RESUMEN
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.
RESUMEN
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.
ABSTRACT 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.
RESUMEN
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.
RESUMEN
Abstract The COVID-19 pandemic puts the healthcare systems at risk due to the still uncertain operational and financial impacts of it. The difficult economic conditions of the population also call for more attention from government officials to define strategies that guarantee access to health services and products. Maintaining the supply chain of pharmaceutical products is not only paramount to cover the immediate medical response but will be fundamental to reducing disruption of the healthcare system. Increasing drug prices during the pandemic is definitely not a strategy that contributes to access. In this sense, this commentary presents a criticism of a decision by the Brazilian government that may impact the availability in health services and the population's access to medicines necessary for the maintenance of life.
RESUMEN
This study shows a descriptive data analysis related to the procurement of medicines for primary care in Brazilian municipalities, as recorded in the National database of Pharmaceutical Service Actions and Services for the period July 2013 - June 2014, by geographic region and population size. Nine hundred and sixty municipalities were analyzed, of which 27% invested monetary value equal to or greater than the minimum statutory recommendations and 43% of these are located in the Southeast. The North region has the highest number of municipalities with less investment. Municipalities with a population over 500,000 inhabitants used, on average, lower resources to provide more items to users. The average number of items purchased was 86 and represents 25% of the National List of Essential Medicines (Rename); 64% had a decentralized resource management and the most commonly used procurement method was "tender". The most purchased drugs are in line with the most prevalent primary care diseases. Findings showed that most municipalities invests below statutory recommendations and are located mainly in the North, Northeast and Midwest. It was not possible to establish a trend between population and amount invested per capita/year.
Asunto(s)
Medicamentos Esenciales/economía , Gastos en Salud/estadística & datos numéricos , Preparaciones Farmacéuticas/economía , Atención Primaria de Salud/economía , Brasil , Ciudades , Estudios Transversales , Humanos , Estudios RetrospectivosRESUMEN
Resumo Este estudo tem por objetivo analisar o valor financeiro aplicado por habitante/ano em municípios brasileiros para aquisição de medicamentos do Componente Básico da Assistência Farmacêutica, segundo porte populacional e região geográfica do país. Foi realizada análise descritiva dos dados de aquisição de medicamentos, registrados na Base Nacional de Dados das Ações e Serviços de Assistência Farmacêutica, no período de julho de 2013 a junho de 2014 (n = 960). A grande maioria dos municípios (73%) aplicou um valor por habitante/ano menor do que o mínimo recomendado pela legislação vigente e, desses, 47% possuem até 20 mil habitantes. Verificou-se também que a região Norte é a que possui maior número de municípios com menor aplicação de recursos e que os da região Sudeste, em média, aplicaram um valor por habitante/ano maior e adquiriram mais itens do que aqueles das demais regiões. As disparidades regionais e demográficas na aplicação de recursos financeiros trazem como reflexão a importância da rediscussão do modelo de financiamento da assistência farmacêutica básica e da responsabilidade das esferas do SUS na gestão eficiente desse recurso para prover o acesso a medicamentos à população.
Abstract This study shows a descriptive data analysis related to the procurement of medicines for primary care in Brazilian municipalities, as recorded in the National database of Pharmaceutical Service Actions and Services for the period July 2013 - June 2014, by geographic region and population size. Nine hundred and sixty municipalities were analyzed, of which 27% invested monetary value equal to or greater than the minimum statutory recommendations and 43% of these are located in the Southeast. The North region has the highest number of municipalities with less investment. Municipalities with a population over 500,000 inhabitants used, on average, lower resources to provide more items to users. The average number of items purchased was 86 and represents 25% of the National List of Essential Medicines (Rename); 64% had a decentralized resource management and the most commonly used procurement method was "tender". The most purchased drugs are in line with the most prevalent primary care diseases. Findings showed that most municipalities invests below statutory recommendations and are located mainly in the North, Northeast and Midwest. It was not possible to establish a trend between population and amount invested per capita/year.
