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

In this paper we will not analyze the responsibility for compensating or restoring the situation of patients for research-related injuries. The obligation in these cases is much less controversial. (See Schroeder D. , “Post-Trial Obligations,” Eletronic Journal of Communication Information & Innovation in Health 2, no. 1 [2006]). The duty to provide post-trial benefits for countries or communities will also not be discussed in this paper. On this topic, see CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Science, Geneva, 2002; Pace C. , “Post Trial Access to Tested Interventions: The Views of IRB/REC Chair, Investigators and Research Participants in a Multinational HIV/AIDS Study,” AIDS Research and Human Retroviruses 22, no. 9 (2006).

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Id. (Schroeder); Id. (Saver), at 439.

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See NBAC, supra note 10; Merritt Grady , supra note 10.

Id. (NBAC); see Schroeder , supra note 10.

Id. (Schroder); Nuffield Council on Bioethics, The Ethics of Research related to Health Care in Developing Countries, 2002; Ananworanich J. , “Creation of a Drug Fund for Post-Clinical Trial Access to Antiretrovirals,” The Lancet 364, no. 9428 (2004): 101–102.

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See Saver , supra note 10.

Id.

See Merritt Grady , supra note 10, at 1792.

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Id., at 1793.

See Saver , supra note 10.

Harada V. , “Introduction,” in Guarantee of Access to Post-Clinical Trial Drugs, Brazilian Association of Clinical Research Organizations, Sao Paulo, 2011; Eliaschewitz F. G. , “Access to Post-Clinical Trial Medication,” in Guarantee of Access to Post-Clinical Trial Drugs, Brazilian Association of Clinical Research Organizations, Sao Paulo, 2011; Dainesi S. , “Guarantee of Post-Study Access,” in Guarantee of Access to Post-Clinical Trial Drugs, Brazilian Association of Clinical Research Organizations, Sao Paulo, 2011.

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See NABC, supra note 10.

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See Schroeder , supra note 10.

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Id. (Shah).

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See Saver , supra note 10, at 412–413, 446.

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Article IV.1. Our free translation, from Portuguese, that reads as follows: L - Assegurar por parte do patrocinador ou, na sua inexistência, por parte da instituição, pesquisador ou promotor, acesso ao medicamento em teste, caso se comprove sua superioridade em relação ao tratamento convencional.

See Harada , supra note 23.

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On these cases, see Wang D. , Health Economics, Policy and Law Journal (2012, in press).

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See Ferraz , supra note 9.

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The complete version of the decision is available online, in Portuguese, available at <http://jurisprudenciabrasil.blogspot.com/2010/01/jurid-pesquisa-em-seres-humanos-130110.html> (last visited May 8, 2012).

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See Wang , supra note 45.

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See Millum , supra note 12, at 154.

See Grady , supra note 12; Shah , supra note 36, at 1560.