Abortion and misoprostol : health practices and scientific controversy

Este artigo coloca em perspectiva a controvérsia entre a associação do uso de misoprostol para aborto e teratogenicidade, encontrada em estudos do tipo relato de caso, e a consagração do uso de medicamentos à base do fármaco na área médico-obstétrica e em documentos normativos nacionais e internacionais que regulam o registro e a circulação de produtos farmacêuticos. Através do método monográfico, foram revisados, sistematizados e analisados documentos oficiais da Anvisa, Ministério da Saúde e Organização Mundial da Saúde sobre o uso do misoprostol, bem como 68 artigos do tipo relato de casos clínicos, publicados em periódicos científicos nacionais, que associam aborto, misoprostol e teratogenicidade. A interdição legal do aborto impede a prescrição e o uso adequados de uma droga que produz efeitos eficazes e seguros como o misoprostol. Assim, o grande malefício à saúde de mulheres está ligado não a características intrínsecas ao fármaco, mas a argumentos morais que representam descaso e desrespeito aos direitos fundamentais de mulheres.This article puts into perspective the controversy between the association of the use of misoprostol for abortion and teratogenicity studies of the type found in a case report. The use of herbal medicinal drugs and the medical-obstetric and national and international norms governing the registration and circulation of pharmaceutical products were examined. Official documents of ANVISA, the Ministry of Health and the World Health Organization on the use of misoprostol, as well as 68 articles such as case reports published in national journals, linking abortion, misoprostol and teratogenicity were reviewed, systematically filed and analyzed using the monographic method. The legal prohibition of abortion prevents the proper prescription and use of a drug such as misoprostol that is both safe and effective. Thus, the danger for the health of women is linked not to the intrinsic characteristics of the drug, but to the moral arguments that constitute negligence and disregard for the fundamental rights of women

O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde

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$2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35$ 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 judiciai

The strategy of pharmaceutical patent protection: the case of atazanavir

The high costs of antiretroviral drugs (ARVs) justifies studies on pharmaceutical patenting strategies vis-à-vis the Brazilian public policy of universal access to ARVs. The analysis of the evolution of technology trends through patent study also provides an overview of those involved in the development of a technology. To trace the patenting profile of atazanavir antiretroviral in Brazil and in the world, a study was conducted using Thomson Reuters Integrity database and such study identified the development, production and marketing of this product. 49 patent documents were identified, having been started the protection of this technology in 1996 with Novartis and its licensee Bristol, which claimed protection for the molecule. It remains until 2013, with protection of incremental inventions originating in China. The study has allowed to discuss the importance of the patent system to promoting innovation, and to highlight different types of protection for a product and related technologies

Registro, incorporação tecnológica e produção pública de medicamento: estudo sobre o atazanavir

Brazil was one of the first countries in the Global South to include in its public health policies robust control measures against HIV/Aids. Thus, in 2015, approximately 450,000 patients were under treatment by the Unified Health System. The sanitary registration is a crucial step for the drug entry into the domestic market, what configures a very favorable element for the drug access. Several sectors of society, even if based on different reasons, act in favor of the incorporation of new technologies; this fact, ultimately, favorably weighs in controlling the epidemic. In this work the atazanavir antiretroviral cycle is discussed through a descriptive documental study; that cycle involves: the selection of the drug by therapeutic consensus; the sanitary registration; and the definition of technological incorporation strategies for a national drug production. In 2003, the registration of atazanavir was granted in Brazil: only three months after being granted by the FDA in America and only five and a half months before being granted in Europe. This resulted in the rapid inclusion in the recommendations and in a therapeutic consensus being adopted in Brazil as the preferred drug (1st choice) in 2004. Moreover, atazanavir’s development became the object of a public-private partnership –known as Productive Development Partnership (PDP)-, inside the hegemonic policy of adopting new health technologies, defined by the Ministry of Health.O Brasil foi um dos primeiros países do Sul Global a incluir em suas políticas de saúde pública robustas medidas de controle contra a epidemia de HIV/Aids. Assim, em 2015, cerca de 450 mil pacientes encontravam-se em tratamento no Sistema Único de Saúde. O registro sanitário é uma etapa crucial para entrada do medicamento no mercado nacional, configurando elemento muito favorável ao acesso. Vários setores da sociedade, ainda que baseados em interesses diversos, atuam em prol da incorporação de novas tecnologias que acabam por pesar favoravelmente no controle da epidemia. Nesse trabalho, por meio de um estudo documental descritivo, foi discutido o ciclo do antirretroviral atazanavir, entendido como um ciclo que envolve a seleção do medicamento pelo consenso terapêutico, o registro sanitário e a definição das estratégias de incorporação tecnológica para a produção nacional do medicamento. O registro do atazanavir no Brasil foi concedido em 2003, três meses após ter sido obtido no FDA e cinco meses e meio antes de ser concedido na Europa. Esses fatores resultaram em sua rápida inclusão nas recomendações no consenso terapêutico brasileiro, que o adotou como medicamento preferencial (1ª escolha), em 2004. Ademais, o atazanavir se tornou objeto de uma parceria público privada para o desenvolvimento do produto, dentro da política hegemônica de incorporação de novas tecnologias em saúde definida pelo Ministério da Saúde, a chamada Política para o Desenvolvimento Produtivo (PDP)

The “Abortion Pill” Misoprostol in Brazil: Women’s Empowerment in a Conservative and Repressive Political Environment

International audienceIn the aftermath of the introduction of severe restrictions on abortion in several US states, some activists have argued that providing widespread access to an abortive drug, misoprostol, will transform an induced abortion into a fully private act and therefore will empower women. In Brazil, where abortion is criminalized, the majority of women who wish to terminate an unwanted pregnancy already use the illegal, but easily accessible, misoprostol. We examine the history of misoprostol as an abortifacient in Brazil from the late 1980s until today and the professional debates on the teratogenicity of this drug. The effects of a given pharmaceutical compound, we argue, are always articulated, elicited, and informed within dense networks of sociocultural, economic, legal, and political settings. In a conservative and repressive environment, the use of misoprostol for self-induced abortions, even when supported by formal or informal solidarity networks, is far from being a satisfactory solution to the curbing of women’s reproductive rights