Abstract Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment. years processes costs Worldwide LM (LM SS, SS , (SS) methods LSS (LSS services Brazil implementation reformulation segment (SS

ABSTRACT Objective: Prospect the evolution of patent applications onIdentify, extract, process data, organize and make available technological information in the form of graphical interfaces described in oncology patents containing the radioisotopes gallium-68 (68Ga), copper-64 (64Cu) and zirconium-89 (89Z) in order to understand the development of science and technology in the area. Method: The ORBIT Intelligence® platform from the company QUESTEL® was used to identify, extract, process the data, organize and make available the technological information in the form of graphical interfaces, analysis of the filed patents in force in the last 20 years in the main patent offices in the world. Result: For gallium-68, copper-64 and zirconium-89, respectively, 36, 18 and 10 families of patents containing the search terms described in the methodology were identified. In both cases, China stands out in the number of filed patent applications, depositing 61% of the total analyzed. It was also observed that many of the analyzed documents were deposited by universities, reinforcing the concept of company-university partnership. The results obtained point out that the area of this study continues to grow and the understanding of the information present in the patent documents makes it possible to reflect on spaces to intensify the development of innovations in the oncology area. Conclusions: The results obtained demonstrate the relevance of information for the management of a country's technological development, which can serve as an efficient method to analyze, compare and monitor research and development activities in cancer and also support the planning processes organizations, as well as supporting public and private health policies. Objective onIdentify extract data gallium68 gallium 68 gallium-6 68Ga, 68Ga Ga , (68Ga) copper64 copper 64 copper-6 64Cu Cu (64Cu zirconium89 zirconium 89 zirconium-8 89Z Z (89Z Method Intelligence QUESTEL identify 2 world Result gallium68, 68, zirconium89, 89, respectively 36 1 identified cases 61 universities companyuniversity university partnership Conclusions countrys country s analyze organizations policies gallium6 6 gallium- (68Ga copper6 copper- zirconium8 8 zirconium- 3

RESUMO Objetivo: Prospectar a evolução dos pedidos de patentes sobre oncológicos contendo os radioisótopos gálio-68 (68Ga), cobre-64 (64Cu) e zircônio-89 (89Zr) visando a compreensão do desenvolvimento da ciência e da tecnologia na área. Método: Utilizou-se a plataforma ORBIT Intelligence® da empresa QUESTEL® para identificar, extrair, tratar os dados, organizar e disponibilizar as informações tecnológicas em formato de interfaces gráficas das patentes depositadas vigentes nos últimos 20 anos nos principais escritórios de patentes no mundo. Resultado: Foram identificadas para gálio-68, cobre-64 e zircônio-89, respectivamente, 36, 18 e 10 famílias de patentes contendo os termos de busca descritos na metodologia. Em ambos os casos, a China se destaca no número de pedidos de patentes depositados, chegando a depositar 61% do total analisado. Observou-se ainda, que muitos dos documentos analisados foram depositados por universidades, reforçando o conceito da parceria empresa-universidade. Os resultados obtidos apontam que a área do presente estudo continua em crescimento e o entendimento sobre as informações presentes nos documentos de patente possibilitam refletir espaços para intensificar o desenvolvimento de inovações na área oncológica. Conclusões: Os resultados obtidos demonstram a relevância das informações para a gestão no desenvolvimento tecnológico de um país, o qual podem servir como método eficiente para analisar, comparar e monitorar atividades de pesquisa e desenvolvimento em câncer e, ainda, subsidiar os processos de planejamento estratégico das organizações, assim como apoiar as políticas públicas e privadas de saúde. Objetivo gálio68 gálio 68 gálio-6 68Ga, 68Ga Ga , (68Ga) cobre64 cobre 64 cobre-6 64Cu Cu (64Cu zircônio89 zircônio 89 zircônio-8 89Zr Zr (89Zr Método Utilizouse Utilizou Intelligence QUESTEL identificar extrair dados 2 mundo Resultado gálio68, 68, zircônio89, 89, respectivamente 36 1 metodologia casos 61 analisado Observouse Observou ainda universidades empresauniversidade. empresauniversidade universidade. universidade empresa-universidade oncológica Conclusões país analisar organizações saúde gálio6 6 gálio- (68Ga cobre6 cobre- zircônio8 8 zircônio- 3

Resumo O artigo objetiva contribuir como reflexão sobre a produção pública de medicamentos no Brasil. Os produtores públicos se apresentam como estratégicos, seja como reguladores de preço ou em atendimento às demandas do Sistema Único de Saúde. O estudo utilizou as bases oficiais do Ministério da Saúde, Agência Nacional de Vigilância Sanitária (ANVISA) e dos Laboratórios Farmacêuticos Oficiais (LFO). Foram identificados 33 LFO, sendo 16 com produção ativa de registro de medicamentos na ANVISA. Para os 17 LFO restantes não foram identificados portfólio ativo nas bases pesquisadas. Identificou-se que 80% do portfólio dos LFO estão concentrados no primeiro nível da “Anatomical Therapeutic Chemical Classification”, como: alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. A participação dos LFO no complexo da saúde é de 48,6% de seu portfólio dedicado ao componente estratégico, 30,6% para atenção básica e 20,7% para o especializado. Conclui-se que os LFO têm relevância para a política de saúde brasileira, com melhor realinhamento da potencialidade dos mesmos frente ao avanço tecnológico, à legislação sanitária, à dependência de fármacos e aos novos protocolos de tratamento.

Abstract The paper aims to contribute as a reflection on the public production of medicines in Brazil. Public producers present themselves as strategic in Brazil, either as price regulators, in meeting the demands of the Ministry of Health (MoH) on neglected products and those at risk of shortage to SUS. The study used the official bases of the MoH, National Health Surveillance Agency (ANVISA) and Website of Official Pharmaceutical Laboratories (OPL). Thirty-three OPL were identified, 16 with active production of drug registration at ANVISA. For the remaining 17 LFOs, no one identified active portfolio in the bases surveyed. There are 80% of the OPL portfolio concentrated in the first level of the Anatomical Therapeutic Chemical Classification, such as alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. The OPL participation in the health complex is 48.6% of its portfolio dedicated to the strategic component, 30.6% for primary care and 20.7% for the specialized. It concludes the relevance of the OPL for the Brazilian health policy, with the better realignment of their potential in the face of technological advancement, health legislation, drug dependence and new treatment protocols.

Resumo O artigo objetiva contribuir como reflexão sobre a produção pública de medicamentos no Brasil. Os produtores públicos se apresentam como estratégicos, seja como reguladores de preço ou em atendimento às demandas do Sistema Único de Saúde. O estudo utilizou as bases oficiais do Ministério da Saúde, Agência Nacional de Vigilância Sanitária (ANVISA) e dos Laboratórios Farmacêuticos Oficiais (LFO). Foram identificados 33 LFO, sendo 16 com produção ativa de registro de medicamentos na ANVISA. Para os 17 LFO restantes não foram identificados portfólio ativo nas bases pesquisadas. Identificou-se que 80% do portfólio dos LFO estão concentrados no primeiro nível da “Anatomical Therapeutic Chemical Classification”, como: alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. A participação dos LFO no complexo da saúde é de 48,6% de seu portfólio dedicado ao componente estratégico, 30,6% para atenção básica e 20,7% para o especializado. Conclui-se que os LFO têm relevância para a política de saúde brasileira, com melhor realinhamento da potencialidade dos mesmos frente ao avanço tecnológico, à legislação sanitária, à dependência de fármacos e aos novos protocolos de tratamento.

Abstract The paper aims to contribute as a reflection on the public production of medicines in Brazil. Public producers present themselves as strategic in Brazil, either as price regulators, in meeting the demands of the Ministry of Health (MoH) on neglected products and those at risk of shortage to SUS. The study used the official bases of the MoH, National Health Surveillance Agency (ANVISA) and Website of Official Pharmaceutical Laboratories (OPL). Thirty-three OPL were identified, 16 with active production of drug registration at ANVISA. For the remaining 17 LFOs, no one identified active portfolio in the bases surveyed. There are 80% of the OPL portfolio concentrated in the first level of the Anatomical Therapeutic Chemical Classification, such as alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. The OPL participation in the health complex is 48.6% of its portfolio dedicated to the strategic component, 30.6% for primary care and 20.7% for the specialized. It concludes the relevance of the OPL for the Brazilian health policy, with the better realignment of their potential in the face of technological advancement, health legislation, drug dependence and new treatment protocols.

History shows that public health actions to combat epidemics are most effective when there is constant synergy of both government and society, exemplified by prevention actions in the fight against dengue fever, H1N1 influenza etc. Private-public-partnerships (PPP) can also provide more dynamic and consistent results in production through interaction among Government, University and Enterprise actors. This article puts forward proposals to tackle the problem of neglected tropical diseases via the formation of a Management Council using Etzkowitz's Triple Helix concept to attenuate this public health issue in Brazil.

The Brazilian government has a Unified Health System, founded by the 1988 constitution and regulated in 1990 (The 8080 Act). The Brazilian Government devised the medical assistance programs for enhancing the public health in Brazil, in which the public pharmaceutical production plays an important role. The objective of this study was to obtain an overview of the Unified Health System, focusing efforts on pharmaceutical care programs and the contribution of the Brazilian Public Pharmaceutical Production Network. To this end, all laboratories were invited to interviews in addition to literature reviews and data obtained from government secretariats and ministries. Twenty two healthcare programs, the cost of drugs and mounted capacity of the public laboratories were identified. The Ministry of Health spent 12 % of its budget in drugs and the mounted capacity of the public pharmaceutical manufacture network amounted to 16.6 billions of pharmaceuticals.

El Gobierno Brasileño cuenta con un Sistema de Salud Unificado, creado por la Constitución de 1988 y reglamentado en el año de 1990 (Ley de 8080). El Gobierno brasileño creó los programas de asistencia para mejorar la salud pública en Brasil, en la que la industria farmacéutica desempeña un papel importante. Este estudio tiene por objetivo proporcionar un panorama general del Sistema de Salud Unificado, concentrando los esfuerzos en los programas de atención farmacéutica y la contribución de la Red de Producción Pública de Medicamentos Brasileña. Para esto se invitó a todos los laboratórios para entrevistas, más allá de una investigación bibliográfica, datos de las secretarías y ministerios gubernamentales. Se pudieron identificar 22 pogramas de salud, el costo de los medicamentos y la capacidad instalada de los laboratorios públicos, el gasto en medicamentos de 12 % del presupuesto del Ministerio de Salud y la capacidad instalada en la Red Pública de la Producción de Medicamentos en el orden de 16,6 billones de unidades de productos farmacéuticos.