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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]