Le médicament est un bien de santé ; il est un élément incontournable d’un droit à la santé efficace. Il doit être de bonne qualité et son accès doit se faire selon les besoins. S’interroger sur la sécurité sanitaire et l’accès aux médicaments c’est tenter de concilier, droit, économie, éthique et politique. Dans les PED, les faiblesses des revenus et de la capacité de production de médicaments sont des facteurs qui perturbent la mise sur le marché et la surveillance du médicament. Une fois sur le marché, sa distribution est également perturbée par des circuits parallèles illicites difficilement maîtrisables. Malgré les efforts des autorités politiques pour rendre le médicament accessible, des difficultés subsistent. Ces difficultés sont liées pour partie au droit des brevets. En effet, la protection du médicament confère un monopole d’exploitation à son titulaire qui fixe les prix en dehors de toute concurrence. Ces difficultés ont conduit à l’assouplissement du droit des brevets, mais l’usage de ces flexibilités n’est pas aisé pour les PED. La recherche de la santé pour tous et l’économie procèdent de logiques distinctes et le concept du médicament comme bien public demeure un idéal à réaliser, ce qui appelle sans doute à une relecture du droit des brevets. / Drug is a public good of health and an essential element of the right to effective health. It has to be of good quality and its access should be made according to the needs. By questioning the safety and the access to medicines, we attempt to reconcile, law, economics, ethics and politics. In developing countries, the weaknesses of income and the limited production capacity of drugs are factors that alter the placing on the market and the supervision of medication. Once on the market, illegal parallel circuits that are difficult to control also disturb its distribution. Despite the efforts of the political authorities to make drugs available, many challenges remain. These difficulties are partly related to patent law. Indeed, the protection of the drugs confers a monopoly on its holder, which sets prices without any competition. These difficulties have led to the relaxation of patent law, but the use of these flexibilities is not easy for developing countries. The pursuit of health for all and the economic system respond to different logics and the concept of drug as a public good remains an ideal to be achieved, which probably calls for a rereading of the patent law.

Por meio de uma intensa exploração doutrinária, vem se discutindo as mutações do direito frente à explosão tecnológica no mundo e, em especial, à tecnificação das atividades de atuação do Estado. Diante dessa situação, exploramos na doutrina internacional e nacional o conceito de um instituto intimamente ligado à tecnificação da atividade Estatal chamado de discricionariedade técnica. Com esta exploração, temos o intuito de demonstrar que, além de esta doutrina ser plenamente aplicável no direito pátrio, a situação de fato correspondente à tecnificação pela aplicação ao direito dos conhecimentos científicos de engenharia, biologia, medicina, saúde pública, entre outros, impulsionado pelas agências reguladoras, demanda o seu reconhecimento como forma de controle e proteção dos direitos contra eventuais abusos e ilegalidades da Administração Pública e, especialmente, da Administração Pública Sanitária. Por isso, iniciamos com os conceitos da discricionariedade técnica em suas duas modalidades e, após isto, buscamos, nas mais recentes doutrinas, os conceitos e limites identificados para a atividade discricionária técnico-administrativa, além de exemplificar ao leitor, circunstâncias em que tal discricionariedade se impõe. Paralelamente à conceituação, demonstramos a correlação e a relevância do reconhecimento deste instituto para o direito sanitário, buscando exemplos existentes neste ramo jurídico para melhor ilustrar a pesquisa. Após conceituar e exemplificar, passamos, finalmente, a justificar a real relevância deste estudo levantando na doutrina os limites formais e materiais deste instituto, como maneira de fornecer ferramentas para a proteção dos direitos coletivos e individuais contra atos ilegais. / By means of an intense doctrinaire exploration, people have discussed the mutations of law before the technological explosion in the world and, especially, to the technological development of the activities which the State acts. Because of that situation, we have explored in the international and national doctrine the concept of an institute connected to the technological development of the State activity which is called technical discretionarity. With this exploration, we wish to demonstrate that, not only is this doctrine fully applicable in Paternal Law, actually the situation corresponding to the technical development by means of the application to the right of the scientific knowledge of engineering, biology, medicine, public health, among others, impelled by Regulatory Authorities, demands its recognition as a way to control and protect the rights against eventual abuses and illegalities of Public Administration and, especially, of Health Administration. Therefore, we began with the concepts of the technical discritionarity in its two modalities and, after that, we searched, in more recent doctrines, the concepts and identified limits for the technical-administrative discretionary activity, besides exemplifying the reader, circumstances in which such discritionarity is imposed. Parallel to the conception, we demonstrated the correlation and the relevance of the recognition of this institute for Health Law, looking for existing examples in this juridical branch in order to better illustrate the research. After classifying and exemplifying it, we finally started to justify the real relevance of this study raising in the doctrine the formal and material limits of this institute, as a way to supply tools for the protection of collective and individual rights against illegal actions.

Made available in DSpace on 2010-04-20T20:51:43Z (GMT). No. of bitstreams: 3 78157.pdf.jpg: 30491 bytes, checksum: 2ce4d991a0a1c52f388fd76e6f9fc00c (MD5) 78157.pdf: 1779874 bytes, checksum: 304164897240614f31e2a09433fcbb53 (MD5) 78157.pdf.txt: 259128 bytes, checksum: c1820fbb6dfc113ae040d668629692ca (MD5) Previous issue date: 2006-01-18T00:00:00Z / Neste trabalho, foi analisada a evolução das práticas de proteção à saúde no Estado de São Paulo, desenvolvidas pelos órgãos estaduais de Saúde Pública, bem como estudada a evolução desses serviços denominados Vigilância Sanitária. Analisou-se também de que modo se desenvolveram, desde sua origem no século XIX até o final do século XX, as principais tarefas dos órgãos do Serviço Sanitário do Estado, quais sejam: controle das localidades, habitações, ocupação e parcelamento do solo; controle do meio ambiente, da poluição do ar e das águas; fiscalização da alimentação pública, do fabrico e consumo de alimentos e bebidas; controle do exercício de profissões ligadas à saúde; normalização do funcionamento de serviços de assistência à saúde e conexos; controle de drogas e medicamentos; controle de produtos ligados à saúde e conexos; saneamento das fábricas, oficinas e saúde do trabalhador; notificação e supervisão de doenças infecto-contagiosas e, finalmente, ações de educação em saúde, que constituem atribuições e funções dessa atividade. Muitas das funções e tarefas desenvolvidas atualmente pelos serviços de Vigilância Sanitária vêm sendo realizadas desde a criação do Serviço Sanitário do Estado, em 1892, ou mesmo anteriormente, apesar da Vigilância Sanitária, enquanto atividade sistematizada e organizada, ser algo recente no Estado de São Paulo, pois o CVS- Centro de Vigilância Sanitária foi criado em 1986. Sendo assim, apresenta-se aqui a evolução histórica dessa atividade sob a responsabilidade do Governo do Estado de São Paulo, apontando fatos relevantes no seu desenvolvimento, bem como os organogramas correspondentes a várias estruturas organizacionais. São analisadas também, segundo as atribuições mencionadas anteriormente, as evoluções da legislação básica presente nos sete Códigos Sanitários Estaduais vigentes nesse período. / This paper analyze the evolution of the practice on health protection in São Paulo State , developed by State Service of Public Health, also studies the evolution of these services known as health surveillance. It also analyzes how the main duties from States Services of Surveillance, such as : home place control, habitation, occupation and parcel ground; environmental control, including air and water pollution; control of food and drink production; control of professional practice related to health; health care services standardization; drugs and medicines control; health products correlated control ; working and occupational health; infectious diseases notification; and finally health education. These are functions and attributions of this activities, that developed from the beginning of the XIX Century until the end of the XX Century. Many of the functions and practices developed nowadays by the health surveillance services have been done since the origin of the State Sanitary Service in 1892, or even before, even though the health surveillance, while organized and systematized activity, is new in São Paulo State, because 'CVS – Centro de Vigilancia Sanitaria' was created in 1986. On this sense, it´s presented here, the historical evolution of this activity under de responsibility of the São Paulo State Government pointing relevant facts in its development, as well as the correspondent organization chart of the many organizational structure. Its also analyses, according to attributions in the seventy State Code Health Law valid in this period.

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No. of bitstreams: 1 Dissertacao Carolina.pdf: 1432080 bytes, checksum: a5e0e845f04d358b368bb6802020460f (MD5) Previous issue date: 2013-08-28 / A pesquisa discute o processo de formulação da política pública em reprodução humana assistida, de modo especial o Projeto de Lei nº 517/2011 e sua entrada na agenda governamental do Estado de São Paulo, no intuito de investigar o porquê, como e para que se dá o processo de formulação do “Programa de Assistência Básica em Reprodução Humana” (Projeto de Lei n º 517/2011) na agenda governamental do Estado de São Paulo. Especificamente, buscou-se ainda: identificar o problema que justifica a formulação da política de assistência em reprodução humana assistida no sistema público de saúde do Estado de São Paulo à luz do modelo teórico de política pública de Kingdon; levantar e sistematizar os documentos existentes sobre as propostas/alternativas para a assistência em reprodução humana assistida no sistema público de saúde do Estado de São Paulo; mapear os atores/participantes do processo de formulação da política pública em reprodução humana assistida na agenda governamental do Estado de São Paulo. Assim, este estudo pretende ampliar a compreensão dos direitos sociais, quais sejam: o direito à saúde e o direito sexual e reprodutivo a luz da Lei do Planejamento Familiar, a fim de que as camadas menos favorecidas economicamente possam desfrutar desses direitos, por vezes tolhidos pelo sistema econômico neoliberal e capitalista. Tais direitos auxiliam na construção de um Estado do Bem Estar Social, no qual a cidadania pode ser exercida de maneira salutar à dignidade da pessoa humana. Nesse sentido, a metodologia adotada foi de uma pesquisa qualitativa com revisão bibliográfica, análise documental e o delineamento do estudo de caso, o qual utilizou como instrumento de coleta de dados a entrevista, para buscar a percepção dos atores envolvidos no processo de formulação da política supramencionada, tendo como referencial teórico o modelo de políticas públicas de Kingdon. O caso estudado foi o Projeto de Lei nº 517/2011, que institui o “Programa de Assistência Básica em Reprodução Humana”, da Assembleia Legislativa do Estado de São Paulo. Os dados obtidos evidenciaram que, no Brasil, a política pública ora abordada é escassa, refletindo, pois, no acesso a uma classe menos favorecida. Desse modo, fica evidenciada a necessidade da participação do Estado, através das ações formuladas pelo Sistema Único de Saúde (SUS) ou pelas Parcerias Público-Privadas (PPP). Ressalta-se, entretanto, que as questões orçamentárias para a consecução das políticas de reprodução humana assistida representam empecilhos para sua implementação, devido à limitação dos recursos governamentais, haja vista que a previsão orçamentária ainda é insuficiente. Outrossim, deve-se atentar para o discurso do benefício das privatizações nas prestações dos serviços garantidos constitucionalmente à população como um todo, uma vez que a ausência de regras bem definidas pode favorecer ao desvio dos objetivos reais da referida política, não atendendo, pois, ao público ao qual se destina. / The research discusses the process of public policy-making in assisted human reproduction, particularly the Bill of Law nº 517/2011 and its entry into the government agenda of the State of São Paulo, in order to investigate why, how and who gives the process of formulating the "Basic Assistance Program in Human Reproduction" (Bill nº 517/2011) on the government agenda of the State of São Paulo. Specifically, we sought also to identify the problem that justifies the policy formulation assistance in assisted human reproduction in the public health system of the State of São Paulo the light of the theoretical model of public policy Kingdon; lift and systematize existing documents on proposals / alternatives for assistance in assisted human reproduction in the public health system of the State of São Paulo; map the actors / participants in the formulation of public policy on assisted human reproduction in the government agenda of the State of São Paulo. Thus, this study aims to broaden the understanding of social rights, namely: the right to health and the right to sexual and reproductive Light Family Planning Law, in order that the economically less privileged can enjoy these rights sometimes hampered by neoliberal and capitalist economic system. Rights which help in building a State of Social Welfare, in which citizenship can be exercised so salutary to human dignity. In this sense, the methodology adopted was a qualitative study with literature review, documentary analysis and design of the case study, which used as a tool for data collection interview to seek the perception of the actors involved in the process of policy formulation above, with the theoretical model of public policies Kingdon. The case studied was the Draft Law nº 517/2011, establishing the "Basic Assistance Program in Human Reproduction," the Legislature of the State of São Paulo. The data showed that, in Brazil, the public policy discussed herein is scarce reflecting, as the access to a class less favored. Thus, it is clear the need for the participation of the state through the actions made by the Unified Health System (SUS) or the Public-Private Partnerships (PPP). It is noteworthy, however, that the budget issues for achieving policy assisted reproduction represent impediments to its implementation due to limited government resources, given that even the budget forecast is still insufficient. Furthermore, attention should be paid to the speech of the benefit of privatization in those services constitutionally guaranteed to the population as a whole, since the absence of well-defined rules may favor the deviation of the real objectives of the policy not serving as the public for which it is intended.

Le droit de la santé réglemente les actions de santé lato sensu. En encadrant juridiquement une pluralité d'actes médicaux, comme l'AMP, l'interruption de grossesse, l'examen des empreintes génétiques ou encore les dons d'éléments et produits du corps humain, il influence le droit extra-patrimonial de la famille. Cette influence est protéiforme et se manifeste à la fois sur la détermination des liens familiaux et sur les droits et devoirs en découlant. Le droit comparé franco-suisse, dans sa fonction de connaissance du droit, permet de révéler les manifestations de cette influence. Le droit de la santé français exerce fréquemment un rôle moteur, subversif des concepts civilistes traditionnels. Le droit de la santé et le droit de la famille sont le plus souvent pensés séparément, le premier tendant parfois à s'autonomiser. À l'inverse, le droit de la santé suisse s'inspire régulièrement des constructions civilistes préexistantes, même si la finalité sanitaire justifie parfois un renouvellement des concepts. Ainsi, les deux champs du droit sont le plus souvent pensés globalement, approche dont le droit français gagnerait à s'inspirer. L'influence du droit de la santé sur le droit extra-patrimonial de la famille doit être repensée en tenant compte des objectifs poursuivis par les différentes règles de droit. La spécificité des actes médicaux à finalité familiale justifie que le droit de la santé soit cantonné à un rôle technique, suiveur de l'évolution du droit de la famille. En revanche, lorsqu'il réglemente les actes médicaux susceptibles d'influencer les droits et devoirs familiaux, le droit de la santé peut exercer un rôle complémentaire à celui du droit de la famille. / Health law regulates medical activity. By giving a legal framework to several medical acts, such as ART, abortion, DNA identification or donations of components and products of the human body, it influences extrapatrimonial family law. This influence is undeniably protean as it is exerted on both the definition and the legal regime of family ties. In its quest for improving knowledge of legal systems, French-Swiss comparative law can reveal and explain the manner in which this influence is expressed. In France, health law often plays a leading role, thus subverting traditional family law concepts and sometimes leading to inconsistencies. Health law and family law are usually viewed separately, with health law often taking an autonomous stance. In Switzerland, on the other hand, health law frequently draws on preexisting civil and family law concepts. Most of the time, these two fields of law are thought of together. This analysis incites us to rebuild French law in the light of Swiss law. The influence of health law on extrapatrimonial family law must be rethought, by taking into account the goal of each legal rule. The specificity of medical acts pursuing family interests justifies confining health law to a technical role, following the evolution of family law. Health law must be a tool for family law. However, health law can complement family law when it comes to the determination of family rights and duties. This complementarity is expressed either through the articulation of both branches of law when common goals are visible, or through the search for criteria capable of reconciling the conflicting goals pursued by these two subjects.

Cette thèse s’intéresse à la protection de la vie privée informationnelle dans le contexte de la biosécurité. La biosécurité se définit comme le processus qui vise à prendre en charge, dans une optique de sécurité nationale, les menaces et dangers que représentent les épidémies de maladies infectieuses pour la santé des populations humaines et la sécurité de l’État. Notre projet remet en question l’idée selon laquelle la conduite des activités de surveillance de la santé publique implique nécessairement une diminution de la protection offerte aux renseignements personnels sur la santé. Nos recherches tendent à démontrer que la conciliation de la surveillance de la santé et la protection de la vie privée est non seulement possible, mais qu’elle est surtout nécessaire. Nous portons plus précisément notre attention sur le cas de la collecte et de l’utilisation de renseignements dépersonnalisés sur la santé par les systèmes de surveillance syndromique. Bien calibrée et soigneusement réglementée, cette forme novatrice et particulière de surveillance offrirait le double avantage de réduire les risques d’atteintes à la vie privée des individus et d’augmenter de manière considérable l’efficacité des capacités étatiques en matière de détection des épidémies. / This thesis focuses on the protection of privacy in the context of biosecurity. Biosecurity is concerned with the threats that epidemics of infectious diseases present to public health and national security. The main goal of my thesis is to challenge the idea that conducting meaningful public health surveillance necessarily implies that the scope of the legal protection given to personal health information has to be reduced. My research demonstrates that, given certain conditions, a public health surveillance conducted with carefully configured syndromic surveillance systems operating with de-identified health data would increase both the efficiency of surveillance in terms of its capacity to detect emerging epidemics and the level of informational privacy of the patients.

Early diagnosis is a promising strategy to reduce premature mortalities and for optimal use of resources. But the absence of mathematical models specific to the data settings in LMIC’s impedes the construction of economic analysis necessary for decision-makers in the development of cancer control programs. This thesis presents a new methodology for parameterizing the natural history model of breast cancer based on data availabilities in low and middle income countries, and formulation of a control optimization problem to find the optimal screening schedule for mammography screening, solved using dynamic programming. As harms and benefits are known to increase with the increase in the number of lifetime screens, the trade-off was modeled by formulating the immediate reward as a function of false positives and life-years saved. The method presented in thesis will provide optimal screening schedules for multiple scenarios of Willingness to Pay (numeric value assigned for each life-year lived), including the resulting total number of lifetime screens per person, which can help decision-makers evaluate current resource availabilities or plan future resource needs for implementation.

The unprecedented growth of the aging population in Tennessee is a significant demographic trend that highlights the necessity for healthcare policy that tackles end-of-life issues. This study examined the perceived quality of end-of-life healthcare in Tennessee, areas that are in need of improvement, policies that have the potential to influence improvements, and the role of politics in end-of-life healthcare policy. It also assessed the support for end-of-life healthcare policy that would advance quality of care and expand end-of-life choices for Tennesseans, while evaluating the policy-making process that legislators employ. For this study, data were collected using semi-structured, in-depth interviews with an open interview guide. These interviews were conducted in a two-tiered format. Tier 1 included ten leading experts in various areas of end-of-life healthcare and aging in Tennessee. Tier 2 included nine legislators who were members of the health committees of either the Tennessee House of Representatives or the Tennessee Senate. Qualitative data were organized into numerous categories, and an initial phase of open coding was completed. From this phase of coding, emergent themes and focuses were discovered. This was followed by focused coding on all nineteen interviews using coding software to organize subtleties. Findings of the Tier 1 interviews indicated that there are many areas of end-of-life healthcare that need improvement including increased funding, expanded caregiver support, improved doctor-patient communication, and increased use of advance directives. Emergent themes included the influence of money, having difficult conversations, the stigma of death and dying, and supporting the caregiver. Tier 2 findings highlighted the motivations behind voting decisions and the level of awareness legislators have in areas of end-of-life healthcare policy. Both tiers also explored the support and opposition of physician-assisted death. The findings of this dissertation are intended to inform health professionals and state legislators. The data gathered through this exploratory research and the knowledge gained will lead to a greater understanding of end-of-life healthcare in Tennessee, and what needs to be done to improve its quality. This will allow individuals and families faced with end-of-life decisions to navigate the process with expanded options, access, and support.

[pt] Esta pesquisa se propõe a reescrever a história do direito à saúde desde a perspectiva da saúde da população negra enquanto campo em construção. Partimos do pressuposto de que as doenças e os agravos em saúde que acometem a população negra resultam, em grande parte, do racismo que não reconhece e invisibiliza os corpos negros. Neste sentido, o trabalho discute a saúde da população negra desde a História do Direito e é influenciada pela Lei número 10.639/2003, que institui a obrigatoriedade do ensino de cultura afro-brasileira e africana nos diferentes níveis e modalidades de ensino. Discute alguns aspectos da luta pelo direito à saúde na Assembleia Nacional Constituinte e advogamos a necessidade de enegrecimento do Direito Sanitário. Demonstramos algumas singularidades que marcam o processo de constituição do campo da saúde da população negra e, por fim, apresentamos o percurso de elaboração da Política Nacional de Saúde Integral da População Negra. O objetivo deste trabalho consiste em problematizar a ausência de pesquisas sobre saúde da população negra no Direito, mais especificamente no Direito Sanitário e na História do Direito. / [en] This research proposes to rewrite the history of the right to health from the perspective of the health of the black population as a field under construction. We assume that the diseases and health problems that affect the black population are largely the result of racism that does not recognize and make black bodies invisible. In this sense, the work discusses the health of the black population since the History of Law and is influenced by Law no. 10,639 / 2003, which establishes the obligation to teach Afro-Brazilian and African culture at different levels and modes of education. It discusses some aspects of the struggle for the right to health in the National Constituent Assembly and we advocate the need for blackening of the Health Law. We demonstrate some singularities that mark the process of constitution of the health field of the black population and, finally, we present the route of elaboration of the National Policy for Integral Health of the Black Population. The objective of this work is to problematize the absence of research on health of the black population in Law, more specifically in Health Law and in the History of Law.

Mental health treatment in state prisons is revealed to be highly variable, under-funded, and systematically inadequate. Existing literature exposes this injustice but fails to provide a comprehensive proposal for reform. This paper attempts to fill that gap, outlining a cost-effective, evidence-based treatment proposal, directly addressing the deficits in care revealed through analysis of our current system. In addition, this paper provides historical overviews of the prison system and mental health treatment, utilizing theoretical perspectives to contextualize this proposal in the present state of affairs. Lastly, the evidence is provided to emphasize the potential economic and social benefits of improving mental health treatment in state prisons. Significant findings suggest a clear financial, legal, and moral incentive for states to address this issue, while the proposal provides a viable method of doing so.