The incorporation of the 3HP regimen for tuberculosis preventive treatment in the Brazilian health system: a secondary-database nationwide analysis.

Introduction: The recommendation of rifampin-based shorter - and safer - regimens for tuberculosis preventive treatment (TPT) is progressively replacing monotherapy with isoniazid by different countries. The Brazilian Ministry of Health (MoH) approved the incorporation of the Rifapentine + isoniazid regimen (3HP) at the end of 2020, with free distribution in the Brazilian Unified Health System (SUS) started from the last quarter of 2021. The objectives were to describe the implementation of the IL-TB System (Information System of TPT Notification) and uptake of Rifapentine + isoniazid (3HP) and Isoniazid (6H or 9H) in Brazil. Methods: A quantitative observational and descriptive was performed using the IL-TB National System as the main data source, from January 2018 to December 2022. Results and discussion: There was a steady increase of the number of TPT prescription quarterly throughout the period, which reflects the implementation of the system itself and the progressive adherence of the health system to the non-compulsory notification of new TPT. The substitution of isoniazid (6H or 9H) by 3HP is progressing. The 3HP regimen represented less than 4% of the total administered by the end of 2021, reaching around 30% in the second half of 2022 and 40% in the last quarters of 2022. The study points not only to the need to expand TPT in the country, but also to accelerate 3HP uptake and to encourage the municipalities to notify to the IL-TB system, since there is still a high level of underreporting.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System.

Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Dynamics of patents, orphan drug designation, licensing, and revenues from drugs for rare diseases: The market expansion of eculizumab.

BACKGROUND: This study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since its first marketing authorization. METHODS: A retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization. RESULTS: Our search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion's revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company's portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues. DISCUSSION: Our findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.

Testing COVID-19 in Brazil: fragmented efforts and challenges to expand diagnostic capacity at the Brazilian Unified National Health System / A testagem para COVID-19 no Brasil: esforços fragmentados e desafios para ampliar a capacidade diagnóstica no Sistema Único de Saúde / Testar para COVID-19 en Brasil: esfuerzos fragmentados y desafíos para expandir la capacidad diagnóstica en el Sistema Único de Salud

Abstract: Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

Resumo: Desde que o primeiro caso de COVID-19 no Brasil foi notificado, em 26 de fevereiro de 2020, o país assiste a um crescimento exponencial no número de casos e mortes. A estratégia nacional de testagem tem sido insuficiente para usar essa ferramenta corretamente no apoio à contenção da epidemia no país. O artigo discute os esforços e desafios para escalonar a testagem para COVID-19 no Sistema Único de Saúde (SUS). O texto apresenta os resultados iniciais de um projeto de pesquisa sobre os aspectos políticos, industriais, tecnológicos e regulatórios que podem afetar a capacidade diagnóstica e de testagem para COVID-19 no Brasil. O estudo se apoia em revisão da literatura cientifica, artigos publicados na mídia e coleta de dados públicos sobre a compra e regulamentação de testes. O texto faz referência a iniciativas para ampliar a testagem de PCR, a produção nacional e o desenvolvimento de tecnologias, além de medidas regulatórias fast-track para novos testes. Nossa análise sugere alguns pontos para reflexão. Primeiro, a falta de uma estratégia nacional consistente para combater a COVID-19 agravou os problemas de fornecimento de reagentes de diagnostico num primeiro momento. Esta situação foi posteriormente resolvida, embora coloque novamente em pauta a dependência estrutural do país na importação de insumos de saúde estratégicos. Em segundo lugar, financiamento e a distribuição de testes, que ocorreram de forma descontinuada, podem indicar a fragmentação da política sanitária, assim como o papel de governos estaduais, municipais e atores não estatais no combate à epidemia no âmbito do SUS. Por último, iniciativas estabelecidas no segundo semestre de 2020 contribuíram para ampliar a capacidade de testagem molecular no SUS. Contudo, essa capacidade não foi suficiente para controlar a epidemia no Brasil.

Resumen: Desde que se registró el primer caso de COVID-19 el 26 de febrero de 2020, Brasil ha visto un crecimiento exponencial en el número de casos y muertes. La estrategia nacional para preconizar el test de diagnóstico ha sido insuficiente en el uso correcto de esta herramienta, con el fin de ayudar a contener la epidemia en el país. Se presentó los esfuerzos y los desafíos para ampliar la realización de pruebas de COVID-19 en el Sistema Único de Salud brasileño (SUS). Este artículo presenta los resultados iniciales del proyecto de investigación sobre los aspectos políticos, industriales, tecnológicos y regulatorios que pueden afectar la capacidad de diagnóstico para la COVID-19 en Brasil. El grupo de investigación realizó una revisión de la literatura académica, medios de comunicación y recogida de datos públicos respecto a la adquisición de tests y su regulación. Se haz referencia a iniciativas para promover la realización de pruebas de PCR, la producción nacional y el desarrollo de tecnologías, así como las medidas regulatorias fast-track para nuevas pruebas. Nuestro análisis indica algunos puntos de reflexión. Primero, la falta de una estrategia nacional consistente para luchar contra la COVID-19 que exacerbó los problemas de sumistro de los componentes de diagnóstico en un primer momento. Se solucionó posteriormente esta situación, aunque se coloque nuevamente en pauta la dependencia estructural del país en la importación de insumos de salud estratégicos. Segundo, la financiación y la distribución de tests de forma descontinuada pueden indicar la fragmentación de la política de salud, así como los gobiernos estaduales, municipales, y atores no estatales asumiendo un rol preponderante en acciones de combate a la epidemia en el SUS. En último, las iniciativas establecidas en el segundo semestre del 2020 contribuyeron para ampliar la capacidad de realización de tests moleculares en el SUS. Sin embargo, esa capacidad no fue suficiente para controlar la epidemia en Brasil.

Inovação biomédica e ética: técnicas substitutivas na experimentação animal / Biomedical innovation and ethics: alternatives to animal testing / Innovación biomédica y ética: técnicas alternativas a la experimentación animal

Resumo A utilização de animais não humanos como ferramenta de pesquisa biomédica e em testes da indústria para consumo humano foi incorporada às práticas científicas e assimilada como fundamental. A revisão sistemática dos resultados de protocolos de fases pré-clínicas não é prática corrente, mas metanálises recentes questionam a capacidade de projeção desses dados para a espécie humana. Atualmente, junto com o questionamento científico há abrangente discussão ética sobre os conflitos inerentes à instrumentalização da vida do animal não humano, cujo ápice é alcançado na criação de animais transgênicos. O objetivo deste artigo é discutir a aplicação do conceito de vulnerabilidade ao animal não humano no contexto da experimentação e pensar as relações de poder implícitas nessas práticas. Como aplicação prática da teoria exposta, propõe-se implantar e desenvolver técnicas substitutivas ao modelo animal, que conjuguem ética e inovação.

Abstract The use of non-human animals has been incorporated into scientific practices as an essential biomedical research tool and in industry tests for human consumption. The systematic review of protocol results of preclinical phases is not a common practice, but recent meta-analyses question the projection accuracy of these data for humans. Currently, along with scientific questioning, there is a comprehensive ethical discussion about the conflicts in the instrumentalization of non-human life, which reached its peak with the creation of transgenic animals. This article discusses the application of the concept of vulnerability to non-human animals in experiments and reflects on the implicit power relations of these practices. We propose to implement and develop alternative techniques to the animal model, combining ethics and innovation.

Resumen El uso de animales no humanos como herramienta para la investigación biomédica y en pruebas de la industria para el consumo humano se ha incorporado a las prácticas científicas y se ha asimilado como fundamental. La revisión sistemática de los resultados de protocolos de fases preclínicas no es una práctica corriente, pero metaanálisis recientes cuestionan la capacidad proyección de estos datos a la especie humana. Actualmente, junto con el cuestionamiento científico, hay una discusión ética sobre los conflictos inherentes a la instrumentalización de la vida del animal no humano, que alcanza su ápice en la creación de animales transgénicos. Este artículo tiene como objetivo discutir la aplicación del concepto de vulnerabilidad al animal no humano en el contexto de la experimentación y proponer una reflexión sobre las relaciones de poder implícitas en estas prácticas. Como una aplicación práctica de la teoría expuesta, se propone implantar y desarrollar técnicas alternativas al modelo animal, que conjuguen ética e innovación.

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health.

OBJECTIVES: This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS: Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS: All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION: Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.

The "Abortion Pill" Misoprostol in Brazil: Women's Empowerment in a Conservative and Repressive Political Environment.

In the aftermath of the introduction of severe restrictions on abortion in several US states, some activists have argued that providing widespread access to an abortive drug, misoprostol, will transform an induced abortion into a fully private act and therefore will empower women. In Brazil, where abortion is criminalized, the majority of women who wish to terminate an unwanted pregnancy already use the illegal, but easily accessible, misoprostol. We examine the history of misoprostol as an abortifacient in Brazil from the late 1980s until today and the professional debates on the teratogenicity of this drug. The effects of a given pharmaceutical compound, we argue, are always articulated, elicited, and informed within dense networks of sociocultural, economic, legal, and political settings. In a conservative and repressive environment, the use of misoprostol for self-induced abortions, even when supported by formal or informal solidarity networks, is far from being a satisfactory solution to the curbing of women's reproductive rights.

Controvérsias em torno do uso experimental da cloroquina / hidroxicloroquina contra a Covid-19: "no magic bullet" / Controversies about the experimental use of chloroquine / hydroxychloroquine against Covid-19: "no magic bullet"

Resumo O artigo apresenta um panorama dos testes clínicos conduzidos em 2020, que visam produzir evidências sobre a eficácia de dois medicamentos utilizados experimentalmente contra a Covid-19 - hidroxicloroquina e cloroquina -, desde que se passou a cogitar eficácia de seu uso, seja no tratamento de doentes graves, de infectados sem quadro clínico importante, ou mesmo como agente preventivo. Foram utilizados dados secundários - bancos de dados de testes clínicos, material da mídia e literatura especializada. Em meio à urgência de tratamentos para contenção da pandemia, o uso experimental gerou controvérsias inicialmente no meio científico, mas que acabaram por ser fortemente capturadas politicamente. Líderes como Trump e Bolsonaro, em discursos mal fundamentados, têm se declarado altamente favoráveis ao uso desses medicamentos, gerando uma minimização da gravidade da epidemia e, simultaneamente, negligenciando a necessidade de elevação importante de gastos públicos em saúde. Face às frágeis evidências científicas produzidas, a euforia social em torno desses medicamentos e sua promoção suscitou exageros e comportamentos irracionais, como automedicação. Esperar-se-ia de governantes e gestores de nações democráticas, muito mais cautela e responsabilidade, que contribuíssem na construção de respostas cientificamente embasadas, racionais e eficazes ao controle da pandemia, protegendo a saúde de suas populações, pressuposto do poder de Estado.

Abstract The article presents an overview of clinical tests conducted in 2020, which aim to produce evidence on the efficacy of two drugs used experimentally against Covid-19 - hydroxychloroquine and chloroquine -, since the effectiveness of their use, whether in the treatment of seriously ill, infected with no significant clinical condition, or even as a preventive agent. Secondary data were used - clinical test databases, media material and specialized literature. Considering the urgency of treatments to contain the pandemic, the experimental use generated controversies initially in the scientific environment, but which ended up being strongly captured politically. Leaders like Trump and Bolsonaro, in ill-founded speeches, have declared themselves highly favorable to the use of these drugs, generating a minimization of the severity of the epidemic and, simultaneously, neglecting the need for significant increase in public spending on health. In view of the fragile scientific evidence produced, the social euphoria surrounding these drugs and their promotion led to exaggerations and irrational behaviors, such as self-medication. It would be expected from governments and managers of democratic nations, much more caution and responsibility, to contribute to the construction of scientifically based, rational and effective responses to the control of the pandemic, protecting the health of their populations, an assumption of state power.

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health / O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde

ABSTRACT OBJECTIVES This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.

RESUMO OBJETIVOS O estudo examinou as aquisições de eculizumabe, um anticorpo monoclonal de alto custo utilizado no tratamento de doenças raras, pelos órgãos federais brasileiros, em termos das quantidades compradas, gastos e preços. MÉTODOS Foram analisadas compras de eculizumabe realizadas entre março de 2007 e dezembro de 2018, por meio de dados secundários extraídos do sistema de compras do governo federal (Siasg). Foram examinados o número de compras, quantidades adquiridas, número de doses diárias definidas por 1.000 habitantes por ano, gastos anuais e preços praticados. Os preços foram corrigidos pelo índice nacional de preços ao consumidor amplo para dezembro de 2018. Regressão linear foi utilizada para análises de tendência. RESULTADOS Todas as aquisições por órgãos federais foram realizadas pelo Ministério da Saúde. As compras se iniciaram em 2009, sendo efetuadas por dispensa de licitação e para atendimento de demanda judicial. Houve tendência crescente no número de compras e quantidades adquiridas ao longo do tempo. Foram realizadas 283 compras, totalizando 116.792 unidades adquiridas, 28,2% compradas em 2018. Os gastos totais contratados corrigidos somaram mais de R$ 2,44 bilhões. Após a aprovação do registro pela Agência Nacional de Vigilância Sanitária, o preço médio ponderado caiu aproximadamente 35%, para valores abaixo dos preços estabelecidos pela Câmara de Regulação do Mercado de Medicamentos. CONCLUSÃO O eculizumabe representou gastos extremamente significativos para o Ministério da Saúde no período. Todas as compras foram feitas para atendimento de demandas judiciais, fora do ambiente competitivo. Seu registro promoveu queda importante nos preços praticados. O estudo aponta a relevância do registro sanitário e da necessidade de monitoramento e auditoria permanentes das compras de medicamentos para atendimento de demandas judiciais.

A incorporação do teste diagnóstico baseado na amplificação de ácidos nucleicos (NAT) para triagem de sangue no SUS: arranjos tecnológicos para a nacionalização do "NAT brasileiro" / The introduction of nucleic acid tests (NAT) for blood screening in the Brazilian public healthcare system: technological arrangements for the nationalization of the "Brazilian NAT"

Resumo Os testes de ácidos nucleicos (NAT) são ferramentas complementares aos testes sorológicos para controle da transmissão de doenças infecciosas por meio de produtos obtidos a partir do sangue. Em 2002, um decreto do Ministério da Saúde tornou obrigatória a realização do NAT por todos os bancos de sangue, medida dificultada por razões como os custos necessários para a sua implantação. Como estratégia para a sua incorporação nos bancos de sangue ligados ao SUS, um consórcio público foi criado para desenvolver uma versão local do kit. A partir de métodos de pesquisa qualitativa, os autores analisam essa iniciativa, visando esmiuçar os detalhes da "nacionalização tecnológica" de um teste diagnóstico in vitro. O artigo descreve como o consórcio compreende o kit e como cada uma das tecnologias que o compõem são obtidas e reunidas no teste brasileiro. A relevância dessa análise é identificar quais os desafios e os limites à produção de testes in vitro para doenças infecciosas no Brasil, assim como a repercussão desse tipo de iniciativa para o sistema nacional de inovação em saúde.

Abstract Nucleic acid based amplification tests (NAT) are employed as complementary tools to control the transmission of infectious diseases through contaminated blood. In 2002, a decree from the Brazilian Ministry of Health made compulsory the use of NAT by all the blood services in the country, a measure that was challenged by costs related to the test incorporation. As the strategy to introduce the test in the blood banks serving the public healthcare system (Sistema Único de Saúde), a public Consortium was constituted to develop a local version of the kit. On the basis of qualitative fieldwork, the authors investigate the strategies used by the Brazilian laboratories and universities to nationalize the kit through capturing and assembling its various components. The paper contributes to revealing the challenges and limits to the production of in vitro tests for infectious diseases in Brazil, as well as the repercussion of such an initiative to the national healthcare innovation system.

Mulheres nas prisões brasileiras: tensões entre a ordem disciplinar punitiva e as prescrições da maternidade / Women in Brazilian prisons: tensions between punitive disciplinary order and maternity prescriptions

Resumo Visando contribuir para o debate acerca da maternidade na prisão, este estudo analisou as interseções das normas de gênero e das relações disciplinares nesse contexto, identificando controvérsias no plano dos valores e das relações de poder que as sustentam. Para tal, entrevistou, em quatro estados brasileiros, 22 mulheres - gestantes e mães com filhos na prisão - e 19 profissionais que atuam nesse ambiente, além de cinco grupos com gestantes e mães e três com profissionais de saúde. Observou-se que o fechamento institucional, regulamentações penais, vigilância constante, restrição do poder decisório das mães e a separação compulsória dos filhos geram tensionamentos e promovem formas peculiares de viver a maternidade. Produziram-se três categorias analíticas distintas: maternidade interrompida, maternidade desautorizada e maternidade exclusiva. Concluiu-se que os mecanismos disciplinares característicos do penitenciário, ao se integrar às práticas de controle de si que as mulheres-mães realizam em função do cuidado e proteção dos filhos, vulnerabilizam concretamente estas mulheres, expondo-as e a seus filhos a sofrimentos psíquicos e morais. Sugere-se a necessidade de intervenções normativas e medidas legais, além de políticas públicas que substituam a intervenção penal como estratégia de controle da pobreza e de outras formas de vida contestadas.

Abstract Aiming to contribute to the debate about maternity in prison, this study analyzed the intersections of gender norms and disciplinary relationships in this context, identifying controversies regarding the values and power relations that sustain them. To that end, she interviewed 22 women - pregnant women and mothers with children in prison - in four Brazilian states, and 19 professionals working in this environment, in addition to five groups with pregnant women and mothers and three with health professionals. It was observed that institutional closure, penal regulations, constant vigilance, restriction of mothers' decision-making power and compulsory separation of children generate tensions and promote peculiar forms of motherhood. Three different analytical categories were produced: interrupted maternity, unauthorized maternity and exclusive maternity. It was concluded that the disciplinary mechanisms characteristic of the penitentiary, by integrating themselves with the self-control practices that mothers perform in function of the care and protection of their children, concretely make these women vulnerable, exposing them and their children to psychic sufferings and moral. It is suggested the need for normative interventions and legal measures, as well as public policies that replace criminal intervention as a strategy to control poverty and other contested ways of life.

Women's reproductive rights in the penitentiary system: tensions and challenges in the transformation of reality. / Direitos reprodutivos das mulheres no sistema penitenciário: tensões e desafios na transformação da realidade.

This article seeks to identify and discuss violations and challenges to the fulfillment of women's reproductive rights in situations of deprivation of liberty, with an emphasis on sexual and reproductive health. Regulatory parameters were considered as analytical frameworks that support these rights identified by the literature, and the discourses and practices linked to their effectiveness in the everyday life of prisons, collected in interviews with pregnant women and children in prisons, and the professionals whose practices interfere with the exercise of these rights. It was discovered that violations of these rights find support in speech that delegitimizes the motherhood of these women. We consider the use of rights as strategic in the struggle for the transformation of this situation.

Direitos reprodutivos das mulheres no sistema penitenciário: tensões e desafios na transformação da realidade / Women´s reproductive rights in the penitentiary system: tensions and challenges in the transformation of reality

Resumo Neste artigo buscou-se identificar e discutir violações e desafios à efetivação dos direitos reprodutivos das mulheres em situação de privação de liberdade, com ênfase na saúde sexual e reprodutiva. Foram considerados como referenciais de análise os parâmetros normativos que sustentam estes direitos, identificados por levantamento bibliográfico, e os discursos e práticas relativos à sua efetivação no dia a dia das prisões, colhidos em entrevistas com mulheres gestantes e com filhos nas prisões e profissionais cujas práticas interferem no exercício destes direitos. Verificou-se que as violações destes direitos sustentam-se em discursos que deslegitimam a maternidade destas mulheres. Considera-se o recurso aos direitos como estratégico nas lutas pela transformação desta situação.

Abstract This article seeks to identify and discuss violations and challenges to the fulfillment of women’s reproductive rights in situations of deprivation of liberty, with an emphasis on sexual and reproductive health. Regulatory parameters were considered as analytical frameworks that support these rights identified by the literature, and the discourses and practices linked to their effectiveness in the everyday life of prisons, collected in interviews with pregnant women and children in prisons, and the professionals whose practices interfere with the exercise of these rights. It was discovered that violations of these rights find support in speech that delegitimizes the motherhood of these women. We consider the use of rights as strategic in the struggle for the transformation of this situation.

Estratégia de proteção de patentes farmacêuticas: o caso do atazanavir / The strategy of pharmaceutical patent protection: the case of atazanavir / Estrategia de protección de patentes farmacéuticas: el caso de atazanavir

O alto custo dos medicamentos antirretrovirais (ARVs) justifica estudos sobre estratégias de patenteamento farmacêutico vis-à-vis à política pública brasileira de acesso universal aos ARVs. A análise da evolução das tendências tecnológicas através do estudo de patentes fornece também uma visão dos envolvidos no desenvolvimento de uma tecnologia. Para traçar o perfil de patenteamento do antirretroviral atazanavir, no Brasil e no mundo, foi realizado um estudo na base de dados Thomson Reuters Integrity que identificou o desenvolvimento, produção e comercialização desse produto. Foram identificados 49 documentos de patentes, tendo a proteção dessa tecnologia se iniciado em 1996, com a empresa Novartis e seu licenciado,a Bristol, que reivindicaram proteção para a molécula. Prossegue até 2013, com proteção de invenções incrementais, originárias na China. O estudo possibilitou discutir a importância do sistema de patentes na promoção da inovação, e evidenciar tipos diversos de proteção para um produto e tecnologias relacionadas...

The high costs of antiretroviral drugs (ARVs) justifies studies on pharmaceutical patenting strategiesvis-à-vis the Brazilian public policy of universal access to ARVs. The analysis of the evolution oftechnology trends through patent study also provides an overview of those involved in the developmentof a technology. To trace the patenting profile of atazanavir antiretroviral in Brazil and in the world,a study was conducted using Thomson Reuters Integrity database and such study identified thedevelopment, production and marketing of this product. 49 patent documents were identified, havingbeen started the protection of this technology in 1996 with Novartis and its licensee Bristol, whichclaimed protection for the molecule. It remains until 2013, with protection of incremental inventionsoriginating in China. The study has allowed to discuss the importance of the patent system to promotinginnovation, and to highlight different types of protection for a product and related technologies...

El alto costo de los medicamentos antirretrovirales (ARVs) justifica estudios sobre estrategias de protecciónde patentes farmacéuticas vis-à-vis la política brasileña de acceso universal a los ARVs. El análisis de laevolución de las tendencias tecnológicas a través del estudio de las patentes posibilita una visión de losdiferentes actores responsables por el desarrollo de la tecnologia. Para analizar el perfil de patentamientodel antirretroviral atazanavir en Brasil y en el mundo se realizó un estudio através de la base de datosde Thomson Reuters Integrity a fin de identificar el desarrollo, la producción y comercialización delproducto. Fueron identificados 49 documentos de patentes y los resultados muestran que la protección dela tecnologia comienza en 1996 con Novartis y el detentor de su licencia, Bristol, las cuales reivindicaronprotección para la molécula. que continúa hasta 2013, con documentos originarios de China, que provienende invenciones incrementales. El estudio posibilitó discutir la importancia del sistema de patentes parafomentar la innovación y permitir diferentes tipos de protección para un producto y tecnologias relacionadas...

Tecnologias de reprodução assistida no Brasil: opções para ampliar o acesso / Assisted reproductive technologies in Brazil: options to improve access

Resumo Este artigo revisita o padrão de assimilação e difusão das tecnologias de reprodução assistida (TRA) no Brasil, caracterizado por altíssima concentração desta tecnologia no setor privado da medicina e baixíssima regulação na aplicação destas técnicas. Este padrão gerou enormes dificuldades e barreiras ao acesso a essas técnicas, basicamente por razões econômicas. A partir da apresentação do panorama da história das TRA, o artigo focaliza dois casos que podem configurar propostas de solução para a excessiva exclusão ao acesso, ainda que não se modifique a mesma lógica privatizante que marca a RA no país, uma vez que o problema das infertilidades não foi priorizado, até o momento, no Sistema Único de Saúde. A primeira, trazida pela indústria farmacêutica, consiste em um programa de compras subsidiadas de medicamentos pelos usuários no chamado Programa Acesso. A segunda proposta, conhecida como doação compartilhada de óvulos, implica a troca, entre duas mulheres, de material reprodutivo biologicamente escasso (ovócitos). Esta troca ocorre, em geral, entre uma mulher que tem óvulos e não pode custear seu tratamento e outra que, não tendo mais óvulos para se reproduzir, custeia o tratamento da doadora. Ambas as propostas se difundem num quadro legal bastante mal regulado em termos da aplicação das TRA, mas que veda práticas não admitidas na Constituição Federal e criminalizadas na lei penal, como a comercialização de órgãos e tecidos humanos em geral, bem como pagamento a voluntários de testes para pesquisa, pela Resolução nº 466 (CNS, 2012). Em termos metodológicos, o artigo assume caráter monográfico e de debate da literatura, mas está baseado também na coleta de dados secundários recentes, assim como em inúmeras pesquisas empíricas realizadas ao longo dos últimos 25 anos pelas autoras.

AbstractThis article revisits the pattern of assimilation and dissemination of assisted reproductive technologies (ART) in Brazil, characterized by extreme concentration of this technology in the private medical sector and very low setting in the application of these techniques. This pattern has generated enormous difficulties and barriers to access to these techniques, basically for economic reasons. From the presentation of the overview of the history of ART, the article focuses on two cases that may propose solutions for excessive exclusion access, although it does not modify the same privatization logic that marks RT in the country, since the problem of infertility was not prioritized, so far, by the Unified Health System. The first, brought by the pharmaceutical industry, consists of a subsidized purchasing program of drug users by the so-called Programa Acesso. The second proposal, known as shared ovules donation, implies the exchange between two women, of biologically scarce reproductive materials (oocytes). This exchange occurs, in general, from a woman who has ovules and cannot afford treatment and another who has no ovules to reproduce, and pays for the treatment of the donor. Both proposals diffuse a legal framework rather poorly regulated in terms of the application of ART, but prohibit practices not authorized in the Constitution and criminalized in penal law such as the sale of human organs and tissues in general, as well as volunteers to payment tests for research. In terms of methodology, the article assumes monographic character and literary debate, but is also based on the collection of recent secondary data, as well as numerous empirical studies conducted over the last 25 years by the authors.