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Background: The pharmaceutical sector undertakes extensive research and development (R&D). Pharmaceutical industries have continued to launch an appreciable number of new medicines, different pharmaceutical formulations, new indications and other innovations that contribute to the growth of this sector. New novel medicines are increasingly essential for continued success given the number of standard medicines now available as low cost generics or biosimilars. Consequently, innovation is a fundamental element in pharmaceutical company competition. Not all innovations though are the same size, type or category with differentiation of innovation essential for commercial success. However, given the wide range of definitions used in the literature, the framing may diffuse. Currently, there are several types and categories of innovation are deficiently harmonized and poorly stratified resulting in analysis trends and provide major obstacles to innovation’s differentiation and in assessing the company's innovative dominant characteristic in the sector. The objective of this study is to stratify and organize, didactically, the field of definitions and concepts of innovation and provide a structural and operational delineation, from a critical point of view, for the classifications of innovation applied to the pharmaceutical industry

Submitted by Maria Creuza Silva (mariakreuza@yahoo.com.br) on 2017-05-26T17:38:50Z No. of bitstreams: 1 Edina Alves Costa. 2015.pdf: 406053 bytes, checksum: b71fdf6dc107005caa8455847e0a4efc (MD5) Made available in DSpace on 2017-05-26T17:38:50Z (GMT). No. of bitstreams: 1 Edina Alves Costa. 2015.pdf: 406053 bytes, checksum: b71fdf6dc107005caa8455847e0a4efc (MD5) Introdução: Acesso a medicamentos é componente-chave na viabilização e mensuração do desempenho dos sistemas de saúde. Objetivos: Este estudo objetivou verificar, por meio de revisão sistemática, o perfil de estudos e os resultados dos indicadores de acesso a medicamentos no Brasil. Métodos: Revisão sistemática de estudos observacionais disponíveis nas bases de dados, US National Library of Medicine (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Centre of Reviews and Dissemination (CRD) e Essential Medicines and Health Products Information Portal (WHO), incluindo busca manual nas referências dos estudos incluídos e literatura cinzenta (Banco de Teses - Capes, Biblioteca Digital de Teses e Dissertações da USP, ProQuest Dissertação e Teses, relatórios técnicos do WHO Medicines Strategy e relatórios de pesquisa: PNAD, Ministério da Saúde, IBGE). Resultados: Foram incluídos 29 estudos sobre Acesso a Medicamentos. Destes, 19 estudos avaliaram acesso no nível municipal, 9 no setor público, 12 sob a perspectiva exclusiva dos usuários, 22 estudos avaliaram medicamentos essenciais, 14 avaliaram mais de uma dimensão do acesso e 24 estudos apresentaram indicadores relacionados à disponibilidade. Entre todas as dimensões do AAM, foram encontrados 19 indicadores distintos. O indicador “disponibilidade física” foi utilizado em 12 estudos. Conclusão: Os estudos tiveram foco na disponibilidade e nenhum estudo avaliou todas as dimensões do acesso. O nível de acesso foi variável entre os estudos. Esta avaliação levanta a necessidade de desenvolver uma diretriz para avaliar AAM, que fomente comparações e avaliações de desempenho dos sistemas de saúde ao longo do tempo. Vitória

Refereed/Peer-reviewed Background and Objective Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. Methods An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. Results Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusions We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.