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

Published online by Cambridge University Press:  01 January 2021

Daniel Wei L. Wang  and
Octavio Luiz Motta Ferraz
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Extract

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 2 , Summer 2012 , pp. 188 - 196
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

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. et al. , “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).Google Scholar
Ribbink, K., “Ola Brazil: Latin America's Biggest Market Accelerates,” Pharma Voice, January 2011.Google Scholar
IMS, “Pharmerging Shake-Up: New Imperatives in a Redefined World,” IMS Health, 2011.Google Scholar
BRICs stand for Brazil, Russia, India, and China — four of the leading emerging economies in the world.Google Scholar
See IMS, supra note 3.Google Scholar
Id.Google Scholar
Lima, M., “Ponto de vista – pesquisa clínica no Brasil,” Scentryphar Clinical Research, 2005, available at <http://www.scentryphar.com/portugues/media/pesquisa__clinica.htm> (last visited May 9, 2012).+(last+visited+May+9,+2012).>Google Scholar
Brazil, , Federal Constitution at Article 196, available at <http://www.planalto.gov.br/ccivil_03/constituicao/constitui%C3%A7ao.htm> (last visited May 22, 2012).+(last+visited+May+22,+2012).>Google Scholar
Ferraz, O., “Brazil. Health Inequalities, Rights and Courts: The Social Impact of the Judicialization of Health,” in Ely Yamin, A. Gloppen, S., Litigating the Right to Health (Cambridge: Harvard University Press, 2011).Google Scholar
NBAC, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume 1 — Report and Recommendation of the National Bioethics Advisory Commission, Bethesda, 2001; Merritt, M. Grady, C., “Reciprocity and Post-Trial Access for Participants in Antiretroviral Therapy Trials,” AIDS 20, no. 14 (2006): 1791–1794; Schroeder, D., “Post-Trial Obligations,” Electronic Journal of Communication Information & Innovation in Health 2, no. 1 (2006): 63–73; see Saver, R., “At the End of the Clinical Trial: Does Access to Investigational Technology End as Well?” Western New England Law Review 31, no. 2 (2009): 411–451, at 439.Google Scholar
Id. (Schroeder); Id. (Saver), at 439.Google Scholar
Grady, C., “The Challenge of Assuring Continued Post-Trial Access to Beneficial Treatment,” Yale Journal of Health Policy, Law and Ethics 5, no. 1 (2005): 425–436; Millum, J., “Post-Trial Access to Antiretrovirals: Who Owes What to Whom,” Bioethics 25, no. 3 (2009): 145–154.Google Scholar
See NBAC, supra note 10; Merritt, Grady, , supra note 10.Google Scholar
Id. (NBAC); see Schroeder, , supra note 10.Google Scholar
Id. (Schroder); Nuffield Council on Bioethics, Bioethics, 2002; Ananworanich, J. et al. , “Creation of a Drug Fund for Post-Clinical Trial Access to Antiretrovirals,” The Lancet 364, no. 9428 (2004): 101–102.CrossRefGoogle Scholar
McMillan, J. R. Conlon, C., “The Ethics of Research Related to Health Care in Developing Countries,” Journal of Medical Ethics 30, no. 30 (2004): 204–206.CrossRefGoogle Scholar
See Saver, , supra note 10.Google Scholar
Id.Google Scholar
See Merritt, Grady, , supra note 10, at 1792.Google Scholar
Id.Google Scholar
Id., at 1793.Google Scholar
See Saver, , supra note 10.Google Scholar
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.Google Scholar
World Medical Association, Declaration of Helsinki, 2000, available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited May 22, 2012).+(last+visited+May+22,+2012).>Google Scholar
CMA J, “Editorial,” Canadian Medical Association Journal 11, no. 169 (2003): 997.Google Scholar
World Medical Association, Workgroup Report on the Revision of Paragraph 30 of the Declaration of Helsinki, 2004, available at <http://www.wma.net> (last visited May 22, 2012).+(last+visited+May+22,+2012).>Google Scholar
Blackmer, J. Haddad, H., “The Declaration of Helsinki: An Update on Paragraph 30,” Canadian Medical Association Journal 173, no. 9 (2005): 1052–1053.CrossRefGoogle Scholar
See World Medical Association, supra note 24.Google Scholar
Id.Google Scholar
CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Science, Geneva, 2002.Google Scholar
See NABC, supra note 10.Google Scholar
UNAIDS, Ethical Considerations in HIV preventive vaccine research: UNAIDS Guidance Document, 2000.Google Scholar
See Schroeder, , supra note 10.Google Scholar
Sofaer, N. Strech, D., “Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review,” Public Health Ethics 4, no. 2 (2011): 160–184.CrossRefGoogle Scholar
Zong, Z., “Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?” Journal of Medical Ethics 34, no. 3 (2008): 188–192.CrossRefGoogle Scholar
Shah, S., “Planning for Posttrial Access to Antiretroviral Treatment for Research Participants in Developing Countries,” Health Policy and Ethics 99, no. 9 (2009); see Millum, , supra note 12; NABC, supra note 10; Ananworanich, J. et al. , “Creation of a Drug Fund for Post-Clinical Trial Access to Antiretrovirals,” The Lancet 364, no. 9428 (2004): 101–102.Google Scholar
Id. (Shah).Google Scholar
See Daneisi, , supra note 23.Google Scholar
Id.Google Scholar
See Saver, , supra note 10, at 412–413, 446.Google Scholar
The Brazilian National Health Council. Resolution 196/1996, at Article III.3.Google Scholar
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.Google Scholar
See Harada, , supra note 23.Google Scholar
Kung, Â. F. C., “Guarantee of Post-Study Access: Legal Aspects,” in Guarantee of Access to Post-Clinical Trial Drugs, Brazilian Association of Clinical Research Organizations, Sao Paulo, 2011.Google Scholar
On these cases, see Wang, D., Health Economics, Policy and Law Journal (2012, in press).Google Scholar
Brazil, , Federal Constitution at Article 196, available at <http://www.planalto.gov.br/ccivil_03/constituicao/constitui%C3%A7ao.htm> (last visited May 22, 2012).+(last+visited+May+22,+2012).>Google Scholar
See Ferraz, , supra note 9.Google Scholar
Vieira, F. Zucchi, P., “Distorções causadas pelas açães judiciais à política de medicamentos no Brasil,” Revista de Saúde Pública 41, no. 2 (2007): 214–222.CrossRefGoogle Scholar
State of Rio Grande do Sul Court of Appeal, Case no. 1.001.032.528, Agreement signed on July 15, 2010.Google Scholar
For more information on this case, see Defensoria Pública, available at <http://www.dpe.rs.gov.br/site/noticias.php?id=925> (last visited May 8, 2012).+(last+visited+May+8,+2012).>Google Scholar
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).+(last+visited+May+8,+2012).>Google Scholar
Id.Google Scholar
Governo de Estado de Sao Paulo, “Casa Civil,” available at <http://www.casacivil.sp.gov.br/conteudo/MostraNoti.asp?par=435> (last visited May 8, 2012).+(last+visited+May+8,+2012).>Google Scholar
See Wang, , supra note 45.Google Scholar
Brazilian National Council of Justice, Recommendation 30/2010, at I, b, 4.Google Scholar
Junior, B. R. S., “Acesso às drogas na pesquisa clínica,” Revista Bioética 15, no. 2 (2007): At 261.Google Scholar
See Millum, , supra note 12, at 154.Google Scholar
See Grady, , supra note 12; Shah, , supra note 36, at 1560.Google Scholar