Regulation of prices and reimbursement of medicinal products Abstract Medicinal products are essentially part of every human life. It is therefore desirable to ensure that they are offered on the market at a fair and affordable price, precisely through price and reimbursement regulation. The aim of this diploma thesis is to analyse how the regulation of prices and reimbursements applies to human medicinal products in the provision of outpatient health care, the price and reimbursement of which is decided by the State Institute for Drug Control in administrative proceedings. In order to achieve this goal, the thesis is divided into four parts. The first part defines the basic concepts needed understand the meaning and purpose of the system of price and reimbursement regulation, such as a medicinal product, price or reimbursement. Furthermore, this part is devoted to the types of administrative acts occurring in the field of price and reimbursement regulation and introduces the Ministry of Health and the State Institute for Drug Control as the most important administrative authorities operating in this field. The second part analyses the legislation effective until 31st December 2007. The forms of administrative activity then performed by the Ministry of Health and the Ministry of Finance are analysed in more...

This thesis is an attempt to constructively interpret and critically evaluate the liberal doctrine that we may not limit a person’s liberty for her own good, and to discuss its implications and alternatives in some concrete areas of public health policy. The thesis starts theoretical and goes ever more practical. The first paper is devoted to positive interpretation of anti-paternalism with special focus on the reason component – personal good. A novel generic definition of paternalism is proposed, intended to capture, in a generous fashion, the object of traditional liberal resistance to paternalism – the invocation of personal good reasons for limiting of or interfering with a person’s liberty. In the second paper, the normative aspect of this resistance is given a somewhat technical interpretation in terms of invalidation of reasons – the blocking of reasons from influencing the moral status of actions according to their strength. It is then argued that normative anti-paternalism so understood is unreasonable, on three grounds: 1) Since the doctrine only applies to sufficiently voluntary action, voluntariness determines validity of reasons, which is unwarranted and leads to wrong answers to moral questions. 2) Since voluntariness comes in degrees, a threshold must be set where personal good reasons are invalidated, leading to peculiar jumps in the justifiability of actions. 3) Anti-paternalism imposes an untenable and unhelpful distinction between the value of respecting choices that are sufficiently voluntary and choices that are not. The third paper adds to this critique the fourth argument that none of the action types typically proposed to specify the action component of paternalism is such that performing an action of that type out of benevolence is essentially morally problematic. The fourth paper ignores the critique in the second and third papers and proposes, in an anti-paternalistic spirit, a series of rules for the justification of option-restricting policies aimed at groups where some members consent to the policy and some do not. Such policies present the liberal with a dilemma where the value of not restricting people’s options without their consent conflicts with the value of allowing people to shape their lives according to their own wishes. The fifth paper applies the understanding of anti-paternalism developed in the earlier papers to product safety regulation, as an example of a public health policy area. The sixth paper explores in more detail a specific public health policy, namely that of mandatory alcohol interlocks in all cars, proposed by the former Swedish government and supported by the Swedish National Road Administration. The policy is evaluated for cost-effectiveness, for possible diffusion of individual responsibility, and for paternalistic treatment of drivers. The seventh paper argues for a liberal policy in the area of dissemination of information about uncertain threats to public health. The argument against paternalism is based on common sense consequentialist considerations, avoiding any appeal to the normative anti-paternalism rejected earlier in the thesis. / QC 20100714

Submitted by ROGERIO BAPTISTA TEIXEIRA FERNANDES (rogeriobteixeira@yahoo.com.br) on 2016-04-25T21:50:10Z No. of bitstreams: 1 EBAPE Dissertação MAP Turma Intensiva Rogerio Fernandes PDF.pdf: 709868 bytes, checksum: 58f8d5750c16cdab6971c0c2bc1d8cad (MD5) / Approved for entry into archive by ÁUREA CORRÊA DA FONSECA CORRÊA DA FONSECA (aurea.fonseca@fgv.br) on 2016-04-29T15:34:19Z (GMT) No. of bitstreams: 1 EBAPE Dissertação MAP Turma Intensiva Rogerio Fernandes PDF.pdf: 709868 bytes, checksum: 58f8d5750c16cdab6971c0c2bc1d8cad (MD5) / Approved for entry into archive by Marcia Bacha (marcia.bacha@fgv.br) on 2016-05-09T14:48:55Z (GMT) No. of bitstreams: 1 EBAPE Dissertação MAP Turma Intensiva Rogerio Fernandes PDF.pdf: 709868 bytes, checksum: 58f8d5750c16cdab6971c0c2bc1d8cad (MD5) / Made available in DSpace on 2016-05-09T14:49:08Z (GMT). No. of bitstreams: 1 EBAPE Dissertação MAP Turma Intensiva Rogerio Fernandes PDF.pdf: 709868 bytes, checksum: 58f8d5750c16cdab6971c0c2bc1d8cad (MD5) Previous issue date: 2015-12-21 / The reimbursement to the Unified Health System (SUS), created by Law No. 9.656 of 1998, showed impressive results in the period 2011-2014, compared to the period 2007-2011. This exploratory study analyzes the reimbursement to the SUS, its origin, legal support, juridical basis, organization, functioning, operating performance and effectiveness, focusing on results achieved in the period 2011-2014. In order to accomplish, the author relied on previous studies, official documents and reports, legislation, judgments of the Court of Audit and lawsuits filed before the Supreme Court. The analysis indicates that the results achieved in the last four years are promising, reflecting a favorable scenario for the consolidation of reimbursement to SUS as an important regulatory instrument for the supplementary health sector. / O ressarcimento ao Sistema Único de Saúde (SUS), criado pela Lei n. 9.656, de 1998, apresentou resultados expressivos no período 2011-2014, em contraposição ao período 2007-2010. O presente estudo, de caráter exploratório, buscou analisar o ressarcimento ao SUS, sua origem, base legal, fundamentação jurídica, organização, funcionamento, desempenho operacional e efetividade, com foco nos resultados alcançados no período 2011-2014. Para isso, o autor apoiou-se em estudos anteriores, em documentos e relatórios oficiais, na legislação em vigor, nos acórdãos do Tribunal de Contas da União e nas ações ajuizadas perante o Supremo Tribunal Federal. As análises efetuadas indicam que os resultados alcançados nos últimos quatro anos são promissores, refletindo um cenário favorável à consolidação do ressarcimento ao SUS como um importante instrumento de regulação para o setor de saúde suplementar.

Submitted by JOACIRA MOTA MATOS SANTOS (joaciramms@gmail.com) on 2018-06-25T17:48:30Z No. of bitstreams: 1 JOACIRA_TA_FINAL_22_06_2018_3.pdf: 969948 bytes, checksum: b466871c53b44e27219e6cfeab1bbb46 (MD5) / Approved for entry into archive by Simone de Andrade Lopes Pires (simone.lopes@fgv.br) on 2018-06-25T20:11:40Z (GMT) No. of bitstreams: 1 JOACIRA_TA_FINAL_22_06_2018_3.pdf: 969948 bytes, checksum: b466871c53b44e27219e6cfeab1bbb46 (MD5) / Approved for entry into archive by Suzane Guimarães (suzane.guimaraes@fgv.br) on 2018-06-26T12:33:20Z (GMT) No. of bitstreams: 1 JOACIRA_TA_FINAL_22_06_2018_3.pdf: 969948 bytes, checksum: b466871c53b44e27219e6cfeab1bbb46 (MD5) / Made available in DSpace on 2018-06-26T12:33:20Z (GMT). No. of bitstreams: 1 JOACIRA_TA_FINAL_22_06_2018_3.pdf: 969948 bytes, checksum: b466871c53b44e27219e6cfeab1bbb46 (MD5) Previous issue date: 2018-05-25 / Estudo quanti-qualitativo que objetivou avaliar a articulação entre serviços de atenção primária à Saúde e da atenção especializada no cuidado de pacientes hipertensos, na rede de atenção à saúde, no Distrito de Saúde do Campo Limpo do município de São Paulo. Participaram do estudo cento e trinta médicos que atuam em vinte e cinco Unidades Básicas de Saúde, sob a lógica da Estratégia de Saúde da Família. A coleta de dados foi feita por meio de questionário autoaplicado e os dados submetidos à análise quantitativa e de conteúdo temática. Ao analisar os dados, concluiu-se que há uma acentuada fragilidade na integração entre as equipes de saúde da família e os serviços de atenção secundária que atendem os pacientes hipertensos. Os achados permitiram analisar que há ausência de contrarreferência frente às demandas encaminhadas, pressão do paciente para ser encaminhado ao especialista; insegurança do médico generalista, envolvendo problemas na formação ou estratégias de educação continuada; falta de comprometimento, responsabilização das equipes de saúde da família, que ser relacionam a vinculação comprometida; total ausência de pactuação entre os serviços no território que corroboram para escassez de integração entre os serviços e ainda questões culturais relacionadas à desvalorização do médico generalista ou da atenção básica. Foi possível observar um grande interesse dos profissionais da atenção básica em melhorarem a relação com os profissionais da atenção especializada. Foram apresentadas propostas voltadas para criação de espaços coletivos de discussão, revisão de protocolos, alinhamento de fluxos e até mesmo, a incorporação entre os serviços e profissionais de mecanismos tecnológicos para favorecer essa integração no cotidiano dos serviços. A partir da análise dos aspectos limitantes e favorecedores para a articulação entre a atenção primária e a atenção especializada, no cuidado do paciente hipertenso, no território estudado foi possível elencar alguns problemas que devem ser superados, na perspectiva de fortalecer o desempenho da Rede de Atenção à Saúde, como também propor o desenvolvimento de um projeto local para fortalecimento do cuidado do paciente hipertenso em rede. / Quantitative-qualitative study aimed at evaluating the articulation between primary health care services and specialized care in the care of hypertensive patients in the health care network in the Campo Limpo Health District of the city of São Paulo. One hundred and thirty physicians working in twenty-five Basic Health Units participated in the study, under the logic of the Family Health Strategy. The data were collected through a self-administered questionnaire and the data submitted to the quantitative analysis and thematic content. When analyzing the data, it was concluded that there is a marked fragility in the integration between the family health teams and the secondary care services that serve hypertensive patients. The findings allowed us to analyze that there is no counter-referral to the demands submitted, the patient's pressure to be referred to the specialist; general practitioner insecurity, involving training problems or continuing education strategies; lack of commitment, accountability of family health teams, to be related to committed commitment; total lack of agreement between the services in the territory that corroborate to the lack of integration between services and also cultural issues related to the devaluation of the general practitioner or primary care. It was possible to observe a great interest of the professionals of the basic attention in improving the relation with the professionals of the specialized attention. Proposals aimed at creating collective spaces for discussion, protocol revision, alignment of flows and even the incorporation among services and professionals of technological mechanisms were proposed to favor this integration in the daily services. From the analysis of the limiting and favorable aspects for the articulation between the primary care and the specialized attention, in the care of the hypertensive patient, in the territory studied it was possible to list some problems that must be overcome, with a view to strengthening the performance of the Attention Network to Health, as well as to propose the development of a local project to strengthen the care of hypertensive patients in a network.