Judicialization of access to medicines: analysis of lawsuits in the state of Rio Grande do Norte, Brazil

This study aimed to analyze the lawsuits demanding access to medicines in the state of Rio Grande do Norte, Brazil, from 2013 to 2017, describing their sociodemographic, legal, and medical/health characteristics. This was a descriptive study in which the unit of analysis was the individual judicial process for requesting medicines in which the state was the defendant. The data were obtained by consulting the website of the Rio Grande do Norte Court of Justice. A total of 987 suits were analyzed, in which the majority of the plaintiffs were females (58.8%), with a mean age of 48.3 years, and residing in the state’s interior (56.9%). The legal aid was predominantly public (52.8%), and 38.1% of the prescriptions originated in the private healthcare sector. Access to the medicines was obtained in 68% of the cases, and the plaintiff was responsible for the purchase in 56.1%, via attachment of public funds. Chronic noncommunicable diseases predominated, as did demands for medicines not supplied by the Brazilian Unified National Health System (SUS). A total of 1,517 medicines were requested, of which 936 (61.7%) were not on the National List of Essential Medicines (Rename). The most frequently demanded drug was insulin glargine (74 case). Of the 10 medicines with the most lawsuits, four were later incorporated by the SUS, featuring insulin analogues. The results showed that legal recourse has been consolidated as a form of access to medicines that have still not been incorporated by the SUS, which can contribute as a form of pressure for such incorporation. The attachment of public funds to comply with these rulings is worrisome for the administration of the SUS, since it jeopardizes the execution of regularly scheduled and budgeted policies in pharmaceutical assistance.

本研究旨在分析2013年至2017年巴西北里奥格兰德州（Rio Grande do Norte）范围内涉及药品获取诉求的诉讼案件，对其社会人口学、法律及医学/健康相关特征进行描述。本研究为描述性研究，分析单位为以该州为被告的药品诉求个人司法程序。研究数据通过查询北里奥格兰德州法院官网获取。本次共分析987起诉讼案件，其中原告以女性居多（占比58.8%），平均年龄48.3岁，且56.9%的原告居住于该州内陆地区。法律援助以公共法律援助为主（占比52.8%），38.1%的处方来自私立医疗保健机构。68%的案件中原告成功获取所需药品，其中56.1%的案件由原告通过公共资金拨付承担购药费用。慢性非传染性疾病相关诉求占比最高，未由巴西统一国家卫生系统（Sistema Único de Saúde，简称SUS）供应的药品诉求同样占据多数。本次共诉求1517种药品，其中936种（61.7%）未纳入国家基本药物清单（Relação Nacional de Medicamentos Essenciais，简称Rename）。诉求频次最高的药品为甘精胰岛素（共74起案件）。在诉讼量排名前十的药品中，有4种后续被SUS纳入供应范围，其中包括胰岛素类似物。研究结果显示，司法途径已成为获取尚未被SUS纳入供应范围的药品的成熟渠道，这可作为推动此类药品纳入SUS的施压手段。为执行此类判决而划拨公共资金的做法，对SUS的管理而言令人担忧，因为这会损害制药援助领域既定规划及预算政策的执行。