Journal of Law, Medicine and Ethics 40 (2):188-196 (2012)
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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
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DOI | 10.1111/j.1748-720X.2012.00657.x |
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References found in this work BETA
Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
The Ethics of Research Related to Health Care in Developing Countries.J. R. McMillan - 2004 - Journal of Medical Ethics 30 (2):204-206.
Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?Z. Zong - 2008 - Journal of Medical Ethics 34 (3):188-192.
Citations of this work BETA
Attitudes Toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines. [REVIEW]Kori Cook, Jeremy Snyder & John Calvert - 2016 - Developing World Bioethics 16 (2):70-79.
Post‐Trial Obligations in the Declaration of Helsinki 2013: Classification, Reconstruction and Interpretation.Ignacio Mastroleo - 2016 - Developing World Bioethics 16 (2):80-90.
Human Dignity as a Basis for Providing Post-Trial Access to Healthcare for Research Participants: A South African Perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
Modelo de reciprocidad democrática: una justificación de la continuidad de tratamiento beneficioso en la investigación clínica.Ignacio Mastroleo - 2016 - Journal of Science Humanities and Arts 3 (7):1-33.
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