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In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow. [ABSTRACT FROM AUTHOR]

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies. [ABSTRACT FROM AUTHOR]

Recent studies of the Brazilian case suggest that successful litigation can have regressive effects and negatively impact the health care system. While the data to support this claim is not conclusive, this paper assumes that such immediate regressive effects are indeed taking place, but asks if these are the only consequences that should be analyzed in assessing the impact of right to health litigation in Brazil. The answer is no. The current perspective adopted to assess right to health litigation in Brazil is too narrow. Other consequences can and should be considered in analyzing the overall impact of litigation. To go beyond the set of questions asked by the existing experts on the topic, this paper analyzes whether the right to health litigation in Brazil has the potential, and could be generating: (i) policy changes within the health care system; (ii) institutional changes within the health care system; and (iii) institutional changes outside the health care system. After presenting anecdotal evidence that suggests these three types of changes may be happening in Brazil, I conclude the paper by discussing what would be required to assess them, and how these changes may affect our overall assessment of the more immediate and supposedly negative impact that litigation has had on the system. [ABSTRACT FROM AUTHOR]

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. [ABSTRACT FROM AUTHOR]

This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, the conclusion summarizes the information in the article and its contribution to the study of the biobanking ethical challenges, especially the protection of privacy. It is highlighted that biobanking regulatory harmonization among countries is necessary, since it increases scientific possibilities that can come from broader cooperation among biobanks and several research centers on the national and international levels. [ABSTRACT FROM AUTHOR]

This article explores the effectiveness of the decision of the Committee on the Elimination of Discrimination against Women in the case of Alyne da Silva Pimentel Teixeira (deceased) v. Brazil, concerning a poor, Afro-Brazilian woman. This is the first decision of an international human rights treaty body to hold a state accountable for its failure to prevent an avoidable death in childbirth. Assessing the future effectiveness of this decision might be undertaken concretely by determining the degree of Brazil's actual compliance with the Committee's recommendations, and how this decision influences pending domestic litigation arising from the maternal death. Alternative approaches include: determining whether, over time, the decision leads to the elimination of discrimination against women of poor, minority racial status in the health sector, and if it narrows the wide gap between rates of maternal mortality of poor, Afro-Brazilian women and the country's general female population. Determining the effectiveness of this decision will guide whether to pursue a more general strategy of judicializing maternal mortality. [ABSTRACT FROM AUTHOR]

Access to medicines faces a new legal threat: 'border enforcement' of drug patents. Using Brazil as an example, this article shows how the right to health depends on international trade. Border seizures of generic drugs present human rights and trade institutions with a unique challenge. Can public health advocates rise to meet it? [ABSTRACT FROM AUTHOR]

An introduction is presented which discusses various reports within the issue on topics including the right to health, Brazil's global model for health care access, and the responsibilities of pharmaceutical companies in 2012.