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Pharmaceutical companies vs. the State : who is responsible for post-trial provision of drugs in Brazil?
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Wang, Daniel Wei L. and Ferrez, O. L. M. (2012) Pharmaceutical companies vs. the State : who is responsible for post-trial provision of drugs in Brazil? The Journal of Law, Medicine & Ethics, Vol.40 (No.2). pp. 188-196. doi:10.1111/j.1748-720X.2012.00657.x ISSN 1748-720X.
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Official URL: http://dx.doi.org/10.1111/j.1748-720X.2012.00657.x
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.
Item Type: | Journal Article | ||||
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Divisions: | Faculty of Social Sciences > School of Law | ||||
Journal or Publication Title: | The Journal of Law, Medicine & Ethics | ||||
Publisher: | Wiley-Blackwell Publishing Ltd. | ||||
ISSN: | 1748-720X | ||||
Official Date: | 2012 | ||||
Dates: |
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Volume: | Vol.40 | ||||
Number: | No.2 | ||||
Page Range: | pp. 188-196 | ||||
DOI: | 10.1111/j.1748-720X.2012.00657.x | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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