Value regimes and pricing in the pharmaceutical industry: financial capital inflation (hepatitis C) versus innovation and production capital savings for malaria medicines.

The idea of this paper is to draw a parallel between two diametrically opposed political economies of medicine that coexist today. The first is embodied in the invention, appropriation, and distribution of antivirals for hepatitis C, particularly sofosbuvir, which was commercialized at an initial price of $85,000 in the United States, €56,000 in France, and $8000 in Brazil. These prices destabilized payers in both the North and the South. The second economy encompasses the invention, industrialization and distribution of new therapeutic combinations for malaria that were commercialized by Sanofi from 2007 onwards at a price of $1 per treatment for public markets. This price was set by a contract negotiated with Médecins sans Frontières. In this paper, I examine the pricing of these 2 classes of drugs, and I argue that the prices synthesize these political economies: they summarize the policy of appropriation of these molecules, aimed at their monopolization or a model of common good; they are referred to economic value regimes designed to optimize the profitability of advanced capital or to increase the accessibility of drugs for public payers and patients; and they are justified or contested by moral economies.

A incorporação do teste diagnóstico baseado na amplificação de ácidos nucleicos (NAT) para triagem de sangue no SUS: arranjos tecnológicos para a nacionalização do "NAT brasileiro" / The introduction of nucleic acid tests (NAT) for blood screening in the Brazilian public healthcare system: technological arrangements for the nationalization of the "Brazilian NAT"

Resumo Os testes de ácidos nucleicos (NAT) são ferramentas complementares aos testes sorológicos para controle da transmissão de doenças infecciosas por meio de produtos obtidos a partir do sangue. Em 2002, um decreto do Ministério da Saúde tornou obrigatória a realização do NAT por todos os bancos de sangue, medida dificultada por razões como os custos necessários para a sua implantação. Como estratégia para a sua incorporação nos bancos de sangue ligados ao SUS, um consórcio público foi criado para desenvolver uma versão local do kit. A partir de métodos de pesquisa qualitativa, os autores analisam essa iniciativa, visando esmiuçar os detalhes da "nacionalização tecnológica" de um teste diagnóstico in vitro. O artigo descreve como o consórcio compreende o kit e como cada uma das tecnologias que o compõem são obtidas e reunidas no teste brasileiro. A relevância dessa análise é identificar quais os desafios e os limites à produção de testes in vitro para doenças infecciosas no Brasil, assim como a repercussão desse tipo de iniciativa para o sistema nacional de inovação em saúde.

Abstract Nucleic acid based amplification tests (NAT) are employed as complementary tools to control the transmission of infectious diseases through contaminated blood. In 2002, a decree from the Brazilian Ministry of Health made compulsory the use of NAT by all the blood services in the country, a measure that was challenged by costs related to the test incorporation. As the strategy to introduce the test in the blood banks serving the public healthcare system (Sistema Único de Saúde), a public Consortium was constituted to develop a local version of the kit. On the basis of qualitative fieldwork, the authors investigate the strategies used by the Brazilian laboratories and universities to nationalize the kit through capturing and assembling its various components. The paper contributes to revealing the challenges and limits to the production of in vitro tests for infectious diseases in Brazil, as well as the repercussion of such an initiative to the national healthcare innovation system.

Producing, controlling, and stabilizing Pasteur's anthrax vaccine: creating a new industry and a health market.

When Pasteur and Chamberland hastily set up their small biological industry to meet the agricultural demand for the anthrax vaccine, their methods for preparation and production had not yet been stabilized. The process of learning how to standardize biological products was accelerated in 1882 when vaccination accidents required the revision of production norms as the first hypotheses on fixity, inalterability, and transportability of vaccines were invalidated and replaced by procedures for continuous monitoring of the calibration of vaccines and the renewal of vaccine strains. Initially, the incompleteness and ongoing development of production standards justified Pasteur's monopoly on the production of the anthrax vaccine under his immediate supervision. Later on, the Pasteur Institute maintained control of these standards in the framework of a commercial monopoly that it established on the veterinary vaccines first sent and then cultivated abroad by the Société de Vulgarisation du Vaccin Charbonneux Pasteur, founded in 1886.

Appropriation and commercialization of the Pasteur anthrax vaccine.

Whereas Pasteur patented the biotechnological processes that he invented between 1857 and 1873 in the agro-food domain, he did not file any patents on the artificial vaccine preparation processes that he subsequently developed. This absence of patents can probably be explained by the 1844 patent law in France that established the non-patentable status of pharmaceutical preparations and remedies, including those for use in veterinary medicine. Despite the absence of patents, the commercial exploitation of the anthrax vaccine in the 1880s and 1890s led to a technical and commercial monopoly by Pasteur's laboratory as well as the founding of a commercial company to diffuse the vaccine abroad. Pasteur repeatedly refused to transfer his know-how and anthrax vaccine production methods to foreign laboratories, on the grounds that he wished to control the quality of the vaccines produced. Indeed, it was relatively difficult to transfer a method that was not yet perfectly stabilized in the early 1880s. Pasteur also wanted to maintain the monopoly of his commercial company and to increase the profits from vaccine sales so that the Institut Pasteur could be financially independent. The 'Pasteur anthrax vaccine' operating licences are described and analysed in detail in this article.