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.

Este trabalho teve por objetivo o desenvolvimento, padronização e avaliação da atividade antioxidante e antimicrobiana de extratos secos nebulizados de Dalbergia ecastaphyllum. Para que os objetivos propostas fossem alcançadosforam desenvolvidas metodologias analíticas capazes de avaliar a qualidade da matériaprima vegetal durante os processos de transformação (extração de compostos ativos, secagem, produto final, etc). A solução extrativa foi obtida a partir das folhas de D. ecastaphyllum empregando-se a extração por maceração dinâmica onde se avaliou fatores como: proporção planta:solvente, tempo e temperatura de extração através de um planejamento composto central (PCC). A solução extrativa otimizada foi avaliada quanto a presença de metabólitos secundários, atividade antioxidante/ antimicrobiana e foi submetida à secagem por nebulização onde foram investigados parâmetros de secagem e adjuvantes tecnológicos sobre o desempenho do equipamento e nas características morfológicas, físico-químicas e farmacológicas do produto. Os extratos secos foram submetidos a um estudo de estabilidade; sendo também utilizados para o desenvolvimento de formulações semi-sólidas cuja estabilidade foi avaliada em estudo acelerado. Pretende-se que os resultados advindos desse trabalho possam servir de base para a padronização de extratos de outras plantas medicinais com interesse terapêutico, bem como contribuir para o aprimoramento dos conhecimentos envolvidos no desenvolvimento tecnológico de produtos fitoterápicos. / This work aimed the development, standardization and evaluation of antioxidant and antimicrobial activity of spray dried extracts from Dalbergia ecastaphyllum. Analytical methodologies for evaluating the quality of the vegetable raw material during processing procedures (such as extraction of active compounds, drying, final product, etc.) were developed in order to achieve the proposed objectives. The extraction solution was obtained from the leaves of D. ecastaphyllum by dynamic maceration. In this stage, some factors were evaluated such as: the plant: solvent ratio, extraction time and temperature using a central composite design (CCD). The optimized extraction solution was evaluated for the presence of secondary metabolites and antioxidant / antimicrobial activity. It was also subjected to spray drying. In this process, the effects of the drying parameters and processing aids on the equipment performance and the morphological, physicochemical and pharmacological properties of the product were investigated. The dry extracts were subjected to a stability study; and were used for the development of semi-solid formulations, also evaluated in an accelerated stability study. It is intended that the results from this work can provide a basis for further standardization of extracts of other medicinal plants with therapeutic interest, as well as to contribute to the enhancement of the knowledge involved in the technological development of herbal products.

O presente trabalho visa desenvolver métodos analíticos que permitam determinar as concentrações de oxitetraciclina por Cromatografia Líquida de Alta Eficiência, no leite, plasma e líquido sinovial, além de analisar as concentrações correspondentes em gado leiteiro em lactação portadoras de doença do casco submetidos aos tratamentos intramuscular e tópico. Adicionalmente, são tecidos comentários sobre a eficácia clínica destes tratamentos. Desta forma, objetivando determinar a depuração de oxitetraciclina no organismo dos animais tratados, a concentração no sítio de ação e a quantidade residual em leite, as amostras biológicas foram colhidas e quantificadas em diferentes tempos pré e pós-administração do fármaco. Os métodos analíticos validados apresentaram linearidade, limite de detecção, quantificação, exatidão, precisão e recuperação adequadas à quantificação do antibiótico nas matrizes estudadas. Através da administração do medicamento por via intramuscular, observou-se resíduos acima dos limites máximos (100ppb) estabelecidos pela legislação brasileira para oxitetraciclina no leite até 120 horas após a última administração do medicamento pelo esquema seriado de doses. Já pela via tópica, não foram observados valores residuais na matriz biológica. Do ponto de vista clínico, o tratamento tópico foi eficiente nos animais tratados, levando a cura das lesões. Com relação ao tratamento intramuscular, não foram observados resultados satisfatórios, pois a maioria das lesões não regrediu após as administrações. / The purpose of the present work is to develop methods which allow the determination of oxytetracycline by High Pressure Liquid Chromatography in milk, serum and synovial fluid, as well as analyze the corresponding concentration in milk cattle with foot lameness subjected to intramuscular and topical administration of the antibiotic. It is also commented the clinical efficacy of these two treatments. Thus, to determine the clearance of oxytetracycline in the body of the treated animals, the concentration on the site of action, and the antibiotic residue in milk, biological samples have been collected and analyzed for the oxytetracycline content at different times before and after the drug administrations. The validated analytical methods showed suitable linearity, detection and quantification limits, accuracy, precision and recovery, allowing proper quantification of the antibiotic in the studied biological matrices. When administered intramuscular1y, oxytetracycline residues were observed in milk above the maximum limits (100ppb) established by the brazilian legislation up to 120 hour after the last administration of the medicine using multiple doses treatment, whereas on topical use, residues were not observed in this matrix. When analyzing the clinical aspects, topical treatment was very efficient, leading to the healing of the treated animals. In relation to intramuscular treatment, non satisfactory results were observed, as most of lesion did not disappear after the antibiotic administration.

[pt] Introdução: A promoção das políticas públicas voltadas à implementação dos direitos sociais (saúde inclusive) lida com a difícil tarefa de distribuir os limitados recursos estatais aos anseios da população, notadamente quando se busca implementar os direitos cujo custo é elevado. Constatou-se que os sujeitos de pesquisas biomédicas, ao final do estudo, têm sido negligenciados no acesso aos benefícios terapêuticos do medicamento ou procedimento para cuja aprovação colaboraram. Finda a pesquisa, há muitas demandas contra o Estado, formuladas pelos sujeitos participantes do ensaio. Objetivos: discutir os posicionamentos judiciais atinentes ao controle jurisdicional de políticas públicas no fornecimento de medicamentos ao participante da pesquisa, após o encerramento do estudo. Métodos: levantamento qualitativo, no sentido de identificar um norte interpretativo e, a partir dele, elaborar um posicionamento crítico e propor um standard decisório que, além juridicamente respaldado, seja eticamente consentâneo aos parâmetros de conduta nos procedimentos envolvendo o participante de pesquisa, de modo a reconhecê-lo como sujeito moral digno ao igual respeito e consideração. Resultados: o levantamento jurisprudencial efetuado não pode fornecer uma ratio decidendi clara no tema. Discussão: o Estado tem dever constitucionalmente assumido de garantir a assistência integral à saúde, portanto, possui legitimidade para ser demandado em ações nas quais o participante da pesquisa busca, ao final do estudo, a continuidade do fornecimento do medicamento. Porém, tanto a Resolução CNS número 466/2012, como a Declaração de Helsinque, que impõem regras a serem cumpridas pelos pesquisadores e patrocinadores, asseguraram aos participantes acesso aos produtos ou agentes obtidos. Considerações finais: o participante da pesquisa titulariza direito subjetivo ao fornecimento do medicamento após o encerramento. Estado e atores da pesquisa (patrocinador e instituição) são devedores solidários dessa obrigação. A demanda direcionada em face de um, ou sua condenação, autoriza o chamamento ou regresso em face do outro. / [en] Introduction: The promotion of public policies aimed at implementation of social rights (including health) deals with the difficult task of distributing limited state resources to popular expectations, especially when one seeks to implement the rights which cost is high. It was found that the subjects of biomedical, researches at the end of the study, have been neglected in accessing therapeutic benefits of the drug or procedure which they cooperated for its approval. Ending the research, there are many claims against the State, formulated by the subjects participating in the trial. Objectives: To discuss matters pertaining to the judicial control of public policies for the supply of medicines to the research participant, after the end of the study. Methods: A qualitative survey to identify an interpretive north, and from it develop a critical approach and propose a decision-making standard that besides being legally backed, also being ethically consistent to the standards of conduct of procedures involving the research participant, in order to recognize it as a moral subject worthy of equal respect and consideration. Results: The case-study carried out can not provide a clear ratio decidendi in the topic. Discussion: the state has assumed constitutional duty to ensure integrate health care, therefore has standing to be sued in actions which the participant within the survey seeks at the end of the study, the continuity of medicine supply. However, both the CNS Resolution No. 466/2012, and the Declaration of Helsinki, which impose rules to be observed by researchers and sponsors, assured the participants access to products or agents obtained. Final considerations: the research participant securitization subjective right to supply the drug after closure. State and research actors (sponsor and institution) are joint debtors of this obligation. The lawsuit directed to one, or its condemnation authorizes the call or return in the face of the other.

Introdução. Desde a promulgação da Constituição Federal de 1988 no Brasil, que consolida a saúde como um direito social, a ser garantido de forma integral e universal pelo Estado brasileiro, os cidadãos passaram a reivindicar este direito em juízo, acionando legitimamente o Estado para a garantia de suas pretensões sanitárias. E, neste sentido, o número de ações que demandam medicamentos vem crescendo de forma exponencial no Brasil, impactando diretamente a política pública de saúde, e suscitando debates sobre a segurança sanitária dos medicamentos dispensados em juízo. Objetivo. Evidenciar de que forma as questões técnicas e políticas que envolvem o direito social à assistência farmacêutica vem sendo debatidas dentro de processos judiciais que tem por objeto a solicitação de medicamentos em face do Estado. Isto para que se possa relacionar estes resultados aos atuais debates sobre o papel do Poder Judiciário em face da garantia do direito à saúde, e seu impacto perante a política pública de saúde. E, também, aos atuais debates político-sanitários sobre a prescrição médica, e sua importância para o exercício do direito em foco. Método. A metodologia de pesquisa revestiu-se em duas etapas distintas. A primeira etapa consistiu na análise de processos judiciais que versavam sobre a demanda de medicamentos em face do Estado, provenientes de quatro Tribunais Estaduais do país, em primeira instância: São Paulo, Minas Gerais, Rio Grande do Sul e Rio de Janeiro. Os processos foram analisados através do uso da Metodologia Qualiquantitativa do Discurso Coletivo. A segunda etapa consistiu na pesquisa de artigos científicos, nas principais bases de dados de periódicos científicos de saúde pública, que tivessem relação com a pergunta de pesquisa: Como hoje estrutura-se a discussão político-sanitária em torno da prescrição médica? Resultados. Pela análise dos processos judiciais, evidencia-se que as demandas que envolvem pedidos de medicamento em juízo vêm sendo deferidas pelos juízes, prioritariamente, com base nas prescrições médicas individuais e com base na leitura pura do ordenamento jurídico, sem considerar as dimensões técnicas e políticas que envolvem o direito à assistência farmacêutica. A análise dos artigos científicos nos demonstra a vasta discussão técnica acerca da prescrição médica e suas implicações sanitárias, e aponta a necessidade de contraditar esses documentos e investir em educação e informação médicas, em prol da segurança sanitária dos pacientes-cidadãos. Conclusão. O direito à saúde é um direito complexo, que requer, para a sua adequada proteção e garantia, que ultrapassemos o paradigma positivista, com sua leitura exclusivamente normativa e dogmática, em prol de um novo paradigma que permita maior penetração de questões e saberes técnicos e políticos no âmbito do direito. Tanto judicial quanto extrajudicialmente precisam ser criados caminhos de proteção à saúde, que abriguem todos os profissionais jurídicos, políticos e técnicos envolvidos na temática, rumo à construção interdisciplinar do direito à saúde e da cidadania sanitária no Brasil / Introduction. Since the enactment of the 1988 Federal Constitution in Brazil, that consolidates health as a social right, the citizens began to demand this right in court, lawfully driving the state to guarantee their health claims. And, in this sense, the number of actions that require medicines is growing exponentially in Brazil, which impact directly the public health policy, and stimulate discussions about the safety of drugs dispensed by the courts. Objective. Show how the technical and political issues, involving the social right to pharmaceutical assistance has been debated in legal proceedings whose objective is the solicitation of drugs against the State. This to be able to relate these findings to the current debates about the role of the judiciary, in view of the guaranteed of right to health and its impact on the public health policy. And, also, to the current political debates about health prescription, and its importance for the right in focus. Method. The research methodology is coated in two stages. The first step was the analysis of court cases that focused the drug demand against the State, from Four State Courts in Brazil: Sao Paulo, Minas Gerais, Rio Grande do Sul and Rio de Janeiro. The processes were analyzed through the use of qualitativequantitative methodology of collective discourse. The second step consisted in the search of scientific articles in major databases of scientific journals of public health, that were related to the following research question: How today\'s discussion is structured around the political health context of the medical prescription? Results. The analysis of court proceedings, results clear that the demands that involve medication in court have been deferred by the judges, primarily, based on the individual medical prescriptions, and based on the pure reading of the legal system, without considering the technical and political dimensions that involve the right to pharmaceutical assistance. The analysis of scientific articles shows us the extensive technical discussion about the prescription and its health implications, and highlights the need to contradict these documents, and invest in education and medical information, towards the safety of patients-citizens. Conclusion. The right to health is a complex right, which requires for its adequate protection and security, that we move beyond the positivist paradigm, with its exclusively normative reading and dogmatic rules, towards a new paradigm which allows greater penetration of issues and political and technical knowledge within the law. Both judicial and extrajudicial ways need to be created to protect health, involving all legal, politicians and technicians professionals involved in the matter, toward interdisciplinary construction of the right to health and health citizenship in Brazil

<p>This thesis analyse how life-histories are expressed and reformulated in connection to a life crisis of ill health. The study is based on ten interviews with people who in connection with ill health have made use of treatments within both orthodox medicine and complementary medicine and who have also developed various forms of self-treatment. The overall aim is, with a point of departure in the concepts health, healing and trust, to analyse narratives as a practice through which the respondents create identity and a life-context. The signifi cance of constructing the (auto)biography of the healing narrative – a form of narrative and performative act – runs as the main thread through the thesis. This act makes up the practice that is recurrently discussed in several of the thesis’ chapters and is synonymously termed the telling of healing narratives or or to narrate health and healing. The analysis of the narrative’s The analysis of the narrative’s healing main themes is mirrored in the order of the chapters. The study is broadly thematic and structured as a generalised healing process beginning with upheaval, continuing with crisis and social drama, and further to the endeavour of expressing values and judgements in a public context.</p><p>The interview themes of self-treatment and alternative treatment have occasioned the investigation into what an ethno-medical perspective can bring to analyses of people’s experiences of ill health in an everyday medical context. One of the points of having the concept ethno-medicine as a starting point is that every practice or narrative formation is ascribed with a potential for interpretation in its creation of knowledge. Another chapter deals with two themes of identity and life-history construction in the practice of healing narratives – the need for a chronology and reappraised perspectives on body, health and lifestyle. Healing narratives can be understood as a genre of life-historical narratives where life is often described as a linear course of events. A model by the anthropologist Victor Turner on the course and content of social drama is used as a comment to analyses of three respondents’ narratives in another chapter. A drama can be understood as a tragic course of events, based on an accident or an upsetting incident that roughly revolves around event/crisis, chaos and the striving for restoration. The concept of other journals is then used to make visible the everyday medical administrative practice and refers to the documentation used in the form of collected documents, written notes, and diaries. As an unexpected part of healing processes, the necessity of familiarising oneself with rules, laws and health insurance systems in order to be able to claim one’s rights is brought forward.</p><p>The social transformation process of various care practices in society makes up both a context and a commonly occurring theme in the narratives that the thesis is based upon. A modern health culture that gains strength from loosely composed social movements exerts infl uence on all levels of society. With an increased individual responsibility, the need grows to fi nd one’s own healing strategies and to create one’s own life-history in narratives that mirror this transformation in an everyday context. Healing narratives can be seen as a form of evaluation of health-care practices where experiences of treatment and notions of health and cure and healing are concretised.</p>

This thesis analyse how life-histories are expressed and reformulated in connection to a life crisis of ill health. The study is based on ten interviews with people who in connection with ill health have made use of treatments within both orthodox medicine and complementary medicine and who have also developed various forms of self-treatment. The overall aim is, with a point of departure in the concepts health, healing and trust, to analyse narratives as a practice through which the respondents create identity and a life-context. The signifi cance of constructing the (auto)biography of the healing narrative – a form of narrative and performative act – runs as the main thread through the thesis. This act makes up the practice that is recurrently discussed in several of the thesis’ chapters and is synonymously termed the telling of healing narratives or or to narrate health and healing. The analysis of the narrative’s The analysis of the narrative’s healing main themes is mirrored in the order of the chapters. The study is broadly thematic and structured as a generalised healing process beginning with upheaval, continuing with crisis and social drama, and further to the endeavour of expressing values and judgements in a public context. The interview themes of self-treatment and alternative treatment have occasioned the investigation into what an ethno-medical perspective can bring to analyses of people’s experiences of ill health in an everyday medical context. One of the points of having the concept ethno-medicine as a starting point is that every practice or narrative formation is ascribed with a potential for interpretation in its creation of knowledge. Another chapter deals with two themes of identity and life-history construction in the practice of healing narratives – the need for a chronology and reappraised perspectives on body, health and lifestyle. Healing narratives can be understood as a genre of life-historical narratives where life is often described as a linear course of events. A model by the anthropologist Victor Turner on the course and content of social drama is used as a comment to analyses of three respondents’ narratives in another chapter. A drama can be understood as a tragic course of events, based on an accident or an upsetting incident that roughly revolves around event/crisis, chaos and the striving for restoration. The concept of other journals is then used to make visible the everyday medical administrative practice and refers to the documentation used in the form of collected documents, written notes, and diaries. As an unexpected part of healing processes, the necessity of familiarising oneself with rules, laws and health insurance systems in order to be able to claim one’s rights is brought forward. The social transformation process of various care practices in society makes up both a context and a commonly occurring theme in the narratives that the thesis is based upon. A modern health culture that gains strength from loosely composed social movements exerts infl uence on all levels of society. With an increased individual responsibility, the need grows to fi nd one’s own healing strategies and to create one’s own life-history in narratives that mirror this transformation in an everyday context. Healing narratives can be seen as a form of evaluation of health-care practices where experiences of treatment and notions of health and cure and healing are concretised.

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences

University of Macau / Institute of Chinese Medical Sciences