Vaccine technology transfer in a global health crisis: Actors, capabilities, and institutions.

The COVID-19 pandemic, which featured international pharmaceutical firms seeking to build global manufacturing networks to scale-up the supply of vaccines, has generated heightened interest in understanding the role of firm-to-firm technology transfer. While considerable attention has been given to tracking the extent of international vaccine technology transfer, we know little about how partnerships were established and work in practice. Understanding the challenges that such projects face, and how such challenges may be overcome, is crucially important. This paper provides an account of the partnership between the British-Swedish multinational pharmaceutical company AstraZeneca, the vaccine developer that has engaged in the most technology transfer and built the widest global manufacturing network, and Bio-Manguinhos, a public laboratory linked to Brazil's Ministry of Health. The case study demonstrates the importance of capabilities and regulatory flexibility. Moreover, the analysis highlights the role of political factors that affect the process of technology transfer, and innovation more broadly. Because of the risks involved and the need to quickly mobilize existing capabilities and build new ones, as well as the imperatives of coordinating among manufacturing and regulatory processes and allocating resources to make such arrangements feasible, technology transfer projects need to be enabled politically. Looking forward, the case study has implications for initiatives to expand technology transfer for broadened production of vaccines in the Global South.

The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil.

As the world struggles to meet the challenges of vaccination against COVID-19, more attention needs to be paid to issues faced by countries at different income levels. Middle-income countries (MICs) typically lack the resources and regulatory capacities to pursue strategies that wealthier countries do, but they also face different sets of challenges and opportunities than low-income countries (LICs). We focus on three dimensions of vaccination: procurement and production; regulation of marketing registration; and distribution and uptake. For each dimension we show the distinct challenges and opportunities faced by MICs. We illustrate these challenges and opportunities with the case of Brazil, showing how each dimension has been affected by intense political conflicts. Brazil's procurement and production strategy, which builds on a long trajectory of local production and technology transfer, has been riddled by conflicts between the national government and state governments. The regulatory approval process, based around one of Latin America's most highly-regarded regulatory authorities, has also been subject to acute inter- and intra-governmental conflicts. And with regard to distribution and uptake, in the face of high uncertainty, even with a solid health infrastructure, Brazil encounters difficulties in promoting vaccine delivery. The research also reveals the importance of coordination among these dimensions, in Brazil and beyond. Pandemic preparedness and response must include sharing knowledge of how to produce vaccines and recognition of the crucial linkages between procurement, regulation, delivery, and uptake that are necessary for ensuring access to these products.

Political discourse, denialism and leadership failure in Brazil's response to COVID-19.

The COVID-19 pandemic posed challenges for healthcare systems and political leaders across the globe. In this case study of Brazil, we argue that leadership failings at the highest level contributed to Brazil's relatively high and escalating death rates during 2020. Drawing on an analysis of a large amount of textual documentation drawn from media reports, we emphasise the role and consequences of President Jair Bolsonaro's political discourse and prioritisation of the economy. We focus on the first wave that swept across the globe between January and late June of 2020, arguing that Bolsonaro underplayed the seriousness of the epidemic, leveraged misinformation as a political strategy, promoted pseudoscience, and undermined the Ministry of Health. He also confronted subnational governments for adopting lockdown measures - a move that enabled him to blame regional governors for the short-term economic costs of COVID-19 related restrictions. We suggest that his denialist approach to climate change paved the way for his subsequent denialism of the seriousness of COVID-19 and for his undermining of social distancing, mask-wearing and other preventative responses supported by science. These sobering findings highlight the role that national leaders can play in undermining scientific approaches to both public health and the environment.

Captura ou não captura? Perspectivas analíticas no estudo de políticas regulatórias / ¿Captura o no captura? Perspectivas analíticas en el estudio de políticas regulatorias / Analytical perspectives in the study of regulatory policies

Resumo A discussão de captura regulatória não é uma agenda recente em estudos do Estado, mas o estabelecimento de critérios para identificação de captura, bem como a definição de protocolos para demonstração e mensuração do fenômeno estão longe de um consenso. O presente artigo tem por objetivo, por meio de uma revisão sistematizada não exaustiva da literatura, identificar as principais estratégias de captura e suas respectivas formas de mensuração. Propõe-se a organização dos estudos de regulação em quatro eixos de estratégias de captura: por incentivos materiais, por incentivos imateriais, por ameaça e por assimetria de informação. Ademais, busca-se examinar a produção sobre o caso brasileiro e discutir os resultados contraditórios de pesquisas recentes sobre o caso da Agência Nacional de Saúde Suplementar (ANS). Identificou-se que, em geral, a literatura brasileira parte de uma abordagem ampla de compreensão de captura e que os trabalhos que se orientam por uma abordagem restritiva exploram, principalmente, o mecanismo de "porta giratória", seguindo uma tendência da literatura internacional, porém ignorando outros mecanismos com potencial explicativo. Esses achados têm implicações para desenhos de pesquisa em estudos sobre regulação, de forma a avançar as análises além das impressões iniciais e em direção a demonstrações empíricas robustas.

Resumen La discusión sobre la captura regulatoria no es una agenda reciente en los estudios del Estado, pero el establecimiento de criterios para la identificación de la captura, así como la definición de protocolos para demostrar y medir el fenómeno están lejos de un consenso. Este artículo tiene como objetivo, a través de una revisión bibliográfica no exhaustiva, identificar las principales estrategias de captura y sus respectivas formas de medición. Se propone organizar los estudios de regulación en cuatro ejes de estrategias de captura: por incentivos materiales, por incentivos inmateriales, por amenaza y por asimetría de información. Además, se busca examinar la producción sobre el caso brasileño y discutir los resultados contradictorios de investigaciones recientes sobre el caso de la Agencia Nacional de Salud Suplementaria (ANS). Se identificó que, en general, la literatura brasileña parte de un enfoque amplio para comprender la captura y que las obras guiadas por un enfoque restrictivo exploran principalmente el mecanismo de "puerta giratoria", siguiendo una tendencia en la literatura internacional, sin tener en cuenta otros mecanismos con potencial explicativo. Estos resultados tienen implicaciones para diseños de investigación en estudios de regulación, con el fin de avanzar en los análisis más allá de las impresiones iniciales y hacia demostraciones empíricas sólidas.

Abstract The discussion of regulatory capture is not recent in state studies. However, the criteria to identify capture and the definition of the research protocols to demonstrate and measure the phenomenon have still not reached a consensus. This article carries out a non-exhaustive literature review to identify the main regulatory capture strategies and their respective measurement methods. We organize the regulation studies in four axes of regulatory capture strategies: capture by material incentives, capture by immaterial incentives, capture by threat, and capture by information asymmetry. Furthermore, the study examines the Brazilian case and discusses the contradictory results of recent research on the case of the National Supplementary Health Agency (ANS). We identified that, in general, Brazilian literature starts from a broad approach to understanding regulatory capture. Also, the studies adopt a restrictive approach mainly to explore the "revolving door" mechanism, following a trend in international literature but ignoring other mechanisms with explanatory potential. These findings have implications for research designs in studies of regulation in order to advance analyses beyond initial impressions and toward robust empirical research.

[The Human Capital Index: a challenge for Brazil]. / O Índice de Capital Humano: um desafio para o Brasil.

The article analyzes the Human Capital Index (HCI) proposed by the World Bank in 2018 to evaluate the performance in the health and education sectors of 157 countries. Brazil's situation is compared to societies with institutionalized social protection systems. It reveals that the condition of Brazil in HCI is deficient due to the poor performance of the education sector and the lack of control of violence against young people.

O Índice de Capital Humano: um desafio para o Brasil / The Human Capital Index: a challenge for Brazil

Resumo O artigo discute o Índice de Capital Humano (ICH) proposto pelo Banco Mundial em 2018 para avaliar o desempenho das áreas de saúde e educação de 157 países. A situação do Brasil é comparada com sociedades com sistemas de proteção social institucionalizados. Demonstra-se que a condição do Brasil no ICH é sofrível em função do baixo desempenho do setor educacional e da falta de controle da violência sobre os jovens.

Abstract The article analyzes the Human Capital Index (HCI) proposed by the World Bank in 2018 to evaluate the performance in the health and education sectors of 157 countries. Brazil's situation is compared to societies with institutionalized social protection systems. It reveals that the condition of Brazil in HCI is deficient due to the poor performance of the education sector and the lack of control of violence against young people.

Promoting and regulating generic medicines: Brazil in comparative perspective / La promoción y la regulación de los medicamentos genéricos: el caso del Brasil desde una perspectiva comparativa

Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.

La promoción del uso de medicamentos genéricos puede ser un instrumento fundamental para la política farmacéutica nacional de los países, puesto que reduce el gasto en medicamentos y, a la vez, amplía el acceso a la atención de salud. A pesar de la importancia que pueden tener esas políticas y de las diferencias entre las prácticas de cada país, los expertos que emprenden análisis comparativos carecen de una hoja de ruta que les permita determinar los aspectos que deben evaluar y comparar de las políticas relativas a los medicamentos genéricos. Este informe subsana esta carencia al examinar las leyes y los reglamentos nacionales en relación con cuatro dimensiones consideradas cruciales en toda evaluación: la demostración de la equivalencia terapéutica, el empaquetado y el etiquetado farmacéutico, la prescripción, y la sustitución. Además, se examina la forma en que los distintos intereses de las partes involucradas de los sectores público y privado podrían configurar la política relativa a los medicamentos genéricos y su aplicación. A fin de ilustrar los retos y los conflictos que subyacen a la formulación y la ejecución de las políticas farmacéuticas, este informe se centra en el caso del Brasil.

Relevance of variation in use of terminology to define generic pharmaceutical products.

The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

Federalism, the Economic-Industrial Health Care Complex and High-Cost Pharmaceutical Assistance in Brazil / Federalismo, complexo econômico-industrial da saúde e assistência farmacêutica de alto custo no Brasil

Brazil has a relevant, although relatively unknown, special medicines programme that distributes high-cost products, such as drugs needed for cancer treatments. In 2009, the purchase of these medicines became the responsibility of the Brazilian Federal Government. Until then, there were no clear norms regarding the responsibilities, in terms of the management/financing of these medicines, of the Brazilian Federal Government and of the states themselves. This qualitative study analyses the policy process needed to transfer this programme to the central government. The study examines the reports of the Tripartite Commission between 2000 and 2012, and in-depth interviews with eleven key informants were conducted. The study demonstrates that throughout the last decade, institutional changes have been made in regard to the federal management of these programmes (such as recentralisation of the purchasing of medicines). It concludes that these changes can be explained because of the efficiency of the coordinating mechanisms of the Federal Government. These findings reinforce the idea that the Ministry of Health is the main driver of public health policies, and it has opted for the recentralisation of activities as a result of the development project implicit in the agenda of the Industrial and Economic Heal.

O Brasil possui um relevante, porém pouco conhecido, programa de medicamentos especializado, com distribuição de produtos de alto custo, como no caso do tratamento do câncer. Em 2009, a compra destes medicamentos passou a ser de responsabilidade federal. Até então, não existiam normas claras sobre as responsabilidades da União e estados na gestão e financiamento deste programa. O presente estudo qualitativo analisa a evolução do processo de transição deste programa para a esfera do governo federal. Através de uma consulta às atas da Comissão Intergestora Tripartite, de 2000 e 2012, e entrevistas com onze informantes, o estudo demonstrou que ao longo da última década foram realizadas alterações institucionais relevantes na gestão federativa destes programas, como a recentralização da compra destes medicamentos e a elaboração de critérios para a introdução de novos medicamentos neste programa, o que é explicável pela eficácia dos mecanismos de coordenação do governo federal. Esses achados reforçam a ideia de que o Ministério da Saúde, além de constituir o principal indutor de políticas públicas de saúde, tem optado pela recentralização de atividades, por força do projeto desenvolvimentista implícito na agenda do Complexo Econômico e Industrial da Saúde.

Relevance of variation in use of terminology to define generic pharmaceutical products / Relevancia de la variación en el uso de la terminología para definir los medicamentos genéricos

The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

La Organización Mundial de la Salud (OMS) promueve el uso de políticas de medicamentos genéricos para estimular la competencia en el sector farmacéutico, reducir los precios y aumentar el acceso a los medicamentos. Sin embargo, hay poca información sobre la aplicación de dichas políticas por parte de los países. Este artículo describe la terminología empleada por los organismos regulatorios nacionales para definir los medicamentos genéricos frente a las especialidades farmacéuticas de marca en los países en desarrollo, incluidos los de América Latina, así como las dificultades que se encuentran en la aplicación de las directrices de la OMS, como por ejemplo en el etiquetado. El autor llega a la conclusión de que la variación en la terminología de los medicamentos genéricos en estos países es resultado del contexto institucional (es decir, el sector público y el ordenamiento jurídico-administrativo del país) y de los legados de las políticas, como los regímenes de propiedad intelectual, y destaca la necesidad de analizar más a fondo los reglamentos farmacéuticos a fin de conocer mejor los obstáculos y las implicaciones de las políticas en materia de medicamentos genéricos.

Resposta brasileira à epidemia de HIV/AIDS entre usuários de drogas injetáveis, 1995-2007: marcos, avanços e desafios / Brazilian response to the epidemic of HIV / AIDS among injecting drug users, 1995-2007: milestones, progress and challenges

O Programa Brasileiro de AIDS é internacionalmente reconhecido pela adoção de políticaspúblicas controversas e bem sucedidas para conter o avanço da epidemia de AIDS no país. A integração de ações de tratamento e prevenção resultaram na redução da mortalidade, morbidade, hospitalizações, e aumento da expectativa de vida das pessoas vivendo com HIV/AIDS no Brasil. Iniciativas de prevenção à AIDS entre usuários de drogas injetáveis (UDI) compreendem, entre outras, a troca de seringas usadas por novas com o propósito de retirar de circulação seringas potencialmente contaminadas pelo HIV (vírus da AIDS). A presente tese de doutorado buscou analisar os marcos, avanços e desafios da resposta brasileira referentes à prevenção do HIV/AIDS entre UDI ao longo dos últimos 12 anos. Procurou-se analisar as principais inter - relações entre as políticas anti-drogas no nível supranacional e doméstico, bem como as alterações nas políticas públicas de prevenção à AIDS entre UDI no Brasil, nesse período. Essa pesquisa realizou uma análise da experiência brasileira no combate à epidemia de AIDS entre UDI. O método utilizado foi o rastreador de processo análise histórica com vista aexplorar a cadeia de eventos envolvidos na formulação e implementação das políticas de prevenção ao HIV / AIDS entre UDI no Brasil, no período 1995-2007. Esse corte temporal baseou-se no fato de que esses projetos foram efetivamente implementados no país a partir de 1995. As informações foram coletadas através de bases de dados secundárias, provenientes do Programa Nacional de DST AIDS, e de pesquisa documental. A tentativa de implementação dos projetos de prevenção a AIDS entre UDI no Brasil se deu no âmbito local, mas foi somente com os recursos do acordo de empréstimo com o Banco Mundial ao Programa Nacional de AIDS que esses programas ganharam impulso e âmbito propriamente nacional. Os pilares da resposta brasileira para prevenir a epidemia de AIDS entre UDI foram...

The Brazilian AIDS Program is internationally renowned for its controversial and successful public policies to curb the spread of HIV/AIDS epidemic. Integrating treatment and prevention initiatives resulted in steep declines in mortality and morbidity, decreases in hospitalization, andalso dramatic improvements in life expectancy for people living with HIV/AIDS in Brazil. AIDS prevention programs for injecting drug users (IDUs) include needle exchange programs in which IDUs exchange used needles for new ones in order to reduce the circulation of needles putativelycontaminated with HIV (AIDS virus).This doctoral dissertation explored the milestones, accomplishments and challenges of the Brazilian response to HIV/AIDS prevention among IDUs during the last 12 years. It explores therelationship between drug policy at the domestic and international level as well as changes in public policies related to HIV/AIDS prevention among IDUs in Brazil in this time period. This doctoral dissertation analyzed the Brazilian experience to curb the HIV/AIDS epidemic among IDUs. The method applied was process tracing – historical analysis – to explore the formulation and implementation of HIV/AIDS prevention policies between 1995 and 2007. This timeframe was adopted because these projects were effectively implemented in 1995. Differentinformation was collected from secondary databases from the National STD AIDS Program, as well as from documental research. The first attempt to implement AIDS prevention projects among IDUs was at the local level;however, it was only with the World Bank loans to the National AIDS Program that these projects became national in scope. Basic tenets of Brazilian prevention programs among IDUs included 1) World Bank loans that emphasized prevention initiatives with this specific population as a cost-effective way to fight the HIV/AIDS epidemic in developing countries...

Descentralização, AIDS e redução de danos: a implementação de políticas públicas no Rio de Janeiro, Brasil / Decentralization, AIDS, and harm reduction: the implementation of public policies in Rio de Janeiro, Brazil

O artigo avalia como a descentralização dos recursos e ações do Programa Nacional de DST e AIDS influenciou as transferências de recursos para os programas de prevenção ao HIV/AIDS entre usuários de drogas injetáveis no Rio de Janeiro, Brasil (1999-2006). Foram avaliados os efeitos da política de descentralização sobre as transferências de recursos para os Programas de Redução de Danos (PRD) no Rio de Janeiro. A descentralização das transferências para os PRD no Rio de Janeiro se efetivou em 2006, com a virtual supressão do financiamento federal direto, obrigando estes programas a buscarem fontes alternativas de financiamento. Constata-se uma fragilidade dos PRD no Estado, agravada pela redução recente do volume de recursos. Dos 22 programas, existentes em 2002, o Estado passou a contar, em 2006, com apenas dois programas, financiados pelo Estado e por um município. A descontinuidade dessas ações pode vir a favorecer a reemergência da epidemia de AIDS nesta população, o que reclama um processo de descentralização mais gradual e melhor pactuado dessas iniciativas.

This paper assesses how decentralization of resources and initiatives by the Brazilian National SDT/AIDS Program has impacted the transfer of funds for programs to prevent HIV/AIDS among injecting drug users in Rio de Janeiro, Brazil (1999-2006). The effects of the decentralization policy on Rio de Janeiro's Syringe Exchange Programs (SEPs) are assessed in detail. Decentralization effectively took place in Rio de Janeiro in 2006, with the virtual elimination of any direct transfer from the Federal government. The elimination of direct transfers forced SEPs to seek alternative funding sources. The structure of local SEPs appears to be weak and has been further undermined by current funding constraints. Of 22 SEPs operating in 2002, only two are still operational in 2006, basically funded by the State Health Secretariat and one municipal government. The current discontinuity of SEP operations may favor the resurgence of AIDS in the IDU population. A more uniform, regulated decentralization process is thus needed.

[Decentralization, AIDS, and harm reduction: the implementation of public policies in Rio de Janeiro, Brazil]. / Descentralização, AIDS e redução de danos: a implementação de políticas públicas no Rio de Janeiro, Brasil.

This paper assesses how decentralization of resources and initiatives by the Brazilian National SDT/AIDS Program has impacted the transfer of funds for programs to prevent HIV/AIDS among injecting drug users in Rio de Janeiro, Brazil (1999-2006). The effects of the decentralization policy on Rio de Janeiro's Syringe Exchange Programs (SEPs) are assessed in detail. Decentralization effectively took place in Rio de Janeiro in 2006, with the virtual elimination of any direct transfer from the Federal government. The elimination of direct transfers forced SEPs to seek alternative funding sources. The structure of local SEPs appears to be weak and has been further undermined by current funding constraints. Of 22 SEPs operating in 2002, only two are still operational in 2006, basically funded by the State Health Secretariat and one municipal government. The current discontinuity of SEP operations may favor the resurgence of AIDS in the IDU population. A more uniform, regulated decentralization process is thus needed.

Syringe exchange programs in Brazil: preliminary assessment of 45 programs.

The present study aims to evaluate the current operation of Brazilian syringe exchange programs (SEP). After consulting national and regional networks of people working in projects/programs aiming to reduce drug-related harm, we identified 134 potential participant programs. Unfortunately, only 45 SEPs answered a survey, even after repeated attempts. The survey addressed: coverage, funding, procurement of basic supplies, managerial capacity, and the local political environment. Findings were triangulated with in-depth interviews with key informants. The main findings included: satisfactory adherence to the initiatives and adequate documentation, but deficiencies in terms of coverage and monitoring, and uneven procurement of resources. Program personnel work mostly on a provisional basis, despite the efforts of local coordinators. Most programs are funded by the National STDs/AIDS Program. A comprehensive agenda aiming to improve current operations should include: concerted efforts to improve local and regional databanks, incentives/sanctions toward full accountability of initiatives carried by the programs, and a genuine culture of monitoring and evaluation.

Syringe exchange programs in Brazil: preliminary assessment of 45 programs

O presente estudo buscou avaliar a operacão cotidiana dos programas de troca de seringas brasileiros (conhecidos, no país, como PRD). Foram identificados 134 PRD, com base na compilacão de informacões das redes que atuam na área. Por intermédio de uma pesquisa, avaliou-se a cobertura dos programas, o seu financiamento, o controle de insumos, a sua capacidade organizacional e o contexto político local. Os achados, referentes a 45 programas (que, de fato, responderam à pesquisa, após repetidos contatos), foram triangulados com entrevistas com informantes-chave. Foi identificada adesão satisfatória às acões e adequada documentacão e registro, mas deficiências de cobertura e monitoramento, além de descontinuidades quanto aos insumos. Os profissionais que atuam nos programas têm, em sua maioria, insercão profissional precária, embora haja coordenacão local, na maior parte dos casos. A maioria dos programas é financiada por verbas provenientes do Programa Nacional de DST/AIDS. Uma agenda abrangente nesse campo deve compreender um aprimoramento dos bancos de dados oficiais referentes aos programas, incentivos/sancões e a exigência de que reportem corretamente as suas acões, além de investimento em monitoracão e avaliacão.

Políticas de redução de danos ao uso de drogas: o contexto internacional e uma análise preliminar dos programas brasileiros / Politics of harm reduction to the use of drugs: the international context and a preliminary analysis of the Brazilian programs

(...) Esta dissertação, em um primeiro momento, revisa as políticas internacionais que têm por objetivo a redução de danos e, em seguida, procede a uma avaliação da implementação atual dessas políticas no Brasil. A dissertação discute as políticas e programas de RD em diferentes contextos globais, enfatizando os aspectos comuns e os contrastes das políticas implementadas nos EUA, Reino Unido e Brasil. Essas diferentes políticas parecem estar associadas ao sucesso e às limitações dos programas desenvolvidos em cada local. Como descrito em manuscrito submetido a uma revista indexada, os dados coletados em 134 PTS foram catalogados, a partir da compilação de informações das redes que atuam na área. Uma breve avaliação foi realizada em 45 programas, buscando avaliar: a cobertura dos programas, o seu financiamento, o controle de insumos, a sua capacidade organizacional e o contexto político. Os maiores desafios enfrentados pelas políticas de RD no Brasil não estão, de forma alguma, restritas ao cotidiano dos programas específicos. Essas políticas mantêm relações complexas com a sociedade civil, formadores de opinião e legisladores. Uma agenda abrangente neste campo deve compreender: o enfrentamento das resistências políticas à implantação e plena operação de políticas e programas de RD; um melhor diálogo e integração com instâncias/instituições que trabalham com o uso de drogas e educação, muitas vezes a partir de filosofias distintas, quando não contrapostas; e uma ampliação das interfaces com outras populações vulneráveis (presidiários, profissionais do sexo, garimpeiros).