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This paper discusses the potential of an international agreement to ensure equitable vaccine distribution, addressing the failures witnessed during the COVID-19 pandemic. COVAX was unable to prevent vaccine monopolization and unequal distribution, which led to significant disparities in vaccination rates and avoidable deaths. Any future agreement on equitable vaccine distribution must address ethical and practical issues to ensure global health equity and access. The proposed agreement should recognize healthcare as a human right and consider vaccines beyond mere commodities, emphasizing the social responsibility of pharmaceutical companies to prioritize affordability, availability, and accessibility, particularly for low-income countries (LICs). Voluntary licensing agreements are suggested as a means to enhance access to essential medicines. The paper also outlines the necessity of international cooperation, with robust compliance mechanisms, to effectively enforce such an agreement and mitigate future health crises.

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Background: The deployment of OpenAI's ChatGPT-3.5 and its subsequent versions, ChatGPT-4 and ChatGPT-4 With Vision (4V; also known as "GPT-4 Turbo With Vision"), has notably influenced the medical field. Having demonstrated remarkable performance in medical examinations globally, these models show potential for educational applications. However, their effectiveness in non-English contexts, particularly in Chile's medical licensing examinations-a critical step for medical practitioners in Chile-is less explored. This gap highlights the need to evaluate ChatGPT's adaptability to diverse linguistic and cultural contexts. Objective: This study aims to evaluate the performance of ChatGPT versions 3.5, 4, and 4V in the EUNACOM (Examen Único Nacional de Conocimientos de Medicina), a major medical examination in Chile. Methods: Three official practice drills (540 questions) from the University of Chile, mirroring the EUNACOM's structure and difficulty, were used to test ChatGPT versions 3.5, 4, and 4V. The 3 ChatGPT versions were provided 3 attempts for each drill. Responses to questions during each attempt were systematically categorized and analyzed to assess their accuracy rate. Results: All versions of ChatGPT passed the EUNACOM drills. Specifically, versions 4 and 4V outperformed version 3.5, achieving average accuracy rates of 79.32% and 78.83%, respectively, compared to 57.53% for version 3.5 (P<.001). Version 4V, however, did not outperform version 4 (P=.73), despite the additional visual capabilities. We also evaluated ChatGPT's performance in different medical areas of the EUNACOM and found that versions 4 and 4V consistently outperformed version 3.5. Across the different medical areas, version 3.5 displayed the highest accuracy in psychiatry (69.84%), while versions 4 and 4V achieved the highest accuracy in surgery (90.00% and 86.11%, respectively). Versions 3.5 and 4 had the lowest performance in internal medicine (52.74% and 75.62%, respectively), while version 4V had the lowest performance in public health (74.07%). Conclusions: This study reveals ChatGPT's ability to pass the EUNACOM, with distinct proficiencies across versions 3.5, 4, and 4V. Notably, advancements in artificial intelligence (AI) have not significantly led to enhancements in performance on image-based questions. The variations in proficiency across medical fields suggest the need for more nuanced AI training. Additionally, the study underscores the importance of exploring innovative approaches to using AI to augment human cognition and enhance the learning process. Such advancements have the potential to significantly influence medical education, fostering not only knowledge acquisition but also the development of critical thinking and problem-solving skills among health care professionals.

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Resumo O artigo aborda o licenciamento ambiental como instrumento de identificação e preservação do patrimônio cultural. Ao longo de 2021 foram conduzidos estudos na área do campus de Manguinhos da Fundação Oswaldo Cruz e vizinhança, associados à instalação de uma rede de coleta e tratamento de esgoto pelo poder público. Os estudos evidenciaram o processo de ocupação do território e permitiram identificar vestígios de cultura material em contexto arqueológico e os bens acautelados pelo Instituto do Patrimônio Histórico e Artístico Nacional - baianas de acarajé, capoeira e literatura de cordel -, saberes e formas de expressão que testemunham a construção do território de Manguinhos, processo em constante movimento.

Abstract This article discusses environmental licensing as an instrument for the identification and preservation of cultural heritage. Throughout 2021, studies were undertaken in and around Fundação Oswaldo Cruz's Manguinhos campus, in Rio de Janeiro, in preparation for the introduction of a sewage system by the local authority. The studies revealed how the territory had been occupied and enabled the identification of vestiges of material culture in an archaeological context and the heritage listed by Iphan, the Brazilian federal heritage protection agency - baianas de acarajé, capoeira, and cordel literature - the knowledge, and the forms of expression that bear witness to the development of the Manguinhos territory, a process in continuous motion.

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BACKGROUND: ChatGPT has shown impressive performance in national medical licensing examinations, such as the United States Medical Licensing Examination (USMLE), even passing it with expert-level performance. However, there is a lack of research on its performance in low-income countries' national licensing medical examinations. In Peru, where almost one out of three examinees fails the national licensing medical examination, ChatGPT has the potential to enhance medical education. OBJECTIVE: We aimed to assess the accuracy of ChatGPT using GPT-3.5 and GPT-4 on the Peruvian National Licensing Medical Examination (Examen Nacional de Medicina [ENAM]). Additionally, we sought to identify factors associated with incorrect answers provided by ChatGPT. METHODS: We used the ENAM 2022 data set, which consisted of 180 multiple-choice questions, to evaluate the performance of ChatGPT. Various prompts were used, and accuracy was evaluated. The performance of ChatGPT was compared to that of a sample of 1025 examinees. Factors such as question type, Peruvian-specific knowledge, discrimination, difficulty, quality of questions, and subject were analyzed to determine their influence on incorrect answers. Questions that received incorrect answers underwent a three-step process involving different prompts to explore the potential impact of adding roles and context on ChatGPT's accuracy. RESULTS: GPT-4 achieved an accuracy of 86% on the ENAM, followed by GPT-3.5 with 77%. The accuracy obtained by the 1025 examinees was 55%. There was a fair agreement (κ=0.38) between GPT-3.5 and GPT-4. Moderate-to-high-difficulty questions were associated with incorrect answers in the crude and adjusted model for GPT-3.5 (odds ratio [OR] 6.6, 95% CI 2.73-15.95) and GPT-4 (OR 33.23, 95% CI 4.3-257.12). After reinputting questions that received incorrect answers, GPT-3.5 went from 41 (100%) to 12 (29%) incorrect answers, and GPT-4 from 25 (100%) to 4 (16%). CONCLUSIONS: Our study found that ChatGPT (GPT-3.5 and GPT-4) can achieve expert-level performance on the ENAM, outperforming most of our examinees. We found fair agreement between both GPT-3.5 and GPT-4. Incorrect answers were associated with the difficulty of questions, which may resemble human performance. Furthermore, by reinputting questions that initially received incorrect answers with different prompts containing additional roles and context, ChatGPT achieved improved accuracy.

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Environmental Education Programs (EEPs) are considered environmental management tools in Brazilian environmental licensing processes, within the scope of mitigatory and compensatory measures to the social, environmental, and economic impacts caused by development projects or new enterprises. Here, we assess the perceptions and expectations regarding environmental education programs of three groups of actors (communities, environmental managers, and environmental agency technicians) involved in the licensing processes of port activities in the region of Paranaguá, in the State of Paraná, Brazil. Paranaguá is the largest coastal municipality of the state of Paraná, in the southern region of Brazil, and is home to Brazil`s second largest port. Since this is environmental conservation area, the conflicts between the port activities, environmental protection and needs of the local communities require efficient environmental management practices, with EEPs as one of their main implementation tools. The evaluation was based on semi-structured interviews which were analyzed using the methods of content analysis and discourse of the collective subject. The actors understand that environmental education is a potentially effective tool to promote the mitigation or compensation of environmental impacts generated by port developments undergoing licensing processes. The groups considered that the continuity, promotion of social organization, and correlation with the actual environmental impacts related to each enterprise are essential qualities for good EEPs. The evaluated perceptions were complementary and indicate a complex but effective ideal scenario for EEPs in the region.

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In recent years, the demand for clean water has been growing all over the world despite the different threats posed, including increasing pollution, increasing deforestation and climate change. Industrial activity is the second largest consumer of water, so highly industrialized regions are more susceptible to water stress. In this sense, reuse strategies have been progressively discussed and used around the world; however, in Brazil there is still place for many advances, whether due to lack of incentives, cultural issues in society, or poor regulation of the subject. The objective of this work was to carry out a diagnosis of raw water uptake by industries in one Hydrographic Region of the state of Rio de Janeiro and to propose a discussion on the adoption of water reuse practices for non-potable purposes from the use of treated effluents. A survey of the theoretical framework on the subject was carried out, as well as an analysis of sustainability indicators and reports of the companies, including the current licensing processes of large undertakings consuming water resources. With this study, it was possible to obtain the average cost of implementing a water reuse unit for an industry in the state of Rio de Janeiro-Brazil, which, despite still being expensive, has a strong tendency to use due to world water shortages. Finally, it was concluded that the state of Rio de Janeiro has a threat of water scarcity that could be aggravated in the coming years, if measures and investments in supply alternatives are not adopted (water reuse), and improvement in all stages of water management water resources.

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Wind energy is an important electricity source. Even though it is cleaner than other energy sources in terms of greenhouse gas emissions, gathering energy from the wind has impact on organisms that fly, including bats. Understanding whether and how bat activity patterns are affected by environmental variables may be useful when trying to mitigate these impacts, for example bat mortality from collisions with wind turbines. Northeastern Brazil concentrates one of the world's largest wind potentials and has thousands of wind turbines in operation. In spite of this scenario, there is a lack of basic information, such as the presence of bat species and their activity patterns in those wind farms. We used passive acoustic monitoring to assess species richness and species composition and obtain data on activity patterns of insectivorous bats in four wind farm complexes in northeastern Brazil. We also investigated the possible correlation between environmental variables (wind speed and direction, air temperature and humidity, and percentage of moon illumination) and bat activity. The acoustic monitoring carried out for 30 nights produced approximately 120,000 bat passes of 29 sonotypes and four families. Environmental variables may influence bat activity, but in a site-specific way, i.e., although the environmental conditions of wind-energy complexes were similar, there was not an activity pattern common to all. Considering such specificities, we strongly recommend long-term specific on-site monitoring in each wind complex, avoiding generalizations for the environmental licensing of wind energy in Brazil.(AU)

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RESUMO A geração de energia fotovoltaica vem crescendo no Brasil, e a capacidade instalada de usinas fotovoltaicas (UFV) deve superar 3 GW em alguns anos. Essa tecnologia causa menor impacto ambiental do que formas de geração tradicionais, como termoelétricas e hidroelétricas. Entretanto os impactos quando da implantação de UFV devem ser considerados no licenciamento ambiental. No Brasil, não há uma legislação federal que estabeleça critérios mínimos para esse tipo de licenciamento. Alguns estados criaram legislações próprias, que divergem nas exigências e critérios adotados. Essa disparidade causa insegurança no processo de licenciamento, dificuldade na aprovação dos estudos, aumento de custos e prazos, podendo inviabilizar empreendimentos. Neste estudo foram analisadas e comparadas as legislações em 12 estados, nas quais está previsto o desenvolvimento de UFV, como base para propor critérios claros, objetivos e padronizados para o enquadramento legal das UFV. Como resultado desta pesquisa, propõe-se o enquadramento como de baixo impacto, com licenciamento simplificado e emissão de licença prévia (LP) e licença de instalação (LI) em etapa única. Os critérios para enquadramento de porte são potência instalada e área diretamente ocupada. Para potencial poluidor, os critérios são necessidade de supressão de vegetação nativa (e/ou em área de preservação permanente - APP) e localização em área de fragilidade socioambiental. A avaliação conjunta desses critérios define qual o estudo ambiental necessário ao licenciamento. O trabalho lista os principais aspectos e impactos ambientais a serem abordados em tais estudos. Estes critérios unificados formam uma ferramenta para promover tanto o desenvolvimento de UFV como a proteção do meio ambiente com minimização de possíveis impactos.

ABSTRACT Photovoltaic power generation is growing in Brazil. It is expected that installed capacity of photovoltaic power plants (PVPP) will exceed 3 GW within a few years. This technology is known to have less environmental impacts than other traditional forms of energy generation, however its environmental impacts should be considered in the environmental licensing process. In Brazil there is no federal legislation establishing the criteria or requirements for licensing this type of power plants. Some states have created their own legislation, whose criteria differ widely. This lack of national standardization causes licensing agencies' insecurity, difficulty in approving studies, increase in costs and deadlines, and has caused many projects to be unfeasible. Therefore, this study did an analysis and comparison of 12 states' legislation regarding environmental licensing of PVPPs. This analysis based the proposal of clear, objective and standardized criteria for PVPPs licencing. It is proposed to normally classify the PVPPs as having low environmental impact, with simplified licensing, issuing Preliminary and Installation License in a single step. The proposed criteria for classification in size are installed power and directly occupied area. Regarding the pollution potential, the criteria are suppression of native vegetation (and/or in a permanent preservation area); and location in environmental fragile areas. The joint evaluation of these criteria defines the type of environmental study to be required for licensing. The main aspects and environmental impacts that should be addressed are listed. These unified criteria are a tool to promote both development of PVPP projects and the protection of the environment, by minimizing their potential environmental impacts.

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A sociedade brasileira vem discutindo, recentemente, a ideia de implementar um exame de licenciamento em Medicina (ELM) para médicos recém-formados no país. Para avaliar a adequação dessa proposta e sua real necessidade, analisa-se neste trabalho se os ELMs estabelecem eficazmente a aptidão dos recém-formados para exercer a Medicina e se os sistemas de avaliação vigentes no ensino médico brasileiro já o fazem. Usando o modelo baseado em competências como referencial, discute-se a experiência da comunidade internacional com os ELMs e as características das avaliações que se propõem a medir, no Brasil, a aptidão dos recém-formados. Conclui-se que, isoladamente, ambas as alternativas são ineficazes para cumprir esse objetivo. Propõe-se o desenvolvimento de um programa mais amplo de avaliação e enfatiza-se a importância da colaboração entre os atores envolvidos para aprimorar a qualidade das avaliações dos médicos recém-formados no Brasil.(AU)

The introduction a medical licensing examination (MLE) for the country's newly qualified doctors has been the subject of discussion recently in Brazil. To assess the suitability of and real need for this test, this article analyzes whether the MLE provides an effective measure of the aptitude of newly qualified doctors and whether the evaluation system currently in place in medical education already does this. Using a competency-based model, we discuss experiences with MLEs in other countries and the features of the examinations proposed in Brazil to measure the aptitudes of newly qualified doctors. It is concluded that, in isolation, both alternatives are inadequate. We propose the development of a broader assessment program and stress the importance of collaboration between the different actors involved in order to enhance the quality of the examinations proposed to test the aptitude of newly qualified doctors in Brazil.(AU)

La sociedad brasileña ha discutido recientemente la idea de implementar un examen de licencia (ELM) para médicos recién graduados en el país. Para evaluar la adecuación de esta propuesta y su real necesidad, se analiza en este trabajo si los ELMs establecen eficazmente la aptitud de los recién graduados para ejercer la Medicina y si los sistemas de evaluación vigentes en la enseñanza médica brasileña ya lo hacen. Usando el modelo basado en competencias como factor referencial, se discute la experiencia de la comunidad internacional con los ELMs y las características de las evaluaciones que se proponen medir, en Brasil, la aptitud de los recién graduados. Se concluye que, aisladamente, ambas alternativas son ineficaces para cumplir ese objetivo. Se propone el desarrollo de un programa más amplio de evaluación y se enfatiza la importancia de la colaboración entre los actores envueltos para perfeccionar la calidad de las evaluaciones de los recién graduados en Brasil.(AU)

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Environmental licensing is a command-and-control (C&C) instrument used at the state level in Brazil to enforce compliance with legal requirements and environmental standards; however, it does not encourage continuous improvement. The objective of this paper is to propose a methodology that can be used as a licensing and monitoring policy for industrial activities, based on both command and control and economic instruments. Therefore, the development of a matrix to measure the environmental performance of companies is proposed so as to include mandatory compliance requirements, environmental management requirements and continuous improvement indicators. Performance assessment could be used by the environmental agency as a tool to support environmental management policy change by working with environmental incentives for better-performing companies. The results obtained with the matrix will demonstrate exactly what the theory describes: in an environment where the control imposed to the entrepreneur is by the attendance of a legislative standard and not the demonstration of continuous improvement, there is no evolution of the environmental performance over the 3-year period of the companies. Consequently, the inclusion of a tool to assess environmental performance constitutes a requirement for the environmental evolution of the country.

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Mesenchymal Stem Cells (MSCs) have gained prominence as an important tool in cell therapy, especially considering their capacity to control the immune system. Due to this property, the application of MSCs has been investigated for the treatment of several immune disorders, such as diabetes, rheumatoid arthritis, Crohn's disease, systemic lupus erythematosus, and graft-versus-host-disease (GvHD). The application of MSCs to treat inflammatory diseases has led to impressive results. However, individual response to treatment is still heterogeneous, and the number of cells required to treat humans is very high. The possibility of increasing the immunosuppressive potential of MSCs is seen at this point as a promising alternative to overcome such limitations. One of the most exploited strategies for this purpose has been the licensing of MSCs prior to clinical application. In this review, we will discuss the mechanisms by which MSCs modulate the immune response and the main advances in the licensing of these cells, with a special focus on the use of interferon gamma (IFN-γ). Also, we will address the main challenges ahead before licensed MSCs are finally used successfully in clinical practice.

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RESUMO A avaliação de impactos ambientais, introduzida por meio da Política Nacional de Meio Ambiente (PNMA), ganhou espaço primordialmente dentro do licenciamento ambiental, cujo modelo atual é questionado pela sua ineficácia em compensar ao ambiente a perda dos recursos naturais. Este estudo teve como objetivo analisar de forma técnica e legal o licenciamento ambiental minerário na Região do Alto São Francisco, Minas Gerais, por intermédio do histórico e fluxo atual dos processos, do levantamento de dados dos de Estudos de Impacto Ambiental, do cumprimento dos Termos de Referência e da legislação ambiental, analisando estes dados pelo método Analytic Hierarchy Process (AHP). Os resultados demonstraram que o licenciamento ambiental não cumpre a função de compensar os impactos socioambientais causados pela atividade nem os requisitos legais obrigatórios ao processo.

ABSTRACT The assessment of environmental impacts, introduced by the National Environmental Policy, has earned a place within the environmental licensing process, which is currently questioned due to its ineffectiveness to compensate nature for resources' loss. This study aimed at technically and legally assessing the mineral environmental licensing process in the Region of Alto São Francisco, Minas Gerais, through history and current flow of processes, as well as by surveying data from Studies on Environmental Impact, and compliance with the Terms of Reference and applicable environmental law, using the Analytic Hierarchy Process (AHP). The results showed that the environmental licensing process does not meet the needs for compensating the socioenvironmental impacts caused by activity and does not comply with the legal requirements that are mandatory in the process.

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Introducción: La política que ha regido la educación superior universitaria en el Perú ha sido variable en el tiempo y su despertar hacia el concepto de calidad es tardío con relación a otros países latinoamericanos. Esta situación se vio agravada en las décadas pasadas por políticas dirigidas a convertir la educación en una empresa rentable con normas poco rígidas para asegurar su calidad. En la actualidad, el Perú se encuentra realizando una reforma de la educación superior universitaria, reformulando sus bases, y tratando de construir estándares de calidad adecuados. Es en este escenario, que hacemos un análisis de los factores que influyen en la calidad de la educación médica, siendo la salud un bien supremo de todos los ciudadanos; y la atención de calidad una responsabilidad compartida entre el Estado y las universidades. Objetivo: Exponer una visión histórica, analítica, crítica y actualizada sobre los aspectos más relevantes a considerar para la mejora de la formación profesional de los médicos en el Perú. Métodos: Se realizó una revisión bibliográfica en la base de datos de MedLine/PubMed, The Cochrane Library y Scielo. Los descriptores utilizados para la búsqueda fueron: educación médica, calidad, acreditación. Las publicaciones y artículos encontrados fueron analizados a profundidad realizándose una síntesis de los mismos. Resultados: Esta revisión permitió identificar las características esenciales y los desafíos a enfrentar por las instituciones de Educación Superior en el ámbito de la educación médica. Esto con fines de lograr la acreditación para asegurar la calidad en la formación de los médicos en el Perú(AU)

Introduction: The policy of university higher education in Peru has been variable over time as well as its progress regarding the concept of quality in relation to other Latin American countries. This situation has worsened in the last decades due to policies aimed at making education profitable, generating companies with few rigid rules to guarantee the quality of education. Currently, Peru is carrying out a reform of university higher education, reformulating its bases and trying to build quality standards. It is in this scenario, that we make an analysis of the factors that influence the quality of medical education, considering health as a supreme good for all citizens and the achievement of quality as a shared responsibility between the State and universities. Objective: To present a historical, analytical, critical and updated view on the most relevant aspects to be considered for the improvement of the professional training of physicians in Peru Methods: A literature review was made in the MedLine / PubMed database, The Cochrane Library and Scielo. The descriptors used for the search were: medical education, quality, accreditation. The found articles were analyzed, making a synthesis of them. Results: This revision has permitted to identify the characteristics and challenges faced by higher medical education institutions to get the accreditation and ensure the quality of the professional training of doctors in Perú(AU)

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When pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implications for attempting CL relevant for middle-income countries in the era of high-cost medicines. CL is not only a politically well-devised measure to achieve universal health coverage, but also a tentative commitment, which is determined both at the country level and at the global level. At the country level, political will, with catalytic roles of civil activism, is important in order to guarantee the right to health. Through this will, the governments can achieve universal health coverage. In addition, electoral systems, political leaders, and a constitution are necessary to attempt CL. In addition, CL should operate along with other policy instruments, including a comprehensive essential medicines list, CL-friendly phrasing in patent law, and a competent pharmaceutical industry. At the global level, the balance of power between the WTO regime and the global justice movement is critical. This provides global-level context that can either encourage or prevent CL.

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Biotherapeutic products which are derived from living organisms using recombinant DNA technology significantly contribute to the progress in the treatment of life-threatening and chronic diseases. The worldwide sale of biological drugs in 2016 was near US $263,700 million. In Latin America, where monoclonal antibodies market was worth US $7000 million, being Mexico the second largest market. Approval is one of the key aspects which influences the market of medicinal products, thus it is responsibility of the regulatory authority to establish a regulatory framework that ensure safety and efficacy of the products, and it is responsibility of the applicants to provide a high quality dossier in accordance with the registration requirements of the country. The applicants submitting registration requests in Mexico need to be aware of the requirements. Similar to many other countries, Mexico has adopted the Common Technical Document (CTD) structure for organizing dossier of the medicinal product for submission into main modules (i.e., quality, non-clinical, and clinical). This facilitates the submission process of medicinal products following a logical sequence aligned to the International Council on Harmonisation (ICH) guidelines. Moreover, this structure improves the transparency and clarity of the dossier in process of evaluation of medicinal products. In Mexico, the Ministry of Health has published a regulation, NOM-257-SSA1-2014, which established the general requirements to be followed by applicants to complete the registration of biotherapeutics. This regulation stipulates that the evaluation process is supported by a regulatory framework involving Good Manufacturing Practices, labeling, stability, clinical trials, biocomparability studies, pharmacovigilance, and a technical evaluation performed by a multidisciplinary team of experts in biotherapeutics development. Additionally, the Mexican regulatory agency, COFEPRIS, has published specific guidelines to facilitate the application process. Despite the availability of this information, the scope is limited to regulatory and administrative purposes, rather than technical-scientific supporting knowledge. The aim of this article is to provide concise information to improve and promote communication between industry and regulatory agencies. Herein, we describe the current process of COFEPRIS in regulating biotherapeutics in Mexico. This process explains the basis for the organization and structure of the technical-scientific information of biotherapeutics required for registration application.

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We analyze the invisibility of fisheries and inadequacy of fishers' participation in the process of hydropower development in the Amazon, focusing on gaps between legally mandated and actual outcomes. Using Ostrom's institutional design principles for assessing common-pool resource management, we selected five case studies from Brazilian Amazonian watersheds to conduct an exploratory comparative case-study analysis. We identify similar problems across basins, including deficiencies in the dam licensing process; critical data gaps; inadequate stakeholder participation; violation of human rights; neglect of fishers' knowledge; lack of organization and representation by fishers' groups; and lack of governmental structure and capacity to manage dam construction activities or support fishers after dam construction. Fishers have generally been marginalized or excluded from decision-making regarding planning, construction, mitigation, compensation, and monitoring of the social-ecological impacts of hydroelectric dams. Addressing these deficiencies will require concerted investments and efforts by dam developers, government agencies and civil society, and the promotion of inter-sectorial dialogue and cross-scale participatory planning and decision-making that includes fishers and their associations.

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Resumo O presente artigo tem como objetivo discutir sobre a Avaliação de Impacto à Saúde (AIS), apontando as principais iniciativas do setor saúde, desafios e perspectivas para a sua aplicação no Brasil. A AIS é uma metodologia preconizada pela OMS já bastante difundida em diversos países, mas com poucas iniciativas no Brasil. As questões de saúde no âmbito dos grandes empreendimentos no país são comumente realizadas de forma pontual nos processos de licenciamento ambiental, diferentemente da AIS que traz uma abordagem integrada, com a participação dos atores sociais no território desde o início do projeto. Trata-se de uma pesquisa de natureza analítica e exploratória. Para tanto, realizou-se uma revisão sistemática sobre o tema, bem como o levantamento de documentos governamentais das principais iniciativas já realizadas pelo Ministério da Saúde, no âmbito da Vigilância em Saúde Ambiental, nos processos de licenciamento de empreendimentos. Buscou-se analisar os principais marcos conceituais, apontando possibilidades para sua aplicação no Brasil, assim como novas perspectivas para atuação do campo da Vigilância em Saúde nessa temática, permitindo que a variável saúde seja avaliada durante as diferentes intervenções de uma política, programa ou projeto.

Abstract This study aims to discuss the Health Impact Assessment (HIA), pointing out the main initiatives of the health sector, challenges and perspectives for its implementation in Brazil. HIA is a methodology recommended by the WHO and is widely used in several countries, but with few initiatives in Brazil. Health issues in the context of large projects are commonly conducted on a timely basis within the environmental licensing processes, unlike HIA, which proposes an integrated approach, with the involvement of social stakeholders in the territory since the beginning of the project. This is an analytical and exploratory research and, thus, a systematic review on the subject was carried out, as well as a survey of government documents on the main initiatives already conducted by the Ministry of Health within Environmental Health Surveillance in the environmental licensing processes of large projects. We sought to analyze the main conceptual frameworks, pointing out possibilities for their implementation in Brazil, as well as new perspectives for Health Surveillance in this area, allowing the health variable to be evaluated during several interventions of a policy, program or project.

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While compulsory licensing (CL) is described in the TRIPS agreement as flexibility to protect public health by improving access to medicines in developing countries, a recent literature contends adversely that CL may harm public health. Therefore, this article intends to evaluate the usefulness of CL in the South through the prism of obligations and goals entrusted to patent holders (the effective and non-abusive exploitation of patents in order to achieve industrial and health developments) and in light of experiences in Thailand and Brazil regarding access to antiretroviral drugs. In this way, it shows that the obligations assigned to patent holders were better served by the recipients of CL and brought significant health and industrial benefits in the two high middle-income countries. In particular, CL allowed the scaling-up of free and universal access to antiretroviral drugs by assuring the financial sustainability of these public health programs endangered by monopolistic practices from patent holders.

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Resumo Audiências públicas são o principal mecanismo para participação em processos de licenciamento ambiental no Brasil. Criadas para informar e ouvir o público, as audiências são criticadas por sua baixa capacidade de influenciar decisões, atribuída, entre outros fatores, à realização tardia no processo de licenciamento. Buscando explorar essa temática em um setor no qual a participação pública é pouco estudada, foi realizada análise documental de 25 audiências públicas de processos de licenciamento ambiental para implantação ou ampliação de usinas de cana-de-açúcar em São Paulo. A maioria dos 62 participantes que fizeram uso da palavra são cidadãos, seguidos de representantes do Poder Executivo e de representantes de entidades da sociedade civil. Quanto às características das falas, 50,9% foram afirmações/comentários, 15,2% ressaltaram aspectos positivos do projeto/empresa, 11,2% apresentaram questionamentos, 9,4% destacaram aspectos negativos, 5,4% apresentaram sugestões, 6,5% foram de endosso ao projeto e 1,4% de oposição. Quanto aos temas abordados, geração de emprego e renda e a reputação da empresa são os mais frequentes, destacados majoritariamente em seus aspectos positivos. Estes temas diferem daqueles destacados na literatura como relevantes para discutir os impactos da expansão da cana-de-açúcar, mostrando a diferença entre a apreciação popular e a técnico-científica dos impactos socioambientais.

Abstract Public hearings are the primary mechanism for public participation in Brazilian environmental licensing. Created to inform and listen to the public, the hearings are criticized for their low influence on decision-making, resulting, among other reasons, from its late occurrence in the licensing process. Seeking to explore the theme in a sector where public participation is not usually researched, this paper presents an analysis of 25 public hearings about the process of environmental licensing of sugarcane mills in the state of São Paulo, Brazil. Most of the 62 participants are citizens, followed by representatives of local governments and representatives of civil society organizations. Regarding the characteristics of speeches, 50.9% were statements/comments, 15.2% highlighted positive aspects of the project/company, 11.2% were questions, 9.4% highlighted negative aspects, 5.4% were suggestions; 6.5% were for endorsing the project, and 1.4% for opposing. As for themes, employment and income generation and the company's reputation are the most frequent, highlighted mainly for its positive aspects. These themes differ from those discussed in the literature as relevant for sugarcane expansion impact, showing a marked difference between citizens' and scientists' perspectives about its social and environmental consequences.

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RESUMO

El artículo resume las actividades desarrolladas por el Centro Nacional de Seguridad Nuclear en sus veinticinco años de trabajo, como Autoridad Reguladora de la República de Cuba en materia de seguridad nuclear, radiológica, así como la contabilidad y control de los materiales nucleares. Se presentan las principales acciones y resultados relacionados con el establecimiento del control regulador en el país, dirigidos a elevar el nivel de seguridad en el uso de las fuentes de radiaciones ionizantes

The article summarizes the activities developed during the last 25 years by the National Centre of Nuclear Safety, as the Regulatory Authority of the Republic of Cuba for the nuclear and radiation safety and for the accountability and control of nuclear materials. It also deals with the main actions and results towards the establishment of the national regulatory control, aimed to guarantee the safe use of ionizing radiation sources in the country