Orientador: Sérgio Robles Reis de Queiroz / Tese (doutorado) - Universidade Estadual de Campinas, Instituto de Geociências / Made available in DSpace on 2018-08-22T15:26:13Z (GMT). No. of bitstreams: 1 Radaelli_Vanderleia1977-_D.pdf: 2860529 bytes, checksum: ab4b3ed61228154f44fc565ea568bdf1 (MD5) Previous issue date: 2012 / Resumo: O entendimento da complexa relação entre conhecimento científico, inovação tecnológica e exploração econômica é o principal desafio para indústrias baseadas em ciência como a da farmacêutica. As vantagens competitivas obtidas pelas empresas mais inovadoras dessa indústria são mais pronunciadas em função da elevada apropriabilidade e das oportunidades tecnológicas derivadas dos avanços científicos, que são explorados comercialmente por investimentos maciços, sistêmicos e dirigidos de P&D. As possibilidades de que uma empresa farmacêutica consiga ser competitiva no mercado internacional realizando apenas engenharia reversa são nulas em função dos requisitos regulatórios e do perfil de conhecimento associado a essa indústria. Neste contexto, o objetivo desta tese foi avaliar as possibilidades de que as empresas farmacêuticas nacionais consigam ocupar posições competitivas na cadeia de valor farmacêutica em face da trajetória corrente e da intensidade com que estão investindo em pesquisa e desenvolvimento. Atualmente as empresas de capital nacional ocupam espaços importantes do mercado farmacêutico doméstico com aumento de participação e receitas, modernização tecnológica e expansão das capacidades produtivas em função das mudanças ocorridas no marco regulatório brasileiro e pela introdução da lei de medicamentos genéricos. O diagnóstico feito com as maiores empresas farmacêuticas nacionais na pesquisa de campo revela que as trajetórias inovativas ainda são bastante incipientes e que a maior parte dos seus laboratórios internos de pesquisa e desenvolvimento se ocupam essencialmente de um caráter incremental dessas atividades. O êxito no lançamento de produtos no mercado está mais atrelado às competências feitas no desenvolvimento do que em pesquisas radicais que combinados com um potencial de mercado em ampliação conseguiu capitalizar essas empresas e torná-las com maior capacidade de produção. As atividades internas de pesquisa e desenvolvimento vêm sendo implementadas nas empresas mas a um processo ainda bastante difuso com respeito às estratégias inovativas e concorrenciais. Corroboram para isso o fato de que as maiores empresas farmacêuticas não lançaram ainda produtos inovadores para o mercado internacional, local onde se obtém os incentivos econômicos para obtenção dos retornos dos investimentos em pesquisas, bem como ainda não estão incorporadas nas atividades inovativas correntes estratégias de cooperação com universidades, patenteamento e absorção de conhecimento externo, gerados além da fronteira da empresa / Abstract: Understanding the complex relationship between scientific knowledge, technological innovation and economic returns is the fundamental challenge for science-based industries, such as the pharmaceutical industry. The competitive advantages gained by the most innovative pharma companies are particularly pronounced" as a result of the greater appropriability and the technological opportunities associated with scientific advances, which are commercially exploited through very large, targeted and systemic Research & Development (R&D) investments. Considering the regulatory requirements and knowledge profile of the pharmaceutical industry, it is virtually impossible for a company to become competitive in the international market solely through reverse engineering. In this context, the purpose of this dissertation was to evaluate the prospects for national pharma companies of securing competitive positions in the pharmaceutical value chain, given their current trajectory and levels of investment in R&D. National companies currently hold a significant segment of the domestic pharmaceutical market, showing increases in market share and revenues, modernization of technologies and expansion of productive capacities. Yet this situation is primarily due to changes in the Brazilian regulatory framework and the passing of the law on generic drugs. The present research, through a diagnostic of the largest national pharma companies, shows that innovation trajectories are still rather incipient and that the majority of in-house R&D laboratories are principally concerned with incremental advances. The successful launch of products in the market is more closely linked to development skills than to pioneering research; skills that, combined with the potential of an expanding market, nevertheless allowed companies to profit and increase their production capacities. While companies are implementing internal R&D efforts, these processes are not sufficiently guided by strategies of innovation and competitiveness. This assessment is corroborated by the fact that these major pharmaceutical companies have not yet launched any innovative products in the international marketplace, where they would encounter the economic incentives for a return on their research investments, nor do their current innovation activities include strategies on cooperations with universities, patenting or assimilation of knowledge generated outside the company's boundaries / Doutorado / Politica Cientifica e Tecnologica / Doutora em Política Científica e Tecnológica

Orientador: Gilberto de Nucci / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-08-21T11:09:12Z (GMT). No. of bitstreams: 1 Modolo_FabianaDuarteMendese_D.pdf: 4445677 bytes, checksum: 5d3f6fadf0884c24742741c6059792dc (MD5) Previous issue date: 2012 / Resumo: Método rápido, sensível e específico foi desenvolvido para quantificar ciprofibrato no plasma humano, utilizando bezafibrato como padrão interno (SI). O analito e o padrão interno foram extraídos do plasma, por extração líquido-líquido, usando um solvente orgânico (éter etílico/diclorometano 70/30 (v/v)). Os extratos foram analisados por cromatografia líquida de alta eficiência acoplada à espectrometria de massa (HPLC-MS/MS), do tipo eletrospray. A cromatografia foi realizada com coluna Gênesis C18 4?m analítica (4,6 x 150mm id) em fase móvel composta de acetonitrila/água (70/30, v/v) e 1 mM de ácido acético. O método teve um tempo de corrida cromatográfica de 2,7min e curva de calibração linear no intervalo de 0,1 - 60 ?g/mL (R2> 0,99). O limite de quantificação foi de 0,1?g/mL. Os valores de acurácia e precisão intra-corrida e inter-corrida foram inferiores a 13,5%. Os testes de estabilidade não indicaram degradação significativa. A recuperação do ciprofibrato foi de 81,2%, 73,3% e 76,2% para as concentrações de 0,3, 5,0 e 48,0 ?g/mL, respectivamente. Para o ciprofibrato, os parâmetros otimizados da energia declustering, energia de colisão e energia de saída foram -51 (V), -16 (eV) e -5 (V), respectivamente. O método também foi validado sem o uso do padrão interno. Este procedimento HPLC-MS/MS foi usado para avaliar a bioequivalência de duas formulações de comprimidos ciprofibrato 100mg, em voluntários sadios de ambos os sexos. Os seguintes parâmetros farmacocinéticos foram obtidos das curvas de concentração plasmática de cipofibrato versus tempo: ASCULTIMO, ASC0-168h, CMAX e TMAX. A média geométrica com intervalo de confiança correspondente a 90% (CI) para a razão de Teste / Referência foram: 93,80% (IC 90%= 88,16 - 99,79%) para CMAX, 98,31% (90% CI = 94,91-101,83%) para ASCULTIMO e 97,67% (90% CI = 94,45-101,01%) para ASC0-168h. Uma vez que o intervalo de confiança de 90% para a razão geométrica de CMAX , ASCÚLTIMO e ASC 0 -168h estavam dentro do intervalo de 80% -125% proposto pelo FDA dos EUA, concluiu-se que ciprofibrato (Lipless® 100mg comprimido) formulação fabricado pela Biolab Sanus Farmacêutica Ltda. é bioequivalente à formulação Oroxadin® (100mg comprimido) para a velocidade e a extensão da absorção / Abstract: A rapid, sensitive and specific method for quantifying ciprofibrate in human plasma, using bezafibrate as the internal standard (IS) is described. The analyte and the IS were extracted from plasma, by liquid-liquid extraction using an organic solvent (diethyl ether / dichloromethane 70/30 (v/v)). The extracts were analyzed by high performance liquid chromatography coupled with electrospray tandem mass spectrometry (HPLC-MS/MS). Chromatography was performed using Genesis C18 4?m analytical column (4.6mm x 150mm i.d.) and a mobile phase consisting of acetonitrile/water (70/30, v/v) and 1mM acetic acid. The method had a chromatographic run time of 2.7 min and a linear calibration curve over the range 0.1-60 ?g/ml (R2>0.99). The limit of quantification was 0.1?g/ml. The intra and interday accuracy and precision values of the assay were less than 13.5%. The stability tests indicated no significant degradation. The recovery of ciprofibrate was 81.2%, 73.3% and 76.2% for the 0.3, 5.0 and 48.0?g/mL standard concentrations, respectively. For ciprofibrate, the optimized parameters of the declustering potential, collision energy and collision exit potential were -51 (V), -16 (eV) and -5 (V), respectively. The method was also validated without the use of the internal standard. This HPLC-MS/MS procedure was used to assess the bioequivalence of two ciprofibrate 100mg tablet formulations, in healthy volunteers of both sexes. The following pharmacokinetic parameters were obtained from the ciprofibrate plasma concentration vs. time curves: AUCLAST, AUC0-168h, CMAX and TMAX. The geometric mean with corresponding 90% confidence interval (CI) for Test/Reference percent ratios were 93.80% (90% CI= 88.16 - 99.79%) for CMAX, 98.31% (90% CI= 94.91 - 101.83%) for AUCLAST and 97.67% (90% CI= 94.45 - 101.01%) for AUC0-168h. Since the 90% CI for AUCLAST, AUC0-168h and CMAX ratios were within the 80-125% interval proposed by the US FDA, it was concluded that ciprofibrate (Lipless® 100 mg tablet) formulation manufactured by Biolab Sanus Farmacêutica Ltda. is bioequivalent to the Oroxadin® (100mg tablet) formulation for both the rate and the extent of absorption / Doutorado / Clinica Medica / Doutora em Clínica Médica

Generic drugs and generic substitution from the patient perspective III. Author: Terezie Papoušková Tutor: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introducion: A generic substitution is one of the instruments of the drug policy in many countries. Its authorization is supposed to bring a considerable savings not only for healthcare systems but also for patients. Objective: The aim of this thesis was to analyse patient's attitudes, opinions and experiences,which are related to the generic drugs and the generic substitution. Methodology: A data collection was gathered in the general practitioner's office in Prague in the time span from 18th of November 2015 to 21st of November 2016. All respondents, who visited the general practitioner during this period, were asked to cooperate. Only those who meet the input criteria could participate in a questionnaire investigation. The questionnaire consists of 36 questions which can be devided into 5 thematic areas (an actual disease and its treatment, socio-demographics characteristics, common awareness about generic substitution and generic drugs, own experiences with this topic, attitudes of the respondents). The questionnaire was piloted. The acquired data has been...

京都大学 / 0048 / 新制・課程博士 / 博士(社会健康医学) / 甲第19638号 / 社医博第71号 / 新制||社医||9(附属図書館) / 32674 / 京都大学大学院医学研究科社会健康医学系専攻 / (主査)教授 中山 健夫, 教授 今中 雄一, 教授 松原 和夫 / 学位規則第4条第1項該当 / Doctor of Public Health / Kyoto University / DFAM

BACKGROUND AND PURPOSE OF RESEARCH: Nigeria’s National Health Insurance Scheme (NHIS) was setup to secure universal access to affordable quality care. However, after 11yrs, and despite launching different programs, NHIS coverage is still less than 3% nationally, and out-of-pocket payments (OOP) remain the major health financing mechanism. The reasons for the low level of enrollment in NHIS are not well understood. Quality of care may be a factor in enrolment. This study compares technical and perceived quality of care between NHIS enrollees and the uninsured, using diabetes as a tracer condition. It also compares OOP and generic prescription patterns by health insurance enrollment status. METHODS: We conducted a cross sectional clinic-based intercept study. Subjects were adult diabetes patients recruited from 10 NHIS accredited hospitals in Abuja, Nigeria. Data collection included survey and chart review, covering technical aspects of quality – performance of eye and feet exam and HbA1c request; perception of quality, generic medication prescribing pattern and OOP. We performed logistic regression analysis to evaluate the effect of NHIS enrollment status on the technical quality of care, perceived quality of care, generic prescribing and OOP. RESULTS: Out of 455 participants, 149 (33%) were NHIS enrollees, 10 (2%) were enrolled in private health insurance and 296 (65%) had no insurance. After adjusting for correlated data and controlling for facility, BMI, chronic disease score, age, sex, and education, patients under NHIS coverage were 0.85 times less likely to have eye exam (Cl=0.4–1.8), 0.98 times less likely to have feet exam (Cl= 0.4–2.2), and 0.98 times less likely to have A1c test requested (Cl= 0.7–1.3), compared to those without insurance. These findings were not statistically significant at alpha=0.05. On the other hand, compared to the uninsured, NHIS covered patients perceived care to be worse even though they spent significantly less, 56% (Cl=45%–69%) in OOP in public hospitals. DISCUSSION/CONCLUSION: Perception of care quality under the NHIS could be a contributory factor to the reluctance of prospective enrollees. To advance towards the goal of universal health coverage, NHIS must strengthen policy to overcome identified barriers such as medication stock outs and wait times at the facility level.

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de maîtrise en droit". Ce mémoire a été accepté à l'unanimité et classé parmi les 10% des mémoires de la discipline. / Les provinces canadiennes sont présentement aux prises avec des dépenses élevées en matière de médicaments. Afin de contrôler ces dépenses, plusieurs d'entre elles ont adopté différentes politiques visant à promouvoir et à accélérer la vente de médicaments génériques, lesquels sont équivalents aux médicaments novateurs mais de trente à quarante pourcents moins chers. Le gouvernement canadien, en vertu de son pouvoir de réglementation en matière de brevets, pourrait contribuer aux efforts des gouvernements provinciaux en assouplissant les règles relatives aux brevets pharmaceutiques pour ainsi promouvoir l'accélération de la mise en marché de médicaments génériques. Le gouvernement hésite toutefois à le faire en raison de sa politique en matière de brevets pharmaceutiques dont les effets se veulent équilibrés tant pour l'industrie pharmaceutique novatrice que pour l'industrie du médicament generique. Précisément, cette politique vise, d'une part, à encourager les investissements en recherche et développement par l'industrie novatrice et, d'autre part, à garantir la vente rapide de médicaments génériques au Canada pour que soient contrôlées les dépenses en matière de médicaments. Ce mémoire consiste en un examen du cadre juridique de la politique canadienne en matière de brevets pharmaceutiques. Nous y soulevons et analysons particulièrement ses glissements, quant à l'objectif d'équilibre recherché de la politique canadienne, qui résultent de son application dans le contexte juridique, politique, scientifique et économique actuel. Notre intention est de démontrer que, dans l'intérêt des Canadiens à court et à long terme, la politique canadienne en matière de brevets pharmaceutiques ne doit pas être assouplie en faveur de l'industrie du médicament générique seulement, ceci malgré la croissance des dépenses en matière de médicaments. En effet, l'intérêt des Canadiens ne peut être maximisé que si cette politique est rééquilibrée en tenant compte de l'ensemble de ses glissements juridiques observés. / All Canadian provinces are presently facing increasingly growing drug expenditures. In order to control these expenditures the provinces have adopted different policies to promote and accelerate the sale of generic drugs, these drugs being equivalent to brand-name drugs but thirty to fourthly percent less expensive. Considering its jurisdiction in the field of patents, the Canadian government could contribute to the efforts of the provincial governments in making more flexible the Canadian patent rules, thus promoting the marketing ofgeneric drugs in Canada. The government is however hesitating to do so because of its policy on pharmaceutical patents, which policy aims at balancing the interests of both the brand-name and generic drug industries. Effectively, the purpose ofthe poltey is to promote, on the one hand, the investments in research and development of new drugs in Canada and, on the other hand, to guarantee the rapid marketing of generic drugs, thus controlling drug expenditures. The purpose of this thesis is to examine the judicial framework of the Canadian policy on pharmaceutical patents. Its weaknesses, with regard to the balanced objective of the policy, resulting from its application in the present judicial, political, and economical and scientific context are the focus of this analysis. Our goal is to demonstrate that, to reach the Canadian social benefit, both in the short and long run, the Canadian policy on pharmaceutical patents should not be relaxed for the sole benefit of the generic drug industry, although the drug expenditures are growing. Rather, the social Canadian benefit would only be maximised by re-balancing the Canadian policy in the light of all its demonstrated weaknesses.

O interesse pelos estudos de bioequivalência iniciou-se na década de 60, sendo o FDA (EUA) a primeira agência reguladora a se interessar por esta questão. No Brasil, uma lei de 1999 regulamentou o medicamento genérico no país, sendo este um importante meio de acesso aos medicamentos pela população e fazendo parte da política de medicamentos do SUS. No Brasil, a ANVISA e responsável por inspecionar os centros de bioequivalência bem como dar as diretrizes para estes. Um modelo paramétrico padrão para a etapa estatística e disponibilizado para a decisão de bioequivalência media e espera-se que este ajuste-se aos dados obtidos nos estudos de bioequivalência, o que nem sempre acontece. Neste sentido, e proposto nesta tese o uso de modelos paramétricos mais abrangentes baseados em outras distribuições de probabilidade para a decisão de bioequivalência media e que possam modelar a assimetria dos dados, dispensando o uso da transformação logarítmica para os parâmetros farmacocinéticos o que afeta a amplitude dos limites de bioequivalência. Propõe-se também o uso de modelos bivariados para a tomada conjunta da decisão de bioequivalência media, quando são analisados simultaneamente dois parâmetros farmacocinéticos. Foram utilizados métodos Bayesianos para a estimação dos parâmetros dado a exibilidade deste enfoque quando combinado ao uso dos métodos MCMC facilitados a partir do uso de softwares livres. Nesta tese e apresentado um estudo do poder empírico dos testes de hipóteses para os modelos univariados propostos bem como são introduzidos quatro exemplos, sendo os três primeiros voltados a aplicação da decisão de bioequivalência media e o quarto para a aplicação da bioequivalência populacional e individual. Nos três primeiros exemplos foram observados ganhos em termos de ajuste dos novos modelos propostos aos dados com relação ao modelo padrão segundo os critérios de seleção de modelos utilizados. O exemplo quatro apresenta uma analise padrão de bioequivalência populacional e individual com o código computacional para a obtenção dos resultados disponível no apêndice A bem como outros códigos para os demais exemplos. Embora a padroniza- ção das análises estatísticas para os estudos de bioequivalência seja importante, não deve-se esperar que um modelo padrão ajuste-se a qualquer conjunto de dados originados destes tipo de estudos. Neste sentido, são apresentados alternativas que podem auxiliar o pesquisador na tomada de uma decisão em termos de bioequivalência media mais segura. / The interest in bioequivalence studies began in the early 1960s especially in the United States of America where the FDA was the rst regulatory agency to show interest upon this issue. In Brazil, this interest started in 1999 the year when a law regulated the generic drugs in the country. The ANVISA is the Brazilian regulatory agency responsible for inspecting the bioequivalence centers and giving guidelines for this issue. In general, a standard parametric model for the statistical step is indicated for the average bioequivalence decision and this model is expected to be tted by the data obtained in the bioequivalence studies. In some cases, this model would not be appropriate. In this way, this thesis proposes the use of more comprehensive parametric models based on other probability distributions for the average bioequivalence decision and that can model asymmetrical data, a common situation in bioequivalence studies. In addition, there is no need of a logarithmic transformation for the pharmacokinetic parameters which could aect the range of the bioequivalence limits. We also propose the use of parametrical bivariate models for the joint decision of the average bioequivalence decision, since these measures are usually analyzed simultaneously with two pharmacokinetic parameters. We use Bayesian methods to estimate the parameters, given the great exibility of this approach when combined with the use of MCMC methods using free available softwares. This thesis also presents a study of the empirical power of hypothesis testing for the proposed univariate models and four examples are introduced. In the examples one, two and three we apply the average bioequivalence decision and in the fourth example we consider for the implementation of population and individual bioequivalence. In the examples one, two and three were observed gains in the tting of the proposed new models for the data where some existing approaches were used in the selection criteria for the proposed models. Example four provides a standard analysis of population and individual bioequivalence with the computer code for obtaining the results available in the Appendix A, as well as other codes. Although the standardization of statistical analysis for bioequivalence studies is important, a standard model is not expected to be well tted to any data set originated by such studies. In this way, we present alternatives that can help researchers in making a decision in terms of average bioequivalence with more security.

O interesse pelos estudos de bioequivalência iniciou-se na década de 60, sendo o FDA (EUA) a primeira agência reguladora a se interessar por esta questão. No Brasil, uma lei de 1999 regulamentou o medicamento genérico no país, sendo este um importante meio de acesso aos medicamentos pela população e fazendo parte da política de medicamentos do SUS. No Brasil, a ANVISA e responsável por inspecionar os centros de bioequivalência bem como dar as diretrizes para estes. Um modelo paramétrico padrão para a etapa estatística e disponibilizado para a decisão de bioequivalência media e espera-se que este ajuste-se aos dados obtidos nos estudos de bioequivalência, o que nem sempre acontece. Neste sentido, e proposto nesta tese o uso de modelos paramétricos mais abrangentes baseados em outras distribuições de probabilidade para a decisão de bioequivalência media e que possam modelar a assimetria dos dados, dispensando o uso da transformação logarítmica para os parâmetros farmacocinéticos o que afeta a amplitude dos limites de bioequivalência. Propõe-se também o uso de modelos bivariados para a tomada conjunta da decisão de bioequivalência media, quando são analisados simultaneamente dois parâmetros farmacocinéticos. Foram utilizados métodos Bayesianos para a estimação dos parâmetros dado a exibilidade deste enfoque quando combinado ao uso dos métodos MCMC facilitados a partir do uso de softwares livres. Nesta tese e apresentado um estudo do poder empírico dos testes de hipóteses para os modelos univariados propostos bem como são introduzidos quatro exemplos, sendo os três primeiros voltados a aplicação da decisão de bioequivalência media e o quarto para a aplicação da bioequivalência populacional e individual. Nos três primeiros exemplos foram observados ganhos em termos de ajuste dos novos modelos propostos aos dados com relação ao modelo padrão segundo os critérios de seleção de modelos utilizados. O exemplo quatro apresenta uma analise padrão de bioequivalência populacional e individual com o código computacional para a obtenção dos resultados disponível no apêndice A bem como outros códigos para os demais exemplos. Embora a padroniza- ção das análises estatísticas para os estudos de bioequivalência seja importante, não deve-se esperar que um modelo padrão ajuste-se a qualquer conjunto de dados originados destes tipo de estudos. Neste sentido, são apresentados alternativas que podem auxiliar o pesquisador na tomada de uma decisão em termos de bioequivalência media mais segura. / The interest in bioequivalence studies began in the early 1960s especially in the United States of America where the FDA was the rst regulatory agency to show interest upon this issue. In Brazil, this interest started in 1999 the year when a law regulated the generic drugs in the country. The ANVISA is the Brazilian regulatory agency responsible for inspecting the bioequivalence centers and giving guidelines for this issue. In general, a standard parametric model for the statistical step is indicated for the average bioequivalence decision and this model is expected to be tted by the data obtained in the bioequivalence studies. In some cases, this model would not be appropriate. In this way, this thesis proposes the use of more comprehensive parametric models based on other probability distributions for the average bioequivalence decision and that can model asymmetrical data, a common situation in bioequivalence studies. In addition, there is no need of a logarithmic transformation for the pharmacokinetic parameters which could aect the range of the bioequivalence limits. We also propose the use of parametrical bivariate models for the joint decision of the average bioequivalence decision, since these measures are usually analyzed simultaneously with two pharmacokinetic parameters. We use Bayesian methods to estimate the parameters, given the great exibility of this approach when combined with the use of MCMC methods using free available softwares. This thesis also presents a study of the empirical power of hypothesis testing for the proposed univariate models and four examples are introduced. In the examples one, two and three we apply the average bioequivalence decision and in the fourth example we consider for the implementation of population and individual bioequivalence. In the examples one, two and three were observed gains in the tting of the proposed new models for the data where some existing approaches were used in the selection criteria for the proposed models. Example four provides a standard analysis of population and individual bioequivalence with the computer code for obtaining the results available in the Appendix A, as well as other codes. Although the standardization of statistical analysis for bioequivalence studies is important, a standard model is not expected to be well tted to any data set originated by such studies. In this way, we present alternatives that can help researchers in making a decision in terms of average bioequivalence with more security.

Made available in DSpace on 2016-07-27T14:22:08Z (GMT). No. of bitstreams: 1 GEORGES HAJJAR JUNIOR.pdf: 4730574 bytes, checksum: bc9316bfa4ed9b01bcdabd07250194aa (MD5) Previous issue date: 2010-04-20 / This paper work was developed with the aim to build up a project management model used by a pharmaceutical industry to supervise the new products launching process (generic drugs) into the Brazilian generic market. This study has the purpose not only to present techniques and methods, that make possible better controls of the development process of a new generic, that will be introduced into the market, but that can be also used as a planned basis, implementation, control and evaluation of the process as a whole. The theoretical basis used in this research is the Project Management theory of the Project Management Institute PMI. The model has been done considering time, cost and project risks. The results obtained by this study indicate that the theoretical model can be used to improve significantly the managing controls of the new generic medications development of pharmaceutical industry. / Este trabalho teve como objetivo construir um modelo de gerência de projetos para o lançamento de novos produtos na indústria farmacêutica de medicamentos genéricos. O foco da pesquisa voltou-se ao desenvolvimento de técnicas e ferramentas de trabalho que possibilitam um maior controle sobre o processo de desenvolvimento de um novo produto a ser lançado no mercado e sirvam como base para planejamento, implantação, controle e avaliação do processo como um todo, fornecendo uma visão geral do trabalho. A base teórica utilizada para a realização deste trabalho foi a teoria de gestão de projetos do Project Management Institute PMI. O modelo foi construído focando prazo, custo e riscos do projeto. Os resultados obtidos mostram que o modelo teórico aplicado pode ser usado para melhorar os controles da gerência dos projetos de desenvolvimento de novos medicamentos genéricos.

Les provinces canadiennes sont présentement aux prises avec des dépenses élevées en matière de médicaments. Afin de contrôler ces dépenses, plusieurs d'entre elles ont adopté différentes politiques visant à promouvoir et à accélérer la vente de médicaments génériques, lesquels sont équivalents aux médicaments novateurs mais de trente à quarante pourcents moins chers. Le gouvernement canadien, en vertu de son pouvoir de réglementation en matière de brevets, pourrait contribuer aux efforts des gouvernements provinciaux en assouplissant les règles relatives aux brevets pharmaceutiques pour ainsi promouvoir l'accélération de la mise en marché de médicaments génériques. Le gouvernement hésite toutefois à le faire en raison de sa politique en matière de brevets pharmaceutiques dont les effets se veulent équilibrés tant pour l'industrie pharmaceutique novatrice que pour l'industrie du médicament generique. Précisément, cette politique vise, d'une part, à encourager les investissements en recherche et développement par l'industrie novatrice et, d'autre part, à garantir la vente rapide de médicaments génériques au Canada pour que soient contrôlées les dépenses en matière de médicaments. Ce mémoire consiste en un examen du cadre juridique de la politique canadienne en matière de brevets pharmaceutiques. Nous y soulevons et analysons particulièrement ses glissements, quant à l'objectif d'équilibre recherché de la politique canadienne, qui résultent de son application dans le contexte juridique, politique, scientifique et économique actuel. Notre intention est de démontrer que, dans l'intérêt des Canadiens à court et à long terme, la politique canadienne en matière de brevets pharmaceutiques ne doit pas être assouplie en faveur de l'industrie du médicament générique seulement, ceci malgré la croissance des dépenses en matière de médicaments. En effet, l'intérêt des Canadiens ne peut être maximisé que si cette politique est rééquilibrée en tenant compte de l'ensemble de ses glissements juridiques observés. / All Canadian provinces are presently facing increasingly growing drug expenditures. In order to control these expenditures the provinces have adopted different policies to promote and accelerate the sale of generic drugs, these drugs being equivalent to brand-name drugs but thirty to fourthly percent less expensive. Considering its jurisdiction in the field of patents, the Canadian government could contribute to the efforts of the provincial governments in making more flexible the Canadian patent rules, thus promoting the marketing ofgeneric drugs in Canada. The government is however hesitating to do so because of its policy on pharmaceutical patents, which policy aims at balancing the interests of both the brand-name and generic drug industries. Effectively, the purpose ofthe poltey is to promote, on the one hand, the investments in research and development of new drugs in Canada and, on the other hand, to guarantee the rapid marketing of generic drugs, thus controlling drug expenditures. The purpose of this thesis is to examine the judicial framework of the Canadian policy on pharmaceutical patents. Its weaknesses, with regard to the balanced objective of the policy, resulting from its application in the present judicial, political, and economical and scientific context are the focus of this analysis. Our goal is to demonstrate that, to reach the Canadian social benefit, both in the short and long run, the Canadian policy on pharmaceutical patents should not be relaxed for the sole benefit of the generic drug industry, although the drug expenditures are growing. Rather, the social Canadian benefit would only be maximised by re-balancing the Canadian policy in the light of all its demonstrated weaknesses. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de maîtrise en droit". Ce mémoire a été accepté à l'unanimité et classé parmi les 10% des mémoires de la discipline.