Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.

The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO - artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm - needs-driven instead of market-driven -, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation.

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.

When the Zika virus burst onto the international scene in the second half of 2015, the development of diagnostic tools was seen as an urgent global health priority. Diagnostic capacity was restricted to a small number of reference laboratories, and none of the few available molecular or serological tests had been validated for extensive use in an outbreak setting. In the early weeks of the crisis, key funders stepped in to accelerate research and development efforts, and the WHO took responsibility for steering diagnostic standardization, a role it had successfully played during the West Africa Ebola virus outbreak. Yet when the WHO declared the end of the Zika Public Health Emergency of International Concern in November 2016, diagnostic capacity remained patchy, and few tools were available at the scale required in the countries that bore the brunt of the epidemic, particularly Brazil. This article analyses the limited impact of global R&D efforts on the availability of Zika diagnostic options where they were most needed and for those most vulnerable: women who might have been exposed to the virus during their pregnancy and children born with suspected congenital Zika syndrome. The truncated legacies of testing during the Zika crisis reveal some of the fault lines in the global health enterprise, particularly the limits of ‘emergency R&D’ to operate in geopolitical contexts that do not conform to the ideal type of a humanitarian crisis, or to tackle technical issues that are inextricably linked to domestic struggles over the scope and distribution of biological citizenship. Diagnostic shortcomings, we argue, lie at the heart of the stunning transformation, in less than two years, in the status of Zika: from international public health emergency to neglected disease.

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This article interrogates the relationship between the development of national diagnostic technologies and the exercise of sovereignty, by analysing a Brazilian project to produce a nucleic acid test (NAT) for the country’s blood screening programme. The concept of ‘molecular sovereignty’ is proposed to demonstrate that exercising sovereignty demands not only technological resources but also a sufficiently powerful and national imaginary to support local knowledge production as a means of advancing national healthcare priorities. First, this research article contextualises the political importance of blood safety for Brazil during its transition to democracy in the 1980s and the creation of its universal healthcare system. Then, it investigates how adopting the NAT led the state to invest in the production of a national technology. Third, the article unpacks the diagnostic test to consider how certain aspects of the project might ultimately strengthen the ability of global capital to cross national boundaries and create new markets. Lastly, it discusses how the project ended up creating a centralised and ‘closed’ system to avoid leaving the country vulnerable to the entry of global diagnostic companies. This case demonstrates how the molecularisation of blood, through the construction of a unified healthcare system driven by the constitutional right to health, can be deployed to construct imagined communities on the scale of a nation.