Pharmaceutical Companies vs. the State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?

• Published in: The Journal of law, medicine & ethics Vol. 40; no. 2; pp. 188 - 196
• Main Authors: Wang, Daniel Wei L., Ferraz, Octavio Luiz Motta
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 22-06-2012; SAGE Publications; Sage Publications, Inc; Cambridge University Press
• Subjects: Brazil; Clawback; Clinical trials; Companies; Constitutions; Courts; Drug Industry - ethics; Drug Industry - legislation & jurisprudence; Drugs; Ethics; Government regulation; Guidelines as Topic; Health policy; Health Services Accessibility - ethics; Health Services Accessibility - legislation & jurisprudence; Health technology assessment; Humans; International Cooperation; Laws, regulations and rules; Markets; Medical research; Medicine; National Health Programs - ethics; National Health Programs - legislation & jurisprudence; Patient Rights - ethics; Patient Rights - legislation & jurisprudence; Patients; Pharmaceutical industry; Pharmaceutical research; Political science; Public health; Research ethics; Research Subjects - legislation & jurisprudence; Responsibility; Social Responsibility; Brazil
• ISSN: 1073-1105; 1748-720X
• DOI: 10.1111/j.1748-720X.2012.00657.x

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.