Moreover, if biological resources and traditional knowledge are taken from indigenous or marginalized groups, the  commercialization  of their natural resource can harm communities. Despite the medicinal and innovative benefits of bioprospecting and biochemical research, the expropriation of indigenous land for their genetic resources without fair compensation inevitably leads to exploitation. Biopiracy can harm indigenous populations in multiple ways. Without proper compensation or reward for traditional knowledge of natural resources, the sudden increase in commercial value of the species producing the  active compound  can make it now unaffordable for the native people. In some cases, a patent filed by the  western  company could prohibit the use or sale of the resource by any individual or institution, including the indigenous group. With nearly one third of all small-molecule drugs approved by the  U.S. Food and Drug Administration  (FDA) between 1981 and 2014 being either  natural products  or compounds derived from natural products, bioprospecting or piracy is growing more significantly, especially in the  pharmaceutical industry . [ 3 ]  Furthermore, the United Nations Educational, Scientific and Cultural Organization (UNESCO) mentions, in the context of intangible cultural heritage (ICH), that the medicinal traditions and knowledge of the Kallawaya communities in Peru have been affected by the lack of legal protection from pharmaceutical companies. A number of research projects are currently being developed on this subject, such as the research carried out using digital methods on the biopiracy of traditional medicines, [ 4 ] [ 5 ]  which shows the current context of the problem by developing a description and analysis of the data, and by visualising and mapping the various organisations and actors in the social networks.


With the advancement of  extraction  techniques of genetic material in  biochemistry  and  molecular biology , scientists are now able to identify a specific  gene , which directs to  enzymes  capable of converting one molecule to another. [ 6 ]  This scientific breakthrough brings up the question of whether the organism containing the gene that has been modified through a series of tests and experiments should be accredited to the country of origin.


Biopiracy is historically associated with colonialism, where developing resource-rich countries and indigenous populations would be exploited without permission. Since the arrival of European settlers in search of gold, silver, and rare spices, the wealth of knowledge on plant-based riches was highly valued. [ 2 ]  Following  Marco Polo 's journey through Southwestern India and  China ,  Christopher Columbus  expanded upon the " Spice Route " with the help of the Spanish Court. These explorers, amongst hundreds more, share an infamous history of pillaging through indigenous villages and depriving countries of their natural resources. Western food and pharmaceutical companies have profited immensely from these efforts. Valuable commodities like sugar, pepper, quinine, and coffee were all taken from colonized countries that led to environmental destructions in the corresponding developing countries. [ 7 ]


The  General Agreement on Tariffs and Trade  (GATT) of 1947 was an effort to encourage international trade by reducing or eliminating trade barriers like tariffs or quotas. [ 8 ]   Trade-Related Intellectual Property Rights  (TRIPS) was negotiated at the end of GATT. Similarly, Columbus set a precedent in 1492 through land titles granted by European kings and queens, which acted as a sort of patent for colonizers. The  World Trade Organization  (WTO) agreement of TRIPS attempts to signal the importance of maintaining a balance between trade and intellectual property. This agreement, since 1994, requires WTO member countries to develop legal frameworks to protect plant and animal resources in agricultural, pharmaceutical, chemical, textile, or other commodity contexts. [ 1 ]  Several countries have criticized this agreement, claiming that it's counterproductive in protecting their natural resources.


The Eurocentric roots of property claiming and piracy are reinforced by modern Intellectual Property laws established by GATT and WTO which supplements the colonial ideas to "discover and conquer" and to "subdue, occupy, and possess." [ 9 ]  Environmental activist and food sovereignty advocate  Vandana Shiva  calls patenting and claiming rights to genetic material and bio-resources "the second coming of Columbus" due to its reinforcement of colonial power dynamics. [ 9 ]  For example, the intellectual property for Indian products like tamarind, turmeric, and Darjeeling tea have been taken and patented by private corporations in historically colonial countries. More specifically, in 2010 The University of Michigan attempted to patent curcumin, the active ingredient of turmeric powder, to create drugs used for wound healing without directly crediting Indian communities, where turmeric was traditionally used in medicine for treating wounds, infections and skin problems for centuries.  [ 1 ]


The "Gene Rush" is the new era of biotechnology that allows scientists to extract specific genes from living organisms as raw materials. With the introduction of deoxyribonucleic acid ( DNA ) research,  Sri Lanka  has been marked with imminent danger as a target of biopiracy. Spotted in the top 34 biodiversity hotspots, Sri Lanka claims the highest biodiversity per unit area of terrestrial among Asian countries. [ 2 ]  Currently, Sri Lanka has 1,500 identified species of  medicinal herbs  and plants, and its attraction to biopiracy has put environment protection and conservation at a significant priority in the country. Recent efforts were enacted by  United Nations Industrial Development Organization  (UNIDO) in collaboration with the Spice Council and the  government of Sri Lanka  to enhance the productive capacities and competitiveness of the cinnamon value chain in the country. [ 10 ]


"Biopiracy" was coined in the early 1990s by  Pat Mooney , founder of ETC Group which works to protect the world's most vulnerable people from socioeconomic and environmental impacts of new, modern technologies. He defines it as when researchers or research organizations take biological resources without official sanction, largely from less affluent countries or marginalized people. [ 7 ]  Biopiracy includes theft or misappropriation of genetic resources and traditional knowledge through the intellectual property system and unauthorized and uncompensated collection of genetic resources for commercial purposes. [ 7 ]  Mooney, along with other critics of the patent system, believes that the current intellectual property system creates inequities in the system by allowing wealthy and powerful groups of people to own the most basic building blocks of life.


Intellectual property (IP) rights include  patents ,  copyright ,  industrial design rights ,  trademarks ,  plant variety rights ,  trade dress ,  geographical indications , and sometimes  trade secrets .


Intellectual property rights (IPR) were created to promote and reward scientific knowledge and creativity. However, they naturally weigh towards benefiting transnational corporations. [ 9 ]


Early intellectual property treaties were crafted in the late 19th century by European powers, and inherently ignored large parts of the impact of intellectual property on non-European peoples, cultures, and traditions.


In the late 20th century, more inequalities were added to the intellectual property system, representing a shift from common rights to private rights of knowledge. The preamble of  TRIPS agreement  acknowledges these rights as private rights. By privatizing intellectual commons, TRIPS encourages corporate  monopoly .


A second restriction comes from the fact that IP rights are only recognized when they generate  profit , rather than then when they meet social needs. The TRIPS agreement clarifies that an innovation must be capable of industrial profit in order to be recognized as an IPR, [ 11 ]  which discourages recognition of  social good .


In parallel, the international community has been working on different legal pathways to rebalance the intellectual property system in favour of  indigenous peoples  and local communities, in an attempt to address concerns related to biopiracy.


First elements related to genetic resources and traditional knowledge were included in the 1992  Convention on Biological Diversity  (CBD). In 2010 (in force 2014), the  Nagoya protocol  to the CBD created actionable mechanisms to ensure a  fair access and benefit-sharing  (FABS or ABS) of  genetic resources  (GR).


In June 2023, the UN adopted the United Nations agreement on biodiversity beyond national jurisdiction (BBNJ Agreement), also called "High Seas Treaty". It concerns the conservation and sustainable use of  marine biological diversity  in areas beyond national jurisdiction, following maritime jurisdictions established under the  United Nations Convention on the Law of the Sea .


Since 2001, the  World Intellectual Property Organization  through its  Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore  (IGC) has worked on several areas to bridge the gaps in international law in relation to biopiracy in genetic resources,  traditional knowledge  (TK), and  traditional cultural expressions  (TCE, formerly called "folklore"). [ 12 ]


The first output from the work of the IGC was a Diplomatic Conference, held in May 2024 to agree on a treaty for patent disclosures requirements in relation to "GR and Associated TK" (hence the treaty's acronym, GRATK). On 24 May 2024, the WIPO Diplomatic Conference finally adopted the "landmark" [ 13 ]   WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge  (GRATK), [ 14 ]  which was signed by 30 countries on the day of its conclusion. [ 15 ]


In the arid areas of India, the neem tree, or  Azadirachta indica , is a fast-growing evergreen of up to 20 meters in height. From its roots to leaves, the tree contains a number of potent chemical compounds, including  azadirachtin  which can be found in the seeds. The neem tree has applications in medicine, toiletries, contraception, timber, fuel, and in agriculture. [ 17 ]  Historically, access to the neem tree's various products has been free or cheap. There are about 14 million neem trees in India, and the centuries old village techniques of seed oil extraction and pesticidal emulsions do not require expensive equipment. Villagers relied on the large number of different medicinal compounds accessible through the neem material which were commonly available. [ 17 ]  When US timber importer Robert Larson noticed the tree's usefulness in 1971, he conducted research over the next decade on the pesticidal properties in the neem extract called  Margosan-O . After gaining clearance for the product from the US Environmental Protection Agency (EPA) in 1985, he sold the patent for the product to  W.R. Grace . While the corporation patented the neem tree seed extract for their antifungal spray, Neemex in 1994, neem extracts have been used by rural farmers in India for more than 2,000 years in insect repellants. [ 7 ]


India-based Research Foundation for Science, Technology, and Ecology (RFSTE) challenged the US patent with the claim that the qualities of the neem tree and their use had been known in India for over 2,000 years. [ 18 ]  The  Congressional Research Service  (CRS) reported to US Congress in justification of the patent claiming that the synthetic form or the process of synthesis of the naturally occurring compound should be patentable. [ citation needed ]  The patent was finally overturned by the EPO in 2000. [ 7 ]  The village neem tree has become a symbol of Indian Indigenous knowledge and resistance against transnational corporations, and protestors against international property rights legislation carried twigs or branches of neem. [ 17 ]


The  Hoodia  plant of the  Kalahari Desert  was used for thousands of years by the  nomadic   San people  in southern Africa to help survive through hunger and thirst during their long expeditions in the desert. [ 19 ]  In 2016, the South African  Council for Scientific and Industrial Research  (CSIR) gained a government-funded patent for a new drug ( P57 ) derived from the succulent for its appetite-suppressing qualities. [ 20 ]  CSIR scientists isolated the P57 molecule in 1996 after decades of research on indigenous plants. [ 21 ]  The patented formula was sold to western pharmaceutical multinational companies  Pfizer  and  Phytopharm  as a miracle drug for weight loss.


Following the confirmation of the patent, representatives of the San people, backed by the global support of patent-law critics and bioethicists, demanded restitution of their rights to their common intellectual property. After a long dispute, CSIR and the San people came to a confidential 'benefit-sharing' agreement where the San people were given royalties, knowledge exchange and creation of jobs from the industry. [ 20 ]


Piña cloth , in the nineteenth century, was a creation unique to the  Philippines . With fibers collected from the leaves of  pineapples , the weaving mechanism of piña is a complex and labor-intensive process used by a small number of women to dress the country's elite. Scraping, the most common method of extracting pineapple leaf fibre (PALF), starts with carefully removing the prickles, epidermis, and pulp from the sides of the leaf with a dull knife. [ 22 ]  This is followed by exposing the fiber and finely combing it to separate the strands. With the help of a bamboo device, the separated strands are then threaded and weaved together through a delicate process to create a continuous filament. After some years of research and development of potential leather alternatives at the  Royal College of Art  in London, Dr. Carmen Hijosa, founder and chief creative innovation officer of Ananas Anam, claimed the rights to  Piñatex , a leather alternative made from PALF. [ 23 ]  The patent on this technology makes it nearly impossible for the people of the Philippines and indigenous people to gain credit for the fabric that greatly impacted the shape of their history and culture for generations. Piñatex recently partnered with  Dole , promising scaled-up leather production with the waste product from their pineapple farms in the Philippines. Despite the violent history of the Dole Empire, Piñatex has been expanding its market by collaborating with brands like  Chanel ,  H&M , and  Nike . [ 24 ]  The patent remains to this day.


Greenwashing  is a term coined by environmentalist  Jay Westervelt  in 1986, meaning the false claims by companies that give the impression of sustainability and environmentalism. [ 25 ]  Without clarifying the metrics and quantifiable goal of the company's environmental agenda, many big companies attempt to paint the picture of  ethical  and  eco-friendly  images. Resources and materials pirated from indigenous communities are often commodified and recycled into corporate environmentalist agendas. Due to the exploitative nature of the  fast fashion   supply chain , many 'green' collections released by corporations only promote their marketing strategies and increase problems with textile waste and  climate change .


Nike  received backlash after the 2020 Impact Report which showed the lack of  sustainability  in  footwear . To tackle the feedback, Nike launched the Happy Pineapple Collection featuring Ananas Anam's  vegan leather  material and a tropical fruit design embroidered across the  Air Max 90 , the Air Max 95,  Air Force One , and Air-Zoom collections. [ 24 ]


The Conscious Collection released by H&M in 2010 also partners with Ananas Anam to produce vegan leather jackets. [ 26 ]  Due to inconclusive data on Piñatex  biodegradability , the Norwegian Consumer Authority accused the brand of misleading customers with vague details of the sustainability claims made. The brand responded by saying they would accept the criticism and communicate the extra value. [ 24 ]


The  Convention on Biological Diversity  created by the  United Nations  in 1992 demanded that  bioprospecting  should not be done without the consent of the host country. The convention concluded that exploitation of local resources for medicinal and pharmaceutical purposes should actively involve local traditional communities and the produced profit and benefits be shared in an equitable way. [ 27 ]


The  International Cooperative Biodiversity Group  (ICBG) is a network of bioprospecting projects funded by the US government. While the main objective is to discover and research plants bearing chemical compounds that could cure diseases in the United States, the countries hosting the searches can expect equitable rewards and benefits. Local job creation in communities is promoted by conducting the initial extraction and analysis steps in local laboratories. If the research leads to commercialized drugs, 50% of the royalties are invested into community development funds run by indigenous people. [ 27 ]


Ayahuasca [ note 1 ]  is a South American  psychoactive  beverage, traditionally used by  Indigenous  cultures and  folk healers  in the  Amazon  and  Orinoco basins  for spiritual ceremonies,  divination , and healing a variety of psychosomatic complaints. [ 1 ]


Originally restricted to areas of  Peru ,  Brazil ,  Colombia  and  Ecuador , in the middle of the 20th century it became widespread in Brazil in the context of the appearance of  syncretic  religions that use ayahuasca as a sacrament, like  Santo Daime ,  União do Vegetal  and  Barquinha , which blend elements of  Amazonian Shamanism , Christianity,  Kardecist Spiritism ,  and  African-Brazilian religions  such as  Umbanda ,  Candomblé  and  Tambor de Mina , later expanding to several countries across all continents, notably the United States and Western Europe, and, more incipiently, in Eastern Europe, South Africa, Australia, and Japan. [ 2 ] [ 3 ] [ 4 ]


More recently, new phenomena regarding ayahuasca use have evolved and moved to urban centers in  North America  and Europe, with the emergence of  neoshamanic  hybrid rituals and  spiritual  and  recreational drug tourism . [ 5 ] [ 6 ]  Also, anecdotal evidence, studies conducted among ayahuasca consumers and clinical trials suggest that ayahuasca has therapeutic potential, especially for the treatment of substance dependence, anxiety, and mood disorders. [ 7 ] [ 8 ] [ 9 ] [ 10 ] [ 11 ]  Thus, currently, despite continuing to be used in a traditional way, ayahuasca is also consumed recreationally worldwide, and is considered as a potential future treatment in modern medicine. [ 12 ]  Ayahuasca often causes nausea and vomiting and has a number of rarer more serious possible side effects including breathing difficulties and seizure; it may cause psychosis in those predisposed to the condition. [ 13 ]


Ayahuasca is a  hallucinogen  commonly made by the prolonged decoction of the stems of the  Banisteriopsis caapi  vine and the leaves of the  Psychotria viridis  shrub, although hundreds of species are used in addition or substitution (See "Preparation" below). [ 14 ]   P. viridis  contains  N , N -Dimethyltryptamine  (DMT), a highly  psychedelic  substance. Although orally inactive,  B. caapi  is rich with  harmala alkaloids , such as  harmine ,  harmaline  and  tetrahydroharmine  (THH), which can act as  monoamine oxidase inhibitors  (MAOi). This halts the liver and gastrointestinal metabolism of DMT, allowing it to reach the systemic circulation and the brain, where it activates  5-HT 1A/2A/2C  receptors in frontal and paralimbic areas. [ 15 ] [ 16 ]


Ayahuasca  is the  hispanicized  spelling (i.e., spelled according to Spanish orthography) of a word that originates from the  Quechuan languages , which are spoken in the Andean states of  Ecuador ,  Bolivia ,  Peru , and  Colombia . Speakers of Quechuan languages who use  modern Quechuan orthography  spell it  ayawaska . [ 17 ]  The word refers both to the  liana   Banisteriopsis caapi , and to the brew prepared from it. In the Quechua languages,  aya  means "spirit, soul", or "corpse, dead body", and  waska  means "rope" or "woody vine", " liana ". [ 18 ]  The word  ayahuasca  has been variously translated as "liana of the soul", "liana of the dead", and "spirit liana". [ 19 ]  In the  cosmovision  of its users, the ayahuasca is the vine that allows the spirit to wander detached from the body, entering the spiritual world, otherwise forbidden for the alive.


Although  ayahuasca  is the most widely used term in  Peru ,  Bolivia ,  Ecuador  and Brazil, the brew is known by many names throughout northern South America:


In the last decades, two new important terminologies emerged. Both are commonly used in the Western world in  neoshamanic ,  recreative  or  pharmaceutical  contexts to address ayahuasca-like substances created without the traditional botanical species, due to it being expensive and/or hard to find in these countries. These concepts are surrounded by some controversies involving  ethnobotany , patents,  commodification  and  biopiracy : [ 38 ] [ 39 ] [ 40 ]


Archaeological evidence of the use of psychoactive plants in northeastern Amazon dates back to 1500–2000 BCE. Anthropomorphic figurines, snuffing trays and pottery vessels, often adorned with mythological figures and sacred animals, offer a glimpse of the  pre-Columbian  culture regarding use of the sacred plants, their preparation and ritual consumption [citar naranjo 86]. [ citation needed ]  Although several botanical specimens (like tobacco,  coca  and  Anadenanthera spp. ) were identified among these objects, [ 43 ]  there is no unequivocal evidence of this date referring directly to ayahuasca.  Banisteriopsis caapi  use is suggested from a pouch containing carved snuffing trays, bone spatulas and other paraphernalia with traces of  harmine  and  DMT , discovered in a cave in southwestern Bolivia in 2008, [ 44 ]  and chemical traces of harmine in the hair of two mummies found in northern Chile. [ 45 ]  Both cases are linked to  Tiwanaku  people, circa 900 CE. There are several reports of oral and nasal use of  Anadenanthera spp.  (rich in  bufotenin ) ritualistically and therapeutically during labor and infancy, and researchers suggest that addition of  Banisteriopsis spp.  to catalyze its psychoactivity emerged later, due to contact between different groups of Amazon and  Altiplano . [ 46 ]


Despite claims by numerous anthropologists and ethnologists, such as  Plutarco Naranjo , [ 47 ]  regarding the millennial usage of ayahuasca, compelling evidence substantiating its pre-Columbian consumption is yet to be firmly established. As articulated by  Dennis McKenna : [ 43 ]


"No one can say for certain where the practice may have originated, and about all that can be stated with certainty is that is already spread among numerous indigenous tribes throughout Amazon basin by the time ayahuasca came to the attention of Western ethnographers in the mid-nineteenth century"


The first western references of the ayahuasca beverage dates back to seventeenth century, during the  European colonization of the Americas . The earlier report is a letter from  Vincente de Valverde  to the  Holy Office of the Inquisition . [ 48 ]   Jose Chantre y Herrera  still in the seventeenth century, provided the first detailed description of a "devilish potion" cooked from bitter herbs and lianas (called  ayaguasca ) and its rituals: [ 49 ]


"[...] In other nations, they set aside an entire night for divination. For this purpose, they select the most capable house in the vicinity because many people are expected to attend the event. The diviner hangs his bed in the middle and places an infernal potion, known as ayahuasca, by his side, which is particularly effective at altering one's senses. They prepare a brew from bitter vines or herbs, which, when boiled sufficiently, must become quite potent. Since it's so strong at altering one's judgment in small quantities, the precaution is not excessive, and it fits into two small pots. The witch doctor drinks a very small amount each time and knows well how many times he can sample the brew without losing his senses to properly conduct the ritual and lead the choir".


Another report produced in 1737 by the missionary  Pablo Maroni , describes the use of a psychoactive liana called ayahuasca for divination in the  Napo River , Ecuador: [ 50 ]


"For divination, they use a beverage, some of  white datura  flowers, which they also call Campana due to its shape, and others from a vine commonly known as Ayahuasca, both highly effective at numbing the senses and even at taking one's life if taken in excess. They also occasionally use these substances for the treatment of common illnesses, especially headaches. So, the person who wants to divine drinks the chosen substance with certain rituals, and while deprived of their senses from the mouth downwards, to prevent the strength of the plant from harming them, they remain in this state for many hours and sometimes even two or three days until the effects run their course, and the intoxication subsides. After this, they reflect on what their imagination revealed, which occasionally remains with them for delirium. This is what they consider accomplished and propagate as an oracle."


Latter reports were produced by  Juan Magnin  in 1740, describing ayahuasca use as a medicinal plant by the  Jivaroan peoples  (called  ayahuessa ) [ 51 ]  and by  Franz Xaver Veigl  in 1768, that reports about several "dangerous plants", including a bitter liana used for  precognition  and sorcery. [ 52 ]  All these reports were written in context of  Jesuit missions  in South America, specially the  Mainas missions , [ 53 ]  in  Latin  and sent only to Rome, so their audience wasn't very large and they were promptly lost in the archives. For this reason, ayahuasca didn't receive interest for the entire subsequent century. [ 54 ]


In academic discourse, the initial mention of ayahuasca dates back to  Manuel Villavicencio 's 1848 book, " Geografía de la República del Ecuador. " This work vividly delineates the employment and rituals involving ayahuasca by the  Jivaro  people. [ 55 ]  Concurrently,  Richard Spruce  embarked on an Amazonian expedition in 1852 to collect and classify previously unidentified botanical specimens. During this journey, Spruce encountered and documented  Banisteriopsis caapi  (at time named  Banisteria caapi ) and observed an ayahuasca ceremony among the  Tucano  community situated along the  Vaupés River . Subsequently, Spruce uncovered the usage and cultivation of  B. caapi  among various indigenous groups dispersed across the Amazon and Orinoco basins, like the  Guahibo  and  Sápara . These multifarious encounters, together with Spruce's personal accounts of subjective ayahuasca experiences, were collated in his 1873 work, "Notes of a Botanist On The Amazon and Andes.". [ 56 ]  By the end of the century, other explorers and anthropologists contributed more extensive documentation concerning ayahuasca, notably the  Theodor Koch-Grünberg 's documents about Tucano and  Arecuna 's rituals and ceremonies, [ 57 ] [ 58 ]   Stradelli 's first-hand reports of ayahuasca rituals and mythology along the  Jurupari  and  Vaupés [ 59 ]  and Alfred Simson's first description of admixture of several ingredients in the making of ayahuasca in  Putumayo  region, published in 1886. [ 60 ]


In 1905,  Rafael Zerda Bayón  named the active extract of ayahuasca as  telepathine,  a name latter used by the Colombian chemist Guillermo Fischer Cárdenas when he isolated the substance in 1932. [ 61 ]  Contemporaneously,  Lewin [ 62 ]  and Gunn [ 63 ]  were independently studying the properties of the  banisterine,  extracted of the  B. caapi,  and its effects on animal models. [ 64 ]  Further clinical trials were being conducted, exploring the effects of banisterine on Parkinson's disease. [ 65 ] [ 66 ]  Later it was found that both  telepathine  and  banisterine  are the same substance, identical to a chemical already isolated from  Peganum harmala  and given the name  Harmine . [ 67 ]


Researchers like  Peter Gow  and  Brabec de Mori  argue that ayahuasca use indeed developed alongside the Jesuit missions after the 17th century. By examining the  ícaros  (ayahuasca-related healing chants), they found that the chants are always sung in  Quechua  (a  lingua franca  along the Jesuit and Franciscan missions in the region), no matter the linguistic background of the group, with similar language structures between different ícaros that are markedly different from other indigenous songs. Moreover, often the cosmology of ayahuasca often mirrors the Catholicism, with particular similarities in the belief that ayahuasca is thought to be the body of  ayahuascamama  that is imbibed as part of the ritual, like wine and bread are taken as being the body and blood of Jesus Christ during  Christian Eucharist . Brabec de Mori called this “Christian camouflage” and suggested that rather than being a way for disguising the ayahuasca ritual, it suggests that practice evolved entirely within these contexts. [ 68 ] [ 53 ]


Indeed, the colonial processes in Western Amazon are intrinsically related with the development of ayahuasca use in the last three centuries, as it promoted a deep reshape in traditional ways of life in the region. Many indigenous groups moved into the Missions, seeking  protection from death and slavery promoted by the  Bandeiras , inter-tribal violence, starvation and disease ( smallpox ). This movement resulted in an intense cultural exchange and resulted in the formation of  mestizos  (in Spanish) or  caboclos  (in Portuguese), a social category formed by people with mixture of European and native ancestry, who were an important part of the economy and culture of the region. [ 69 ]  According to Peter Gow, the ayahuasca shamanism (the use of ayahuasca by a trained shaman to diagnose and cure illnesses) was developed by these  mestizos  in the processes of colonial transformation. [ 68 ]  The  Amazon rubber cycles  (1879–1912 and 1945–1945) sped up these transformations, due to slavery, genocide and brutality against indigenous populations and large migratory movements, specially from the Brazilian  Northeast Region  as a workforce for the rubber  plantations . The  mestizo  practices became deeply intertwined with the culture of rubber workers, called  caucheros  (in Spanish) or  seringueiros  (in Portuguese). Ayahuasca use with therapeutic goals is the main result of this  Trans-cultural diffusion , with some practitioners pointing the  caucheros  as the main responsible for using ayahuasca to cure  all sort of ailments of the body, mind and soul , with even some regions using the term  Yerba de Cauchero  ("rubber-worker herb"). As a result, the ayahuasca shamans in urban areas and  mestizo  settlements, specially in the regions of  Iquitos  and  Pucallpa  (in Peru), became the  vegetalistas,  folk healers who are said to gain all their knowledge from the plants and the spirits bound to it. [ 70 ]


So the  vegetalist  movement was a heterogeneous mixture of Western Amazon ( mestizo  shamanic practices and  cauchero  culture) and  Andean  elements (shaped by other migratory movements, like those originated from Cuzco through  Urubamba Valley  and from western Ecuador), influenced by Christian aspects derived from the Jesuit missions, as reflected by the mythology, rituals and moral codes related to  vegetalista  ayahuasca use. [ 70 ]


Although  mestizo ,  vegetalista  and indigenous ayahuasca use was part of a longer tradition, these several configurations of  mestizo vegetalismo  were not isolated phenomena. In the end of the nineteenth century, several messianic/ millennialist  cults sparkled across semi-urban areas across the entire Amazon region, merging different elements of indigenous and  mestizo  folk culture with Catholicism, Spiritism and  Protestantism . [ 70 ] [ 71 ]  In this context, the use of ayahuasca will take form of urban, organized non-indigenous religions in outskirts of main cities of northwest of Brazil, (along the basins of  Madeira ,  Juruá  and  Purus River ) [ 72 ]  within the  cauchero/seringueiro  cultural complex, resignifying and adapting both the  vegetalista  and  mestizo  shamanism to new urban formations, unifying essential elements to building a cosmology for the new emerging cult/faith, merging with elements of folk Catholicism, African-Brazilian religions and Kardecist spiritism. These new cults arise from charismatic leaderships, often messianic and prophetic, who came from rural areas after migration movements, sometimes called  ayahuasqueiros , in semi-urban communities across the borders of Brazil, Bolívia and Peru (a region that will later form the state of  Acre ). [ 69 ]  This new configuration of these belief systems is referred by Goulart as  tradição religiosa ayahuasqueira urbana amazônica  ("urban-amazonian  ayahuasqueiro  religious tradition") [ 73 ]  or  campo ayahuasqueiro brasileiro  ("brazilian  ayahuasqueiro  field") by Labate, [ 74 ]  emerging as three main structured religions, the Santo Daime and Barquinha, in  Rio Branco  and the União do Vegetal (UDV) in  Porto Velho , three denominations that, notwithstanding shared characteristics besides ayahuasca utilization, have several particularities regarding its practices, conceptions and processes building social legitimacy and relationships with Brazilian government, media, science and other society stances. [ 75 ]  Since the latter half of twentieth century, the ayahuasca religious expanded to other parts of Brazil and several countries in the world, notably in the West. [ 76 ]


Beat writer  William S. Burroughs  read a paper by  Richard Evans Schultes  on the subject and while traveling through South America in the early 1950s sought out ayahuasca in the hopes that it could relieve or cure  opiate   addiction  (see  The Yage Letters ). Ayahuasca became more widely known when the McKenna brothers published their experience in the Amazon in  True Hallucinations .  Dennis McKenna  later studied pharmacology,  botany , and  chemistry  of ayahuasca and  oo-koo-he , which became the subject of his master's thesis.


Richard Evans Schultes  allowed  Claudio Naranjo  to make a special journey by canoe up the Amazon River to study ayahuasca with the South American Indians. He brought back samples of the beverage and published the first scientific description of the effects of its active alkaloids. [ 77 ]


In recent years, the brew has been popularized by  Wade Davis  ( One River),  English novelist  Martin Goodman  in  I Was Carlos Castaneda , [ 78 ]  Chilean novelist  Isabel Allende , [ 79 ]  writer  Kira Salak , [ 80 ] [ 81 ]  author Jeremy Narby ( The Cosmic Serpent ), author  Jay Griffiths  ( Wild: An Elemental Journey ), American novelist Steven Peck, radio personality  Robin Quivers , [ 82 ] [ unreliable source? ] , writer  Paul Theroux  ( Figures in a Landscape: People and Places ), [ 83 ]  and NFL quarterback  Aaron Rodgers . [ 84 ]


Sections of  Banisteriopsis caapi  vine are  macerated  and boiled alone or with leaves from any of a number of other plants, including  Psychotria viridis  ( chacruna ),  Diplopterys cabrerana  (also known as  chaliponga  and  chacropanga ), [ 85 ]  and  Mimosa tenuiflora , among other ingredients which can vary greatly from one shaman to the next. The resulting brew may contain the powerful  psychedelic drug   dimethyltryptamine  and  monoamine oxidase inhibiting   harmala alkaloids , which are necessary to make the  DMT  orally active by allowing it (DMT) to be processed by the  liver . The traditional making of ayahuasca follows a ritual process that requires the user to pick the lower Chacruna leaf at sunrise, then say a prayer. The vine must be "cleaned meticulously with wooden spoons" [ 86 ]  and pounded "with wooden mallets until it's fibre." [ 86 ]


Brews can also be made with plants that do not contain DMT,  Psychotria viridis  being replaced by plants such as  Justicia pectoralis ,  Brugmansia , or sacred tobacco, also known as  mapacho  ( Nicotiana rustica ), or sometimes left out with no replacement. This brew varies radically from one batch to the next, both in potency and psychoactive effect, based mainly on the skill of the shaman or brewer, as well as other admixtures sometimes added and the intent of the ceremony. Natural variations in plant alkaloid content and profiles also affect the final concentration of  alkaloids  in the brew, and the physical act of cooking may also serve to modify the alkaloid profile of  harmala  alkaloids. [ 87 ] [ 88 ]


The actual preparation of the brew takes several hours, often taking place over the course of more than one day. After adding the plant material, each separately at this stage, to a large pot of water, it is boiled until the water is reduced by half in volume. The individual brews are then added together and brewed until reduced significantly. This combined brew is what is taken by participants in ayahuasca ceremonies.


The uses of ayahuasca in traditional societies in  South America  vary greatly. [ 89 ]  Some cultures do use it for shamanic purposes, but in other cases, it is consumed socially among friends, in order to learn more about the natural environment, and even in order to visit friends and family who are far away. [ 89 ]


Nonetheless, people who work with ayahuasca in non-traditional contexts often align themselves with the philosophies and cosmologies associated with ayahuasca  shamanism , as practiced among  Indigenous peoples  like the  Urarina  of the  Peruvian Amazon . [ 90 ] [ 89 ]  Dietary taboos are often associated with the use of ayahuasca, [ 91 ]  although these seem to be specific to the culture around  Iquitos ,  Peru , a major center of ayahuasca tourism. [ 89 ]  Ayahuasca retreats or  healing centers  can also be found in the  Sacred Valley  of Peru, in areas such as  Cusco  and  Urubamba , where similar dietary preparations can be observed. These retreats often employ members of the  Shipibo-Konibo  tribe, an indigenous community native to the Peruvian Amazon. [ 92 ]


In the rainforest, these taboos tend towards the purification of one's self—abstaining from spicy and heavily seasoned foods, excess fat, salt, caffeine, acidic foods (such as citrus) and sex before, after, or during a ceremony. A diet low in  foods containing tyramine  has been recommended, as the speculative interaction of  tyramine  and  MAOIs  could lead to a  hypertensive crisis ; however, evidence indicates that  harmala alkaloids  act only on  MAO-A , in a reversible way similar to  moclobemide  (an antidepressant that does not require dietary restrictions). Dietary restrictions are not used by the highly urban Brazilian ayahuasca church  União do Vegetal , suggesting the risk is much lower than perceived and probably non-existent. [ 91 ]


Shamans ,  curanderos  and experienced users of ayahuasca advise against consuming ayahuasca when not in the presence of one or several well-trained shamans. [ 93 ]


In some areas, there are purported  brujos  (Spanish for " witches ") who masquerade as real shamans and who entice tourists to drink ayahuasca in their presence. Shamans believe one of the purposes for this is to steal one's energy and/or power, of which they believe every person has a limited stockpile. [ 93 ]


The shamans lead the ceremonial consumption of the ayahuasca beverage, [ 94 ]  in a rite that typically takes place over the entire night. During the ceremony, the effect of the drink lasts for hours. Prior to the ceremony, participants are instructed to abstain from spicy foods, red meat and sex. [ 95 ]  The ceremony is usually accompanied with  purging  which include vomiting and diarrhea, which is believed to release built-up emotions and  negative energy . [ 96 ]


It is believed that the Shipibo-Konibo are among the earliest practitioners of Ayahuasca ceremonies, with their connection to the brew and ceremonies surrounding it dating back centuries, perhaps a millennium. [ 97 ]


Some members of the Shipibo community have taken to the media to express their views on Ayahuasca entering the mainstream, with some calling it "the  commercialization  of ayahuasca." Some of them have even expressed their worry regarding the increased popularity, saying "the contemporary 'ayahuasca ceremony' may be understood as a substitute for former  cosmogonical   rituals  that are nowadays not performed anymore." [ 98 ]


The Shipibo have their own language, called  Shipibo , a  Panoan language  spoken by approximately 26,000 people in Peru and Brazil. This language is commonly sung by the shaman in the form of a chant, called an  Icaro , during the Ayahuasca ritual as a way to establish a "balance of energy" during the ritual to help protect and guide the user during their experience. [ 99 ]


Traditional ayahuasca brews are usually made with  Banisteriopsis caapi  as an  MAOI , while  dimethyltryptamine  sources and other admixtures vary from region to region. There are several  varieties of caapi , often known as different "colors", with varying effects, potencies, and uses.


DMT admixtures:


Other common admixtures:


Common admixtures with their associated ceremonial values and spirits:


In the late 20th century, the practice of ayahuasca drinking began spreading to Europe, North America and elsewhere. [ 103 ]  The first ayahuasca churches, affiliated with the Brazilian  Santo Daime , were established in the  Netherlands . A legal case was filed against two of the Church's leaders, Hans Bogers (one of the original founders of the Dutch Santo Daime community) and Geraldine Fijneman (the head of the  Amsterdam  Santo Daime community). Bogers and Fijneman were charged with distributing a  controlled substance  (DMT); however, the prosecution was unable to prove that the use of ayahuasca by members of the Santo Daime constituted a sufficient threat to public health and order such that it warranted denying their rights to  religious freedom  under  ECHR Article 9 . The 2001 verdict of the Amsterdam district court is an important precedent. Since then groups that are not affiliated to the Santo Daime have used ayahuasca, and a number of different "styles" have been developed, including non-religious approaches. [ 104 ]


In modern Europe and North America, ayahuasca analogs are often prepared using non-traditional plants which contain the same alkaloids. For example, seeds of the  Syrian rue  plant  can be used as a substitute for the ayahuasca vine, and the DMT-rich  Mimosa hostilis  is used in place of  chacruna . Australia has several indigenous plants which are popular among modern  ayahuasqueros  there, such as various DMT-rich species of  Acacia .


The name "ayahuasca" specifically refers to a botanical  decoction  that contains  Banisteriopsis caapi . A synthetic version, known as  pharmahuasca , is a combination of an appropriate MAOI and typically DMT. In this usage, the DMT is generally considered the main psychoactive active ingredient, while the MAOI merely preserves the psychoactivity of orally ingested DMT, which would otherwise be destroyed in the gut before it could be absorbed in the body. In contrast, traditionally among Amazonian tribes, the  B. Caapi  vine is considered to be the "spirit" of ayahuasca, the gatekeeper, and guide to the otherworldly realms. [ 105 ]


Brews similar to ayahuasca may be prepared using several plants not traditionally used in South America:


MAOI admixtures:


Ingesting Ayahuasca can cause nausea, vomiting and diarrhea in the short term.  Other short-term side effects include  increased blood pressure  and  tachycardia . Rarer side effects include  dyspnea ,  seizures  and  serotonin syndrome . Ayahuasca is suspected of triggering  psychosis  in people with a predisposition to the condition, and there is a lack of safety information for Ayahuasca's possible effects on pregnancy and breastfeeding. [ 13 ]


People who have consumed ayahuasca report having mystical experiences and  spiritual  revelations regarding their purpose on earth, the true nature of the  universe , and deep insight into how to be the best person they possibly can. [ 107 ]   Many people also report therapeutic effects, especially around depression and personal traumas. [ 108 ]


This is viewed by many as a spiritual awakening and what is often described as a near-death experience or rebirth. [ 93 ] : 67–70   It is often reported that individuals feel they gain access to higher spiritual  dimensions  and make contact with various spiritual or extra-dimensional beings who can act as guides or healers. [ 109 ]


The experiences that people have while under the influence of ayahuasca are also culturally influenced. [ 89 ]  Westerners typically describe experiences with psychological terms like " ego death " and understand the hallucinations as repressed memories or metaphors of mental states. [ 89 ]  However, at least in  Iquitos , Peru (a center of ayahuasca ceremonies), those from the area describe the experiences more in terms of the actions in the body and understand the visions as reflections of their environment, sometimes including the person who they believe caused their illness, as well as interactions with spirits. [ 89 ]


There are potential  antidepressant  and  anxiolytic  effects of ayahuasca. [ 110 ] [ 111 ] [ 112 ]


Ayahuasca has also been studied for the treatment of addictions and shown to be effective, with lower  Addiction Severity Index  scores seen in users of ayahuasca compared to controls. [ 113 ] [ 114 ] [ 115 ] [ 112 ]  Ayahuasca users have also been seen to consume less  alcohol . [ 116 ]


Harmala alkaloids  are MAO-inhibiting  beta -carbolines . The three most studied harmala alkaloids in the  B. caapi  vine are  harmine ,  harmaline  and  tetrahydroharmine . Harmine and harmaline are  selective  and  reversible  inhibitors of  monoamine oxidase A  (MAO-A), while tetrahydroharmine is a weak  serotonin reuptake inhibitor  (SRI). [ medical citation needed ]


Individual  polymorphisms  of the  cytochrome P450-2D6 enzyme , and more over the isolated indocine metabolite from the inhabitation of CPY134a, with a varied rate of gustation due to physiological factors affect the ability of individuals to metabolize harmine. [ 117 ]


Internationally, DMT is a Schedule I drug under the  Convention on Psychotropic Substances . The Commentary on the Convention on Psychotropic Substances notes, however, that the plants containing it are not subject to international control: [ 118 ]


The cultivation of plants from which psychotropic substances are obtained is not controlled by the Vienna Convention... Neither the crown (fruit, mescal button) of the  Peyote  cactus nor the roots of the plant  Mimosa hostilis  nor Psilocybe mushrooms themselves are included in Schedule 1, but only their respective principals,  mescaline ,  DMT , and  psilocin .


A  fax  from the Secretary of the  International Narcotics Control Board  (INCB) to the Netherlands Ministry of Public Health sent in 2001 goes on to state that "Consequently, preparations (e.g. decoctions) made of these plants, including ayahuasca, are not under international control and, therefore, not subject to any of the articles of the 1971 Convention." [ 119 ]


Despite the INCB's 2001 affirmation that ayahuasca is not subject to drug control by international convention, in its 2010 Annual Report the Board recommended that governments consider controlling (i.e. criminalizing) ayahuasca at the national level. This recommendation by the INCB has been criticized as an attempt by the Board to overstep its legitimate mandate and as establishing a reason for governments to violate the human rights (i.e., religious freedom) of ceremonial ayahuasca drinkers. [ 120 ]


Under American federal law, DMT is a Schedule I drug that is illegal to possess or consume; however, certain religious groups have been legally permitted to consume ayahuasca. [ 121 ]  A court case allowing the  União do Vegetal  to import and use the tea for religious purposes in the United States,  Gonzales v. O Centro Espírita Beneficente União do Vegetal , was heard by the  U.S. Supreme Court  on November 1, 2005; the decision, released February 21, 2006, allows the UDV to use the tea in its ceremonies pursuant to the  Religious Freedom Restoration Act . In a similar case in Ashland, Oregon-based Santo Daime church sued for their right to import and consume ayahuasca tea. In March 2009, U.S. District Court Judge Panner ruled in favor of the Santo Daime, acknowledging its protection from prosecution under the Religious Freedom Restoration Act. [ 122 ]


In 2017 the  Santo Daime  Church Céu do Montréal in Canada received religious exemption to use ayahuasca as a sacrament in their rituals. [ 123 ]


Religious use in Brazil was legalized after two official inquiries into the tea in the mid-1980s, which concluded that ayahuasca is not a recreational drug and has valid spiritual uses. [ 124 ]


In France,  Santo Daime  won a court case allowing them to use the tea in early 2005; however, they were not allowed an exception for religious purposes, but rather for the simple reason that they did not perform chemical extractions to end up with pure DMT and harmala and the plants used were not scheduled. [ 125 ]  Four months after the court victory, the common ingredients of ayahuasca as well as harmala were declared  stupéfiants , or narcotic schedule I substances, making the tea and its ingredients illegal to use or possess. [ 126 ]


In June 2019,  Oakland , California, decriminalized natural entheogens. The City Council passed the resolution in a unanimous vote, ending the investigation and imposition of criminal penalties for use and possession of entheogens derived from plants or fungi. The resolution states: "Practices with Entheogenic Plants have long existed and have been considered to be sacred to human cultures and human interrelationships with nature for thousands of years, and continue to be enhanced and improved to this day by religious and spiritual leaders, practicing professionals, mentors, and healers throughout the world, many of whom have been forced underground." [ 127 ]
In January 2020,  Santa Cruz , California, and in September 2020,  Ann Arbor , Michigan, decriminalized natural entheogens. [ 128 ] [ 129 ] [ 130 ]


Ayahuasca has stirred debate regarding intellectual property protection of  traditional knowledge . [ 131 ]  In 1986 the US Patent and Trademarks Office (PTO) allowed the granting of a patent on the ayahuasca vine  B. caapi . It allowed this patent based on the assumption that ayahuasca's properties had not been previously described in writing. Several public interest groups, including the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Coalition for Amazonian Peoples and Their Environment (Amazon Coalition) objected. In 1999 they brought a legal challenge to this patent which had granted a private US citizen "ownership" of the knowledge of a plant that is well-known and sacred to many  Indigenous peoples of the Amazon , and used by them in religious and healing ceremonies. [ 132 ]


Later that year the PTO issued a decision rejecting the patent, on the basis that the petitioners' arguments that the plant was not "distinctive or novel" were valid; however, the decision did not acknowledge the argument that the plant's religious or cultural values prohibited a patent. In 2001, after an appeal by the patent holder, the US Patent Office reinstated the patent, albeit to only a specific plant and its asexually reproduced offspring. The law at the time did not allow a third party such as COICA to participate in that part of the reexamination process. The patent, held by US entrepreneur Loren Miller, expired in 2003. [ 133 ]


The  Convention on Biological Diversity  ( CBD ), known informally as the  Biodiversity Convention , is a  multilateral treaty . The Convention has three main goals: the conservation of biological diversity (or  biodiversity ); the sustainable use of its components; and the fair and equitable sharing of benefits arising from  genetic resources . Its objective is to develop national strategies for the conservation and sustainable use of biological diversity, and it is often seen as the key document regarding  sustainable development .


The Convention was opened for signature at the  Earth Summit  in  Rio de Janeiro  on 5 June 1992 and entered into force on 29 December 1993. The United States is the only UN member state which has not ratified the Convention. [ 1 ]  It has two supplementary agreements, the  Cartagena Protocol  and  Nagoya Protocol .


The Cartagena Protocol on Biosafety to the Convention on Biological Diversity  is an international treaty governing the movements of  living modified organisms  (LMOs) resulting from modern  biotechnology  from one country to another. It was adopted on 29 January 2000 as a supplementary agreement to the CBD and entered into force on 11 September 2003.


The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity  is another supplementary agreement to the CBD. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The Nagoya Protocol was adopted on 29 October 2010 in  Nagoya, Japan , and entered into force on 12 October 2014.


2010 was also the  International Year of Biodiversity , and the Secretariat of the CBD was its focal point. Following a recommendation of CBD signatories at Nagoya, the UN declared 2011 to 2020 as the  United Nations Decade on Biodiversity  in December 2010. The Convention's  Strategic Plan for Biodiversity 2011-2020 , created in 2010, include the Aichi Biodiversity Targets.


The meetings of the Parties to the Convention are known as Conferences of the Parties (COP), with the first one (COP 1) held in  Nassau, Bahamas , in 1994 and the most recent one (COP 16) in 2024 in  Cali ,  Colombia . [ 2 ]


In the area of marine and coastal biodiversity CBD's focus at present is to identify Ecologically or Biologically Significant Marine Areas (EBSAs) in specific ocean locations based on scientific criteria. The aim is to create an international legally binding instrument (ILBI) involving area-based planning and decision-making under UNCLOS to support the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction (BBNJ treaty or  High Seas Treaty ). [ 3 ]


The notion of an international convention on biodiversity was conceived at a  United Nations Environment Programme  (UNEP) Ad Hoc Working Group of Experts on Biological Diversity in November 1988. The subsequent year, the Ad Hoc Working Group of Technical and Legal Experts was established for the drafting of a legal text which addressed the conservation and sustainable use of biological diversity, as well as the sharing of benefits arising from their utilization with  sovereign states  and local communities.
In 1991, an intergovernmental negotiating committee was established, tasked with finalizing the Convention's text. [ 4 ]


A Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity was held in Nairobi, Kenya, in 1992, and its conclusions were distilled in the Nairobi Final Act. [ 5 ]  The Convention's text was opened for signature on 5 June 1992 at the United Nations Conference on Environment and Development (the Rio "Earth Summit"). By its closing date, 4 June 1993, the Convention had received 168 signatures. It entered into force on 29 December 1993. [ 4 ]


The Convention recognized for the first time in international law that the conservation of biodiversity is "a common concern of humankind" and is an integral part of the development process. The agreement covers all  ecosystems ,  species , and genetic resources. It links traditional conservation efforts to the economic goal of using biological resources sustainably. It sets principles for the fair and equitable sharing of the benefits arising from the use of genetic resources, notably those destined for commercial use. [ 6 ]  It also covers the rapidly expanding field of biotechnology through its  Cartagena Protocol on Biosafety , addressing technology development and transfer, benefit-sharing and  biosafety  issues. Importantly, the Convention is legally binding; countries that join it ('Parties') are obliged to implement its provisions.


The Convention reminds decision-makers of the finite status of natural resources and sets out a philosophy of  sustainable use . While past  conservation  efforts were aimed at protecting particular species and habitats, the Convention recognizes that ecosystems, species and genes must be used for the benefit of humans. However, this should be done in a way and at a rate that does not lead to the long-term decline of biological diversity.


The Convention also offers decision-makers guidance based on the  precautionary principle  which demands that where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat. The Convention acknowledges that substantial investments are required to conserve  biological diversity . It argues, however, that conservation will bring us significant environmental, economic and social benefits in return.


The Convention on Biological Diversity of 2010 banned some forms of  geoengineering .


As of April 2024, the acting executive secretary is Astrid Schomaker. [ 7 ]


The previous executive secretaries were: David Cooper (2023-2024), Elizabeth Maruma Mrema (2020-2023),
 pl:Cristiana Pașca Palmer  (2017–2019),  Braulio Ferreira de Souza Dias  (2012–2017),  Ahmed Djoghlaf  (2006–2012),  Hamdallah Zedan  (1998–2005),  Calestous Juma  (1995–1998), and  Angela Cropper  (1993–1995). [ 8 ]


Some of the many issues dealt with under the Convention include: [ 9 ]


The Convention's governing body is the Conference of the Parties (COP), consisting of all governments (and regional economic integration organizations) that have ratified the treaty. This ultimate authority reviews progress under the Convention, identifies new priorities, and sets work plans for members. The COP can also make amendments to the Convention, create expert advisory bodies, review progress reports by member nations, and collaborate with other international organizations and agreements. [ citation needed ]


The Conference of the Parties uses expertise and support from several other bodies that are established by the Convention. In addition to committees or mechanisms established on an  ad hoc  basis, the main organs are:


The CBD Secretariat, based in  Montreal , Quebec, Canada, operates under UNEP, the  United Nations Environment Programme . Its main functions are to organize meetings, draft documents, assist member governments in the implementation of the programme of work, coordinate with other international organizations, and collect and disseminate information.


The SBSTTA is a committee composed of experts from member governments competent in relevant fields. It plays a key role in making recommendations to the COP on scientific and technical issues. It provides assessments of the status of biological diversity and of various measures taken in accordance with Convention, and also gives recommendations to the Conference of the Parties, which may be endorsed in whole, in part or in modified form by the COPs. As of 2024 [update]  SBSTTA had met 26 times, with a 26th meeting taking place in Nairobi, Kenya in 2024. [ 10 ]


In 2014, the Conference of the Parties to the Convention on Biological Diversity established the Subsidiary Body on Implementation (SBI) to replace the Ad Hoc Open-ended Working Group on Review of Implementation of the Convention. The four functions and core areas of work of SBI are: (a) review of progress in implementation; (b) strategic actions to enhance implementation; (c) strengthening means of implementation; and (d) operations of the Convention and the Protocols. The first meeting of the SBI was held on 2–6 May 2016 and the second meeting was held on 9–13 July 2018, both in Montreal, Canada. The latest (fifth) meeting of the SBI was held in October 2024 in Cali, Colombia. [ 11 ]  The Bureau of the Conference of the Parties serves as the Bureau of the SBI. The current chair of the SBI is Ms. Clarissa Souza Della Nina of  Brazil .


As of 2016, the Convention has 196 Parties, which includes 195 states and the  European Union . [ 12 ]  All UN member states—with the exception of the United States—have ratified the treaty. [ 13 ]  Non-UN member states that have ratified are the  Cook Islands ,  Niue , and the  State of Palestine . The  Holy See  and the  states with limited recognition  are non-Parties. The US has signed but not ratified the treaty, [ 14 ]  because ratification requires a two-thirds majority in the  Senate  and is blocked by  Republican Party  senators. [ 15 ] [ 1 ]


The European Union created the Cartagena Protocol (see below) in 2000 to enhance  biosafety  regulation and propagate the "precautionary principle" over the "sound science principle" defended by the United States. Whereas the impact of the Cartagena Protocol on domestic regulations has been substantial, its impact on international trade law remains uncertain. In 2006, the  World Trade Organization  (WTO) ruled that the European Union had violated international trade law between 1999 and 2003 by imposing a moratorium on the approval of  genetically modified organisms  (GMO) imports. Disappointing the United States, the panel nevertheless "decided not to decide" by not invalidating the stringent European  biosafety  regulations. [ 16 ]


Implementation by the Parties to the Convention is achieved using two means:


National Biodiversity Strategies and Action Plans  ( NBSAP ) are the principal instruments for implementing the Convention at the national level. The Convention requires that countries prepare a national biodiversity strategy and to ensure that this strategy is included in planning for activities in all sectors where diversity may be impacted. As of early 2012, 173 Parties had developed NBSAPs. [ 17 ]


The United Kingdom, New Zealand and Tanzania carried out elaborate responses to conserve individual species and specific habitats. The United States of America, a signatory who had not yet ratified the treaty by 2010, [ 18 ]  produced one of the most thorough implementation programs through species recovery programs and other mechanisms long in place in the US for species conservation. [ 19 ]


Singapore  established a detailed  National Biodiversity Strategy and Action Plan . [ 20 ]  The  National Biodiversity Centre  of Singapore represents Singapore in the Convention for Biological Diversity. [ 21 ]


In accordance with Article 26 of the Convention, Parties prepare national reports on the status of implementation of the Convention.


The Cartagena Protocol on Biosafety, also known as the Biosafety Protocol, was adopted in January 2000, after a CBD Open-ended Ad Hoc Working Group on Biosafety had met six times between July 1996 and February 1999. The Working Group submitted a draft text of the Protocol for consideration by Conference of the Parties at its first extraordinary meeting, which was convened for the express purpose of adopting a protocol on biosafety to the Convention on Biological Diversity. After a few delays, the Cartagena Protocol was eventually adopted on 29 January 2000. [ 22 ]  The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. [ 23 ] [ 24 ]


The Biosafety Protocol makes clear that products from new technologies must be based on the  precautionary principle  and allow developing nations to balance public health against economic benefits. It will, for example, let countries ban imports of a  genetically modified organism  if they feel there is not enough scientific evidence the product is safe and requires exporters to label shipments containing genetically modified commodities such as corn or cotton. [ 23 ]


The required number of 50 instruments of ratification/accession/approval/acceptance by countries was reached in May 2003. In accordance with the provisions of its Article 37, the Protocol entered into force on 11 September 2003. [ 25 ]


In April 2002, the Parties of the UN CBD adopted the recommendations of the Gran Canaria Declaration Calling for a Global Plant Conservation Strategy, and adopted a 16-point plan aiming to slow the rate of plant extinctions around the world by 2010. [ 26 ]


The  Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity  was adopted on 29 October 2010 in Nagoya,  Aichi Prefecture , Japan, at the  tenth meeting of the Conference of the Parties , [ 27 ]  and entered into force on 12 October 2014. [ 28 ]  The protocol is a supplementary agreement to the Convention on Biological Diversity, and provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. It thereby contributes to the conservation and sustainable use of biodiversity. [ 27 ] [ 29 ]


Also at the  tenth meeting of the Conference of the Parties , held from 18 to 29 October 2010 in Nagoya, [ 30 ]  a revised and updated "Strategic Plan for Biodiversity, 2011-2020" was agreed and published. This document included the "Aichi Biodiversity Targets", comprising 20 targets that address each of five strategic goals defined in the plan. The  strategic plan  includes the following strategic goals: [ 31 ] [ 30 ]


Upon the launch of  Agenda 2030 , CBD released a technical note mapping and identifying synergies between the 17  Sustainable Development Goals  (SDGs) and the 20 Aichi Biodiversity Targets. [ 32 ]  This helps to understand the contributions of biodiversity to achieving the SDGs. [ citation needed ]


A new plan, known as the post-2020 Global Biodiversity Framework (GBF) was developed to guide action through 2030. [ 33 ]  A first draft of this framework was released in July 2021, [ 34 ]  and its final content was discussed and negotiated as part of the COP 15 meetings. Reducing  agricultural pollution  and sharing the benefits of  digital sequence information  arose as key points of contention among Parties during development of the framework. [ 35 ]  A final version was adopted by the Convention on 19 December 2022. [ 36 ] [ 37 ]  The framework includes a number of ambitious goals, including a commitment to designate at least 30 percent of global land and sea as protected areas (known as the " 30 by 30 " initiative). [ 38 ]


The CBD has a significant focus on  marine and coastal biodiversity . [ 39 ]  A series of expert workshops have been held (2018–2022) to identify options for modifying the description of Ecologically or Biologically Significant Marine Areas (EBSAs) and describing new areas. [ 40 ]  These have focused on the North-East, North-West and South-Eastern  Atlantic Ocean ,  Baltic Sea ,  Caspian Sea ,  Black Sea , Seas of East Asia, North-West  Indian Ocean  and Adjacent Gulf Areas, Southern and North-East Indian Ocean,  Mediterranean Sea , North and South Pacific, Eastern Tropical and Temperate Pacific, Wider  Caribbean  and Western Mid-Atlantic. The workshop meetings have followed the EBSA process based on internationally agreed scientific criteria. [ 41 ] [ 42 ]  This is aimed at creating an international legally binding instrument (ILBI) under  UNCLOS  to support the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction (BBNJ or  High Seas Treaty ). [ 43 ]  The central mechanism is area-based planning and decision-making. [ 44 ]  It integrates EBSAs, Vulnerable Marine Ecosystems (VMEs) and High Seas ( Marine Protected Areas ) with  Blue Growth  scenarios. There is also linkage with the  EU Marine Strategy Framework Directive .


There have been criticisms against CBD that its implementation has been weakened due to resistance of Western countries to the implementation of pro-South provisions of the Convention. [ 45 ]  CBD is also regarded as a case of a hard treaty gone soft in the implementation trajectory. [ 46 ]  The argument to enforce the treaty as a legally binding multilateral instrument with the Conference of Parties reviewing the infractions and non-compliance is also gaining strength. [ 47 ]


Although the Convention explicitly states that all forms of life are covered by its provisions, [ 48 ]  examination of reports and of national biodiversity strategies and action plans submitted by participating countries shows that in practice this is not happening. The fifth report of the European Union, for example, makes frequent reference to animals (particularly fish) and plants, but does not mention  bacteria ,  fungi  or  protists  at all. [ 49 ]  The International Society for Fungal Conservation has assessed more than 100 of these CBD documents for their coverage of fungi using defined criteria to place each in one of six categories. No documents were assessed as good or adequate, less than 10% as nearly adequate or poor, and the rest as deficient, seriously deficient or totally deficient. [ 50 ]


Scientists working with biodiversity and medical research are expressing fears that the Nagoya Protocol is counterproductive, and will hamper disease prevention and conservation efforts, [ 51 ]  and that the threat of imprisonment of scientists will have a chilling effect on research. [ 52 ]  Non-commercial researchers and institutions such as  natural history museums  fear maintaining biological reference collections and exchanging material between institutions will become difficult, [ 53 ]  and medical researchers have expressed alarm at plans to expand the protocol to make it illegal to publicly share  genetic information , e.g. via  GenBank . [ 54 ]


William Yancey Brown , when with the  Brookings Institution , suggested that the Convention on Biological Diversity should include the  preservation of intact genomes and viable cells  for every known species and for new species as they are discovered. [ 55 ]


A Conference of the Parties (COP) was held annually for three years after 1994, and thence biennially on even-numbered years.


The first ordinary meeting of the Parties to the Convention took place in November and December 1994, in  Nassau, Bahamas . [ 56 ]  The  International Coral Reef Initiative  (ICRI) was launched at this first COP for the Convention on Biological Diversity.


The second ordinary meeting of the Parties to the Convention took place in November 1995, in  Jakarta ,  Indonesia . [ 57 ]


The third ordinary meeting of the Parties to the Convention took place in November 1996, in  Buenos Aires ,  Argentina . [ 58 ]


The fourth ordinary meeting of the Parties to the Convention took place in May 1998, in  Bratislava ,  Slovakia . [ 59 ]


The First Extraordinary Meeting of the Conference of the Parties took place in February 1999, in  Cartagena, Colombia . [ 60 ]  A series of meetings led to the adoption of the  Cartagena Protocol  on Biosafety in January 2000, effective from 2003. [ 22 ]


The fifth ordinary meeting of the Parties to the Convention took place in May 2000, in  Nairobi ,  Kenya . [ 61 ]


The sixth ordinary meeting of the Parties to the Convention took place in April 2002, in  The Hague ,  Netherlands . [ 62 ]


The seventh ordinary meeting of the Parties to the Convention took place in February 2004, in  Kuala Lumpur ,  Malaysia . [ 63 ]


The eighth ordinary meeting of the Parties to the Convention took place in March 2006, in  Curitiba , Brazil. [ 64 ]


The ninth ordinary meeting of the Parties to the Convention took place in May 2008, in  Bonn ,  Germany . [ 65 ]


The tenth ordinary meeting of the Parties to the Convention took place in October 2010, in  Nagoya ,  Japan . [ 66 ]  It was at this meeting that the  Nagoya Protocol  was ratified.


2010 was the  International Year of Biodiversity , which resulted in 110  reports on the loss of biodiversity in different countries, but little or no progress toward the goal of "significant reduction" in the problem. [ 67 ]  Following a recommendation of CBD signatories, the UN declared 2011 to 2020 as the  United Nations Decade on Biodiversity . [ 68 ]


Leading up to the Conference of the Parties (COP 11) meeting on biodiversity in  Hyderabad, India , 2012, preparations for a World Wide Views on Biodiversity has begun, involving old and new partners and building on the experiences from the  World Wide Views on Global Warming . [ 69 ]


Under the theme, "Biodiversity for Sustainable Development", thousands of representatives of governments, NGOs, indigenous peoples, scientists and the private sector gathered in  Pyeongchang , Republic of Korea in October 2014 for the 12th meeting of the Conference of the Parties to the Convention on Biological Diversity (COP 12). [ 70 ] [ 71 ]


From 6–17 October 2014, Parties discussed the implementation of the Strategic Plan for Biodiversity 2011-2020 and its Aichi Biodiversity Targets, which are to be achieved by the end of this decade. The results of Global Biodiversity Outlook 4, the flagship assessment report of the CBD informed the discussions.


The conference gave a mid-term evaluation to the UN Decade on Biodiversity (2011–2020) initiative, which aims to promote the conservation and sustainable use of nature. The meeting achieved a total of 35 decisions, [ 72 ]  including a decision on "Mainstreaming gender considerations", to incorporate gender perspective to the analysis of biodiversity.


At the end of the meeting, the meeting adopted the "Pyeongchang Road Map", which addresses ways to achieve biodiversity through technology cooperation, funding and strengthening the capacity of developing countries. [ 73 ]


The thirteenth ordinary meeting of the Parties to the Convention took place between 2 and 17 December 2016 in  Cancún , Mexico.


The 14th ordinary meeting of the Parties to the Convention took place on 17–29 November 2018, in  Sharm El-Sheikh , Egypt. [ 74 ]  The 2018 UN Biodiversity Conference closed on 29 November 2018 with broad international agreement on reversing the global destruction of nature and  biodiversity loss  threatening all forms of life on Earth. Parties adopted the Voluntary Guidelines for the design and effective implementation of  ecosystem-based approaches to climate change adaptation  and disaster risk reduction. [ 75 ] [ 76 ]  Governments also agreed to accelerate action to achieve the  Aichi Biodiversity Targets , agreed in 2010, until 2020. Work to achieve these targets would take place at the global, regional, national and subnational levels. [ citation needed ]


The 15th meeting of the Parties was originally scheduled to take place in  Kunming, China  in 2020, [ 77 ]  but was postponed several times due to the  COVID-19 pandemic . [ 78 ]  After the start date was delayed for a third time, the Convention was split into two sessions. A mostly online event took place in October 2021, where over 100 nations signed the Kunming declaration on biodiversity. The theme of the declaration was "Ecological Civilization: Building a Shared Future for All Life on Earth". [ 79 ] [ 80 ]  Twenty-one action-oriented draft targets were provisionally agreed in the October meeting, to be further discussed in the second session: an in-person event that was originally scheduled to start in April 2022, but was rescheduled to occur later in 2022. [ 81 ] [ 82 ] [ 83 ] [ 84 ]  The second part of COP 15 ultimately took place in  Montreal , Canada, from 5–17 December 2022. [ 85 ]  At the meeting, the Parties to the Convention adopted a new action plan, the  Kunming-Montreal Global Biodiversity Framework . [ 38 ]


The 16th meeting of the Parties is scheduled to be held in  Cali , Colombia in 2024. [ 86 ]  Originally, Turkey was going to host it but after a  series of earthquakes in February 2023  they had to withdraw. [ 87 ] [ 88 ]


Bioprospecting  (also known as  biodiversity prospecting ) is the exploration of natural sources for  small molecules ,  macromolecules  and biochemical and genetic information that could be developed into  commercially  valuable products for the  agricultural , [ 2 ] [ 3 ]   aquaculture , [ 4 ] [ 5 ]   bioremediation , [ 4 ] [ 6 ]   cosmetics , [ 7 ] [ 8 ]   nanotechnology , [ 4 ] [ 9 ]  or  pharmaceutical [ 2 ] [ 10 ]  industries. In the pharmaceutical industry, for example,  almost one third of all small-molecule drugs approved by the  U.S. Food and Drug Administration  (FDA) between 1981 and 2014 were either  natural products  or compounds derived from natural products. [ 11 ]


Terrestrial  plants ,  fungi  and  actinobacteria  have been the focus of many past bioprospecting programs, [ 12 ]  but interest is growing in less explored ecosystems (e.g. seas and oceans) and organisms (e.g.  myxobacteria ,  archaea ) as a means of identifying new compounds with novel  biological activities . [ 7 ] [ 10 ] [ 13 ] [ 14 ]   Species may be randomly screened for bioactivity or rationally selected and screened based on  ecological ,  ethnobiological ,  ethnomedical ,  historical  or  genomic  information. [ 10 ] [ 15 ] [ 16 ]


When a region's biological resources or  indigenous knowledge  are unethically appropriated or commercially  exploited  without providing fair compensation, this is known as  biopiracy . [ 12 ] [ 17 ]   Various international treaties have been negotiated to provide countries legal recourse in the event of biopiracy and to offer commercial actors legal certainty for investment.  These include the  UN   Convention on Biological Diversity  and the  Nagoya Protocol . [ 2 ] [ 10 ]  The  WIPO  is currently  negotiating more treaties  to bridge gaps in this field.


Other risks associated with bioprospecting are the overharvesting of individual species and environmental damage, but legislation has been developed to combat these also.  Examples include national laws such as the US  Marine Mammal Protection Act  and US  Endangered Species Act , and international treaties such as the UN Convention on Biological Diversity, the UN  Convention on the Law of the Sea , the  Biodiversity Beyond National Jurisdictions Treaty , and the  Antarctic Treaty . [ 10 ] [ 18 ]


Bioprospecting-derived resources and products used in agriculture include  biofertilizers ,  biopesticides  and  veterinary antibiotics .   Rhizobium  is a genus of soil bacteria used as biofertilizers, [ 20 ]   Bacillus thuringiensis  (also called Bt) and the  annonins  (obtained from seeds of the plant  Annona squamosa ) are examples of biopesticides, [ 21 ] [ 22 ] [ 19 ] [ 23 ]  and  valnemulin  and  tiamulin  (discovered and developed from the  basidiomycete  fungi  Omphalina mutila  and  Clitopilus passeckerianus ) are examples of veterinary antibiotics. [ 24 ] [ 25 ]


Examples of bioprospecting products used in bioremediation include  Coriolopsis gallica - and  Phanerochaete chrysosporium -derived  laccase  enzymes, used for treating  beer factory   wastewater  and for dechlorinating and decolorizing  paper mill   effluent . [ 9 ]


Cosmetics and personal care products obtained from bioprospecting include  Porphyridium cruentum -derived  oligosaccharide  and oligoelement blends used to treat  erythema  ( rosacea ,  flushing  and  dark circles ), [ 7 ]   Xanthobacter autotrophicus -derived  zeaxanthin  used for  skin hydration  and  UV  protection, [ 8 ]   Clostridium histolyticum -derived  collagenases  used for  skin  regeneration, [ 8 ]  and  Microsporum -derived  keratinases  used for  hair removal . [ 8 ]


Because  microbial   laccases  have a broad  substrate  range, they can be used in  biosensor  technology to detect a wide range of  organic compounds .  For example, laccase-containing  electrodes  are used to detect  polyphenolic compounds  in  wine , and  lignins  and  phenols  in  wastewater . [ 9 ]


Many of the  antibacterial drugs  in current clinical use were discovered through bioprospecting including the  aminoglycosides ,  tetracyclines ,  amphenicols ,  polymyxins ,  cephalosporins  and other  β-lactam antibiotics ,  macrolides ,  pleuromutilins ,  glycopeptides ,  rifamycins ,  lincosamides ,  streptogramins , and  phosphonic acid  antibiotics. [ 10 ] [ 26 ]   The aminoglycoside antibiotic  streptomycin , for example, was discovered from the soil bacterium  Streptomyces griseus , the fusidane antibiotic  fusidic acid  was discovered from the soil fungus  Acremonium fusidioides , and the pleuromutilin antibiotics (eg.  lefamulin ) were discovered and developed from the basidiomycete fungi  Omphalina mutila  and  Clitopilus passeckerianus . [ 10 ] [ 24 ]


Other examples of bioprospecting-derived anti-infective drugs include the  antifungal  drug  griseofulvin   (discovered from the soil fungus  Penicillium griseofulvum ), [ 27 ]  the antifungal and  antileishmanial  drug  amphotericin B  (discovered from the soil bacterium  Streptomyces nodosus ), [ 28 ]  the  antimalarial  drug  artemisinin  (discovered from the plant  Artemisia annua ), [ 1 ] [ 29 ]  and the  antihelminthic  drug  ivermectin  (developed from the soil bacterium  Streptomyces avermitilis ). [ 30 ]


Bioprospecting-derived pharmaceuticals have been developed for the treatment of  non-communicable diseases  and conditions too.  These include the  anticancer drug   bleomycin  (obtained from the soil bacterium  Streptomyces verticillus ), [ 31 ]  the  immunosuppressant  drug  ciclosporin  used to treat autoimmune diseases such as  rheumatoid arthritis  and  psoriasis  (obtained from the soil fungus  Tolypocladium inflatum ), [ 32 ]  the anti-inflammatory drug  colchicine  used to treat and prevent  gout  flares (obtained from the plant  Colchicum autumnale ), [ 1 ]  the  analgesic  drug  ziconotide  (developed from the  cone snail   Conus magus ), [ 13 ]  and the  acetylcholinesterase inhibitor   galantamine  used to treat  Alzheimer's disease  (obtained from plants in the  Galanthus  genus). [ 33 ]


Bioprospecting has both strengths and weaknesses as a strategy for discovering new genes, molecules, and organisms suitable for development and commercialization.


Bioprospecting-derived  small molecules  (also known as  natural products ) are more structurally complex than synthetic chemicals, and therefore show greater  specificity  towards  biological targets .  This is a big advantage in  drug discovery  and  development , especially  pharmacological  aspects of drug discovery and development, where off-target effects can cause  adverse drug reactions . [ 10 ]


Natural products are also more amenable to  membrane transport  than synthetic compounds.  This is advantageous when developing  antibacterial  drugs, which may need to traverse both an  outer membrane  and  plasma membrane  to reach their target. [ 10 ]


For some  biotechnological  innovations to work, it is important to have  enzymes  that function at unusually high or low temperatures.  An example of this is the  polymerase chain reaction  (PCR), which is dependent on a  DNA polymerase  that can operate at 60°C and above. [ 14 ]   In other situations, for example  dephosphorylation , it can be desirable to run the reaction at low temperature. [ 13 ]   Extremophile  bioprospecting is an important source of such enzymes, yielding thermostable enzymes such as  Taq  polymerase  (from  Thermus aquaticus ), [ 14 ]  and cold-adapted enzymes such as shrimp  alkaline phosphatase  (from  Pandalus borealis ). [ 13 ]


With the Convention on Biological Diversity (CBD) now ratified by most countries, bioprospecting has the potential to bring biodiversity-rich and technologically advanced nations together, and benefit them both educationally and economically (eg. information sharing,  technology transfer ,  new product development ,  royalty payment ). [ 2 ] [ 35 ]


For useful molecules identified through  microbial  bioprospecting, scale up of production is feasible at reasonable cost because the producing microorganism can be  cultured  in a  bioreactor . [ 8 ] [ 36 ]


Although some potentially very useful microorganisms are known to exist in nature (eg.  lignocellulose -metabolizing microbes), difficulties have been encountered cultivating these in a laboratory setting. [ 38 ]   This problem may be resolvable by  genetically manipulating  easier-to-culture organisms such as  Escherichia coli  or  Streptomyces coelicolor  to express the  gene cluster  responsible for the desired activity. [ 14 ] [ 39 ]


Isolating and identifying the  compound(s)  responsible for a biological extract's activity can be difficult. [ 39 ]   Also, subsequent elucidation of the  mechanism of action  of the isolated compound can be time-consuming. [ 39 ]   Technological advancements in  liquid chromatography ,  mass spectrometry  and other techniques are helping to overcome these challenges. [ 39 ]


Implementing and enforcing bioprospecting-related treaties and legislation is not always easy. [ 2 ] [ 35 ]   Drug development is an inherently expensive and time-consuming process with low success rates, and this makes it difficult to quantify the value of potential products when drafting bioprospecting agreements. [ 2 ]   Intellectual property rights  may be difficult to award too.  For example, legal rights to a  medicinal plant  may be disputable if it has been discovered by different people in different parts of the world at different times. [ 2 ]


Whilst the structural complexity of natural products is generally advantageous in drug discovery, it can make the subsequent manufacture of drug candidates difficult.  This problem is sometimes resolvable by identifying the part of the natural product structure responsible for activity and developing a simplified synthetic analogue.  This was necessary with the natural product halichondrin B, its simplified analogue  eribulin  now approved and marketed as an  anticancer drug . [ 40 ]


Errors and oversights can occur at different steps in the bioprospecting process including collection of source material, screening source material for  bioactivity , testing isolated compounds for  toxicity , and identification of  mechanism of action .


Prior to collecting  biological  material or  traditional knowledge , the correct permissions must be obtained from the source country, land owner etc.  Failure to do so can result in  criminal proceedings  and rejection of any subsequent  patent  applications.  It is also important to collect biological material in adequate quantities, to have biological material formally  identified , and to deposit a voucher specimen with a  repository  for long-term preservation and storage.  This helps ensure any important discoveries are reproducible. [ 10 ] [ 13 ]


When testing extracts and isolated compounds for bioactivity and toxicity, the use of  standard  protocols (eg.  CLSI ,  ISO ,  NIH ,  EURL ECVAM ,  OECD ) is desirable because this improves test result accuracy and reproducibility.  Also, if the source material is likely to contain known (previously discovered) active compounds (eg. streptomycin in the case of actinomycetes), then dereplication is necessary to exclude these extracts and compounds from the discovery pipeline as early as possible.  In addition, it is important to consider  solvent  effects on the cells or  cell lines  being tested, to include reference compounds (ie. pure  chemical compounds  for which accurate bioactivity and toxicity data are available), to set limits on cell line passage number (eg. 10–20 passages), to include all the necessary positive and negative  controls , and to be aware of assay limitations.  These steps help ensure assay results are accurate, reproducible and interpreted correctly. [ 10 ] [ 13 ]


When attempting to elucidate the mechanism of action of an extract or isolated compound, it is important to use multiple orthogonal assays.  Using just a single assay, especially a single  in vitro  assay, gives a very incomplete picture of an extract or compound's effect on the human body. [ 41 ] [ 42 ]   In the case of  Valeriana officinalis  root extract, for example, the  sleep-inducing  effects of this extract are due to multiple compounds and mechanisms including interaction with  GABA receptors  and  relaxation  of  smooth muscle . [ 41 ]   The mechanism of action of an isolated compound can also be misidentified if a single assay is used because some compounds  interfere  with assays.  For example, the sulfhydryl-scavenging assay used to detect  histone acetyltransferase  inhibition can give a false positive result if the test compound reacts covalently with cysteines. [ 42 ]


The term  biopiracy  was coined by  Pat Mooney , [ 43 ]  to describe a practice in which indigenous knowledge of nature, originating with  indigenous peoples , is used by others for profit, without authorization or compensation to the indigenous people themselves. [ 44 ]  For example, when bioprospectors draw on indigenous knowledge of medicinal plants which is later  patented  by medical companies without recognizing the fact that the knowledge is not new or invented by the patenter, this deprives the indigenous community of their potential rights to the commercial product derived from the technology that they themselves had developed. [ 45 ]  Critics of this practice, such as  Greenpeace , [ 46 ]  claim these practices contribute to inequality between developing countries rich in  biodiversity , and developed countries hosting  biotech  firms. [ 45 ]


In the 1990s many large pharmaceutical and drug discovery companies responded to charges of biopiracy by ceasing work on natural products, turning to  combinatorial chemistry  to develop novel compounds. [ 43 ]


The  rosy periwinkle  case dates from the 1950s. The rosy periwinkle, while native to  Madagascar , had been widely introduced into other tropical countries around the world well before the discovery of  vincristine . Different countries are reported as having acquired different beliefs about the medical properties of the plant. [ 47 ]  This meant that researchers could obtain local knowledge from one country and plant samples from another. The use of the plant for  diabetes  was the original stimulus for research. Effectiveness in the treatment of both  Hodgkin lymphoma  and  leukemia  were discovered instead. [ 48 ]  The Hodgkin lymphoma chemotherapeutic drug  vinblastine  is derivable from the rosy periwinkle. [ 49 ]


The  Maya ICBG bioprospecting controversy  took place in 1999–2000, when the  International Cooperative Biodiversity Group  led by  ethnobiologist   Brent Berlin  was accused of being engaged in unethical forms of bioprospecting by several  NGOs  and indigenous organizations. The ICBG aimed to document the biodiversity of  Chiapas ,  Mexico , and the  ethnobotanical  knowledge of the indigenous  Maya people  – in order to ascertain whether there were possibilities of developing medical products based on any of the plants used by the indigenous groups. [ 50 ] [ 51 ]


The Maya ICBG case was among the first to draw attention to the problems of distinguishing between benign forms of bioprospecting and unethical biopiracy, and to the difficulties of securing community participation and prior informed consent for would-be bioprospectors. [ 52 ]


In 1994, the  U.S. Department of Agriculture  and  W. R. Grace and Company  received a European patent on methods of controlling fungal infections in plants using a composition that included extracts from the  neem  tree ( Azadirachta indica ), which grows throughout  India  and  Nepal . [ 53 ] [ 54 ] [ 55 ]   In 2000 the patent was successfully  opposed  by several groups from the EU and India including the EU Green Party,  Vandana Shiva , and the  International Federation of Organic Agriculture Movements  (IFOAM) on the basis that the fungicidal activity of neem extract had long been known in  Indian traditional medicine . [ 55 ]   WR Grace appealed and lost in 2005. [ 56 ]


In 1997, the US corporation  RiceTec  (a subsidiary of RiceTec AG of Liechtenstein) attempted to patent certain hybrids of  basmati  rice and semidwarf long-grain rice. [ 57 ]  The Indian government challenged this patent and, in 2002, fifteen of the patent's twenty claims were invalidated. [ 58 ]


The Enola bean is a variety of Mexican  yellow bean , so called after the wife of the man who patented it in 1999. [ 59 ]  The allegedly distinguishing feature of the variety is seeds of a specific shade of yellow. The patent-holder subsequently sued a large number of importers of Mexican yellow beans with the following result: "...export sales immediately dropped over 90% among importers that had been selling these beans for years, causing economic damage to more than 22,000 farmers in northern Mexico who depended on sales of this bean." [ 60 ]  A lawsuit was filed on behalf of the farmers and, in 2005, the US-PTO ruled in favor of the farmers. In 2008, the patent was revoked. [ 61 ]


Hoodia gordonii , a  succulent plant , originates from the  Kalahari Desert  of  South Africa . For generations it has been known to the traditionally living  San people  as an  appetite suppressant . In 1996 South Africa's  Council for Scientific and Industrial Research  began working with companies, including  Unilever , to develop dietary supplements based on  Hoodia . [ 62 ] [ 63 ] [ 64 ] [ 65 ]  Originally the San people were not scheduled to receive any benefits from the commercialization of their traditional knowledge, but in 2003 the South African San Council made an agreement with CSIR in which they would receive from 6 to 8% of the revenue from the sale of  Hoodia  products. [ 66 ]


In 2008 after having invested €20 million in R&D on  Hoodia  as a potential ingredient in  dietary supplements  for weight loss, Unilever terminated the project because their clinical studies did not show that  Hoodia  was safe and effective enough to bring to market. [ 67 ]


The following is a selection of further recent cases of biopiracy.  Most of them do not relate to traditional medicines.


One common misunderstanding is that pharmaceutical companies  patent  the plants they collect. While obtaining a patent on a naturally occurring organism as previously known or used is not possible, patents may be taken out on specific chemicals isolated or developed from plants. Often these patents are obtained with a stated and researched use of those chemicals. [ citation needed ]  Generally the existence, structure and synthesis of those compounds is not a part of the indigenous medical knowledge that led researchers to analyze the plant in the first place. As a result, even if the indigenous medical knowledge is taken as prior art, that knowledge does not by itself make the active chemical compound "obvious," which is the standard applied under patent law.


In the  United States ,  patent law  can be used to protect "isolated and purified" compounds – even, in one instance, a new chemical element (see USP 3,156,523).  In 1873,  Louis Pasteur  patented a "yeast" which was "free from disease" (patent #141072).  Patents covering biological inventions have been treated similarly.  In the 1980 case of  Diamond v. Chakrabarty , the  Supreme Court  upheld a patent on a bacterium that had been genetically modified to consume petroleum, reasoning that U.S. law permits patents on "anything under the sun that is made by man."  The  United States Patent and Trademark Office  (USPTO) has observed that "a patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature". [ 76 ]


Also possible under US law is patenting a  cultivar , a new variety of an existing organism. The patent on the Enola bean (now revoked) [ 77 ]  was an example of this sort of patent.  The  intellectual property  laws of the US also recognize  plant breeders' rights  under the  Plant Variety Protection Act , 7 U.S.C. §§ 2321–2582. [ 78 ]


The Convention on Biological Diversity (CBD) came into force in 1993. It secured rights to control access to  genetic resources  for the countries in which those resources are located. One objective of the CBD is to enable lesser-developed countries to better benefit from their resources and traditional knowledge. Under the rules of the CBD, bioprospectors are required to obtain  informed consent  to access such resources, and must share any benefits with the biodiversity-rich country. [ 80 ]  However, some critics believe that the CBD has failed to establish appropriate regulations to prevent biopiracy. [ 81 ]  Others claim that the main problem is the failure of national governments to pass appropriate laws implementing the provisions of the CBD. [ 82 ]  The  Nagoya Protocol  to the CBD, which came into force in 2014, provides further regulations. [ 83 ]   The CBD has been ratified, acceded or accepted by 196 countries and jurisdictions globally, with exceptions including the  Holy See  and  United States . [ 79 ]


The requirements for bioprospecting as set by CBD has created a new branch of international  patent  and  trade law , bioprospecting contracts. [ 2 ]  Bioprospecting contracts lay down the rules of benefit sharing between researchers and countries, and can bring royalties to  lesser-developed countries . However, although these contracts are based on prior informed consent and compensation (unlike biopiracy), every owner or carrier of an indigenous knowledge and resources are not always consulted or compensated, [ 84 ]  as it would be difficult to ensure every individual is included. [ 85 ]  Because of this, some have proposed that the indigenous or other communities form a type of representative micro-government that would negotiate with researchers to form contracts in such a way that the community benefits from the arrangements. [ 85 ]  Unethical bioprospecting contracts (as distinct from ethical ones) can be viewed as a new form of biopiracy. [ 81 ]


An example of a bioprospecting contract is the agreement between  Merck  and  INBio  of  Costa Rica . [ 86 ]