Comparative price analysis of biological medicines: disparities generated by different pricing policies.

Introduction: Biological medicines have been assuming an important role among the therapeutic options for several diseases, however, due to their complex production process, the products obtained from this technology have a high added value and do not reach the purchasing power of most patients, which overwhelms the budget of health systems. With the development of biosimilars, which have reduced production costs, it is expected that access to biological medicines will become broader. However, in Brazil, the criteria for determining the price of biosimilars, unlike the generic policy in the country, do not foresee a price reduction due to the reduction of development costs. Objective: To understand the impact of the current model of economic regulation on the availability and access of these products in the country, based on a comparative analysis in selected countries, and identify trends that can help to expand the availability and access to biological medicines. Method: Quantitative and qualitative study, to identify the variation between the entry prices of biological medicines in Brazil and in selected countries, as well as the differences in the economic regulation policies established in these countries. Results: The results demonstrate that the current pricing model in Brazil has generated distortions in the prices of biosimilars in the market, which, consequently, makes it difficult for the population to access this category of products, in addition to allowing unsustainable market practices for the systems of public and private health in Brazil. It was also found that most of the analyzed countries, unlike Brazil, seek to harmonize the prices of different brands of the same molecule marketed in the country and with the international market, in addition to establishing incentive policies for indication and replacement by biosimilars, which expands the participation of biosimilars in the market significantly. Conclusion: Based on the data presented, it is concluded that it is essential to build a broader political and regulatory debate on the market for biologicals and biosimilars in the country to guarantee the access of the Brazilian population to more cost-effective technologies, generate a more competitive market and consequently contribute to the financial sustainability of health systems.

Suitability of two WHO research and development initiatives for COVID-19 to promote equitable innovation: the Access to COVID-19 Tools Accelerator and COVID-19 Technology Access Pool.

Objectives: To analyze the World Health Organization's (WHO's) contribution to promotion of access to innovative technologies by assessing its initiatives on coronavirus disease 2019 (COVID-19) research, development, and innovation. Methods: A document search was done for previous criteria used by WHO working groups to evaluate innovation and access merits. Two sets of criteria were identified. One set was used to assess the suitability of existing mechanisms to coordinate research, development, and innovation and pool funds globally. The second set was used to measure success in implementing demonstration projects and consider the extent of innovative components being implemented by them. These criteria were applied to the COVID-19 Technology Access Pool (C-TAP) and Access to COVID-19 Tools Accelerator (ACT-A) initiatives. Scores were classified as: meets the criteria (2); partially meets the criteria (1); does not meet the criteria (0). Results: Both initiatives met all the first set of criteria. C-TAP, an initiative based on a patent pool and other open knowledge approaches, best met the second set of criteria, scoring 7 out of 12 points. ACT-A, based on pooled funds, advanced purchase agreements, and voluntary contributions, met none of the second set of criteria. Conclusions: Equitable access to health technologies has been a recurring problem in recent pandemics and initiatives were proposed to prevent it. However, even though COVID-19 has been the greatest health crisis in the 21st century, market dynamics still prevailed. Income disparities between countries and lack of support for solidarity and a global health approach only aggravated the negative health and economic impacts.

Perspectivas em cirurgia robótica: a visão do cirurgião / Robotic surgery: the surgeon's perspective

Introdução: Avaliar os níveis de conhecimento, interesse e treinamento dos cirurgiões inscritos no Colégio Brasileiro dos Cirurgiões (CBC) da cidade de Porto Alegre, Rio Grande do Sul, em relação à cirurgia robótica. Métodos: Estudo transversal, baseado em informações coletadas por meio de questionário enviado via plataforma digital para potenciais participantes. O formulário continha perguntas estruturadas e autoaplicáveis, a fim de caracterizar o perfil profissional, capacitação em cirurgia minimamente invasiva, conhecimento, opinião e treinamento específico em cirurgia robótica. Resultados: Dos 146 membros inscritos no CBC na cidade de Porto Alegre, 99 (67,8%) responderam ao questionário. Houve predomínio do sexo masculino (88%) e a mediana de idade dos participantes foi de 48 anos. Os procedimentos videolaparoscópicos ou vídeo-assistidos foram maioria na rotina dos cirurgiões. Da totalidade da amostra, a maior parte (78%) já assistiu ao menos um procedimento robótico, e um terço (n = 30) já realizou algum tipo de treinamento ou simulação em cirurgia robótica. Entre os que não realizaram, dois terços pretendem se qualificar no futuro. Apenas 10% dos cirurgiões possuem certificação na área. Conclusão: A maioria dos cirurgiões respondentes inscritos no CBC em Porto Alegre tem em sua rotina predominância de procedimentos minimamente invasivos e acredita que a plataforma robótica será o futuro da cirurgia. Embora ainda não disponível na maioria dos serviços gaúchos, espera-se que o desenvolvimento de novas plataformas e a redução dos custos envolvidos na aquisição de equipamento e de capacitação do cirurgião facilitem a disseminação dessa tecnologia.

Introduction: To assess the practical knowledge, interest, and training levels of surgeons enrolled in the Brazilian College of Surgeons (CBC) of the municipality of Porto Alegre, Rio Grande do Sul, regarding robotic surgery. Methods: Cross-sectional study, based on information collected with a questionnaire sent to potential participants via digital platform. The form contained structured and self-administered questions, to characterize their professional profile, skills in minimally invasive surgery, knowledge, opinion, and specific training in robotic surgery. Results: Of the 146 members enrolled in the CBC of the municipality of Porto Alegre, 99 (67.8%) responded to the questionnaire. Most were males (88%) with a mean age of 48 years. Video-laparoscopic or video-assisted procedures were the most frequent in the participants' practice. Of the sample, most (78%) already watched at least one robotic surgery, and one third (n = 30) had already completed some sort of training or simulation course in robotic surgery. Among those who did not, two thirds intend to pursue formal training in the future. Only 10% of participating surgeons are certified in the area. Conclusion: Most responding surgeons enrolled in the CBC in Porto Alegre perform mostly minimally invasive procedures daily and believe that the robotic technology will be the future of surgery. Although not yet available in most services of the state of Rio Grande do Sul, it is expected that the development of new platforms and the reduction of costs involved in equipment acquisition and surgical training will facilitate the dissemination of this technology.

Suitability of two WHO research and development initiatives for COVID-19 to promote equitable innovation: the Access to COVID-19 Tools Accelerator and COVID-19 Technology Access Pool / Idoneidad de dos iniciativas de la OMS de investigación y desarrollo sobre la COVID-19 para promover la innovación equitativa: Acelerador del Acceso a las Herramientas contra la COVID-19 y Acceso Mancomunado a las Tecnologías contra la COVID-19 / Adequação de duas iniciativas de pesquisa e desenvolvimento da OMS para COVID-19 destinadas a promover a inovação equitativa: o Acelerador de Acesso a Ferramentas contra a COVID-19 e o Grupo de Acesso às Tecnologias contra a COVID-19

ABSTRACT Objectives. To analyze the World Health Organization's (WHO's) contribution to promotion of access to innovative technologies by assessing its initiatives on coronavirus disease 2019 (COVID-19) research, development, and innovation. Methods. A document search was done for previous criteria used by WHO working groups to evaluate innovation and access merits. Two sets of criteria were identified. One set was used to assess the suitability of existing mechanisms to coordinate research, development, and innovation and pool funds globally. The second set was used to measure success in implementing demonstration projects and consider the extent of innovative components being implemented by them. These criteria were applied to the COVID-19 Technology Access Pool (C-TAP) and Access to COVID-19 Tools Accelerator (ACT-A) initiatives. Scores were classified as: meets the criteria (2); partially meets the criteria (1); does not meet the criteria (0). Results. Both initiatives met all the first set of criteria. C-TAP, an initiative based on a patent pool and other open knowledge approaches, best met the second set of criteria, scoring 7 out of 12 points. ACT-A, based on pooled funds, advanced purchase agreements, and voluntary contributions, met none of the second set of criteria. Conclusions. Equitable access to health technologies has been a recurring problem in recent pandemics and initiatives were proposed to prevent it. However, even though COVID-19 has been the greatest health crisis in the 21st century, market dynamics still prevailed. Income disparities between countries and lack of support for solidarity and a global health approach only aggravated the negative health and economic impacts.

RESUMEN Objetivos. Analizar la contribución de la Organización Mundial de la Salud (OMS) a la promoción del acceso a tecnologías innovadoras mediante la evaluación de sus iniciativas de investigación, desarrollo e innovación sobre la enfermedad por coronavirus del 2019 (COVID-19). Métodos. Se realizó una búsqueda de documentos de acuerdo con los criterios previamente utilizados por los grupos de trabajo de la OMS para evaluar méritos en cuanto a acceso e innovación. Se determinó que se usarían dos conjuntos de criterios: el primero para evaluar la idoneidad de los mecanismos existentes para coordinar la investigación, el desarrollo y la innovación y mancomunar fondos a nivel mundial; el segundo para medir el éxito en la ejecución de proyectos de demostración y valorar el alcance de los componentes innovadores que se están poniendo en marcha. Estos criterios se aplicaron a las iniciativas Acceso Mancomunado a las Tecnologías contra la COVID-19 (C-TAP) y Acelerador del Acceso a las Herramientas contra la COVID-19 (Acelerador ACT). Se asignaron las siguientes puntuaciones: cumple con los criterios (2); cumple parcialmente con los criterios (1); no cumple con los criterios (0). Resultados. Ambas iniciativas cumplieron con el primer conjunto de criterios en su totalidad. El C-TAP, una iniciativa basada en un consorcio de patentes y otros enfoques de conocimiento abierto, obtuvo la mejor clasificación en el segundo conjunto de criterios, con una puntuación de 7 sobre 12 puntos. El Acelerador ACT, basado en fondos mancomunados, acuerdos de compra anticipada y contribuciones voluntarias, no reunió ninguno de los criterios del segundo conjunto. Conclusiones. El acceso equitativo a las tecnologías sanitarias ha sido un problema recurrente en las pandemias recientes; se propusieron distintas iniciativas para prevenirlo. Sin embargo, a pesar de que la COVID-19 ha supuesto la mayor crisis de salud en el siglo XXI, la dinámica del mercado ha prevalecido. Las disparidades de ingresos entre los países y la falta de solidaridad y de un enfoque mundial de salud solo agravaron las repercusiones negativas a nivel económico y de salud.

RESUMO Objetivos. Analisar a contribuição da Organização Mundial de Saúde (OMS) promover o acesso a tecnologias inovadoras mediante avaliação de suas iniciativas de pesquisa, desenvolvimento e inovação para a doença por coronavírus 2019 (COVID-19). Métodos. Realizou-se uma pesquisa documental dos critérios anteriores usados por grupos de trabalho da OMS para avaliar os méritos de inovação e acesso. Identificaram-se dois grupos de critérios. Um deles foi usado para avaliar a adequação dos mecanismos existentes para coordenar a pesquisa, o desenvolvimento e a inovação e reunir fundos mundialmente. O segundo grupo foi usado para medir o sucesso na implementação de projetos de demonstração e avaliar a envergadura dos componentes inovadores implementados por eles. Esses critérios foram aplicados às iniciativas Grupo de Acesso às Tecnologias contra a COVID-19 (C-TAP, na sigla em inglês) e Acelerador de Acesso a Ferramentas contra a COVID-19 (ACT-A, na sigla em inglês). A pontuação foi atribuída da seguinte maneira: cumpre os critérios (2); cumpre parcialmente os critérios (1); não cumpre os critérios (0). Resultados. As duas iniciativas cumpriram todos os critérios do primeiro grupo. O C-TAP, uma iniciativa com base em um consórcio de patentes e outras estratégias de conhecimento aberto, cumpriu melhor o segundo grupo de critérios, alcançando 7 de 12 pontos. O ACT-A, com base em fundos conjuntos, contratos de compra antecipada e contribuições voluntárias, não cumpriu nenhum critério do segundo grupo. Conclusões. O acesso equitativo às tecnologias de saúde foi um problema recorrente nas pandemias recentes e foram propostas iniciativas para evitar esse problema. Entretanto, embora a COVID-19 tenha sido a maior crise de saúde do século XXI, ainda prevaleceu a dinâmica de mercado. As disparidades de renda entre os países e a falta de apoio à solidariedade e a uma estratégia de saúde global só agravaram os impactos negativos na saúde e na economia.

Potencialidades de um website para um centro de atenção psicossocial infantojuvenil / Potentials of a website for a child and youth psychosocial care center / Potencialidades de un sitio web para un centro de atención psicosocial para niños y adolescentes

Objetivo: evidenciar, a partir do feedback dos usuários, familiares, coordenadores e profissionais do Centro de Atenção Psicossocial Infanto Juvenil (CAPSi), a potencialidade do e-Mental Health na promoção do acesso através de um website.Método: pesquisa com abordagem metodológica qualitativa através de um estudo exploratório, do tipo pesquisa-ação utilizando o Knowledge Translation e a Metodologia da Dinâmica do Espelhamento Digital. A coleta de dados ocorreu entre os meses de agosto e setembro de 2018 no CAPSi da cidade de Pelotas, RS, Brasil. Resultados: o website iCanguru demonstrou ser capaz de melhorar o acesso, atuar na prevenção e promoção em saúde mental infanto-juvenil, aproximar a população rural e dar suporte cidades desassistidas. Conclusão: o website iCanguru pode ser uma excelente estratégia para superar algumas das barreiras de acesso e ser uma porta de entrada para o CAPSi. Descritores: e-Saúde; Serviços comunitários de saúde mental; Intervenção baseada em internet; Acesso a tecnologias em saúde; Avaliação das tecnologias de Saúde. (AU)

Objective: To demonstrate, based on the feedback from users, family members, coordinators, and professionals of the Center for Psychosocial Care for Children and Youths, the potential of e-Mental Health in promoting access through a website. Methods: Qualitative research approach through an exploratory study - action research, using Knowledge Translation and the Methodology of Digital Mirroring Dynamic. Data collection occurred between August and September 2018 at Center for Psychosocial Care for Children and Youths in the city of Pelotas, RS, Brazil. Results: The iCanguru website demonstrated to be able to improve access, prevention, and mental health promotion for children and youths, approaching the rural population and unsupported cities. Conclusion: The iCanguru website can be an excellent strategy to overcome some of the barriers to access and be a gateway to Center for Psychosocial Care for Children and Youths. (AU)

Objetivo: Destacar, a partir de la retroalimentación de los usuarios, familias, coordinadores y profesionales del Centro de Atención Psicosocial a la Infancia y la Adolescencia, el potencial de la e-Salud Mental para promover el acceso a través de un sitio web. Métodos: Investigación con enfoque metodológico cualitativo a través de un estudio exploratorio, del tipo de investigación acción utilizando la Traducción del Conocimiento y la Metodología de la Dinámica del Mirroring Digital. La recolección de datos se llevó a cabo entre agosto y septiembre de 2018 en Centro de Atención Psicosocial a la Infancia y la Adolescencia en la ciudad de Pelotas, RS, Brasil. Resultados: El sitio web iCanguru demostró ser capaz de mejorar el acceso, actuar en la prevención y promoción de la salud mental de niños y adolescentes, acercar a la población rural y apoyar a las ciudades no asistidas. Conclusión: El sitio web de iCanguru puede ser una excelente estrategia para superar algunas de las barreras de acceso y ser una puerta de entrada a Centro de Atención Psicosocial a la Infancia y la Adolescencia. (AU)