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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]

In Brazil, in spite of advances in the field of pharmaceutical care, problems in assurance, by the State, of access to medicines persist. Since the early 1990s, the judicial demand of medicines by citizens has increased. The lawsuits demand medicines that are out-of-stock in the public sector as well as medicines that have not yet been incorporated by the Brazilian Health System. This phenomenon may be analyzed under different perspectives, including the health perspective, which is basically related to health outcomes for these individuals. This paper discusses the main characteristics of judicial demands, especially regarding the rational use of medicines, the use of scientific evidence to examine and substantiate the intended therapeutic use, and the justification of litigation as a means of access to medicines, in light of the concepts of access adopted by the field of pharmaceutical services in Brazil. Health risks to individuals demanding medicines through the Judiciary must be scrutinized when the demanded medicines do not belong to essential medicines lists, when their indication may be viewed as off-label, or if they have not obtained market approval in the country. The assumption is that the Judicial System aims to warrant the health of plaintiffs and in this ultimately the dignity of the individual. But this objective will only be met if in guaranteeing health all aspects of safety for the individual are involved, including the use of medicines. [ABSTRACT FROM AUTHOR]

Background: To guarantee the right to health, the health system must also ensure access to medicines. Several financial arrangements to provide these technologies are implemented and range from the direct (either total or partial) to indirect payment by the patient, being necessary to evaluate its effect on access to medicines. However, to ensure access to medicines is not just about ensuring its availability, as this only materializes in its use. Thus, evaluation studies of interventions in access to medicines have been using indicators related to the health results and use of health services as its outcomes. Furthermore, as this relationship is not direct, it is important to critically assess the adequacy of these tools to measure this phenomenon and, additionally, the ability to use it in the Brazilian scenario. Therefore, this study sought to identify, describe, and analyze the use of these indicators as medicine access outcomes, through a review of the scientific literature. Methods: An extensive literature review was done using a bibliographic database for a systematic review. The references were selected based on inclusion and exclusion criteria, and the indicators from the papers retained were analyzed using the parameters of validity, measurability, reliability, and relevance. Results: We have analyzed over 12,000 references of which 30 references were included, describing the use of 49 health outcomes and health service use indicators. The majority reported the use of health service utilization measures. In our evaluation, the best indicators for assessing the effects of co-payment intervention on access are the ones aimed at specific populations or symptomatic health conditions in which the response to the therapeutic treatment is known and occurs in a short period of time. It was evident the lack of information on the indicators analyzed as well as the limitation of the Brazilian secondary databases for its calculation. Conclusions: This research showed the variety and heterogeneity of the indicators used in scientific studies. The best indicators for access to medicines are sought to measure the use of health services for symptomatic health conditions that are quickly responsive to pharmacological treatment, while the indicators related to worker productivity loss was the most suitable for health outcomes. [ABSTRACT FROM AUTHOR]