wider cultivation of medicinal plants across landscapes can help disseminate agroecological and organic farming techniques among small-farmers, while also securing a tangible income stream to them. Should other conditions also be ideal, the HMP segment and would have ample room for growth, including through exports, which is currently insignificant. The HMP sector has an opportunity to capitalize on Brazil´s significant biodiversity endowment, develop new products, carve out new market niches and in the process generate wider societal benefits.
15. Within this context, ILC groups can potentially make a significant contribution to the country’s sustainable development, if they decide to share, on their own terms, the special knowledge and traditions on the use of native medicinal plants that are part of their culture—including within the HMP segment. This may represent a relevant opportunity for wide benefit sharing. This must be coupled with safeguards to guarantee that harvesting and cultivation of HMPs is carried out in a sustainable way and to ensure adherence to social safeguards.
Threats
16. Brazil’s floral diversity is under threat in various parts of the country due to a variety of causes. It is estimated that Pantanal, Amazon, Caatinga, Cerrado, Pampas and Atlantic Forest biomes hold, respectively, 83.1%, 53.4%, 51.2%, 35.6%, and 21.9% of their original vegetation. Historically, the Atlantic Forest had been the severely affected even before the 20th century, when rapid urban expansion and industrialization became the main drivers of forest loss. In the latter decades of the 20th century, deforestation accelerated and reached significant scale in the Amazon biome, where it peaked in 1994-95.[footnoteRef:21] Accounting for its size, Brazil became the largest deforester in the world between 2000 and 2005, responsible for 47% of global forest loss. The trend has been since reverted with steady decreases in the deforestation rates for the Amazon region until 2013, when the annual area deforested increased again. [21: Data from INPE. ]
17. In all Brazilian terrestrial biomes, deforestation occurs mainly due to changes in land uses, driven by agriculture, in particular, cattle ranching and perennial crops (such as soybean and sugarcane), but also pushed by land market forces. Forest clearing, logging, and forest fires all contribute to deforestation and the degradation of Brazilian forests to different degrees, leading invariably to the loss of habitats and/or their fragmentation. Forest clearing and forest fires are intrinsically associated with land use change. Logging and forest pruning, even if only selective and without the intention of removing the forest cover, tend to degrade forests, leaving them susceptible to subsequent clearing. These direct threats to forests are therefore self-reinforcing in typical patterns of land-use succession that take place, for example, in the Amazon basin.
18. Deforestation, at scale, results in significant biodiversity loss, as well as severe degradation of key ecosystem services associated with this vegetation, such as loss of top soil and disturbances in the water cycle. It leads to pervasive habitat loss, resulting in fewer refugia, and consequently in increased threats to species. Deforestation also contributes to the shrinking of entire gene pools, resulting in decreased diversity. At scale, this impact forecloses countless opportunities linked to bioprospecting and related economic activities, which would otherwise be more promising if it could access wider genetic variations across diverse habitats. In addition, deforestation is linked to high CO2 emissions, thereby contributing to climate change.
Role and Impacts of HMP segment
19. The production and commercialization of plant material for the HMP segment may provide an economic incentive to change production activities away from deforestation/ land use change and degrading practices, such as monoculture cropping and cattle ranching. This requires, however, that sourcing of these materials be based on sustainable plant extractivism or that the cultivation of medicinal plants takes place on degraded lands or in already established agricultural zones, thus avoiding the clearing of new areas.
20. If this is not the case, plant production or extraction in the HMP sector could result in direct threats to biodiversity due to harvesting. Overharvesting is particularly problematic when the plant itself, or parts thereof, are harvested beyond the species’ natural regeneration rate, or when the plant is not very resilient (e.g. due to its morphology, genetics or growth conditions). At the level of landscapes, resilience will depend on a number of complex conditions that are contextual to each habitat and its interaction with value-chains and the individual species’ populations.
21. Overexploitation can lead to the degradation of species’ valuable gene pool and it ultimately undermines the biotrade activity that it supports. The conditions under which a species population and/or its genetic diversity will be impacted by extinction or near-extinction threats will depend on the intensity of use, the type of use and the spatial-temporal variations in these parameters. In such cases, market demand for a specific natural product is also a known to be powerful determinant. It is therefore crucial for species survival and the viability of value chains to consider the pre-existing level of threat to a species before making a recommendation on sustaining wild harvesting as the prevailing method for sourcing plant material. This diagnosis must be undertaken taking in account ILCs´ perspectives and participation. A swift transition to cultivation, the enrichment of the environment, coupled with targeted conservation measures may save an overharvested species from extinction. In extreme cases, and without adequate monitoring, overharvesting could lead overexploited species to extirpation or extinction.
22. At the moment, there is little information to document overharvesting due to herbal medicinal plant production in Brazil, although some examples do exist. For example, Maytenus ilicifolia (espinheira-santa), which is rare in the biome that it occurs, has been affected by high levels of extractivism which have led to the genetic erosion of the species[footnoteRef:22]. It is now considered a priority for conservation. [22: http://www.ufrgs.br/seerbio/ojs/index.php/rbb/article/download/677/567]
23. Other medicinal plants such as Bertholletia excelsa (Brazil nut) face some level of threat in Brazil but mainly due to habitat loss linked to agriculture and land degradation, rather than due to overharvesting for medicinal plant production. Although selective pressure on medicinal plant species could increase, overharvesting is currently a significantly lesser threat to biodiversity than deforestation due to land use change.
24. Indigenous people, traditional people and communities hold traditional knowledge not only about plant uses, but also about their ecology based on their own locally developed practices of resource use. Traditional Ecological Knowledge (TEK) can play an important role in monitoring, responding to, and managing ecosystem processes and functions, with special attention to ecological resilience.[footnoteRef:23] If sufficient precautions and safeguards are put in place as part of the mainstreaming approach, threats to the ecological sustainability of wild harvesting activities can be addressed through best of practices and close monitoring. [23: Berkes et al. 2000. Rediscovery of traditional ecological knowledgeas adaptive management. Ecological Applications,10(5), pp. 1251–1262. Ecological Society of America. https://esajournals.onlinelibrary.wiley.com/doi/epdf/10.1890/1051-0761%282000%29010%5B1251%3AROTEKA%5D2.0.CO%3B2]
Root causes
25. One of the principal root causes of deforestation and loss of biodiversity in Brazil is the lack of a mainstreamed development vision that takes into account the development potential associated with biodiversity. As a result, large-scale agro-industrial projects, usually for monoculture production of commodities, account for significant deforestation, as do dams, roads and mining
26. Linked to this is the fact that there is little livelihood diversification opportunities so that two of the main land uses in the project´s areas of intervention are agriculture and livestock. There are insufficient livelihood opportunities based on sustainable use of biodiversity that offer significant socio-economic development benefits to communities. Even though sustainable harvesting is the main income in some areas, phytotherapic value chains using native species are poorly developed and structured and therefore do not yet contribute in an important way to local livelihoods. Low levels of education in some cases also mean that there are few other opportunities for ILCs to seek different jobs. In other communities, in which education levels have increased, the lack of job opportunities drive ILCs to leave their territories and migrate to urban areas.
Barriers
27. There are three overarching barriers that stand in the way of advancing the long-term solution of promoting the conservation of native Brazilian biodiversity through strong phytotherapic value chains that are environmentally sustainable and ABS compliant and that promote socio-economic co-benefits. These include:
Barrier 1: Phytotherapic value chains based on native Brazilian species are still underdeveloped and do not contribute sufficiently to biodiversity conservation and socio-economic development.
28. There is a lack of information on the current state of phytotherapic value chains, which makes it difficult to plan adequate and sustainable interventions to strengthen the sector and increase the role of native Brazilian plant species. While some communities are involved in the harvesting and processing of medicinal plants and production of herbal medicines and their marketing, there are information gaps related to production, added value aspects, transportation, and commercialization. With regard to the geographic origin of supplies, information is available on the four native species already included in the National List of Essential Medicines (RENAME) that can be prescribed by doctors in the public health system, including the distribution of these species and the areas in which companies are producing HMP. For other native Brazilian species with therapeutic potential included in the list produced by the Ministry of Health, information is available on the geographic areas in which they are found. However, for some species, the concentration of secondary metabolites produced by the plant with the active ingredients responsible for the therapeutic properties varies depending on the growing conditions of the plants, such as climate, soil, sun exposure, rainfall patterns, temperature and variations of the conditions through the seasons or biomes. This means that each species will grow at optimum conditions in specific parts of the country and will have ideal phases and seasons for harvesting. This information is not always available in order to determine the most promising regions for sustainable production of these species and to provide recommendations for the management of planting and harvesting.
29. Data on which groups of small farmers and communities are involved in the production or extraction of herbal medicinal plants and their contribution to the phytotherapic value chains are not structured or consolidated. Nor have the volumes produced and the socio-economic impacts of these activities been adequately identified and mapped in most cases. There is therefore inadequate understanding of who does what, where, and at what scale, which limits the strengthening of the sector to make it more sustainable and to maximize its impacts on livelihoods. The lack of data on levels of production is coupled with the fact that levels of market demand for different species and products are not always available. All of this undermines efforts to determine whether there is sufficient production to meet market demand and to assess the current impacts of production on the health and sustainability of populations of herbal medicinal plant species.
30. The level of ecological sustainability of current cultivation and harvesting practices among ILCs is not fully understood but it is important that protection measures for species that are either threatened or likely to face increased threat because of their use in value chains at scale be put in place. Without this, both the harvesting of plants in the wild and the cultivation of species for the supply chain could potentially have negative impacts on biodiversity and ecosystem. It is important that ILCs with territories in the range area of herbal medicinal species participate in the strategy of establishing and enforcing parameters of sustainability and putting in place the required strong safeguards. Currently this is a ‘missing link’ in the upstream part of many HMP supply chains in order to foster adaptive management and sustainability. For example, information on sustainable harvesting limits and thresholds and species-specific agronomic guidelines for the cultivation of medicinal plants are often unavailable. Training on best practices is also needed to increase the implementation of more ecologically sustainable practices, integrating herbal medicine quality requirements and ILCs’ traditional ecological knowledge. During meetings of the PPG phase, some community representatives highlighted difficulties in obtaining adequate assistance for the sustainable management of herbal medicinal plant production and in complying with the existing regulations of ANVISA and of the Ministry of Agriculture Livestock and Food Supply (MAPA), related to the production, commercialization of HMP and use of seeds and seedlings of medicinal species.
31. With regard to the downstream elements of phytotherapic value chains, communities sometimes lack equipment to be able to process raw materials[footnoteRef:24], which forces them to sell their products as unprocessed or only partially processed raw materials. This leads to a situation where intermediaries take over the role of production and adding value and as a result benefit from a disproportionately large share of the profits. Moreover, ILCs often depend on negotiations with middlemen to sell their products, which decreases their economic returns per unit produced. Stronger, more direct linkages between ILCs and markets would increase the economic profitability of engaging in herbal medicinal plant production and would provide greater incentives to ILCs to sustainably produce herbal medicinal plants, and would make them less vulnerable to degrading labor and land uses. [24: In the consolidation of norms regarding medicinal plants and herbal medicines from ANVISA, the processing of the medicinal plant is described including all the stages to which the plant is subjected, including stabilization, when applied, drying and preservation. The stabilization aims at the inactivation of enzymes and can be performed in several ways: by heating, solvent use or irradiation. For some medicinal plants the stabilization stage is essential to guarantee that the therapeutic properties of the final product are conserved. As exemplified in the consolidation, cardiotonic drugs have enzymes that unfold the glycosidic chain and reduce pharmacological activity, making the stabilization stage essential. ]
32. Finally, it is important to ensure that partnerships between producers and other actors in the value chain are ABS compliant and lead to a fair and equitable sharing of the benefits. In many cases, there is little experience in setting up fair and profitable value chains between local cooperatives or small businesses and markets or between local producers, industry, and markets.
Barrier 2: Insufficient partnerships between indigenous and local communities (ILCs), science and industry to promote ABS-compliant R&D on herbal medicinal products and increase the level of scientific knowledge on native medicinal plants and their products.
33. The scientific knowledge about native medicinal plants is substantial and there are many research groups and publications, but the potential products that the plants could yield is still limited and is not on par with the scale and diversity of Brazil’s immense richness in plant species. The Ministry of Health published the National List of Essential Drugs (RENAME) in 2012, which lists the medicinal drugs, including HMPs, to be prescribed by physicians through the SUS. Only 12 plant-based drugs are listed on RENAME and have therefore undergone thorough research and testing and are considered safe for human use, of which only four are native from Brazil. There are prior experiences in value chain development with each of these, although the market is different for each species. Similarly, the National List of Medicinal Plants of Interest for the SUS (RENISUS – Relação Nacional de Plantas Medicinais de Interesse ao SUS) only includes 40 native plants from Brazil with the potential to lead to plant drug development. It is evident that the number of native plant species that have been identified in these and other lists developed by the Ministry of Health is still very limited.
34. Both the pharmaceutical sector in Brazil and the government are increasingly investing in R&D, the latter through universities, federal institutes and business incubators. However, these processes often take time to go from the discovery phase of a new product to its successful production and sale at scale (although the processes for the development of traditional herbal products are much shorter than those for herbal medicines). There is a dire need for R&D in this area.
35. Currently there are still limited partnerships between indigenous and local communities, science and industry to promote research and development of herbal medicinal products based on native Brazilian species. There is great scope for ILCs to take a more proactive role in kickstarting such processes[footnoteRef:25]. Where partnerships do develop based on access to genetic resources or access to associated traditional knowledge, this imposes the need to ensure compliance with the 2015 ABS law. It is also important to enable ILCs to be in a position to negotiate fair terms for the equitable sharing of benefits. [25: In this respect, the IPR initiative has great importance. In a legal case in Brazil related to access to TK, which resulted in a cosmetic product, for the decision, the judge reverted the titularity of intellectual property rights request to the Ashaninka indigenous people, based on the fact that the research started as a result of indigenous interest and initiative. ]
36. In addition, there is insufficient integration between research centres, ILCs and companies. Furthermore, the research is not carried out with a focus on the requirements defined by the health surveillance authority. As a result, research that takes place in Brazilian universities on herbal medicinal plants often does not lead to the development and licensing of products. The systematic review and the R&D promoted through the project can develop a new research culture, oriented toward the development and licensing of new products.
Barrier 3: Regulatory and institutional challenges limit the registry, notification and commercialization of herbal medicinal products based on native Brazilian species and traditional knowledge in the Unified Public Health System (SUS), with opportunities lost for wider benefit sharing with ILCs
37. The public health sector in Brazil faces the challenge of dispensing medicine that is accessible, affordable and effective to a large portion of its population of 200+ million people. The role that herbal medicinal products could potentially play in helping address these challenges show promise. Yet a number of conditions need to be in place to increase the number of products available in the public health system (SUS) that are based on native Brazilian species, to strengthen the role of ILCs in phytotherapic value chains, and to ensure full compliance with ABS and related legislation.
38. Brazil already has significant experience in implementing ABS legislation since 2001. However, ABS procedures and related regulations established prior to 2015 were very complex and time consuming, inhibiting research based on Brazilian biodiversity, including to develop plant-based drug products. The new 2015 ABS Law brings clarity on rights and obligations related to access to genetic heritage, protection and access to traditional knowledge and benefit sharing. The Law also stipulates that the process for registry and notification of herbal medicinal products based on traditional knowledge of native species be simplified, and that the development of new regulations be carried out in a participatory fashion. In addition, sanitary norms were adjusted in 2014 as part of efforts to guarantee quality control, safety and efficacy of herbal medicines.
39. However, not all necessary regulations and procedures are in place to promote greater licensing of HMP based on native species and with the involvement of ILCs. There is a need to review the regulatory framework at different stages of the value chain[footnoteRef:26]. Currently, the existing standards for quality control and the good manufacturing practice rules for herbal medicines registration work as a barrier to the development of products in this sector by medium and small organizations, including those associated with ILCs. Furthermore, other regulations may also require consolidation and simplification, such as those of the Ministry of Agriculture, Livestock and Food Supply related to the production of seeds and seedlings of medicinal plants. Such regulatory revisions would enable ILCs to take on a much more important role in phytotherapic value chains, by enabling them to register and notify their products and enabling them to sell them to the public health system (SUS). In addition, there is a need to facilitate administrative procedures and coordination among government agencies responsible for the regulation and inspection of different stages involved in phytotherapic value chains.[footnoteRef:27] [26: Hasenclever et al. 2017.] [27: Ibid.]
40. In order to develop a well-established market for native medicinal plants based on access to genetic resources, it is also key that the SUS allows and stimulates Brazilian physicians and other health professionals to prescribe HMPs to their patients and that these practices became gradually institutionalized in the SUS. This currently limited by the fact that medical practitioners have often received limited to no training on phytotherapy and phytotherapy is not an obligatory part of the curriculum of the medical, dentistry, nursing or other university programs in the field of health (if present, it is optional and only offered by a few universities. Even in these cases, continuous capacity building is required, considering the prospects of increased R&D initiatives and the private sector interest in developing new herbal medicinal products to satisfy the Brazilian market and exports. They therefore have limited experience in prescribing these types of products, even as a complement or a substitute for conventional products. In a study carried out in the city of Pelotas, for example, it was found that only 10% of health professionals prescribed herbal medicines to their patients[footnoteRef:28]. In addition, as previously mentioned, only four native Brazilian species are included in the RENAME list of medicinal drugs to be prescribed by physicians through the SUS. [28: OSHIRO et al., 2016. ]
41. Finally, with regard to the SUS, the municipalities are responsible for basic health assistance, including medicine purchasing. Municipalities have little experience and awareness of the uses of herbal medicinal products. Institutional strengthening in this regard could play an important role in increasing the market for herbal medicinal products based on native species and traditional knowledge.
2
III. Strategy
Approach and Theory of Change
42. The project’s Objective is to enhance global biodiversity benefits, as well as multiple national and local co-benefits, arising from the sustainable, accessible, and innovative use of medicinal plants in Brazilian ecosystems. The project will introduce and test a novel model for HMP value chains, which encourages the consistent valuation and prioritization of native Brazilian species in the HMP segment, as well as ABS compliance. It is expected that this will lead to sustainable management and conservation of gene pools, as well as to socio-economic benefits. The model will support agroecological land-uses and sustainable practices, more specifically by mainstreaming sustainability models and standards into the upstream aspect of HMP’s value chains (whether raw materials are obtained through cultivation or wild harvesting).
43. The project will apply a value chain approach through the strengthening of phytotherapic value chains at the site level in LPAs, while at the same supporting more research on promising herbal medicinal products and increasing demand for such products by working with the country´s public health system (SUS). This integrated approach will ensure that barriers undermining the strengthening of value chains based on herbal medicinal plants are tackled at all relevant levels. At the same time, the project involves an interesting hybrid of work to mainstream biodiversity as well as to promote access and benefit sharing (ABS), thus promoting biodiversity, social safeguards and socio-economic benefits.
44. Through effective collaboration and partnerships, a diverse range of actors with a stake in phytotherapic value chains will be integrated in the project, such as Indigenous and Local Communities (ILCs), industry suppliers, research institutes, regulatory agencies, municipalities, and medical practitioners, to name a few. The approach to working with ILCs includes helping interested groups to implement sustainable agroecological production methods, supporting the production of herbal medicinal products and their commercialization at the level of target sites. The project will also work in a fully participatory manner with ILCs to increase their understanding of ABS-related legislation, to strengthen their ability to negotiate fair ABS agreements and to involve them fully in consultations to simplify regulations to better enable them to register or notify their products.
45. In addition to the promotion of social inclusion and socio-economic benefits for ILCs, the project will target gender equality through the empowerment of women as both protagonists and beneficiaries in phytotherapic value chains. This will include providing training to women in cooperatives on sustainable phytotherapic extraction and cultivation methods and disseminating best practices, facilitating production aspects and market linkages, strengthening cooperatives and increasing women´s awareness of ABS legislation and negotiation skills to put in place fair ABS agreements, among others.
46. Furthermore, the project will also demonstrate practical mechanisms for facilitating access to genetic resources within a fair and equitable framework, as well as the sharing of benefits that may be derived from the use of genetic resources within the HMP segment, and as applicable, from the associated traditional knowledge. These frameworks will be developed in full compliance with the 2015 national legislation on access and benefit sharing (ABS), which in turn, is aligned with the Nagoya Protocol on ABS.
47. The project´s Theory of Change (please see Figure 3 below) is based on the premise that the strengthening of value chains based on native Brazilian species, promotion of R&D on such species and engagement with the public health system to support the increased incorporation of native herbal medicinal products will serve as drivers to strengthen the phytotherapic sector, and in this way promote the conservation of native species and encourage equitable access and benefit sharing of genetic resources. Biodiversity threats will be reduced by stimulating sectoral growth based on sustainability criteria, which will serve as an incentive to put in place sustainable livelihoods in place of more degrading land use alternatives.
48. The project´s Theory of Change includes several key assumptions. It is expected that with project support, inhabitants of selected target LPAs will be actively engaged in the strengthening of phytotherapic value chains, ensuring ecological sustainability and ABS compliance. Knowledge management and communications will then support upscaling of the experiences at the level of target LPAs. The project plans to work with various target LPAs whose medicinal plant value chains are sufficiently advanced to enable commercialization of HMP in a short time frame and thereby increase family incomes. It is assumed that the promotion of ecologically sustainable phytotherapic value chains and support for filling the gaps in these value chains including as they relate to market access will provide financial incentives that will help divert ILC members away from ecologically destructive practices in the target LPAs. Dissemination of best practice guidelines and implementation of an agroecological self-certification scheme will also promote the adoption of more environmentally sustainable natural resource management practices. Finally, it is expected that new and effective herbal medicinal products will be included in the RENAME list, as a result of research and development activities, which will therefore stimulate more demand for sustainable production thereof.
Figure 3: Project´s Theory of Change
Contribution to SGDs and to national development priorities
49. The project is relevant to, and will contribute to several of the Sustainable Development Goals (SDGs), including:
· Goal 3 – Good health and well-being, by investing in developing the value chains of promising species of herbal medicines and increasing the population’ access to herbal medicinal products by promoting their use within the public health system (SUS).
· Goal 5 – Gender equality, by strengthening a sector in which women already play an important role and thereby broadening their livelihood options, and increasing their income;
· Goal 8 – Decent work and economic growth, by focusing on a sector that is high-value adding and labour intensive and by decoupling economic growth from environmental degradation;
· Goal 9 – Industry, innovation and infrastructure, by promoting the integration of private sector and markets into value chains and by enhancing scientific research and encouraging innovation in the phytotherapic sector involving Brazilian native medicinal plants;
· Goal 10 – Reduced inequalities, by empowering Indigenous and Local Communities to enter into fair and equitable Access and Benefit Sharing agreements;
· Goal 12 – Responsible consumption and production, by promoting ecologically sustainable herbal medicinal plant cultivation and extraction; and
· Goal 15 – Life on land, by promoting the sustainable management of medicinal plants and shifting incentives away from degrading land uses, while at the same time ensuring that medicinal plant harvesting and cultivation are ecologically sustainable.
50. The project contributes to the UNDAF (2017-2021) Outcome 3: “Institutional capacities strengthened to promote public policies, their coherence and implementation, for the sustainable management of natural resources and ecosystem services and the fight against climate change and its adverse effects”.
51. In addition, the project supports key development priorities in Brazil, including increasing access to affordable medicines for its population. The National Policy and Program on Medicinal Plants and Phytotherapic Products (PNPMF), launched in 2006 and in 2008, respectively, share the same objective: ensuring safe access to, and rational use of medicinal plants and herbal medicinal products by the Brazilian population, by promoting the sustainable use of biodiversity, the development of productive value chains and of a truly domestic industry. Also, in 2006, the National Policy on Integrative and Complementary Practices (PNPIC) included phytotherapy in the list of health care options to be made available in the Unified Health System (SUS). Together with the PNPMF, this served to kickstart the interest in investments from the private sector. In addition, it should be noted that Brazil has put in place several incentive programs to stimulate an increase in the number of licensed herbal medicinal products.
52. These policies and the objectives of this project are in line with other national priority policies and actions established by the Brazilian government. For example, the 2016-2019 Pluriannual Plan (PPA), which consolidates government projects and public policy priorities for every four-year period, was designed with a focus on promoting a development model with social inclusion and less inequalities. Each agency and government institution puts in place different policies to achieve this goal. Among some that relate to this project, we can mention:
• National Plan for the Promotion of Social Biodiversity Product Chains (PNPSB). Promote and accelerate the elimination of poverty and social inequality in rural areas, including inequality related to gender, race and ethnicity, through a sustainable territorial development strategy.
• The National Plan for Agroecology and Organic Production (PLANAPO II) addresses the gender perspective through 3 goals and 23 initiatives;
• The National Policy Plan for Women - PNPM addresses biodiversity and gender issues through three chapters;
• Decree No. 6,040, of February 7, 2007, establishes the National Policy for the Sustainable Development of Traditional Peoples and Communities. The goal is to strengthen programs and actions aimed at enhanced gender relations in traditional peoples and communities, women's contributions and participation in government initiatives, valuing the historical importance of women and their ethical and social leadership.
53. Another development priority is ensuring that the Brazilian population benefits from its natural resources and biodiversity and promoting a sustainable bioeconomy. To underscore this, Article 1 of the 2015 ABS Law stresses that ‘Brazilian genetic resources’ are assets for ‘the shared use of the people’. This project will facilitate greater benefit sharing from genetic resources linked to herbal medicinal products. Additional details on the project´s consistency with National Priorities, including national strategies and plans, reports and assessments can be found in section B1 of the CEO Endorsement.
Knowledge, Good Practice and Lessons Learned from Past Initiatives
54. The Ministry of Health issued a call for proposals from 2012-2015 to support Local Productive Arrangements. A total of over 70 LPAs involved in food production and medicinal plant production, among others, received funding. While no final report or analysis is publicly available, discussions with stakeholders involved during the PPG phase indicated that to increase the sustainability of this type of support, it is important to strengthen cooperatives, in particular their ability to manage business and funding. Without this type of support, funds are spent but activities often did not continue once support ceased. Based on this lesson learned, the project has integrated support under Output 1.3 for the strengthening of cooperatives that will be involved in the target LPAs. Another lesson learned is that value chain establishment in LPAs takes time to achieve sustainability. For this reason, much of the funding for LPAs will be dedicated to LPAs that are already established but that face certain barriers to their consolidation in order to be able to sustainably produce and commercialize herbal medicines.
55. Experience has shown that ILCs suffer from public policies that prioritize large scale industrial development rather than local economy strengthening[footnoteRef:29]. A preservationist environmental policy that does not value the role of ILCs in the monitoring and management of natural resources and biodiversity is also problematic. For this reason, this project has a strong focus on strengthening local livelihoods and involving ILCs fully in value chain strengthening and other project activities. [29: Albuquerque et al. 2015 (http://conexoes.ifce.edu.br/index.php/conexoes/article/download/826/611 ).]
56. A lesson learned document[footnoteRef:30] based on brazil nuts value chains in Acre State points to the importance of creating multi-institutional coordination spaces with the aim of integrating actions. Official data indicate a production of more than 10,000 tons of Brazil nuts as raw material. Originally the sale of the production was made directly to companies, through consolidated routes, with significant middlemen activity. In order to increase the value added and the autonomy with regard to sales, commercialization cooperatives were created. Our proposed project has taken this lesson learned on board and will be promoting the strengthening of cooperatives in LPAs. In 2008, a project aiming to integrate actions, elaborated and constituted a multi-institutional Local Productive Arrangement – LPA- the Brazil Nut Support Group. Economic and social benefits increased each year, including: price, producers´ income, loyalty and transparency mechanisms, linked to a significant increase in purchasing and processing capacities, as well as a certification process established for part of the production. Currently a cooperative, through a network of more than 20 associations and small cooperatives, it is the largest Brazil nut producer in the country. According to information from the cooperative, in 2011 COOPERACRE handled 4,000 tons of nuts (40% of Acre state´s production). [30: http://www.terrabrasilis.org.br/ecotecadigital/images/abook/pdf/1sem2015/Abril/26-Governanca%20Sociobiodiversidade.pdf]
IV. Results and Partnerships
Expected Results
57. The project’s Objective is to enhance global biodiversity benefits, as well as multiple national and local co-benefits, arising from the sustainable, accessible, and innovative use of medicinal plants in Brazilian ecosystems. It will do so by strengthening promising phytotherapic value chains, based on indigenous and local communities’ traditional knowledge, in compliance with the applicable ABS regime, and while adhering to ecological sustainability criteria. The project will be implemented through the following four Outcomes:
Outcome 1: Sustainable phytotherapic value chains established in indigenous and local communities (ILCs) within Local Productive Arrangements (LPAs)
Outcome 2: Public and private R&D for the development of native Brazilian herbal medicinal products accelerated through strategic support for more equitable partnerships, ensuring the full engagement of ILCs and ABS compliance
Outcome 3: Simplified and ABS-compliant regulations mainstreamed in the national public health system to increase the demand for, and provide broader access to, herbal medicinal products based on native plants
Outcome 4: Knowledge management, monitoring and evaluation carried out to disseminate information on ABS-compliant and environmentally sustainable phytotherapic value chains and to promote upscaling
Outcome 1: Sustainable phytotherapic value chains established in indigenous and local communities (ILCs) within Local Productive Arrangements (LPAs)[footnoteRef:31] [31: LPAs are clusters of businesses located in the same territory, which present a profile of productive specialization and maintain joint linkages, interaction, cooperation and learning from each other and with other stakeholders, as a means of promoting local development. ]
58. This Outcome will contribute to the strengthening of promising value chains associated with native medicinal plants in the project´s four target biomes. On the supply side, the project will promote agroecological practices in production landscapes in a mosaic of Brazilian ecosystems. The project will ensure the sustainable management of both the medicinal plant species and the landscapes in which they are found. It will also provide support to ILCs to add value to herbal medicinal plants as needed and to access markets and improve their livelihoods. At the same time, this Outcome will ensure that the traditional knowledge associated with the species’ genetic resources is safeguarded and enhanced and that gender and ethnic considerations are mainstreamed. Promising species and value chains will be the focus of field level work within Local Productive Arrangements (arranjos produtivos locais or LPAs), which are clusters of businesses that are mutually strengthening, share a productive profile and adhere to ecological principles. The project will strengthen LPAs and promote collaborative arrangements between ILCs and other key stakeholders. ILCs will be key protagonists in this work as they are the first link in a value chain to be developed or supported by the project, and are also expected to be the end-recipients of ABS-related benefits.
Output 1.1: Value chain mapping is based on existing research on medicinal plant species, feasibility and sustainability analyses to guide the selection of promising phytotherapic chains
59. Under Output 1.1, the project will focus on improving the hotlist of promising native species with medicinal value, produced during the PPG phase[footnoteRef:32] that was built based on research carried out by the Ministry of Health. The goal is to work together with specialists and strategic actors to review and refine the list, identifying current gaps, review what scientific information is missing and identify the most promising species to develop herbal medicinal products. The project will focus on the 10-20 most promising species per biome. This will include gathering information on the geographic origin of these species as well as information on differences in the concentrations of the active pharmaceutical ingredients responsible for the phytotherapic properties produced by the plant depending on many factors associated with the local environment and harvesting conditions. The project will also analyze potential species in terms of their climate change vulnerability and will ensure that the species selected for the final hotlist are resilient to different climate scenarios (in so far as this information is available). [32: During the PPG phase, the long list of promising phytotherapic species produced by the Ministry of Health of over 350 species was shortened to 125 species by including only native Brazilian species. The following data was collected for each species during the PPG: therapeutic use, available information on toxicology (from pre-clinical or clinical studies), states in which found/ geographic distribution, whether or not endemic, whether or not on any list of threatened species (such as IUCN Red List), whether or not on any of Ministry of Health´s official lists, any existing guidelines for cultivation and harvesting, and whether or not used traditionally. Output 1.1 will build on the information already gathered and systematized during the PPG.]
60. In addition to collecting data on the individual species, this output will include an analysis of the state of the relevant value chains, including at the production, manufacturing, transportation, and commercialization stages. The stakeholders involved in the value chains will be identified, mainly including Indigenous and Local Communities, to determine what is working well, gaps that require strengthening and how well positioned ILCs are to participate in value chain strengthening. This will also include mapping the existing relationships between ILCs and companies that currently produce herbal medicinal products with native plants (already established value chains). In addition, this work will entail establishing a baseline regarding the participation of women in particular value chains and the identification of promising value chains that could increasingly include women at different levels. This mapping exercise will include a feasibility analysis of value chains, by screening and categorizing different products with respect to market viability[footnoteRef:33] and benefit generation potential. As part of this, data on the volumes of raw materials or finished materials produced, the therapeutic use indication (analgesic, anti-inflammatory, antibiotic, etc.) and the SUS demand for medicines with the same use indication, the level of interest of the private sector, the availability of markets for the products, and the level of profitability for ILCs will be gathered. [33: This will include an assessment of current costs of production and market prices, among other elements.]
61. This will result in a database of native Brazilian herbal medicinal plant species, along with their medicinal value, relevant scientific information, and information on the viability of value chains in order to define which species and herbal medicinal products are most promising. This information will identify phytotherapic value chains that can be supported by the project under Output 1.2 and will also feed information into Outcome 2 on research gaps that must be filled for specific species. The aim is to work on this Output at the outset of project implementation to make this information available as soon as possible. Once the assessment is complete, the project will be responsible for setting up a website to disseminate the information to the public. As part of the work under this Output, the project will also prepare a diagnosis of the state of the art of ILC medicinal plant value chains. Finally, the project will interact with stakeholders, including with industry and with market players, to promote interest in the development of the value chains that are identified as most promising.
62. The activities under this output include:
0. Carry out feasibility and other analyses to review and refine the hotlist prepared during the PPG phase in order to qualify and add information on the most promising medicinal plant species and value chains for further strengthening under Output 1.2. This will also include a diagnosis of the state of the art of ILC medicinal plant value chains.
0. Establish and maintain the hotlist on a project database and on the project website
0. Carry out a dialogue with market stakeholders, ILCs, industry and other strategic actors about the hotlist species in order to share the information on promising phytotherapic value chains to stimulate their development and/or strengthening.
Output 1.2: Phytotherapic value chains are developed and strengthened in Local Productive Arrangements (LPAs) in the project´s four target biomes
63. This output will test and adapt methods for developing phytotherapic value chains by providing support to target LPAs that offer the best conditions for value chain strengthening. The project will likely work with some LPAs that are already operating and working with value chains, having benefitted in the past from government-backed LPAs. The project will provide the necessary support for them to cultivate or harvest medicinal plants sustainably. In other cases, the project may support communities without previous experience in either value chains or medicinal plants. For all target sites, these interventions will work to ensure ecological sustainability, agroecology, gender equality, social inclusion, regional balance across biomes[footnoteRef:34], equitable sharing of benefits and socio-environmental safeguards. It will also strive to establish a new model of herbal medicinal product production that prioritizes native Brazilian species. The purpose of this output is to provide the LPA with the necessary technical assistance, supplies and equipment to sustainably produce the medicinal plants, to transform the plants to products for the market as needed and to facilitate their commercialization, with the view to ensuring that a greater proportion of the benefits remain with the communities instead of being taken by intermediaries. The goal is to ensure that ILCs and other stakeholders such as the private sector have sufficient incentives for sustainably using biodiversity and associated resources in productive landscapes and for using native (instead of non-native) plant species as raw materials for herbal medicinal products. [34: Currently there is a disproportionate number of companies working in the Southern and Southeast regions of the country, despite the fact that the North and Northeast is known for having very high levels of biodiversity and ILC territories. The project will promote value chain strengthening in four target biomes which have the most biodiversity in Brazil, namely, Amazon, Caatinga, Atlantic Forest and Cerrado.]
64. The following type of support will be provided to LPAs: (a) Providing machinery and equipment to LPAs to promote sustainable production and harvesting, while also benefitting socio-economic development; (b) Improving the capacity of targeted LPAs to adopt best practices for high quality sustainable production. This will include training in agroecological methods as well in ensuring standards are applied to achieve consistent concentrations of the active pharmaceutical ingredients (taking into consideration factors that affect concentration levels, such as harvesting periods, for example).; (c) Developing business plans with engaged ILCs for enhancing multiple benefits in the supply and value chains (including social and livelihoods related), while safeguarding the sustainability of resource use; and finally (d) fostering and developing links between LPAs and promising markets, by taking advantage of scale, synergies and ‘capacity multipliers’ that are a key comparative advantage of LPAs.
65. The PPG phase carried out an analysis of the value chains of four promising species (please see Annex M for the state of these value chains and elements that need strengthening). These include: Schinus terebinthifolius (aroeira); Maytenus ilicifolia (espinheira santa); Mikania glomerata (guaco); and Uncaria tomentosa (unha-de-gato). Based on this analysis, it was deemed beneficial not to limit the list of species to be supported by the project to these species[footnoteRef:35] and to broaden the scope to all species and value chains that are confirmed as promising under Output 1.1. [35: The PPG analyses revealed that the Amazon biome should include another species, since Uncaria tomentosa seems to be more restricted to Acre state, and that Caatinga biome species were not represented. Moreover, these four species are the only Brazilian native species already included in the RENAME list. The project intends to broaden the scope to other promising species and value chains based on the findings of output 1.1 mapping. This can also result on broadening RENAME´s list. ]
66. The project will likely work with a Responsible Party[footnoteRef:36] (the specific organization is still to be confirmed), such as an experienced NGO to manage the implementation of the grants for the projects. This Responsible Party will issue one or more calls for proposals. The preliminary criteria to select grantees (to be confirmed during project implementation) include: [36: Among possible Responsible Parties with know-how in the promotion of value chains involving ILCs and smallholders are: Institute Society, Population and Nature (ISPN), Socio-environmental Institute (ISA), International Institute of Education of Brazil (IEB), Foundation for Scientific and Technological Development in Health (FIOTEC)/Oswaldo Cruz Foundation (FIOCRUZ), Forestry and Agricultural Management and Certification Institute (IMAFLORA), Banco do Brasil Foundation, Floravida Institute, Institute of Conservation and Sustainable Development of Amazonas (IDESAM), SOS AMAZÔNIA, Center of Alternative Agriculture of the North of Minas (CAA-NM), Advice and Management in Nature Studies, and Human Development and Agroecology (AGENDHA).]
· The species of interest are capable of being harvested without threatening the sustainability of the species populations;
· Proximity to areas of high conservation value;
· High level of threats to biodiversity and drivers of deforestation;
· Willingness of communities to establish/strengthen value chains associated with one or more of the native plant species included in the medicinal plant hotlist produced under Output 1.1;
· Commitment of community members to implement ecologically sustainable practices and to adhere to the best practice guidelines for extraction/ cultivation to be produced under Output 1.3;
· Balance of target LPAs in the project´s four target biomes (Caatinga, Cerrado, Amazon and Atlantic Forest).
· Ability or willingness of communities to organize themselves to ensure sufficient production to meet local market demands
· Minimum percentage of women´s or female-led cooperatives and groups
67. The proposals received will be reviewed by the Responsible Party in charge of overseeing this Output, as well as by the project´s technical committee. The final list of selected grantees will be approved by the Project Board. It is expected that a minimum of four LPAs will be funded.
68. Before any activities under this Output can begin in the target LPAs, an Indigenous Peoples Plan will be prepared at project outset, which will contain measures for managing risks identified in the social and environmental screening that pertain to indigenous peoples, traditional communities and family farmers.
69. The following activities are envisaged under this output:
1.2.1 Issuance of calls for proposals and selection of winning grantees based on established
criteria
1.2.2 Development of Indigenous Peoples Plan (that also covers traditional communities and family farmers)
1.2.3 Implementation of grant funds to support value chain strengthening in target LPAs
Output 1.3: Best practice guidelines, agroecological self-certification system and safeguards are put in place to mainstream biodiversity conservation and landscape-level management in targeted productive landscapes within LPAs.
70. The project will systematize and develop best practice guidelines for herbal medicinal product production and harvesting for specific priority species being targeted under Output 1.2 that do not already have such data, working together with the Ministry of Agriculture, Livestock and Food Supply and with the Ministry of Environment to do so. These guidelines will establish sustainable harvesting limits and thresholds of potential concern for the in-situ harvest of targeted species and agronomic guidelines for cultivation in the target LPAs (based on yield studies, regeneration surveys, harvest assessments and harvest adjustments, etc., as needed). Best practices will be outlined to ensure that the cultivation or harvesting of the targeted plant species do not negatively impact plant species populations or biodiversity and that landscape-level criteria such as connectivity are taken into consideration. These guidelines will be shared with the grantees under Output 1.2, and adherence will be mandatory.
71. The project will also put in place an agroecological self-certification scheme that will be applied to all the target LPAs to certify that the LPAs meet the requirements for producing the raw material for the herbal medicinal products in an ecologically sustainable way. This will be a means of promoting adoption of sustainable agroecological practices. This will also enable the products sourced from these sites to have a mark of recognition of their sustainable sourcing. This certification scheme will be designed to meet the needs of ILCs and will therefore not be overly burdensome; as such, it will likely involve self-certification overseen by peers.
72. In order to increase the sustainability of project interventions, the project will also provide training to the cooperatives/ small organizations that receive funding under Output 1.2[footnoteRef:37]. Specifically, this will involve training in business administration and in fund management. It will also include disseminating information to the cooperatives on existing government credit lines and how to prepare proposals to access these, which is often a limiting factor for cooperatives to continue to engage in sustainable production and activities related to value chains. Finally, the project will provide cooperatives with information on possible opportunities for technical support for the development of business plans to stimulate investment by the private sector and to promote financially viable value chains. [37: This work will be carried out under Output 1.3 rather than Output 1.2 to enable the PMU to apply a consistent approach and manage this training for cooperatives across the different LPAs supported by the project. (Under Output 1.2 the funds will go to the different individual LPAs).]
73. Training will also be provided to Technical Assistance and Rural Extension (ATER) in order to strengthen the knowledge among extensionists and those providing technical assistance on medicinal plants on good practices for their extractivism, cultivation and processing. This will include training, for example, on agroecological methods of cultivation, on how to ensure standards are applied in order to achieve consistent concentrations of active pharmaceutical ingredients and on how to comply with MAPA regulations related to the production, commercialization and use of seeds and seedlings of medicinal species.
74. As part of the environmental and social safeguards to be put in place, the Project Management Unit will regularly monitor the projects being implemented with the support of a Responsible Party and verify for compliance with the conditions established for the grants and with UNDP SES requirements. This will include ensuring that the phytotherapic value chains are ABS-compliant and adhere to all the legislation in place on ILCs on the one hand and that they promote biodiversity-friendly management on the other hand (adhering to the best practice guidelines and to the agroecological self- certification scheme).
75. The following activities will be carried out under this output:
1.3.1 Development of species-specific best practice guidelines for medicinal plant production and harvesting and their dissemination
1.3.2 Implementation of agroecological self-certification scheme to be applied to all the target LPAs
1.3.3 Provision of training to cooperatives involved in Output 1.2 on business administration, fund management and on accessing existing government credit lines
1.3.4 Provision of training to extensionists on best practices for medicinal plant harvesting and cultivation, with a focus on project target species
1.3.5 Project monitoring of environmental and social safeguards
Outcome 2: Public and private R&D for the development of native Brazilian herbal medicinal products is accelerated through strategic support for more equitable partnerships, ensuring the full engagement of ILCs and ABS compliance
76. This Outcome is focused on addressing knowledge barriers, which currently prevent many native Brazilian medicinal plants from being included in the national list of products that can be prescribed by physicians in the public health system and can be used by the population. This Outcome will support research on native plant species´ genetic resources by public institutions and the private sector, research that will be carried out in collaboration with traditional knowledge holders and in compliance with ABS legislation. New uses of genetic resources and derivatives may be explored with scientists, industry and ILCs working side-by-side in an ABS compliant fashion, registering traditional knowledge in the process and paving the way for equitable benefit sharing. Existing uses can also be strengthened and nuanced. In addition to supporting this R&D, the project will enable indigenous and local communities to have greater awareness of the existing ABS legislation and greater capacity to enter into fair agreements with research institutes and the private sector for the research and development of phytotherapic products.
Output 2.1: ABS-compliant partnerships between research institutes, private sector and/or NGOs are established to promote research and development on medicinal plants and herbal medicinal products
77. This Output will support the funding of research to fill in knowledge gaps for promising medicinal plant species identified in the hotlist, including for the development of traditional herbal products and herbal medicines. Funding will be provided to public universities, research centres, private sector and/or NGOs, prioritizing those with substantial capacity and experience in medicinal plants and herbal medicinal product research and those that have additional funds available for research so that the support will be fully collaborative and the impact will be maximized. The project will support R&D in each of the project´s four target biomes of Brazil.
78. For public universities, the project will enter into cooperation agreements, which would be formalized through Letters of Agreement detailing the funding amounts, responsibilities and deliverables. The Table in Annex F with the Stakeholder Engagement Plan identifies possible universities and research centres with which the project may work, which are already engaging in research on medicinal plants and herbal medicinal products. In the event that private companies or NGOs are also identified to carry out some of this R&D, a competitive procurement process would be followed and the selected entities would adhere to Terms of Reference. Co-financing from public institutions, companies and NGOs will significantly increase the impact of the funds provided by the project, including beyond the project’s lifetime, given the relatively long R&D time for products in the pharmaceutical sector.
79. The project will enable researchers to systematize existing information through a bibliographic review and to perform additional tests through lab work to fill data gaps as needed in order to produce monographs. The latter includes information such as the therapeutic uses of the product, the part of the product that is used, side effects, and methods of administering the herbal medicinal products and posology. Pending validation and approval by ANVISA, the regulatory agency, these species could then be added to the Herbal Medicine Memento, which gathers information on the therapeutic uses and botanical characteristics of medicinal plants and is one of the Compendiums of the Brazilian Pharmacopoeia[footnoteRef:38]. This research will provide information that can be built upon by private sector for further clinical studies and product development as needed. [38: A book, especially an official publication, containing a list of medicinal drugs with their effects and directions for their use.]
80. The research will be undertaken following the principles of free, prior and informed consent (FPIC) and in collaboration with indigenous and local communities for the herbal medicinal products based on traditional knowledge. The R&D will also be carried out in compliance with ABS legislation and will ensure transparency so that local stakeholders can accompany the development of herbal medicinal products.
81. The project may work with existing Nuclei of Technological Innovation and Technology Transfer (NITs) of research centres under this Output. These nuclei must be established by all technological and research institutes and are responsible for managing the institutional innovation policy[footnoteRef:39]. The project will provide support and training for NITs that want to work to integrate the research institutes in community-science-industry partnership arrangements among ILCs and the private sector. This will help bridge existing gaps and enable the integration of the R&D activities of research institutions with other stakeholders engaged in the medicinal plant sector for the development of ABS-compliant herbal medicinal products. [39: ]
82. The main activities under this output will be:
2.1.1: Identify organizations and award funding for phytotherapic research through cooperation agreements with public universities and/or contracts with private sector research centres and/or NGOs.
2.1.2: Carry out research and development on promising medicinal plant species to produce a maximum of 60 monographs.
2.1.3. Identify focal points in the public research institutes engaged in phytotherapic research and provide them with support and training to increase the level of coordination with ILCs and industry/ private sector for the development of herbal medicinal products.
Output 2.2: ILC’s negotiating capacity to enter into ABS agreements related to research and development on medicinal plant resources with research institutions and private sector companies is enhanced
83. This output will provide capacity building to indigenous and local communities to strengthen their knowledge of ABS legislation and their negotiation capacity when it comes to genetic resources from medicinal plants and their associated traditional knowledge in order to ensure a fair distribution of the benefits arising from the commercialization of herbal medicinal products. The project will target ILC stakeholders involved in phytotherapic/medicinal plant value chains who have little or no knowledge related to ABS and who have not already built up their negotiating capacity from participation in other types of value chains (such as for cosmetics). With the support of the Ministry of Environment, an ABS expert will provide specific training on the following topics: a) ABS-related legislation; b) business models of pharmaceutical, botanical, biotechnology and other industries that use genetic resources and associated traditional knowledge for the development of phy