Marcos regulatórios das políticas de fomento de medicamentos biológicos na América Latina: o que há de novo? / Regulatory frameworks for policies to promote biological medicines in Latin America: what is new?

Introdução: Um diagnóstico setorial sobre as políticas de fomento de biofarmacêuticos pode indicar percursos exitosos, além oferecer uma melhor compreensão sobre suas trajetórias evolutivas recentes, na América Latina (AL). Objetivo: Este artigo busca identificar, descrever e comparar os marcos das políticas de fomento de medicamentos biológicos e biossimilares na Argentina, Brasil, Chile, Colômbia, México e Uruguai. Método: Realizou-se um estudo exploratório, descritivo, com análise documental. Além de revisão da literatura científica sobre o tema, levantou-se informações e normas oficiais das autoridades de ciência e tecnologia, indústria e saúde. As categorias selecionadas para aprofundarmos a análise destas políticas foram: (a) políticas industriais (PI); (b) parceria para o desenvolvimento produtivo (PDP) e (c) políticas nacionais de medicamentos biológicos (PNMB). Resultados: As políticas de fomento da região são diversas, mas poucas são direcionadas somente a biotecnologia. Colômbia parece ser o país com maiores necessidades quanto a PI e PDP. As questões patentárias atravessam todas as políticas nacionais e impactam no acesso. Conclusões: A PI desempenhou um papel importante na coordenação de distintas ações, estimulando tanto o crescimento de parques industriais quanto a produção de agentes biológicos, principalmente na imitação criativa de biossimilares

Facing the coronavirus crisis: Opportunities and challenges in developing countries, the Argentina case

The coronavirus crisis has exposed tensions in the global pharmaceutical industry and shortages of the global supply chains within the framework of an unprecedented concentration and centralization of capital, highlighting countries interest in having domestic capabilities to respond to pandemic demands. The breaking down of pharmaceutical production chains, and the collapse of the private led manufacture and distribution system, underlines the need for global scientific cooperation and health sovereignty, requiring scientific internationalization, national technological catching up and industrial policy actions on a national or regional basis. As the pandemic reveals a systemic failures of developed countries innovation systems, the weak coherence between scientific opportunities and manufacturing base in new biotechnology fields opens transitory and small windows of opportunity for developing countries. They can insert as early imitators at a lower cost than big pharma profiting from backwardness advantages. Given the knowledge thresholds achieved by local scientific base in molecular biology, the learning and R&D thresholds achieved by the actual public and private technological capabilities, and the productive experience in bioprocesses and in biosimilars, biotech companies in Argentina have a chance to continue an updated import substitution process and to face the challenges posed by the pandemic. This requires advances in three areas of intervention: i) The strengthening of scientific and technological opportunities in close cooperation with the international scientific community; ii) support for the accelerated generation of learning in manufacturing; and (iii) the strategic role of public procurement in enhancing local production of complex drugs, guiding scientific and technological developments to meet the needs of the public health system, and boosting public production of medicinesIn short, the COVID 19 challenge opens up the possibility (driven by the health crisis), of building strategic high-cost drug development and manufacturing capabilities for the public health system. This requires articulating a deliberate action of international North South and South-South scientific cooperation with existing actions and instruments into "big structuring projects" at a national scale.Fil: Gutman, Graciela Elena. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Centro de Estudios Urbanos y Regionales; ArgentinaFil: Lavarello, Pablo Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Centro de Estudios Urbanos y Regionales; ArgentinaThe Eu-SPRI 2021 conferenceOsloNoruegaThe European Forum for Studies of Policies for Research and Innovatio

Intellectual Capital and Financial Performance of Biotech Companies in the Pharmaceutical Industry

The paper’s aim is to analyse the interdependency between the intellectual capital and the financial performance of biotechnological (biotech) companies in the pharmaceutical industry. The analysis was performed for 24 biotech companies in this branch considered during 2002-2014, based on several indicators available on the Thomson Reuters database. The financial performance was measured through the return on assets (ROA), return on equity (ROE) and the debt-to-equity ratio (DE). In order to capture the intellectual capital, the focus was on a designing a new indicator, proposed by the authors, respectively the efficiency of research and development expenditures (ECD), along with another proxy, previously attested by the literature and reflected through the market to-book ratio (MTB). The research methodology resides on applying the correlation method, robust regression, and structural equations modelling (SEM). The results reveal a significant negative relationship between ROA, ROE and MTB, which contradicts the literature and suggests that, for this particular type of companies, MTB isn’t relevant to express the intellectual capital. MTB was positively correlated with DE. When we used the ECD, the results attested a strongly positive and significant relation with ROA and ROE, and a negative one with DE. Therefore, the applied tests confirm ECD as the most suitable indicator to appreciate the intellectual capital for the biotech companies in the pharmaceutical industr

Problemas económico-financieros del sector farmacéutico y posibles soluciones. Análisis de las empresas más representativas en León = Economic-financial problems of the pharmaceutical sector and possible solutions. Analysis of the most representative companies in León

La pérdida de las patentes en los productos farmacéuticos está permitiendo un crecimiento exponencial de la industria no sólo a nivel mundial, sino también a nivel nacional. Más concretamente, la provincia leonesa goza de gran potencial al situarse entre las 5 que más facturan en España, por lo que resulta de especial interés un análisis económico-financiero que esclarezca la situación de las empresas más relevantes del sector. Así pues, el presente trabajo detalla cómo partiendo de situaciones semejantes y nefastas, las tres sociedades analizadas han tomado caminos diferentes que les han posicionado en disímiles situaciones. Las técnicas de contabilidad creativa, la elusión de la realidad, las decisiones precipitadas, el cinismo y la ambición son algunos de los aspectos prácticos que aquí se reflejan, pero también la prudencia y la complicidad empresarial. Adicionalmente, se evalúa el porqué de sus actos y se prevé su situación en el corto plazo, planteando soluciones que les permitirán optimizar la gestión de sus recursos y resultados