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.

Assistência Farmacêutica e governança global da saúde em tempos de Covid-19 / Pharmaceutical Services and global health governance in times of COVID-19

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.

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia.

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.

Cooperação internacional: doações de medicamentos realizadas pelo governo brasileiro de 2005 a 2016

[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 farmacéuticas 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.

[ABSTRACT]. Objective. To perform a survey of international drug donations by the Brazilian government from 2005 to 2016, identifying the number of drug units donated and the corresponding financial amount. Method. This descriptive and exploratory study used secondary data available at the Brazilian Health Ministry’s Materials Management System (SISMAT). The following information was retrieved: requesting country, year of donation, drug donated, number or pharmaceutical unit donated, and corresponding amount (in Brazilian reais). Results. During the study period, 66 554 892 pharmaceutical units were donated, corresponding to R$ 84 371 308.72 (US$ 25 505 235.70). Drugs were donated to Angola, Benin, Bolivia, Burkina Faso, Cape Verde, Colombia, Ivory Coast, Cuba, El Salvador, Ecuador, Guatemala, Guiana, Republic of Guinea-Bissau, Haiti, Honduras, Libya, Mozambique, Nicaragua, Paraguay, Peru, Dominican Republic, Sao Tome and Principe, Syria, and Suriname, countries from the Caribbean Community and Common Market (CARICOM), and Pan-American Health Organization (PAHO). No distribution pattern was detected in quantitative terms. Peaks in the number of drugs donated were recorded in 2008, 2011, and 2012, with the largest number of countries receiving donations in 2006 (n=13) and 2012 (n=14). Drugs were donated for the treatment of HIV/Aids, malaria, leishmaniasis, diabetes, cholera, schistosomiasis, tuberculosis, influenza, opportunistic diseases, immunizations, nutrition support, and health conditions associated with natural disasters. Conclusions. The drugs donated by the Brazilian government included mostly antimicrobial agents used for the treatment of neglected tropical diseases. Further studies are suggested to correlate public health interventions with the donation of drugs as a means to promote the sustainable economic development of the recipient countries.

[RESUMEN]. Objetivo. Hacer un inventario de las donaciones internacionales de medicamentos del gobierno brasileño entre el 2005 y el 2016, estableciendo el número de unidades de medicamentos donadas y el monto económico que representa ese volumen. Métodos. Estudio descriptivo y exploratorio utilizando análisis de datos secundarios disponibles en el Sistema de Gestión de Materiales del Ministerio de Salud (SISMAT). Se recogió información sobre el país solicitante, año de la donación, medicamento, número de unidades farmacéuticas donadas y valor correspondiente (en reales brasileños). Resultados. En el período estudiado, se donaron 66 554 892 unidades de medicamentos, que corresponden a 84 371 308,72 reales (25 505 235,70 dólares). Se donaron medicamentos a Angola, Benin, Bolivia, Burkina Faso, Cabo Verde, Colombia, Côte d’Ivoire, Cuba, El Salvador, Ecuador, Guatemala, Guyana, Guinea Bissau, Haití, Honduras, Libia, Mozambique, Nicaragua, Paraguay, Perú, República Dominicana, Santo Tomé y Príncipe, Siria y Suriname, y a otros países miembros del Mercado Común y Comunidad del Caribe (CARICOM) y de la Organización Panamericana de la Salud (OPS). No se ha detectado ningún patrón de distribución en términos cuantitativos. Hubo picos en el número de medicamentos donados en el 2008, el 2011 y el 2012, con un mayor número de países receptores en el 2006 y el 2012 (13 y 14 países, respectivamente). Se donaron medicamentos para la infección por el VIH/sida, la malaria, la leishmaniasis, la diabetes, el cólera, la esquistosomiasis, la tuberculosis, la gripe aviar y las infecciones oportunistas, así como insumos para vacunaciones, apoyo nutricional y desastres. Conclusiones. La mayoría de los medicamentos donados eran antimicrobianos utilizados para el tratamiento de enfermedades tropicales desatendidas. Se sugiere llevar a cabo estudios adicionales para mostrar la relación entre las intervenciones de salud pública y las donaciones de medicamentos como forma de promover el desarrollo económico sostenible de los países beneficiarios.

[International cooperation: drugs donated by the Brazilian government, 2005-2016Cooperación internacional: donaciones de medicamentos del gobierno brasileño entre el 2005 y el 2016]. / Cooperação internacional: doações de medicamentos realizadas pelo governo brasileiro de 2005 a 2016.

OBJECTIVE: To perform a survey of international drug donations by the Brazilian government from 2005 to 2016, identifying the number of drug units donated and the corresponding financial amount. METHOD: This descriptive and exploratory study used secondary data available at the Brazilian Health Ministry's Materials Management System (SISMAT). The following information was retrieved: requesting country, year of donation, drug donated, number or pharmaceutical unit donated, and corresponding amount (in Brazilian reais). RESULTS: During the study period, 66 554 892 pharmaceutical units were donated, corresponding to R$ 84 371 308.72 (US$ 25 505 235.70). Drugs were donated to Angola, Benin, Bolivia, Burkina Faso, Cape Verde, Colombia, Ivory Coast, Cuba, El Salvador, Ecuador, Guatemala, Guiana, Republic of Guinea-Bissau, Haiti, Honduras, Libya, Mozambique, Nicaragua, Paraguay, Peru, Dominican Republic, Sao Tome and Principe, Syria, and Suriname, countries from the Caribbean Community and Common Market (CARICOM), and Pan-American Health Organization (PAHO). No distribution pattern was detected in quantitative terms. Peaks in the number of drugs donated were recorded in 2008, 2011, and 2012, with the largest number of countries receiving donations in 2006 (n=13) and 2012 (n=14). Drugs were donated for the treatment of HIV/Aids, malaria, leishmaniasis, diabetes, cholera, schistosomiasis, tuberculosis, influenza, opportunistic diseases, immunizations, nutrition support, and health conditions associated with natural disasters. CONCLUSIONS: The drugs donated by the Brazilian government included mostly antimicrobial agents used for the treatment of neglected tropical diseases. Further studies are suggested to correlate public health interventions with the donation of drugs as a means to promote the sustainable economic development of the recipient countries.

OBJETIVO: Hacer un inventario de las donaciones internacionales de medicamentos del gobierno brasileño entre el 2005 y el 2016, estableciendo el número de unidades de medicamentos donadas y el monto económico que representa ese volumen. MÉTODOS: Estudio descriptivo y exploratorio utilizando análisis de datos secundarios disponibles en el Sistema de Gestión de Materiales del Ministerio de Salud (SISMAT). Se recogió información sobre el país solicitante, año de la donación, medicamento, número de unidades farmacéuticas donadas y valor correspondiente (en reales brasileños). RESULTADOS: En el período estudiado, se donaron 66 554 892 unidades de medicamentos, que corresponden a 84 371 308,72 reales (25 505 235,70 dólares). Se donaron medicamentos a Angola, Benin, Bolivia, Burkina Faso, Cabo Verde, Colombia, Côte d'Ivoire, Cuba, El Salvador, Ecuador, Guatemala, Guyana, Guinea Bissau, Haití, Honduras, Libia, Mozambique, Nicaragua, Paraguay, Perú, República Dominicana, Santo Tomé y Príncipe, Siria y Suriname, y a otros países miembros del Mercado Común y Comunidad del Caribe (CARICOM) y de la Organización Panamericana de la Salud (OPS). No se ha detectado ningún patrón de distribución en términos cuantitativos. Hubo picos en el número de medicamentos donados en el 2008, el 2011 y el 2012, con un mayor número de países receptores en el 2006 y el 2012 (13 y 14 países, respectivamente). Se donaron medicamentos para la infección por el VIH/sida, la malaria, la leishmaniasis, la diabetes, el cólera, la esquistosomiasis, la tuberculosis, la gripe aviar y las infecciones oportunistas, así como insumos para vacunaciones, apoyo nutricional y desastres. CONCLUSIONES: La mayoría de los medicamentos donados eran antimicrobianos utilizados para el tratamiento de enfermedades tropicales desatendidas. Se sugiere llevar a cabo estudios adicionales para mostrar la relación entre las intervenciones de salud pública y las donaciones de medicamentos como forma de promover el desarrollo económico sostenible de los países beneficiarios.

Cooperação internacional: doações de medicamentos realizadas pelo governo brasileiro de 2005 a 2016 / International cooperation: drugs donated by the Brazilian government, 2005-2016 / Cooperación internacional: donaciones de medicamentos del gobierno brasileño entre el 2005 y el 2016

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.

ABSTRACT Objective. To perform a survey of international drug donations by the Brazilian government from 2005 to 2016, identifying the number of drug units donated and the corresponding financial amount. Method. This descriptive and exploratory study used secondary data available at the Brazilian Health Ministry's Materials Management System (SISMAT). The following information was retrieved: requesting country, year of donation, drug donated, number or pharmaceutical unit donated, and corresponding amount (in Brazilian reais). Results. During the study period, 66 554 892 pharmaceutical units were donated, corresponding to R$ 84 371 308.72 (US$ 25 505 235.70). Drugs were donated to Angola, Benin, Bolivia, Burkina Faso, Cape Verde, Colombia, Ivory Coast, Cuba, El Salvador, Ecuador, Guatemala, Guiana, Republic of Guinea-Bissau, Haiti, Honduras, Libya, Mozambique, Nicaragua, Paraguay, Peru, Dominican Republic, Sao Tome and Principe, Syria, and Suriname, countries from the Caribbean Community and Common Market (CARICOM), and Pan-American Health Organization (PAHO). No distribution pattern was detected in quantitative terms. Peaks in the number of drugs donated were recorded in 2008, 2011, and 2012, with the largest number of countries receiving donations in 2006 (n=13) and 2012 (n=14). Drugs were donated for the treatment of HIV/Aids, malaria, leishmaniasis, diabetes, cholera, schistosomiasis, tuberculosis, influenza, opportunistic diseases, immunizations, nutrition support, and health conditions associated with natural disasters. Conclusions. The drugs donated by the Brazilian government included mostly antimicrobial agents used for the treatment of neglected tropical diseases. Further studies are suggested to correlate public health interventions with the donation of drugs as a means to promote the sustainable economic development of the recipient countries.

RESUMEN Objetivo. Hacer un inventario de las donaciones internacionales de medicamentos del gobierno brasileño entre el 2005 y el 2016, estableciendo el número de unidades de medicamentos donadas y el monto económico que representa ese volumen. Métodos. Estudio descriptivo y exploratorio utilizando análisis de datos secundarios disponibles en el Sistema de Gestión de Materiales del Ministerio de Salud (SISMAT). Se recogió información sobre el país solicitante, año de la donación, medicamento, número de unidades farmacéuticas donadas y valor correspondiente (en reales brasileños). Resultados. En el período estudiado, se donaron 66 554 892 unidades de medicamentos, que corresponden a 84 371 308,72 reales (25 505 235,70 dólares). Se donaron medicamentos a Angola, Benin, Bolivia, Burkina Faso, Cabo Verde, Colombia, Côte d'Ivoire, Cuba, El Salvador, Ecuador, Guatemala, Guyana, Guinea Bissau, Haití, Honduras, Libia, Mozambique, Nicaragua, Paraguay, Perú, República Dominicana, Santo Tomé y Príncipe, Siria y Suriname, y a otros países miembros del Mercado Común y Comunidad del Caribe (CARICOM) y de la Organización Panamericana de la Salud (OPS). No se ha detectado ningún patrón de distribución en términos cuantitativos. Hubo picos en el número de medicamentos donados en el 2008, el 2011 y el 2012, con un mayor número de países receptores en el 2006 y el 2012 (13 y 14 países, respectivamente). Se donaron medicamentos para la infección por el VIH/sida, la malaria, la leishmaniasis, la diabetes, el cólera, la esquistosomiasis, la tuberculosis, la gripe aviar y las infecciones oportunistas, así como insumos para vacunaciones, apoyo nutricional y desastres. Conclusiones. La mayoría de los medicamentos donados eran antimicrobianos utilizados para el tratamiento de enfermedades tropicales desatendidas. Se sugiere llevar a cabo estudios adicionales para mostrar la relación entre las intervenciones de salud pública y las donaciones de medicamentos como forma de promover el desarrollo económico sostenible de los países beneficiarios.