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

Journal of Law, Medicine and Ethics, 40 (2) (2012)

King's College London Law School Research Paper Forthcoming

17 Pages Posted: 4 Dec 2020

See all articles by Daniel Wang

Daniel Wang

Getulio Vargas Foundation (FGV) - Fundação Getulio Vargas Law School at São Paulo

Octavio Luiz Motta Ferraz

King's College London - The Dickson Poon School of Law

Date Written: 2012

Abstract

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.

Suggested Citation

Wang, Daniel and Ferraz, Octavio Luiz Motta, Pharmaceutical Companies vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil? (2012). Journal of Law, Medicine and Ethics, 40 (2) (2012), King's College London Law School Research Paper Forthcoming, Available at SSRN: https://ssrn.com/abstract=3709543 or http://dx.doi.org/10.2139/ssrn.3709543

Daniel Wang (Contact Author)

Getulio Vargas Foundation (FGV) - Fundação Getulio Vargas Law School at São Paulo ( email )

São Paulo
Brazil

Octavio Luiz Motta Ferraz

King's College London - The Dickson Poon School of Law ( email )

Somerset House East Wing
Strand
London, WC2R 2LS
United Kingdom

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