Resumo Este documento de opinião é baseado na contribuição da ABRASCO e do CEBES para o 8º Simpósio Nacional de Ciência, Tecnologia e Assistência Farmacêutica promovido pelo Conselho Nacional de Saúde. Trata da política de Ciência, Tecnologia e Inovação em Saúde e a inscreve nos três pilares para uma agenda de desenvolvimento em saúde: O Sistema Único de Saúde, a base produtiva de bens e serviços de saúde e a capacidade instalada de ciência, tecnologia e inovação em saúde.

RESUMO Objetivo. Fazer um levantamento acerca das doações internacionais de medicamentos pelo governo brasileiro de 2005 a 2016, identificando o número de unidades de medicamentos doadas e o montante financeiro que esse volume representa. Métodos. Estudo descritivo e exploratório utilizando análise de dados secundários disponíveis no Sistema de Gestão de Materiais do Ministério da Saúde (SISMAT). Foram levantadas informações sobre país solicitante, ano da doação, medicamento, número de unidades farmacêuticas doadas e valor correspondente (em reais). Resultados. No período estudado, 66 554 892 unidades de medicamentos foram doadas, correspondendo a 84 371 308,72 reais (25 505 235,70 dólares). Foram doados medicamentos para Angola, Benin, Bolívia, Burkina Faso, Cabo Verde, Colômbia, Costa do Marfim, Cuba, El Salvador, Equador, Guatemala, Guiana, Guiné Bissau, Haiti, Honduras, Líbia, Moçambique, Nicarágua, Paraguai, Peru, República Dominicana, São Tomé e Príncipe, Síria e Suriname, países do Mercado Comum e Comunidade do Caribe (CARICOM) e Organização Pan-Americana da Saúde (OPAS). Não foi detectado nenhum padrão de distribuição em termos quantitativos. Picos no número de medicamentos doados ocorreram em 2008, 2011 e 2012, com maior número de países contemplados em 2006 e 2012 (13 e 14 países, respectivamente). Foram doados medicamentos para HIV/Aids, malária, leishmaniose, diabetes, cólera, esquistossomose, tuberculose, gripe influenza, doenças oportunistas, imunizações, suporte nutricional e calamidade pública. Conclusões. Em grande medida, os medicamentos doados foram antimicrobianos utilizados para tratamento de doenças tropicais negligenciadas. Estudos adicionais são sugeridos para correlacionar intervenções de saúde pública com as doações de medicamentos, como forma de promover o desenvolvimento econômico sustentável dos países beneficiários.

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RESUMO Este ensaio aborda como e em que níveis a Assistência Farmacêutica é atravessada pela dinâmica da governança global da saúde, e como se relaciona com aspectos geopolíticos e socioeconômicos. Tenta-se ir além do acesso a medicamentos e produtos para saúde, abordando também o uso racional de medicamentos, seu impacto na resistência aos antimicrobianos e na saúde dos povos. Além disso, discute como a Assistência Farmacêutica pode ser vista nesse contexto.

This essay addresses how and at what levels Pharmaceutical Services is affected by the dynamics of global health governance, and how it correlates with geopolitical and socioeconomic aspects. It attempts to go beyond access to medicines and health products, as well as to address the rational use of medicines, the impact in antimicrobial resistance and in people’s health. Furthermore, it debates how Pharmaceutical Services can be seen in this context.

Transparency on drug costs and prices has been debated in the main areas of high-level governance in recent years. Brazil is one of the signatory countries to the Resolution of the World Health Organization on the transparency of the markets for medicines, vaccines, and other technologies and the transparency of the composition of the price of medicines can have an impact on the Brazilian health system. The aim of this scoping review was through documentary and literature analysis for definitions, characteristics, description, and theoretical grounding of Brazil’s attributes related to the voluntary commitments signed in the Resolution. Despite some limitations and barriers to achieving transparency in the composition of drug prices in Brazil, the country has a regulatory framework and successful experiences that can contribute towards improving price transparency. The Brazilian case indicates that transparency laws, policies, and institutional capacity could help provide some additional information for policymakers. Policymakers should also consider the use of health data interoperability standards to share information on the costs and pricing of medicines at all levels.

Introduction: The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems.Objective: This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia.Method: A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals.Results: Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making.Conclusion: The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.

Introduction: Financing the access to medicines has been one of the greatest challenges facing health systems all around the world. For diseases that attract lower levels of interest and medicine offers across the market, that challenge gets bigger. This study investigates the main strategies adopted by the Brazilian government to guarantee access to medicines for diseases identified as "poverty-related". Methods: We analyzed acquisitions made by the Brazilian federal government over 10 years (2005 to 2014) sourced from the database of the Ministry of Health, indicating three main strategies to face the difficulties of guaranteeing access to these medicines. (I) Centralization of the financing and acquisition for the great majority of the medicines; (II) Acquisition via multilateral organizations and (III) Production of medicines by official laboratories. Results: 132 medicines are included in the National List of Essential Medicines (RENAME in force, used in order to prevent and treat poverty-related diseases. More than a half (55.3%) of the items have only one national producer or are not registered and therefore can only be obtained through international acquisition to attend consolidated health programs such as tuberculosis, leprosy, malaria or even for disease prevention of nutritional actions and for immunization actions. However, the findings from this study document ways to approach access to medicines for poverty-related diseases.