A democracia sanitária exige que as normas do direito à saúde sejam derivadas de processos deliberativos que permitam a troca de argumentos que, por sua vez, conduzam à formação da vontade política, sendo que essa vontade deve ser constantemente submetida à confirmação em debates públicos para garantir a responsividade do governo e o controle do exercício do poder político. A partir dessa noção, pretendíamos verificar se, caso fosse aprovado o projeto de Marco para colaboração com os atores não estatais, no seio da reforma da Organização Mundial da Saúde, seriam criadas instituições e processos deliberativos que oportunizassem a participação democrática da sociedade civil internacional. Para tanto, realizamos uma pesquisa qualitativa, e, por meio do método da análise documental, estudamos os documentos básicos e documentos oficiais concernentes à reforma da Organização Mundial da Saúde. A conclusão alcançada foi que, embora o instrumento analisado não promovesse a democracia sanitária em conformidade com o marco teórico adotado no trabalho, ele criaria novas instâncias em que a sociedade civil internacional poderia exercer sua influência. / Health democracy requires that the norms of right to health are derived from deliberative processes that allow the exchange of arguments which, in turn, conduct to the formation of the political will, and this will must be constantly subject to confirmation in public debates to ensure the responsiveness of government and control of the exercise of political power. Based on this notion, we intended to verify whether, if it were approved the draft Framework for engagement with non-state actors, within the reform of the World Health Organization, it would create institutions and decision-making processes that would enable democratic participation of international civil society. To this end, we conducted a qualitative research, and through the method of document analysis, we studied the basic documents and official documents concerning the reform of the World Health Organization. The conclusion reached was that, although the analyzed instrument did not promote health democracy in accordance with the theoretical framework adopted at this work, it would create new instances in which the international civil society could exert their influence.

A democracia sanitária exige que as normas do direito à saúde sejam derivadas de processos deliberativos que permitam a troca de argumentos que, por sua vez, conduzam à formação da vontade política, sendo que essa vontade deve ser constantemente submetida à confirmação em debates públicos para garantir a responsividade do governo e o controle do exercício do poder político. A partir dessa noção, pretendíamos verificar se, caso fosse aprovado o projeto de Marco para colaboração com os atores não estatais, no seio da reforma da Organização Mundial da Saúde, seriam criadas instituições e processos deliberativos que oportunizassem a participação democrática da sociedade civil internacional. Para tanto, realizamos uma pesquisa qualitativa, e, por meio do método da análise documental, estudamos os documentos básicos e documentos oficiais concernentes à reforma da Organização Mundial da Saúde. A conclusão alcançada foi que, embora o instrumento analisado não promovesse a democracia sanitária em conformidade com o marco teórico adotado no trabalho, ele criaria novas instâncias em que a sociedade civil internacional poderia exercer sua influência. / Health democracy requires that the norms of right to health are derived from deliberative processes that allow the exchange of arguments which, in turn, conduct to the formation of the political will, and this will must be constantly subject to confirmation in public debates to ensure the responsiveness of government and control of the exercise of political power. Based on this notion, we intended to verify whether, if it were approved the draft Framework for engagement with non-state actors, within the reform of the World Health Organization, it would create institutions and decision-making processes that would enable democratic participation of international civil society. To this end, we conducted a qualitative research, and through the method of document analysis, we studied the basic documents and official documents concerning the reform of the World Health Organization. The conclusion reached was that, although the analyzed instrument did not promote health democracy in accordance with the theoretical framework adopted at this work, it would create new instances in which the international civil society could exert their influence.

Submitted by William Justo Figueiro (williamjf) on 2015-07-15T19:42:02Z No. of bitstreams: 1 09c.pdf: 1353240 bytes, checksum: e5c5d11257a52ceb697f9e8098a26190 (MD5) / Made available in DSpace on 2015-07-15T19:42:02Z (GMT). No. of bitstreams: 1 09c.pdf: 1353240 bytes, checksum: e5c5d11257a52ceb697f9e8098a26190 (MD5) Previous issue date: 2013 / Nenhuma / O tema envolvendo políticas públicas e a sua efetividade foi secularmente objeto de estudos e pesquisas. A forma de controle e fiscalização das ações e programas públicos ganha relevância no cenário contemporâneo, onde a sociedade clama por ações efetivas e gestões de resultados. As novas tecnologias, aliadas às suas peculiares formas de contextualização e compartilhamento de informações, inaugurou uma nova forma de controle social, que atua de forma deliberada e exerce uma nova função que transcende a simplória democracia representativa do voto popular. Na medida em que a boa governança deixa de ser encarada somente como um direito do cidadão e passa a ser vista como um dever dos gestores públicos quando do desempenho de suas funções governamentais, o poder de controle dos atos de gestão, realizado pela sociedade civil em seus mais diversos campos de atuação, torna-se das mais efetivas formas de combate aos desvios de recursos e finalidades. Priorizando o tema de controle das finanças públicas e a efetividade do sistema de saúde, procurou-se analisar os diversos diplomas legais que tratam a matéria, juntamente com os princípios que regem as condutas públicas. A complexidade da efetivação do direito à saúde, na sua mais ampla concepção, perpassa pela apreciação dos desafios impostos ao poder público, referente a falta de profissionais médicos, a restrição orçamentária e a forma com que o judiciário vem enfrentando a questão referente ao resguardo desse direito fundamental. A participação ativa dos cidadãos no processo de tomada de decisões concernentes a execução das políticas públicas de saúde, como forma de exercício do controle social, estabelece um novo marco na democracia contemporânea, denominado de democracia sanitária. / The theme involving public policies and their effectiveness has been object of study and research for centuries. The forms to control and supervise the actions of public programs gain relevance in the contemporary scenery, where society claims for effective action and managements of results. The ways the policies of public programs are to be controlled and supervised gain particular relevance in the contemporary political scenery, as today´s society is more politically aware and claims for more effective action and better final results. New technologies, with their peculiar forms of contextualization and information sharing, have inaugurated a new form of social control, which acts powerfully and exerts a new function, which transcends the simplistic representative democracy of the popular vote. As good government is no longer seen only as a citizen's right but as a duty of public officials when performing their governmental functions, the power to control the acts of the government officials, undertaken by the civil society in its various fields of action, becomes a most effective way to combat the fraudulent use of public resources. Upon giving priority to public finances control and to effective public health systems, I have tried to analyze the legislation that deals with the subject, together with the principles governing the conduct of public officials. The complexity involving safeguarding the right to health, in its broadest conception, has to do with assessing the challenges the state and federal governments have to face, namely, shortage of medical professionals and budget constraints, and with examining how the judiciary is managing the problems involved in preserving this fundamental right. The active participation of every citizen in the decision-making process concerning the implementation of public health policies, as an exercise of citizenship and social control, establishes a new landmark in today’s democracy, which has already been called a pro-health democracy.

La prescription de médicament hors AMM est légitime quand elle s’appuie sur les connaissances médicales acquises ou validées au moment de la proposition de soins, lors du colloque singulier patient-médecin. L’AMM d’un médicament ne représente qu’un sous-ensemble de connaissances médicales, sans cesse changeantes, qui ne peut être regardée comme le référentiel idoine de la prescription d’un médicament, à la fois sur un plan médical et sur un plan juridique. La démocratie sanitaire est particulièrement inachevée dans la gestion européenne ou nationale de l’AMM d’un médicament. / The off-label drug prescribing is legitimate when it is based on accepted or validated medical knowledge at the time of the proposal care during the patient-physician singular interview. The marketing authorization of a drug represents only a fraction of medical knowledge, constantly changing, which can not be considered as a suitable reference document of drug prescribing, both from a medical and legal aspect. Health democracy is particularly incomplete in the European or national management of the drug marketing authorization.

En 2005-6, le virus du chikungunya, transmis par les moustiques Aedes albopictus, touche 38% des habitants de La Réunion. Cette épidémie marque la fin de l'usage systématique des insecticides et la refonte des politiques de santé. Les pouvoirs publics enrôlent les citoyens et les moustiques dans l'élaboration de nouvelles frontières, matérielles et symboliques, entre les deux espèces. Cette thèse a pour objectif d'interroger les effets de ces changements de pratiques sur les rapports sociaux de pouvoir en contexte post-colonial, et sur les relations entre humains et moustiques. Pour saisir les dynamiques socio-naturelles à l'œuvre, une ethnographie combinatoire a permis d'observer les co-constructions de savoirs et de pratiques dans plusieurs espaces où s'organise la mise à distance des moustiques. Elle s'est appuyée sur le recueil de discours et l'observation de pratiques au sein du service de lutte contre les moustiques, au cœur d'une équipe de recherche sur la Technique de l'insecte stérile (visant à relâcher des moustiques stériles sur l'île) et auprès de non professionnels de la lutte. Une collecte d'articles de presse et d'archives a achevé de constituer le corpus de données. L'enjeu de cette thèse est de montrer que bien loin d'opérer une simple séparation entre humains et moustiques, les nouvelles pratiques de lutte ont intensifié leurs interactions. En parallèle, elle propose une réflexion sur les dynamiques liées à la coexistence de plusieurs systèmes interprétatifs, permettant d'appréhender – ou non – collectivement la prise en charge du risque épidémique. C'est l’occasion de réfléchir aux relations entre l'État, les scientifiques et les citoyens. / In 2005-6, the chikungunya virus, transmitted by the Aedes albopictus mosquito, affects 38% of the inhabitants of Reunion Island. This outbreak marks the end of the systematic use of insecticides and the consolidation of health policies. Public authorities enlist citizens and mosquitoes in the development of new frontiers, material and symbolic, between the two species. This thesis aims to examine the effects of these changes in practices on the social relations of power in post-colonial context, and the relationship between humans and mosquitoes.To apprehend the socio-natural dynamics at work, a combinatorial ethnography allowed to observe the co-construction of knowledge and practices in several areas where the distancing mosquitoes gets organized. It was based on the collection of speeches and observing practices in the vector control service, in the heart of a research team on the Sterile insect technique (to release sterile mosquitoes on the island) and from non-control professionals. A collection of articles and archives finalized to constitute the body of data.The aim of this thesis is to show that far from making a simple separation between humans and mosquitoes, new management practices have intensified their interactions. In parallel, it proposes a reflection on the dynamics associated with the coexistence of several interpretive systems, allowing to understand - or not - the collective management of epidemic risk. This is an opportunity to reflect on the relationship between the state, scientists and citizens

La recherche dans le domaine des maladies sans traitement existant obéit à plusieurs impératifs définis par le législateur européen dans le règlement (CE) n° 141/2000 du 16 décembre 1999 concernant les médicaments orphelins. Les patients atteints de maladies rares et négligées ont le droit à « la même qualité de traitement que les autres » ce qui suppose de prendre les mesures d'incitation nécessaires pour « promouvoir la recherche, le développement et la commercialisation de traitements adéquats ». C'est un « domaine prioritaire ». Après avoir désigné les médicaments concernés, l'Union européenne veut « éviter la dispersion de ressources limitées » notamment par la promotion d'une « coopération transnationale ». Dans une démarche téléologique, cette recherche décrit les effets de la législation européenne sans ignorer la réception de ce droit par les États membres. Des fondements théoriques à même d'assurer une meilleure performativité du droit et des propositions concrètes en vue de conformer le droit positif à l'intention du législateur et aux attentes des parties prenantes sont proposés. En se focalisant sur le seul levier de la propriété intellectuelle, ce droit spécial et incitatif ne semble pas en mesure d'apporter aux patients la plupart des traitements attendus. La régulation de la concurrence et la compétence nationale sur le prix des médicaments perpétuent un seuil de rentabilité éloignant de nombreuses recherches de la phase du développement. L'accès aux médicaments orphelins demeure très restreint. Un changement de paradigme dans la construction de ce droit apparaît nécessaire afin qu'un modèle économique favorable se mette en place. Il convient que le profit des pharmaciens de l'industrie ne dépende plus de la conquête de parts de marché, mais de l'intérêt de leurs inventions pour les besoins de santé non satisfaits. / Research in the field of diseases without an existing treatment is governed by several requirements defined by the European legislator in Regulation (CE) No 141/2000 of 16 December 1999 on orphan medicinal products. Patients with rare and neglected diseases have the right to "the same quality of treatment as other patients" which means taking the necessary incentives to stimulate research, development and bringing to the market of appropriate medications". It is a "priority area". After designating the drugs concerned, the European Union wants to "avoid the dispersion of limited resources", in particular by promoting "cross national co-operation". In a teleological approach, this research analyses the positive law endeavouring to implement the objectives of Orphan Drug Law. It describes the effects of European legislation without ignoring the receipt of this law by the Member States. Theoretical foundations that can ensure a better performativity of the law, as well as concrete proposals to conform the positive law to the intention of the legislator and to the stakeholders' wills are proposed. By focusing solely on the leverage of intellectual property rights, this special and incentive law does not seem to be able to provide patients with many of the expected treatments. Competition regulation and setting of the price which is a national competency perpetuate a high profitability threshold, often withholding research projects from reaching the development phase. Access to orphan drugs remains very limited. A paradigm shift in the construction of this law appears necessary in order for a favorable economic model to emerge. The profit of the industry's pharmacists should no longer depend on the conquest of market shares, but on the value of their inventions for unmet health needs.