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1.
Preprint in Portuguese | SciELO Preprints | ID: pps-6303

ABSTRACT

The construction of public policies for the prevention and treatment of HIV/AIDS in Brazil is a history of struggle that unites sanitarians, researchers and activists since the 1980s. An important part of this path is linked to the production and distribution of antiretroviral drugs (ARV), initiatives to reduce the price of ARVs and civil society mobilizations for the guarantee of rights, which contributed to create one of the most successful programs to combat the disease in the country. world. Based on this history, this study aimed to analyze government spending on the acquisition of selected ARVs in the period between 2005 and 2020, making a comparison with international prices, in the light of determinants related to patent disputes, voluntary licensing, PDPs and ARV price reduction initiatives. Among other results, it was possible to observe that there was no immediate relationship between the end of the patent concession and the reduction of prices. Filings of other patent applications and the lack of nationally registered competitors, even after patent expiration, can be significant factors in maintaining high prices.


A construção de políticas públicas para a prevenção e tratamento do HIV/Aids no Brasil é uma história de luta que une sanitaristas, pesquisadores e ativistas desde os anos 1980. Parte importante desse caminho está ligado à produção e distribuição de medicamentos antirretrovirais (ARV), iniciativas de redução do preço dos ARV e mobilizações da sociedade civil pela garantia de direitos, que contribuíram para criar um dos programas mais bem-sucedidos de combate à doença no mundo. Com base nesse histórico, este trabalho teve por objetivo analisar os gastos governamentais na aquisição de ARV selecionados no período entre 2005 e 2020, fazendo uma comparação com preços internacionais, à luz dos determinantes relacionados às disputas patentárias, ao licenciamento voluntário, às PDPs e às iniciativas para redução de preços de ARVs. Entre outros resultados, foi possível observar que não houve uma relação imediata entre o fim da concessão patentária e a redução de preços. Depósitos de outros pedidos de patente e a inexistência de concorrentes registrados nacionalmente, mesmo após a expiração da patente, podem ser fatores significativos para a manutenção de altos preços.

2.
PLoS One ; 16(3): e0247853, 2021.
Article in English | MEDLINE | ID: mdl-33667235

ABSTRACT

BACKGROUND: This study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since its first marketing authorization. METHODS: A retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization. RESULTS: Our search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion's revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company's portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues. DISCUSSION: Our findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.


Subject(s)
Antibodies, Monoclonal, Humanized , Drug Approval , Orphan Drug Production , Brazil , Humans , Retrospective Studies
3.
Rev Saude Publica ; 54: 22, 2020.
Article in English, Portuguese | MEDLINE | ID: mdl-32130309

ABSTRACT

OBJECTIVES: This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS: Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS: All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION: Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.


Subject(s)
Antibodies, Monoclonal, Humanized/economics , Federal Government , Health Expenditures , Brazil , Complement Inactivating Agents , Drug and Narcotic Control/economics , Drug and Narcotic Control/legislation & jurisprudence , Government Agencies , Humans
4.
Rev. saúde pública (Online) ; 54: 22, 2020. tab, graf
Article in English | LILACS | ID: biblio-1094420

ABSTRACT

ABSTRACT OBJECTIVES This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, and prices. METHODS Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis. RESULTS All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices. CONCLUSION Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.


RESUMO OBJETIVOS O estudo examinou as aquisições de eculizumabe, um anticorpo monoclonal de alto custo utilizado no tratamento de doenças raras, pelos órgãos federais brasileiros, em termos das quantidades compradas, gastos e preços. MÉTODOS Foram analisadas compras de eculizumabe realizadas entre março de 2007 e dezembro de 2018, por meio de dados secundários extraídos do sistema de compras do governo federal (Siasg). Foram examinados o número de compras, quantidades adquiridas, número de doses diárias definidas por 1.000 habitantes por ano, gastos anuais e preços praticados. Os preços foram corrigidos pelo índice nacional de preços ao consumidor amplo para dezembro de 2018. Regressão linear foi utilizada para análises de tendência. RESULTADOS Todas as aquisições por órgãos federais foram realizadas pelo Ministério da Saúde. As compras se iniciaram em 2009, sendo efetuadas por dispensa de licitação e para atendimento de demanda judicial. Houve tendência crescente no número de compras e quantidades adquiridas ao longo do tempo. Foram realizadas 283 compras, totalizando 116.792 unidades adquiridas, 28,2% compradas em 2018. Os gastos totais contratados corrigidos somaram mais de R$ 2,44 bilhões. Após a aprovação do registro pela Agência Nacional de Vigilância Sanitária, o preço médio ponderado caiu aproximadamente 35%, para valores abaixo dos preços estabelecidos pela Câmara de Regulação do Mercado de Medicamentos. CONCLUSÃO O eculizumabe representou gastos extremamente significativos para o Ministério da Saúde no período. Todas as compras foram feitas para atendimento de demandas judiciais, fora do ambiente competitivo. Seu registro promoveu queda importante nos preços praticados. O estudo aponta a relevância do registro sanitário e da necessidade de monitoramento e auditoria permanentes das compras de medicamentos para atendimento de demandas judiciais.


Subject(s)
Humans , Health Expenditures , Federal Government , Antibodies, Monoclonal, Humanized/economics , Brazil , Drug and Narcotic Control/legislation & jurisprudence , Complement Inactivating Agents , Complement Inactivating Agents/economics , Government Agencies
5.
Physis (Rio J.) ; 28(1): e280107, 2018.
Article in Portuguese | LILACS | ID: biblio-895650

ABSTRACT

Resumo O artigo aborda o problema do acesso aos medicamentos ARVs e a construção da agenda de lutas do movimento social da AIDS, especificamente o caso do tenofovir, suas pró-drogas e a combinação com a emtricitabina. Discute de que estratégias o movimento AIDS lançou mão para evitar que tais medicamentos fossem patenteados, utilizando o método monográfico e a posição de insider do autor para fazer a análise.


Abstract This article brings the issue of access to ARV drugs and the construction of the struggles agenda of the Aids social movement regarding the tenofovir case as well as its prodrugs and the combination with emtricitabine. The article discusses which strategies the HIV movement used to avoid the patenting of such drugs, using the monographic method and the author's inside position to conduct this analysis.


Subject(s)
Access to Essential Medicines and Health Technologies , Acquired Immunodeficiency Syndrome , Brazil , HIV , Intellectual Property of Pharmaceutic Products and Process , Political Activism , Tenofovir
6.
Article in Portuguese | ECOS, Coleciona SUS | ID: biblio-1014906

ABSTRACT

Este artigo analisa a recente proposta de norma do Ministério da Indústria, Comércio Exterior e Serviços (MDIC) e do Instituto Nacional da Propriedade Industrial (Inpi) que dispõe sobre o procedimento simplificado de deferimento de pedidos de patente. Os autores reconhecem que o backlog é um importante entrave do sistema de patentes no Brasil, mas argumentam que optar por uma solução à revelia do rigor legal necessário para concessão de patentes, possibilitando a concessão automática desses pedidos, não pode ser, em hipótese alguma, a solução. Deve-se, portanto, demandar a existência de quadro funcional suficiente, qualificado e com condições necessárias para verificação do cumprimento das normas jurídicas estabelecidas no país.


Subject(s)
Drug Industry , Patent , Intellectual Property , Government Regulation
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