O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil / The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

Association between hospitalizations for sensitive conditions and quality of primary care.

OBJECTIVE: To analyze the association between municipal rates of ambulatory care sensitive conditions (ACSC) hospitalization and the quality of primary health care (PHC), socioeconomic, and demographic variables and those related to local characteristics of the health system from 2010 to 2019. METHOD: Ecological time series study in Brazilian municipalities analyzing the correlation of ACSC hospitalization rates with PHC quality measured by the three cycles of the Primary Care Access and Program for improving primary care access and quality (PMAQ-AB). The study included municipalities whose teams participated in 80% or more of at least two PMAQ-AB cycles. The correlation between standardized ACSC hospitalization rates and PHC quality and other variables was analyzed. Spearman's test was used between the response variable and numerical explanatory variables. Generalized equations estimation was used as a multivariate model associating ACSC hospitalization rates with the other variables over the years. RESULTS: A total of 3,500 municipalities were included in the models. The quality of PHC (PMAQ-AB score) showed an inverse association with the variation in ACSC hospitalization rates. Hospitalization rates fell by -2% per year every ten-point increase in the PMAQ-AB score, adjusted by the remaining variables. A one-unit increase in the beds per 1,000 inhabitants variable had an impact of approximately +6.4% on ACSC hospitalization rates. Regarding population size, larger municipalities had lower ACSC hospitalization rates. Increased PHC coverage and lower socioeconomic inequality were also associated with the reduction in hospitalizations. CONCLUSIONS: The reduction in ACSC hospitalization rates over time was associated with an increase in the quality of PHC. It was also associated with a reduction in the number of hospital beds and municipalities with better socioeconomic indicators.

Use of Telehealth Resources in Primary Care and Its Association with Facing the COVID-19 Pandemic in Minas Gerais, Brazil.

Introduction: Use of telehealth (TH) resources increased dramatically during the COVID-19 pandemic. This study set out to examine associations between the level of integration of TH resources and the level of Primary Health Care (PHC) structuring to deal with the COVID-19 pandemic in the State of Minas Gerais, Brazil. Methods: This work was a cross-sectional study conducted through the application of a semistructured questionnaire to a sample of 260 PHC Teams working in the state of Minas Gerais, Brazil, from September to December 2020. This study was approved by the Research Ethics Committee and logged under report number 44.294.637. Results: Two variables were created - Level of the PHC structuring to deal with the COVID-19 pandemic and Level of TH structuring. Variables were grouped into five categories (poor to excellent). Associations between variables were examined using the Tukey's test for multiple comparisons and the Spearman correlation coefficient. Variables associated with socioeconomic dimensions (human development index and Gini index) and health care were also analyzed. Levels of TH structuring in PHC ranged from poor (43%) to regular (40%) in most cases. Most PHC teams had regular (56%) or good (37%) levels of PHC structuring to deal with the pandemic. The greater the availability and use of TH resources at a given unit, the better the structure to face COVID-19 (0.45 - p < 0.001). Conclusion: PHC was structured to tackle the pandemic. However, there is a lot to be done before TH resources are effectively incorporated into PHC. Whenever incorporated, TH resources contributed to a more robust response to the COVID-19 pandemic.

Association between hospitalizations for sensitive conditions and quality of primary care / Associação entre internações por condições sensíveis e qualidade da atenção primária

ABSTRACT OBJECTIVE To analyze the association between municipal rates of ambulatory care sensitive conditions (ACSC) hospitalization and the quality of primary health care (PHC), socioeconomic, and demographic variables and those related to local characteristics of the health system from 2010 to 2019. METHOD Ecological time series study in Brazilian municipalities analyzing the correlation of ACSC hospitalization rates with PHC quality measured by the three cycles of the Primary Care Access and Program for improving primary care access and quality (PMAQ-AB). The study included municipalities whose teams participated in 80% or more of at least two PMAQ-AB cycles. The correlation between standardized ACSC hospitalization rates and PHC quality and other variables was analyzed. Spearman's test was used between the response variable and numerical explanatory variables. Generalized equations estimation was used as a multivariate model associating ACSC hospitalization rates with the other variables over the years. RESULTS A total of 3,500 municipalities were included in the models. The quality of PHC (PMAQ-AB score) showed an inverse association with the variation in ACSC hospitalization rates. Hospitalization rates fell by -2% per year every ten-point increase in the PMAQ-AB score, adjusted by the remaining variables. A one-unit increase in the beds per 1,000 inhabitants variable had an impact of approximately +6.4% on ACSC hospitalization rates. Regarding population size, larger municipalities had lower ACSC hospitalization rates. Increased PHC coverage and lower socioeconomic inequality were also associated with the reduction in hospitalizations. CONCLUSIONS The reduction in ACSC hospitalization rates over time was associated with an increase in the quality of PHC. It was also associated with a reduction in the number of hospital beds and municipalities with better socioeconomic indicators.

RESUMO OBJETIVO Analisar a associação entre taxas municipais de internações por condições sensíveis à atenção primária (ICSAP), com a qualidade da atenção primária à saúde (APS), variáveis socioeconômicas, demográficas e relacionadas a características locais do sistema de saúde, de 2010 a 2019. MÉTODOS Estudo ecológico de séries temporais nos municípios brasileiros analisando a correlação das taxas de ICSAP, com a qualidade da APS medida pelos três ciclos do Programa de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ-AB). Foram incluídos municípios que participaram com 80% ou mais de suas equipes em, ao menos, dois ciclos do PMAQ-AB. Foi analisada a correlação entre as taxas de ICSAP padronizadas com a qualidade da APS e demais variáveis. Empregou-se o teste de Spearman entre a variável resposta e as variáveis explicativas numéricas. Foi usado o generalized equations estimating como modelo multivariado associando as taxas de ICSAP e as demais variáveis ao longo dos anos. RESULTADOS Foram incluídos 3.500 municípios nos modelos. A qualidade da APS (nota do PMAQ-AB) apresentou associação inversa com a variação das taxas de ICSAP. As taxas de internação tiveram queda de -2% ao ano a cada aumento de dez pontos na nota do PMAQ-AB, ajustado pelas demais variáveis. O aumento de uma unidade na variável leitos por mil habitantes impactou em uma elevação de aproximadamente +6,4% nas taxas de ICSAP. Quanto ao porte populacional, municípios maiores tiveram menores taxas de ICSAP. Também se associaram à redução das internações o aumento da cobertura da APS e a menor desigualdade socioeconômica. CONCLUSÕES A redução das taxas de ICSAP ao longo do tempo mostrou-se associada com o aumento da qualidade da APS. Além disso, esteve associada com diminuição do número de leitos hospitalares e a municípios com melhores indicadores socioeconômicos.

[Quality of prehospital fixed components of the Brazilian Emergency and Urgent Care Network: a study based on data from PMAQ-AB and PNASS]. / Qualidade dos componentes pré-hospitalares fixos da Rede de Urgência e Emergência no Brasil: um estudo a partir de dados do PMAQ-AB e PNASS.

The organization and management of integrated health systems is complex and challenging. As a strategy to improve the quality and access to urgent services, the Brazilian Ministry of Health implemented the Emergency and Urgent Care Network (RUE), comprised of care facilities with different technological levels. Assess the quality of prehospital fixed components of the RUE in health macroregions. A cross-sectional study using data from the Brazilian National Health Services Evaluation Program (PNASS) and the Brazilian National Program for Improvement of Access and Quality of Basic Care (PMAQ-AB) was carried out. A typology was built for the quality of the emergency care units (UPAs) and the first visit by health macroregion, correlating it with socioeconomic variables. A cluster analysis was performed. In total, 280 UPAs, 21,182 basic health units (UBSs), and 27,335 family health teams from 74 health macroregions were evaluated. The general indicator of the quality of the components presented an average of 0.687 (reference score: 1.00). UPA quality (0.61) was positively influenced by the indicators Pharmacy support and Immediate emergency and urgent care, with worse results in Contract management, Planning and organization, and Organizational model. In primary healthcare (PHC) quality (0.78), the dimensions with better evaluations were Articulation with the network, Reception and procedures, unlike Exams and medications. Health macroregions were allocated to three clusters. Cluster 3 obtained a much higher overall average score (0.81) than the others (0.64 and 0.63). A lower quality of PHC was observed in Cluster 1, which showed the highest level of social vulnerability.

A organização e gestão de sistemas de saúde integrados são complexas e desafiadoras. Como estratégia para melhoria da qualidade e do acesso aos serviços de urgência, o Ministério da Saúde adotou a implantação da Rede de Urgência e Emergência (RUE), composta por pontos de atenção de diferentes densidades tecnológicas. O objetivo foi avaliar a qualidade dos componentes pré-hospitalares fixos da RUE em macrorregiões de saúde. Foi realizado estudo transversal utilizando dados do Programa Nacional de Avaliação dos Serviços de Saúde (PNASS) e do Programa de Melhoria da Qualidade da Atenção Básica (PMAQ-AB). Foi construída uma tipologia da qualidade das unidades de pronto atendimento (UPAs) e do acolhimento, por macrorregião de saúde, correlacionando-as com variáveis socioeconômicas. Foi realizada uma análise de clusters. Foram avaliadas 280 UPAs, 21.182 unidades básicas de saúde (UBS) e 27.335 equipes de saúde da família (EqSF) de 74 macrorregiões de saúde. O indicador geral da qualidade dos componentes apresentou média 0,687 em 1,00. A qualidade da UPA (0,61) foi positivamente influenciada pelos indicadores Assistência farmacêutica e Atenção imediata à urgência e emergência, com piores resultados em Gestão de contratos, Planejamento e organização e Modelo organizacional. Na qualidade da atenção primária à saúde (APS) (0,78), as dimensões mais bem avaliadas foram Articulação com a rede, Acolhimento e procedimentos, ao contrário de Exames e medicamentos. As macrorregiões de saúde foram alocadas em três clusters. O Cluster 3 obteve nota média geral (0,81) bem superior aos demais (0,64 e 0,63). Observou-se qualidade inferior da APS no Cluster 1, aquele com maior vulnerabilidade social.

La organización y la gestión de los sistemas de salud integrados es compleja y desafiante. Como estrategia para mejorar la calidad y el acceso a los servicios de urgencia, el Ministerio de Salud brasileño adoptó la implementación de la Red de Urgencia y Emergencia (RUE), compuesta por puntos de atención de diferentes densidades tecnológicas. Evaluar la calidad de los componentes prehospitalarios fijos de RUE en las macrorregiones de salud. Se llevó a cabo un estudio transversal utilizando datos del Programa de Evaluación de los Servicios Nacionales de Salud (PNASS) y del Programa Nacional de Mejoría de Acceso y Calidad de la Atención Básica (PMAQ-AB). Fue construida una tipología de la calidad de las unidades de atención de urgencias (UPAs) y de la recepción por macrorregión de salud, correlacionándolas con variables socioeconómicas. Se realizó un análisis de grupos. Evaluadas 280 UPAs, 21.182 servicios de salud básicos (UBSs) y 27.335 equipos de salud familiares de 74 macrorregiones de salud. El indicador general de la calidad de los componentes promedió mostró una media de 0,687 sobre 1,00. En la calidad de las UPAs (0,61) influyeron positivamente los indicadores Asistencia farmacéutica y Atención inmediata de urgencias y emergencias, con peores resultados en Gestión de contratos, Planificación y organización y Modelo organizativo. En la calidad de la atención primaria en salud (APS) (0,78) las dimensiones mejor evaluadas fueron la Coordinación con la red, la Recepción y los procedimientos, frente a los Exámenes y la medicación. Las macrorregiones de salud se asignaron en tres grupos. El Grupo 3 obtuvo nota media general (0,81) muy superior a los demás (0,64 y 0,63). Se observó una calidad inferior de la APS en el Grupo 1, aquel con mayor vulnerabilidad social.

Admissions due to ambulatory care-sensitive conditions (ACSC): an analysis based on socio-demographic characteristics, Brazil and regions, 2010 to 2019.

OBJECTIVE: To analyze the temporal trend of hospital admissions due to Ambulatory Care-Sensitive Conditions (ACSC) in Brazil per sex, region, cause and age group, from 2010 to 2019. METHODS: This is an ecological study based on the temporal trend of ACSC rates. Standardized rates were analyzed in a simple linear regression and a generalized linear model (GLM) Gamma. The percentage change was also checked over three periods: 2010-2014, 2015-2019 and 2010-2019. RESULTS: There was a reduction in hospital admission rates between 2010 and 2019 for Brazil: 124.3/10,000 inhab. to 88.2/10,000 inhab. among women (-29.0%) and 119.0/10,000 inhab. to 88.2/10,000 inhab. (-25.9%) among men in all regions. The decrease was more prominent between 2010-2014 (-17.7%) and (-17.8%) than between 2015-2019 (-.2%) and (-5.9%) for females and males, respectively. The milder decline in the period from 2015 to 2019 was more noticeable among age groups 0-4y and 5-19y in all regions. As for the causes, most ICD-10 diseases had a downward trend, the more expressive ones being gastroenteritis (-60%); however, an increase was seen in cerebrovascular diseases among women (11.2%) and men (17.1%), and angina (15% %) and skin infections (56.1%) among men. CONCLUSION: There was a significant drop in ACSC rates in the period analyzed, especially for age groups 0-4y and 5-19y. The rates had a milder drop from 2015 to 2019, a period of austerity and economic crisis.

Admissions due to ambulatory care-sensitive conditions (ACSC): an analysis based on socio-demographic characteristics, Brazil and regions, 2010 to 2019 / Internações por condições sensíveis à atenção primária (ICSAP): uma análise segundo características sociodemográficas, Brasil e regiões, 2010 a 2019

ABSTRACT: Objective: To analyze the temporal trend of hospital admissions due to Ambulatory Care-Sensitive Conditions (ACSC) in Brazil per sex, region, cause and age group, from 2010 to 2019. Methods: This is an ecological study based on the temporal trend of ACSC rates. Standardized rates were analyzed in a simple linear regression and a generalized linear model (GLM) Gamma. The percentage change was also checked over three periods: 2010-2014, 2015-2019 and 2010-2019. Results: There was a reduction in hospital admission rates between 2010 and 2019 for Brazil: 124.3/10,000 inhab. to 88.2/10,000 inhab. among women (-29.0%) and 119.0/10,000 inhab. to 88.2/10,000 inhab. (-25.9%) among men in all regions. The decrease was more prominent between 2010-2014 (-17.7%) and (-17.8%) than between 2015-2019 (-.2%) and (-5.9%) for females and males, respectively. The milder decline in the period from 2015 to 2019 was more noticeable among age groups 0-4y and 5-19y in all regions. As for the causes, most ICD-10 diseases had a downward trend, the more expressive ones being gastroenteritis (-60%); however, an increase was seen in cerebrovascular diseases among women (11.2%) and men (17.1%), and angina (15% %) and skin infections (56.1%) among men. Conclusion: There was a significant drop in ACSC rates in the period analyzed, especially for age groups 0-4y and 5-19y. The rates had a milder drop from 2015 to 2019, a period of austerity and economic crisis.

RESUMO: Objetivo: Analisar a tendência temporal das internações por condições sensíveis à atenção primária (ICSAP) no Brasil, por sexo, regiões, causas e faixas etárias, no período de 2010 a 2019. Métodos: Trata-se de estudo ecológico baseado na tendência temporal das taxas de ICSAP. Foram analisadas as taxas padronizadas segundo regressão linear simples e modelo linear generalizado (MLG) gama. Observou-se também a variação percentual em três períodos: 2010-2014, 2015-2019 e 2010-2019. Resultados: Ocorreu redução nas taxas de internação entre 2010 e 2019 para Brasil: 124,3/10.000 hab. para 88,2/10.000 hab. em mulheres (-29,0%) e 119,0/10.000 hab. para 88,2/10.000 hab. (-25,9%) em homens, em todas as regiões. A queda foi maior entre 2010 e 2014 (-17,7% e -17,8%) do que entre 2015 e 2019 (-9,2% e -5,9%) — valores para sexo feminino e masculino, respectivamente. Esse declínio menor no período de 2015 a 2019 foi mais perceptível entre as faixas de zero a quatro anos e de cinco a 19 anos em todas as regiões. Quanto às causas, foi verificada redução para maioria dos códigos da Classificação Internacional de Doenças (CID-10), mais expressiva para gastroenterites (-60%), entretanto tiveram aumento doenças cerebrovasculares entre mulheres (11,2%) e homens (17,1%) e angina (15%%) e infecções da pele (56,1%) entre homens. Conclusão: Ocorreu importante queda das taxas de ICSAP no período analisado, especialmente para as faixas etárias de zero a quatro e de cinco a 19. As taxas tiveram menor queda entre 2015 e 2019, período de austeridade e crise econômica.

Notas para uma reinterpretação crítica dos processos de determinação social das iniquidades étnico-raciais em saúde / Notes for a critical reinterpretation of the processes of social determination of ethnic and racial inequities in health

Esta dissertação, em forma de ensaio, pretende problematizar as interpretações e abordagens dominantes das iniquidades étnico-raciais em saúde e objetiva propor reflexões para uma reinterpretação dos processos de determinação social das iniquidades étnico-raciais em saúde desde a perspectiva da Medicina Social e Saúde Coletiva Latinoamericana (MS-SC) e da “inflexão descolonial” do Grupo Modernidade/Colonialidade (Grupo M/C). Partimos do pressuposto de que os processos envolvidos na configuração das iniquidades étnico-raciais em saúde continuam pouco reconhecíveis nas abordagens dominantes no campo da saúde pública e epidemiologia, principalmente como consequência de interpretações reducionistas dos processos de determinação social da saúde-doença e ainda como consequência do silenciamento sistemático de reinterpretações contra hegemônicas, cujas interpretações permitiriam reconhecer as manifestações dos processos de subordinação social e desumanização, que se engendram no contexto da acumulação capitalista e da concentração de poder que caracteriza o sistema-mundo capitalista/colonial, nos processos saúde-doença.O presente ensaio encontra-se dividido em três capítulos. No primeiro capítulo abordamos o que é sistematicamente excluído das interpretações dominantes das iniquidades étnico-raciais (em saúde): os processos de subalternização das populações não-brancas e o racismo. No segundo capítulo objetivamos problematizar as bases epistemológicas das interpretações dominantes, abordando o modelo de racionalidade dominante e a epistemologia epidemiológica. No terceiro capítulo buscamos exemplificar e detalhar a crítica articulada nos dois primeiros capítulos, analisando a abordagem dos Determinantes Sociais da Saúde (DSS), que assumiu centralidade nos debates ao redor das iniquidades sociais em saúde nos últimos anos.

This dissertation, written as an essay, seeks to critically review dominant approaches and interpretations of ethnic and racial inequities in health and further aims to develop notes toward a reinterpretation of the processes of social determination of ethnic and racial inequities in health from the perspective of the Latin American Social Medicine and Collective Health movement and the Modernity/Coloniality research program. We argue that the processes involved in shaping ethnic and racial inequities in health remain poorly recognizable in dominant approaches in the field of public health and epidemiology. From our perspective, this is primarily a result of reductionist interpretations of the processes of social determination in health and also a consequence of the systematic invisibilization of contrahegemonic reinterpretations, which have articulated the health-disease processes and particularly the social determination of (etnic and racial) health inequities with processes of oppression, marginalization and exploitation, engendered in the context of the consolidation of capitalist accumulation structures along the lines of class, gender and etnic/racial priviledge and subordination.This essay is divided in three chapters. In the first chapter we discuss what is systematically excluded from dominant interpretations of ethnic and racial inequities (in health), particularly the processes of oppression, marginalization and exploitation defining the subordination of non-white populations in capitalist modernity and structural racism. In the second chapter we aim to critically review the epistemological foundations of dominant interpretations in public health and epidemiology and argue that the hegemonic model of rationality and specifically epidemiological epistemology, forges and reproduces reductionist interpretations. In the third chapter we seek to illustrate and detail this critique, analyzing the WHO Social Determinants of Health approach, which has dominanted the debates on health inequities during the last couple of years.