Agencies In Brazil Research Articles

Resolução eletrônica de conflitos em agências reguladoras

Resumo Este artigo tem por objetivo analisar empiricamente as funções jurisdicionais e extrajurisdicionais dos meios eletrônicos de resolução de conflitos (MERC) geridos por agências reguladoras no Brasil. Os MERC adotados por agências reguladoras têm especificidades na medida em que desempenham funções não apenas extrajudiciais, mas também extrajurisdicionais. Para além de resolver conflitos entre agentes econômicos regulados e consumidores, os MERC são também importantes ferramentas para auxiliar nas ações regulatórias, fiscalizatórias e sancionadoras das agências. É analisada também a eficácia dos MERC no desempenho dessas funções a partir da análise de dados abertos da Agência Nacional de Saúde Suplementar (ANS) e da Agência Nacional de Aviação Civil (Anac). Entre os fenômenos analisados estão a evolução nos índices de reclamações contra agentes regulados e as taxas de resolução dos conflitos dos MERC adotados por ambas as agências reguladoras. O artigo revela tendência de crescimento dos índices de reclamações e níveis modestos de resolutividade dos conflitos.

Review of Decisions of the Competition Authority in Brazil: Reconciliation of the Judicial Trend with Due Process of Law

The present essay approaches an issue on transparency, due process and procedural fairness in Brazil’s competition law. Rather than extensively describing the Brazilian system, this paper intends to propose a solution to the problem of the Supreme Federal Court (STF) decision to deny the review on merits in the Judiciary of decisions issued by the Administrative Council for Economic Defense (CADE). Such a proposition aims to reconcile the trend set by the Brazilian Judiciary with the right of undertakings to a due process of law, in particular, the right to the double degree of jurisdiction. To do so, it will consider the peculiarities of the Brazilian Competition System, in special the unsuccessfully attempted previous models, the benchmark provided by the two main models (European and American) and peer agencies in Brazil, to finally propose and justify the implementation of a Second Instance Administrative Appellate Tribunal within CADE.

Carbon footprint of public agencies: The case of Brazilian prosecution service

Abstract While recognizing the Carbon Footprint (CF) is relevant for fighting the climate change, it is uncommon to estimate in public agencies the well-known “other indirect emissions”, of Scope 3. This work is a pioneer in estimating CF of the Prosecution Service of the State of Bahia (MPBA), a Brazilian public agency, considering a wide range of Scope 3 emission sources, aiming at identifying the main GHG sources and emissions, assessing Scope 3 participation and providing an analytical basis for the elaboration of a low-carbon policies in public agencies. Thus, for the first time in a Brazilian public agency BookFeel was used as a calculation tool based on the Compound Method Based on Financial Accounts (MC3) approach, which considered the financial expenses of the agency to estimate part of Scope 3 emissions. The total CF 2017 was 5,257.92 tCO2e, 83% of which belong to Scope 3, with “purchase of products/services” as the largest issuer. This case study showed that Scope 3 calculation in public agencies is indispensable, with BookFeel and MC3 being able to calculate the CF in a practical way. It also provided some strategies to mitigate the carbon emissions in public agencies, which should prioritize green public procurement and eco-innovation of its supply chain, eco-efficiency in consumption of materials and services, biofuels, high energy efficiency in public buildings and new management strategies such as the home office. Thus, this study fills part of the gap that exists in view of the scarce number of peer-reviewed studies regarding the recognition of CF in public agencies in Brazil and worldwide.

A INTERVENÇÃO DO CONGRESSO NACIONAL NA AUTONOMIA DAS AGÊNCIAS REGULADORAS

Este artigo tem por objetivo analisar como o poder legislativo tem buscado, por meio de sua atividade legislativa, intervir na autonomia dos órgãos reguladores. Parte-se, neste artigo, da hipótese de que o poder legislativo, insatisfeito com o arranjo institucional vigente, age estrategicamente para afastar as agências reguladoras da ingerência do poder executivo. O artigo desenvolve um estudo qualitativo de leis e especialmente proposições legislativas de iniciativa parlamentar que buscam afetar diretamente a autonomia das agências reguladoras. As leis e proposições legislativas analisadas neste artigo foram divididas em categorias que representam diferentes formas de intervenção na autonomia das agências. Para responder ao problema proposto, o artigo subdivide-se em duas partes. Na primeira, apresenta-se uma breve revisão teórica sobre controle legislativo da administração pública. As estratégias de controle político que afetam diretamente aautonomia das agências reguladoras são analisadas em abstrato. Na segunda parte, analisa-se a produção legislativa do Congresso Nacional sobre autonomia regulatória. Pretende-se, com este estudo, qualificar o debate sobre autonomia das agências reguladoras no Brasil. Ver-se-á que a autonomia das agências reguladoras é um conceito em disputa, sensível às transformações nas relações entre poder legislativo, poder executivo e agências reguladoras.

Objetivos estratégicos de Agências Reguladoras em Saúde: um estudo comparativo internacional

Introduction: This article presents a comparative panorama between the current strategic maps of three of the world’s major regulatory agencies, in order to allow the analysis of the future objectives of these entities, as well as to understand the alignments and particularities of each organization. Objective: To analyze and compare the strategic maps of the National Health Regulatory Agency in Brazil (Anvisa); the US Food and Drug Administration (FDA) in the United States; and the European Medicines Agency (EMA) in the European Union. Method: This is a qualitative research which used the content analysis method and the technique of meaning condensation to structure and interpret findings. Results: It can be seen that all the analyzed entities have, in the organization of their management, the definition of planning processes, with the design of strategic objectives in synthetic maps and focused on problems, declaring their strategy with clarity, conciseness and objectivity. In addition, the degree of homogeneity of issues, as well as a text that is coherent with the state of the art of the regulatory field, favor the alignment between such agencies, making possible a greater international regulatory convergence. Conclusions: Explaining the strategy in the right way helps to provide organizational management with systemic analysis, focus, direction and intentionality,which certainly influences the achievement of the expected results.

A publicidade no Brasil: identidades profissionais e organização do trabalho nas agências

Este trabalho pretende realizar uma interpretação do mundo da publicidade e das identidades profissionais nele negociadas através da teoria da ação coletiva de Howard Becker. O objetivo é pensar as várias funções e denominações corporativas elaboradas dentro de uma agência de propaganda no Brasil. Os elos cooperativos e redes de convenções estabelecidos no campo foram determinantes para o reconhecimento da profissão e para a materialização desse tipo específico de comunicação. Atores sociais e suas ações são partes determinantes da produção do conhecimento e da construção das identidades em um determinado sistema social. Neste sentido, é possível entender o discurso que a publicidade deposita na cultura, analisando o resultado da ação conjunta e coordenada de identidades profissionais cuja colaboração é necessária para que o trabalho se realize.

Quantitative regulatory impact analysis: Experience of regulatory agencies in Brazil

This research considers the experience of Brazilian agencies with the application of complex Regulatory Impact Analysis (RIA) using based on quantitative methods of cost-benefit analysis. Public consultations with regulatory agencies were held to verify how the agencies have applied RIA. The collection of documents and information allows us to conclude that Brazilian agencies have little or no experience in conducting RIA with quantitative cost-benefit analysis.

Diligência da Inovação: Estudo de Caso sobre uma Metodologia de Avaliação Tecnológica no Contexto de NIT’S Brasileiros

Os Núcleos de Inovação Tecnológica (NIT's) no Brasil são um fenômeno recente e ainda em processo de amadurecimento. Inspirados nos Escritórios de Transferência de Tecnologia internacionais, cumprem a missão de incentivar o transbordamento do conhecimento das universidades e centros de pesquisa de modo a promover a inovação e o desenvolvimento nacional. Por uma série de motivos, o contexto dos NIT's brasileiros se caracteriza pela ausência de suporte e escassez de recursos humanos, com equipes pequenas e pouca estrutura institucional para cumprir a missão a que são destinados. Deste modo, o processo de transferência de tecnologia e incentivo à inovação se torna mais árduo que o usual, além de pouco conhecimento ter sido produzido para a orientação dos NIT's perante à realidade da estrutura brasileira. O presente artigo tem como objetivo apresentar uma metodologia voltada para suporte ao processo de transferência de tecnologia em um contexto nacional. A pesquisa se baseia em um estudo de caso cuja coleta de dados se deu por meio de entrevistas e materiais internos de uma organização reconhecida pelo trabalho com NIT's em diversas regiões do Brasil. Os resultados se destacam pelo ineditismo em propor um processo formalizado na avaliação de tecnologias para transferência em contextos de escassez de recursos. Além do processo apresentado, o artigo complementa com detalhamento de boas práticas e desafios específicos nas discussões finais. Espera-se, deste modo, oferecer suporte aos NIT's nacionais e avançar as pesquisas relativas a estágios de maturidade de mecanismos ligados aos processos de transferência tecnológica.

Selected cases of failure analysis and the regulatory agencies in Brazil. Part 1: Aviation, railway and health

Abstract Three cases of failure analysis (aircraft landing gear, cast railway wheel and unalloyed Ti orthopaedic implant) representing three different industry sectors were selected to compose a critical study of their respective regulatory agency in Brazil. The implementation and achieved transparency of the National Civil Aviation Agency (ANAC) for the investigation of aircraft accidents are recognized as state of the art and is consistent with the economic importance of this sector for the country. In contrast, the transparency of the National Land Transportation Agency (ANTT) for the investigation of railway accidents is considered to be deficient. The current organization and transparency of the Brazilian Health Regulatory Agency (ANVISA) for the investigation and prevention of the failure of orthopaedic implants can be criticised as severely flawed. This agency should take immediate actions to adopt the compulsory notification and investigation of the failures of orthopaedic implants and implement a more reliable certification procedure of implants to ensure the protection of the Brazilian health care patients. The transparency of information might play an important role in the trade-off between the independence and the political control of the regulatory agencies in Brazil. In this sense, the publication of conducted failure analyses and general access to their reported findings are seen as a valuable driving force to improve the impact the regulatory agencies have on the general welfare of the country.

Financing Innovation in Brazil: the role of the Brazilian Development Bank

This paper presents the role of the National Development Bank (BNDES), the main public development agency in Brazil, in financing technological innovation. The scarcity of financing for innovation has always been considered as a limiters to Brazilian technological development. And, given the characteristics of the innovative process, public funding plays a central role. Therefore, understanding the evolution of the role of the BNDES - one of the largest development banks in the world - in stimulating innovation is essential. Firstly, it presents a historical description of the Bank's activities, followed by a brief description of the measures to support innovation in Brazil over the last two decades. In the third section we discuss the evolution of BNDES as a financing agent for technological development, including the instruments offered by the institution and their reformulations over time. In the fourth section, the profile of innovation expenditures carried out by BNDES, according to their origin (instruments used) and destination (sectors and profile of companies supported), is evaluated. Finally, the fifth section presents the final considerations.The differential of this article is to detail, for the first time, the participation of this relevant Brazilian institution in financing innovation. The analysis has an institutional approach: it does not present an impact analysis, but it allows the reader to understand the changes in the instruments and in the priorities that the institution has assumed in the last decades. This analysis is essential to understand the logic and evolution of the country's largest development institution.

A “miséria” da educação: análise de um manual de “empreendedorismo” do SEBRAE para professores do ensino fundamental.

O Serviço Brasileiro de Apoio às Micro e Pequenas Empresas (Sebrae) tem sido a principal agência no Brasil a difundir o chamado “empreendedorismo”. Nas capitais e, especialmente, no interior do país, uma das ações da agência tem sido estabelecer convênios com prefeituras municipais, com vistas a vender projetos voltados para a formação de sujeitos empreendedores. Entre os projetos está o programa Jovens Empreendedores Primeiros Passos, que consiste em um curso de “empreendedorismo” voltado para crianças e jovens de escolas públicas e privadas. Este trabalho analisa o conteúdo discursivo do manual do professor, elaborado por essa agência, destinado a educadores do primeiro ano do ensino fundamental. Na análise, consideramos o Sebrae aparelho privado de hegemonia, conceito do pensador italiano Antonio Gramsci, e buscamos compreender o manual tendo como base a concepção de ideologia concebida pelo mesmo autor. Nossa análise identificou aspectos que evidenciam recursos narrativos que visam enaltecer e naturalizar o ato de abrir uma empresa. Esses recursos buscam, entre outras coisas, atrelar ao mundo dos negócios aspectos que lhe são alheios, além de ocultar fatores importantes para a compreensão da realidade concreta. Ao fim, constatamos que o curso estimula a valorização do valor de troca, desconsidera o valor-trabalho e reproduz do fenômeno da alienação.

The potential use of probiotic and beneficial bacteria in the Brazilian dairy industry.

Scientific studies demonstrate the importance of intestinal microbiota to human health and how probiotic microorganisms can positively affect health when administered regularly and in adequate amounts. Probiotic bacteria can be part of fermented products and their functional importance is associated mainly with their metabolism. They are thought to benefit individuals to maintain their health and also to strengthen resistance against various types of diseases. The acceptance of probiotic cultures and products by consumers increased when these bacteria were marketed as natural cultures that help in digestion and health. Considering this, the food industry has an increasing demand for new candidates as probiotic cultures, and the dairy industry has a particular interest for fermented milks and other dairy products, since these are the most common food vehicles for probiotic cultures. Therefore, the dairy industries are increasingly seeking to improve their products with these beneficial bacteria. However, the legal peculiarities and excess of control agencies in Brazil makes the registration of these products and the collection of data very complex. Prospective analysis suggests that probiotic foods have the potential to effect a considerable expansion of the dairy industry, allowing the dairy sector to grow and for these products to be increasingly sought by consumers globally. For this, not only actions on research and innovation are necessary, but also official clarifications on the claims for considerations of microbiological security and functionality of these products. This review aims to elucidate important probiotic research regarding the isolation and characterization of beneficial cultures in Brazil, and to demonstrate the relevance of the dairy chain as a potential source of novel cultures for the development of new probiotic products to expand the Brazilian dairy industry.

Viability of creating a water agency in the Grande river basin, Bahia

ABSTRACT The work was developed from the analysis of the viability of creating a water agency in the Grande river basin, located in western Bahia, Brazil. The charging mechanisms of five different water agencies in Brazil were applied to the basin. The simulations showed the possibility of an average annual collection in the basin of over R$ 2.2 million, which would provide a median value above R$ 160,000 per year for administrative costs of the agency. Thus, considering that the median value of the annual administrative cost to state agencies is close to R$ 300,000, the collection provided by the mechanisms studied would not initially allow the creation of a water agency for the Grande river basin. However, the adoption of one of the existing water agencies would be a more appropriate alternative for the implementation during a shorter period of time, given the technical and operational structure within which the current agencies function.

Diagnóstico dos processos de homologação e certificação de produtos de natureza cibernética: perspectivas para a construção de um sistema nacional

O uso de computadores, tablets, smartphones, relógios inteligentes, smartmeters, sistemas GPS e assim por diante, traz um benefício comum a todos aqueles que acessam tais tecnologias, porém, ao mesmo tempo, tais sistemas têm uma influência fundamental no aspecto da privacidade do indivíduo. Desta forma, torna-se premente em nossa sociedade ter um sistema que permita homologar e certificar produtos de natureza cibernética. O presente artigo tem como objetivo retratar um diagnóstico dos processos de homologação e certificação de produtos de natureza cibernética que são usados por órgãos da administração central e pelas forças armadas, com vistas a desenvolver um Sistema Nacional de homologação e certificação desse tipo de produto. A fim de desenvolver o diagnóstico foram realizadas pesquisas documentais em órgãos responsáveis pela certificação de produtos tecnológicos e foram realizados estudos de caso em cinco organizações públicas e privadas. Os resultados desses estudos foram sistematizados para serem validados em grupo focal com especialistas. Demonstrou-se uma visão compartilhada pelas empresas e órgãos quanto ao aspecto da certificação de produtos, mas não houve um entendimento consensual sobre a homologação. Foram identificados ainda processos realizados por órgãos governamentais que fogem ao escopo tradicional da homologação de produtos na literatura científica.

Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations

BackgroundThe quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures.MethodsThis is a descriptive study based on CONITEC official reports from July 2012 through December 2016. Data were collected with a specific extraction form and analysed using descriptive statistics.ResultsWe evaluated 199 CONITEC recommendation reports. The annual number of reports increased during the study period. The absolute annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed for 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The type of technology most frequently evaluated was ‘drugs’ (68.3%), followed by ‘procedures’ (20.1%). Overall, 117 (58.8%) reports were internal demands, 75 (37.7%) were external demands and 7 (3.5%) were mixed demands. There were differences between internal and external demands in terms of the evidence used in the reports and the decision regarding the recommendation to incorporate the technologies. Among the internal demands, the recommendation to incorporate the new technology was made for 70.9% of the reports, only 9.6% of which included full HTAs. Among the external demands, the incorporation of the new technology was recommended for 17.3% of the reports, 76.9% of which included full HTAs. Of the 101 reports in which incorporation of the new technology was recommended, 88 (87.1%) did not include a full health economic evaluation and ICER calculation. There are compliance difficulties with the recommendations in the CONITEC internal regulations regarding the type and quality of evidence considered in the analysis of recommendation reports.ConclusionsThe characteristics of the evidence used in recommendation reports and those considered to be mandatory were very different, indicating problems in decision-making processes. There is a need to study, with a broader perspective, the factors that influence the type of evidence used in decision-making processes in order to contribute to the development of better practices and policies.

Evidence of learning processes in EIA systems

Learning is recognized as an important component of environmental impact assessment (EIA) in particular, due to its potential to transform individual, social, and organizational values, standards and practices to support a sustainable development. Nevertheless, only a few models developed to describe learning processes in EIA systems seem to be grounded on the combination of both theoretical aspects and empirical evidence of learning, which requires further investigation. This paper is based on the development of a conceptual model to understand learning processes through the practice of EIA, and evidence-gathering of learning in EIA systems focused on the role played by the leading organization. The outcomes were based on literature review and empirical research using two EIA regulatory agencies in Brazil as case studies. Data collection and analysis were supported by participant observation, personal interviews and qualitative content analysis. Although specific to the context, the evidence produced have corroborated the implicit feature of learning in EIA systems and, we believe, reinforced the relevance of the conceptual model as developed in the paper.

Method Validation Using Normal and Weighted Linear Regression Models for Quantification of Pesticides in Mango (Mangifera indica L.) Samples

A fast and efficient method was developed and validated for the determination of pesticides in mangos, which uses the QuEChERS citrate and gas chromatography–mass spectrometry (GC–MS) techniques. A detailed statistical analysis was performed to study the matrix effect. The calibration model using the method of weighted least squares is used in cases, where heteroscedasticity is observed. The matrix effect was observed for most studied compounds using analytical curves based on a spiked matrix. The limits of detection were 0.0025–0.01 mg kg−1, and the limits of quantification (LOQ) were 0.008–0.03 mg kg−1. The LOQ values were minor or equal to the established MRLs by major regulatory agencies in Brazil (ANVISA), the United States (US-EPA), and Europe (CE). The compounds showed acceptable recovery levels of 71–109% with a standard deviation less than 15%. The method was applied to determine pesticide residues in mango samples. For 12 samples, five compounds (chloroneb, propachlor, α-chlordane, chlorpyrifos, DCPA, chlorobenzilate, and trans-permethrin) were detected, with contents of 0.004–0.042 mg kg−1. For chloroneb, propachlor, and α-chlordane, the found concentrations were above the maximum permitted residue limit, according to data from the European Commission.

Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

ABSTRACT This study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agencia Nacional de Vigilância Sanitaria-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) off-label prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The off-label use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns.

HEGEMONIA E OS PROGRAMAS DE EDUCAÇÃO INDÍGENA NO MÉXICO E NO BRASIL (1940 — 1970)

Neste artigo, apresento informações sobre os programas de educação indígena das agências indigenistas do Brasil e do México, entre 1940 e 1970, e realizo uma breve discussão sobre a influência desses programas nos processos de formação de hegemonia dos Estados ampliados entre os povos indígenas desses países, no período citado. Nas escolas do Instituto Nacional Indigenista (INI), no México, e principalmente do Serviço de Proteção aos Índios (SPI), no Brasil, as escolas enfatizaram o ensino da língua nacional em seus currículos e influenciaram na criação da ideia da existência da nacionalidade mestiça, visando o desenvolvimento e a integração dos povos indígenas à nação. Em ambos os países, missões religiosas participaram da educação indígena e aqui destaco a atuação do Summer Institute of Linguistics (SIL). No México, a participação dos promotores culturais bilíngues como intermediários culturais entre as instituições indigenistas e as comunidades resultou na grande importância da educação indígena para a formação da hegemonia. Já no caso do Brasil, os professores e professoras eram não indígenas e sua influência foi mais restrita.

ANÁLISE DA VULNERABILIDADE SOCIAL E RISCO AMBIENTAL NO MUNICÍPIO DO RIO DE JANEIRO / ANALYSIS OF SOCIAL VULNERABILITY AND ENVIRONMENTAL RISK IN THE MUNICIPALITY OF RIO DE JANEIRO

doi: 10.12957/geouerj.2017.28311 The issue of vulnerability is increasingly present in academic studies and in research activities from government agencies in Brazil and the world, this growth occurs through the need to understand society more deeply and its different degrees of vulnerability, seeking solutions for a more inclusive society. The objective of this study is to analyze the areas of social vulnerability and environmental risk in the municipality of Rio de Janeiro. With the application of GIS techniques, areas of Very High, High, Moderate and Low social vulnerability and environmental risk were identified. These results were obtained through the spatial overlap between the Social Vulnerability Index and areas susceptible to landslide. The results of this article express the starting point for further analysis of social vulnerability and environmental risk.