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The Nagoya Protocol is a legal framework focused on the Access and Benefit Sharing of genetic resources, including Biological Control Agents. In order to comply with the Nagoya Protocol, countries in Latin America are establishing legal frameworks for access to genetic resources. Scientists face the challenges of the bureaucratic and administrative burden to obtain the access permits to study the biodiversity present in Latin American countries, which include the evaluation of biological control agents that can be used in sustainable production programs. In order to avoid the demotivation of scientists and students to work on biological control by blocking the opportunities to get new bioproducts, it is important to increase the communication between the regulatory authorities and the scientific community, to ensure the establishment of an effective structure and mechanisms to facilitate the process and reduce the time needed to obtain the access permits. On the other hand, the establishment of regional platforms for the exchange of information and harmonization of procedures can contribute to reinforce the collaboration among Latin American countries and facilitate regional studies and biocontrol activities. In this article, the legal framework in place in different countries in Latin America will be discussed and some possible solutions and ways forward to the major challenges observed will be presented.

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ETHNOPHARMACOLOGICAL RELEVANCE: The Peruvian Amazon holds more than 1000 plant species with commercial potential and the national sales of natural products derived from medicinal and aromatic plants have exceeded $ 400 million per year. Research and development activities carried out on the genetic and biochemical composition of Peruvian flora have to abide by national and international regulations, such as the Nagoya Protocol (NP). AIM OF THE STUDY: The aim of this paper is to describe the implications of the current implementation of the NP in Peru for performing research on national genetic resources. MATERIALS AND METHODS: A review of the current legal framework and status of the NP in Peru was performed accompanied by first-hand experience undertaken by submitting a request for access to genetic resources related to wild continental species. RESULTS: So far, Peru has issued 16 Internationally Recognized Certificates of Compliance (IRCCs) through 2 of the identified National Authorities. Some of the difficulties and challenges observed have to do with the degree of effective implementation of the Access and Benefit-Sharing (ABS) system, the fact that the application process is not sufficiently clear, and the wide gap between this formal system and what occurs informally outside of it. In response to this, training and implementation projects have been launched and a new law on the access to genetic resources has been proposed. CONCLUSIONS: The difficulties observed still represent an obstacle to scientific research and the development of new commercial products based on Peruvian traditional knowledge and genetic resources. Although improvements have been made to the ABS framework, there remain major challenges to encouraging and ascertaining the equitable and sustainable use of Peru's biodiversity.

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RESUMEN Se realiza un análisis empírico y actualizado de las solicitudes de patente en trámite ante la oficina colombiana de patentes y que requieren de contrato de acceso a recursos genéticos y/o productos derivados (CARG o PD). Se identifican 15 casos y a partir del análisis del trámite, se describen los principales mitos existentes sobre este tema, analizando para cada uno si se trata de afirmaciones ciertas o falsas. Se destaca que hay mejoras en los tiempos y número de contratos de acceso firmados por parte del Ministerio de Ambiente y Desarrollo Sostenible (MADS), que los solicitantes de patente y/o apoderados no están haciendo un correcto uso de la declaración juramentada o divulgación de origen sobre uso de recursos genéticos y/o productos derivados, y que aún se debe mejorar en la identificación de casos que requieren CARG o PD por parte de la Superintendencia de Industria y Comercio (SIC). Asimismo, se estudian las obligaciones adquiridas por los firmantes del CARG o PD y los beneficios monetarios y no monetarios acordados con el MADS, encontrando que mientras las obligaciones suelen ser estándar para todos los CARG o PD, los beneficios pactados tanto monetarios como no monetarios sí son distintos. Se enuncian estadísticas actualizadas de los contratos de acceso firmados. Se concluye identificando los principales temas y destinatarios que deben reforzarse en las capacitaciones de estos asuntos y los espacios para mejorar la interacción entre el MADS, la SIC y los usuarios e investigadores.

ABSTRACT An empirical and updated analysis is made of the patent applications that are processed in the Colombian patent office and that require a contract for access to genetic resources or derivatives (CARG or PD). 15 cases of this type of requests are identified and from the study of the process, the main existing myths on this subject are identified, analyzing for each one whether they are true or false statements. It is highlighted that there are improvements in the times and number of access contracts signed by the Ministry of Environment and Sustainable Development (MADS), that patent applicants and /or attorneys are not making a correct use of the sworn statement about the use of genetic resources or PD, and that still needs to be improved in the identification of cases that require CARG or PD by the Patent Office Superintendence of Industry and Commerce (SIC). Likewise, the obligations acquired by the signatories of the CARG or PD and the monetary and non-monetary benefits that the MADS is demanding are analyzed, finding that while the obligations are usually standard for all the CARG or PD, the agreed benefits, both monetary and non-monetary are different. It concludes by identifying the main topics and actors on which the training on these issues should be reinforced and the spaces to improve the interaction between the patents and environmental authorities.

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Esta contribución debate los grandes retos que enfrenta Perú en la implementación nacional del régimen de acceso a recursos genéticos y distribución de beneficios, tema conocido por las siglas "ABS" del inglés Access and Benefit-Sharing. El ABS es un mecanismo que incentiva la conservación de la diversidad genética mediante la distribución justa y equitativa de los beneficios que se deriven de la utilización de recursos genéticos entre el país que los provee y el usuario de éstos. Perú afronta cuatro desafíos en relación con el tema: (1) su procedimiento de acceso a recursos genéticos es complejo y burocrático, desalentándose así la negociación de contratos sobre ABS. (2) el rol de la "institución nacional de apoyo" ha sido desvirtuado, exacerbándose su función de mero controlador; con ello se han perdido valiosas colaboraciones científicas a favor de las instituciones científicas locales. (3) la legislación peruana sobre ABS posee efectos retroactivos, infringiendo el principio de seguridad jurídica que debe reinar en toda relación contractual. (4) si bien se han previsto medidas de cumplimiento y un punto de verificación de acuerdo a lo establecido por el Protocolo de Nagoya, no se establece un control sobre la legalidad del acceso a recursos genéticos y conocimiento tradicional asociado al uso de éstos cuando ellos provengan de cualquier otro país que no sea el Perú. Al finalizar el artículo se proponen algunas mejoras a realizar a fin de afrontar los desafíos encontrados en el estudio.

This essay intends to debate the major challenges that Peru faces as it implements a national regime on Access to genetic resources and Benefit-Sharing (ABS). The ABS encourages the conservation of genetic diversity by means of the fair and equitable distribution of the benefits arisen from the utilization of genetic resources. Distribution is to take place between the providing country and the user of the resources. Peru features four main weaknesses in relation to ABS: (1) Firstly; its national legislation on the topic sets a bureaucratic and complex procedure that hinders the negotiation of fructiferous ABS contracts. (2) The role of the "national scientific partner" has been distorted and true opportunities for scientific cooperation are missed. (3) Peruvian legislation on ABS establishes retroactive effects infringing the principle of legal certainty. (4) Even though the national legal framework establishes a set of compliance measures and a checkpoint to verify the legal access of genetic resources in accordance to the Nagoya Protocol, these measures do not cover the control of genetic resources and traditional knowledge associated to their utilization from countries other than Peru. Improvements to face the challenges encountered are offered at the end of the article.

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ETHNOPHARMACOLOGICAL RELEVANCE: Without an understanding of the geography of traditional knowledge, implementing the Nagoya Protocol and national or regional strategies for benefit-sharing with local and indigenous communities will be difficult. We evaluate how much traditional knowledge about medicinal palm (Arecaceae) uses is unique and how much is shared across (i) four countries (Colombia, Ecuador, Peru, Bolivia), (ii) two cultural groups (Amerindian and non-Amerindian), (iii) 52 Amerindian tribes, (iv) six non-Amerindian groups, (v) 41 communities, and (vi) individuals in the 41 communities. MATERIALS AND METHODS: We first sampled traditional knowledge about palms from 255 references and then carried out 2201 field interviews using a standard protocol. Using the combined data set, we quantified the number of "singletons" that were unique to one of the analyzed scales. For the 41 communities, we evaluated how many uses were cited by <10% and by ≥50% of informants. We performed a Kruskal-Wallis test to evaluate whether the number of unshared uses (cited by <10%) differed significantly in relation to the informants׳ gender and degree of expertise, and performed a two-way ANOVA to test for differences in the number of unshared and shared uses accounted for by the five birth cohorts. RESULTS: We found that most knowledge was not shared among countries, cultural groups, tribes, communities, or even individuals within them. Still, a minor knowledge component was widely shared, even across countries. General informants cited a significantly higher number of unshared uses than experts, whereas no significant differences were found in the number of unshared uses cited by men and women or by different age groups. CONCLUSION: Our region-wide analysis highlights the geospatial complexity in traditional knowledge patterns, underscoring the need for improved geographic insight into the ownership of traditional knowledge in areas where biocultural diversity is high. This high geographic complexity needs consideration when designing property right protocols, and calls for countrywide compilation efforts as much localized knowledge remains unrecorded.

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A pesar del avance en el marco reguladorinternacional sobre bioprospección, la normatividad internacarece de uniformidad en torno a la política internacional enla materia. Por tal razón, se analizó la eficacia de la políticacolombiana sobre bioprospección en consonancia con lasdirectrices y tratados internacionales, para evidenciar su nivelde cumplimiento. Se solicitó información a las autoridadesambientales sobre los permisos de estudio con fines deinvestigación científica en diversidad biológica y acceso arecursos genéticos y se consultó el registro de los grupos deinvestigación en Colombia a la luz de la regulación nacional.Se evidenció que la actividad científica en bioprospecciónha crecido en los últimos cinco años tanto en númerode grupos de investigación (30%) como en número deproyectos registrados (ocho veces). Sin embargo, el númerode proyectos no coincide con el número de permisos,verificándose un margen de informalidad (70%). Losobstáculos para la legalización de las actividades científicasen biodiversidad hace necesario cambiar las normas paraque el Estado cumpla con su deber de promoción de lainvestigación en el tema...

Despite the evolution of international policy on bioprospecting, Colombian regulations on the matter stilllack uniformity with these international policies. Here we examine the effectiveness of Colombian policyon bioprospecting and its consonance with international guidelines and treaties. To this end, we requestedinformation from the environmental authorities regarding study permits issued for scientific research onbiodiversity and access granted to genetic resources. We also examined the number of research groups inColombia registered under national directives. We found that scientific bioprospecting has increased inthe last five years both in number of research groups (30%) and in the number of registered projects (8times); however, the number of undertakings does not match the number of permits issued, suggestinga margin of informality (70%) in the execution of these activities. For the State to fulfill its duty andpromote research in biodiversity, a change in policy must take place to remove the obstacles that hinderthe legalization of scientific bioprospecting activities...

Apesar da evolução das políticas internacionaisem bioprospeção, os regulamentos Colombianos carecemde uniformização com estas políticas. Examinámos aeficácia das políticas Colombianas em bioprospeção e suaconcordância com normas e tratados internacionais. Paraeste fim, solicitamos informação das autoridades ambientaissobre licenças de emissão de estudo para a investigaçãocientífica sobre biodiversidade e acesso concedido a recursosgenéticos. Ademais, examinamos o número de gruposde investigação em Colômbia registados sob diretrizesnacionais. Descobrimos que a bioprospeção científica temaumentado nos últimos cinco anos, tanto em número degrupos de investigação (30%) como no número de projetosinscritos (8 vezes), porém o número de projetos não coincidecom o número de licenças emitidas, sugerindo uma margemde informalidade (70%) na execução dessas atividades. Parao Estado cumprir o seu dever e promover a investigaçãoem biodiversidade, uma mudança na política deve ser feitapara remover os obstáculos que impedem a legalização dasatividades científicas de bioprospeção.

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