Cristiane Quental

Saúde e inovação: uma abordagem sistêmica das indústrias da saúde

Recognizing the importance of generating and disseminating innovation for the social and economic development of capitalist countries and the systemic, institutional, and historical nature of this process, this paper emphasizes the need to deal with innovation in the health sector within a framework linking economic, institutional, and policy dynamics. Analysis of the main health goods industries (manufacturers of pharmaceuticals, vaccines, and diagnostics) shows that in the developed countries there is a certain compatibility between the health system and the innovation systems in terms of requirements, and that the state is an essential player in this articulation. In Brazil, however, there is a marked disconnection between the health and innovation systems. The few initiatives aimed at this link have enhanced the competitiveness of national agents and have been essential elements in national health policy. Based on this analysis, it is argued that beyond its social dimension, health policy is a strategic means to consolidate a dynamic innovation system, with direct effects on national development.

Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional

This paper echoes recent works of Abrasco1, Gadelha2 and Guimaraes3 emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreus analysis of industrial competitiveness in the Brazilian generics industry.

Ensaios clínicos: capacitação nacional para avaliação de medicamentos e vacinas

O trabalho apresenta uma analise da capacitacao dos centros de pesquisa clinica brasileiros para realizar ensaios voltados para a avaliacao de medicamentos e vacinas, como suporte ao desenvolvimento de novos produtos. Utiliza bases de dados publicas para a quantificacao dos ensaios realizados e entrevistas com patrocinadores e centros de pesquisa clinica para a analise das competencias envolvidas na sua realizacao. Conclui que, embora a capacitacao nacional seja alta na realizacao de ensaios na fase III e razoavel nas fases II e IV, ainda e incipiente na fase I, na qual existem poucos centros com experiencia. E maior na execucao da pesquisa do que no seu desenho. Este perfil foi forjado em resposta a demanda das multinacionais farmaceuticas, majoritaria nos ultimos anos. Entretanto, e diferente daquele demandado pelos empreendimentos nacionais, que inclui competencias no desenho do ensaios, e precisaria ser ajustado para atende-los, no caso da demanda nacional aumentar, seja por estudos de avaliacao tecnologica governamentais (para subsidiar a politica de assistencia - area que esta sendo enfatizada pelo governo federal), seja pelo desenvolvimento de novos medicamentos, seja ate para a regularizacao da situacao dos produtos similares atualmente no mercado. No caso dos medicamento genericos e, mais recentemente, dos medicamentos similares, a regulamentacao criou uma firme demanda por testes de bioequivalencia e biodisponibilidade por parte das empresas nacionais. Poucos centros, entretanto, a estao atendendo: 78% dos estudos realizados em 2005 foram realizados por 5 dos 24 centros nacionais credenciados pela Anvisa para tal. Sao apresentadas propostas para o fortalecimento do setor.

National research for health systems in Latin America and the Caribbean: moving towards the right direction?

BackgroundNational Research for Health Systems (NRfHS) in Latin America and the Caribbean (LAC) have shown growth and consolidation in the last few years. A structured, organized system will facilitate the development and implementation of strategies for research for health to grow and contribute towards people’s health and equity.MethodsWe conducted a survey with the health managers from LAC countries that form part of the Ibero-American Ministerial Network for Health Education and Research.ResultsFrom 13 of 18 questionnaires delivered, we obtained information on the NRfHS governance and management structures, the legal and political framework, the research priorities, existing financing schemes, and the main institutional actors. Data on investment in science and technology, scientific production, and on the socio-economic reality of countries were obtained through desk review focused on regional/global data sources to increase comparability.ConclusionsBy comparing the data gathered with a review carried out in 2008, we were able to document the advances in research for health system development in the region, mostly in setting governance, coordination, policies, and regulations, key for better functionality of research for health systems. However, in spite of these advances, growth and consolidation of research for health systems in the region is still uneven.

Research for better health: the Panamanian priority-setting experience and the need for a new process.

BackgroundPanama is, economically, the fastest growing country in Central America and is making efforts to improve management mechanisms for research and innovation. However, due to contextual factors, the Panamanian Health Research System is not well developed and is poorly coordinated with the Health System. Likewise, despite recent efforts to define a National Health Research Agenda, implementing this agenda and aligning it with Panamanians’ health needs remains difficult. This articles aims to review Panama’s experience in health research priority setting by analyzing the fairness of previous prioritization processes in order to promote an agreed-upon national agenda aligned with public health needs.MethodsThe three health research prioritization processes performed in Panama between 2006 and 2011 were analyzed based on the guidelines established by the four “Accountability for Reasonableness” principles, namely “relevance”, “publicity”, “revision”, and “enforcement”, which provide a framework for evaluating priority-setting fairness.ResultsThe three health research priority-setting events performed in Panama during the reference period demonstrated a heterogeneous pattern of decision-making strategies, stakeholder group composition, and prioritization outcomes. None of the three analyzed events featured an open discussion process with the scientific community, health care providers, or civil society in order to reach consensus.ConclusionsThis investigation makes evident the lack of a strategy to encourage open discussion by the multiple stakeholders and interest groups that should be involved during the priority-setting process. The analysis reveals the need for a new priority-setting exercise that validates the National Agenda, promotes its implementation by the National Secretariat for Science, Technology and Innovation in conjunction with the Ministry of Health, and empowers multiple stakeholders; such an exercise would, in turn, favor the implementation of the agenda.

The Panamanian health research system: a baseline analysis for the construction of a new phase

BackgroundIn Panama, the health research system has been strengthened during recent years by the development of new financing opportunities, promotion of scientific and technological activities, and initiation of human capital training to ultimately improve competitiveness. However, aligning this system with the population’s health needs is a significant challenge. This study was designed to characterize the National Health Research System in Panama, aiming to understand it within a local context to facilitate policymaking.MethodsThe study was based on the analysis of operative and functional components of the National Health Research System, characterized by four specific components: stewardship, financing, creation and maintenance of resources, and production and use of research results. The analysis was based on official documents from key local institutions in the areas of science, technology and innovation management, and health and health research, as well as bibliographic databases.ResultsPanama’s National Health Research System is characterized by the presence of only two biomedical research institutes and reduced research activity in hospitals and universities, ambivalent governance, a low critical mass of researchers, reduced capacity to recruit new researchers, poor scientific production, and insufficient investment in science and technology.ConclusionsThe present study illustrates an approach to the context of the Panamanian Health Research System which characterizes the system as insufficient to accomplish its operative role of generating knowledge for new health interventions and input for innovations. In turn, this analysis emphasizes the need to develop a National Health Research Policy, which should include longer-term plans and a strategy to overcome the asymmetries and gaps between the different actors and components of the current system.

Metodologia para gerenciar projetos de pesquisa e desenvolvimento com foco em produtos: uma proposta

As atividades de pesquisa e desenvolvimento (P&D) realizadas nos institutos publicos de pesquisa (IPPs) tem como caracteristica uma gestao arraigada nas premissas academicas, que priorizam a geracao e difusao do conhecimento. Em contrapartida, a necessidade de competitividade tecnologica no mercado e a pressao pela participacao, como instrumentos da politica publica do esforco nacional rumo a inovacao, tem pressionado os IPPs para a busca por resultados mais concretos. Esse fato acarreta a geracao de grandes lacunas nos processos relacionados a gestao, induzindo a uma constante necessidade de aperfeicoamento gerencial, no sentido de criar e melhorar ferramentas que contribuam para adequa-la a nova realidade. Este artigo propoe uma metodologia de gestao de projetos de P&D, que se baseia no direcionamento dos projetos de pesquisa para a obtencao de produtos, e considera suas caracteristicas multidisciplinares e interdisciplinares e a incerteza inerentes a esse processo. Essa metodologia foi desenvolvida no Instituto de Tecnologia de Farmacos da Fiocruz e e proposta como um modelo original para instituicoes semelhantes.

Modelo para análise estratégica de indústrias baseadas em ciência

This paper presents a strategic analysis model for science-based industries in process of innovation and technological development, operating in developing countries. The model is based on five main elements: technological regime; marketing structure; organizational process; knowledge and available resources, and governmental role. It can be applied in both industry and firm level, and aims to support the alignment of innovation strategies to general firm strategy. Applied to the Brazilian vaccines industry, the framework highlighted the Brazilian vaccine manufacturers’ limitations in terms of technological regime and organizational processes, as well as the opportunities of market growth.

Questões relevantes para a aprovação de medicamentos biossimilares

When the patent of a drug expires, low cost generics may be introduced in market. Trial results that demonstrate the safety and efficacy of the reference product can be extrapolated to the generic, simplifying the approval process. This paradigm cannot be applied to biopharmaceutical products, large molecules difficult to be characterized. Minor changes in the production process can influence the biological and clinical properties of the product and result in differences in efficacy and safety profiles. It is not possible to demonstrate the identical nature of biopharmaceuticals arising from different manufacturing sources, so they cannot be approved as simple generics and need specific regulation. A bibliographical survey of the main issues involved in the approval of similar versions of biopharmaceuticals was performed as well as a comparative analysis of the regulatory situation in the largests pharmaceutical markets - U.S. and European Union - based on legislation, draft laws, guidelines and technical references issued by their regulatory agencies - FDA (Food and Drug Administration) and EMEA (European Medicines Agency), respectively, in order enlight the discussion now taking place in Brazil. Based on the laws and guidelines studied, it is concluded that, although Brazil, Europe and the United States are at different stages of setting their regulatory framework for biossimilars, it is possible to identify some similarities in approach, such as the need for different treatment for each product class (or a case by case focus) and a step by step comparison exercise, the results of which will define the amount of data and non-clinical and clinical studies required. However, issues such as interchangeability and automatic substitution of biossimilars for reference products are not yet clearly defined. From the sanitary point of view, Europe has a more conservative posture, while the U.S. and Brazil seem to be building a more flexible framework. Besides the health issues, however, we highlight the economic issues, of great importance in Europe and U.S. legislation, and not addressed in the Brazilian regulation - which can bring insecurity to producers interested in this market.