Health Rights and Intellectual Property Rights: Ministry of Health Prior Consent for Pharmaceutical Patents in Brazil

  • Eduardo Guimarães


This chapter examines the institution and practice of a highly original and equally controversial system consisting of the prior consent that the agency for sanitary security must submit to the national industrial property institute before a pharmaceutical patent can be issued. This mechanism has been strongly challenged by pharmaceutical groups through the courts. In this chapter, which is devoted to “prior consent”, Eduardo Guimaraes shares with us the results of an ethnographic study that he carried out at the examination office of the agency for sanitary security. The work of the Coopi-Anvisa entailed developing technical interpretations of the various types of pharmaceutical patent that could lead to improper monopolies and thus affect access to health by Brazil’s population. For its first decade, the Anvisa was much stricter than the INPI in its patent application examinations, acknowledging patentability only for inventions that achieve high levels of novelty and inventiveness. This special regulation of pharmaceutical patents by Anvisa is cited in a manual published by the World Health Organization to help developing countries apply industrial property rights by siding with the interests of public health.


  1. ANVISA. (2011). Relatório sobre a atuação da Anvisa no exame de prévia anuência a pedidos de patente na área farmacêutica.Google Scholar
  2. Barbosa, D. (2004, September). A questão do segundo uso farmacêutico. Available at Accessed 21 Aug. 2007.
  3. Bourdieu, P. (2003). O poder simbólico. Rio de Janeiro: Bertrand Brasil.Google Scholar
  4. Cambrosio, A., & Keating, P. (1996). Technique, outil, invention: Les transformations d’une biotechnologie. Sociologie du Travail, 38(3), 349–364.CrossRefGoogle Scholar
  5. Cassier, M. (2004). Brevets pharmaceutiques et santé publique en France: Opposition et dispositifs spécifiques d’appropriation des médicaments entre 1791 et 2004. Entreprises et Histoire, 36, 29–47.CrossRefGoogle Scholar
  6. Cassier, M., & Correa, M. (2007). Intellectual property and public health: Copying of HIV/Aids drugs by Brazilian public and private pharmaceutical laboratories. RECIIS, Fondation Oswaldo Cruz, 1(June), 83–90.Google Scholar
  7. CDPI. (2003). Intégrer les droits de propriété intellectuelle et la politique de dévellopement. London: CDPI.
  8. Correa, C. (2004). Ownership of knowledge – The role of patents in pharmaceutical R&D. Bulletin of the World Health Organisation, 82(10), 784–790.Google Scholar
  9. Correa, C. (2007). Guidelines for the examination of pharmaceuticals patents: Developing a public Health Perspective, WHO, 65p.Google Scholar
  10. Da Fonseca, E. (2011). Reforming pharmaceutical regulation: A case study of generic drugs in Brazil. PhD Thesis in Social Policy, University of Edinburgh, Edinburgh.Google Scholar
  11. De Raymond, A., Israel, L., Jimenez, R., Mallard, G., & Révillard, A. (2004). Droit, réflexivité et sciences sociales. Autour du livre de Bruno Latour: La Fabrique du droit (confrontations). Terrains & Travaux, 6, 159–180.Google Scholar
  12. Drahos, P. (1999). The universality of intellectual property rights: Origins and development. Accessed 2 May 2008.
  13. Fassin, D. (2003). La démocratie sud-africaine à l’épreuve du sida. Critique internationale, 3(20), 93–112.CrossRefGoogle Scholar
  14. Fassin, D. (2005). Une chronique sud-africaine du sida. Études, 403(3), 617–627.Google Scholar
  15. Gaudillière, J.-P. (2010). Une marchandise scientifique? Savoirs, industrie et régulation du médicament dans l’Allemagne des années trente. Annales HSS, 65(1), 87–120.CrossRefGoogle Scholar
  16. Guimaraes, E. (2008). Direito à saúde e propriedade intelectual de medicamentos no Brasil. A anuência prévia da Agência Nacional de Vigilância Sanitária. 122p. (Masters in Collective Health). Instituto de Medicina Social, UERJ.Google Scholar
  17. Guimaraes, E. (2013). A regulação das patentes farmacêuticas no Brasil: entre saúde pública, política e Direito. 207p. (PhD in Collective Health). Instituto de Medicina Social, UERJ.Google Scholar
  18. Latour, B. (2002). La fabrique du droit. Une ethnologie du Conseil d’Etat. Paris: La Découverte. 320p.Google Scholar
  19. Latour, B. (2010). The making of law: An ethnography of the Conseil d’Etat. Cambridge: Polity Press.Google Scholar
  20. Lima, L. A. (2004). Anvisa, as patentes e o acesso a medicamentos. Fármacos & Medicamentos, 30, 28–32.Google Scholar
  21. Loyola, M. A. (2008). Medicamentos e saúde pública em tempos de Aids. Ciência & Saúde Coletiva, Rio de Janeiro, 13, 603–618.CrossRefGoogle Scholar
  22. Mattos, R., & Baptista, T. (Eds.). (2011). Caminhos para análise das políticas de saúde. Rio de Janeiro: Faperj.Google Scholar
  23. Myers, G. (1995). From discovery to invention: The writing and rewriting of two patents. Social Studies of Science, 25(1), 57–105.CrossRefGoogle Scholar
  24. NIHCM. (2002). Changing patterns of pharmaceutical innovation. Washington, DC: NIHCM.Google Scholar
  25. Noguès, J. (1993). Social costs and benefits of introducing patent protection for pharmaceutical drugs in developing countries. Developing Economies, 31, 24–53.CrossRefGoogle Scholar
  26. Parasie, S. (2008). Une poule devant un couteau? Un ethnographe plongé dans des archives juridiques. Droit et Société n. 69–70, 363–379.Google Scholar
  27. Reis, R. (2012). Panorama patentário dos medicamentos antiretrovirais no Brasil. PhD Thesis in Public Policy, Strategies and Development, Instituto de Economia, Universidade Federal do Rio de Janeiro, Rio de Janeiro.Google Scholar
  28. Reis, A., Bermudez, J., & Oliveira, M. (2004). Effects of the TRIPS Agreement on the access to medicines: Considerations for monitoring drug prices. In J. Bermudez & M. Oliveira (Eds.), Intellectual property rights in the context of the WTO TRIPS Agreement: Challenges for the public health. Rio de Janeiro: ENSP.Google Scholar
  29. Scherer, F., & Watal, J. (2001). Post-TRIPS for access to patented medicines in developing countries. WHO: Commission on macroeconomics and health, Paper no. WG4 1.Google Scholar
  30. SENADO FEDERAL. (2005, November 8). Minutes of the 28th (extraordinary) meeting of the environment, consumer protection, and inspection and oversight committee of the 3rd regular legislative session of the 52nd legislature. (in Portuguese). Accessed 27 Jun 2007.
  31. Shadlen, K. (2011). The political contradictions of incremental innovation: Lessons from pharmaceutical patent examination in Brazil. Politics & Society, 39(2), 143–174.CrossRefGoogle Scholar
  32. Sidou, J. M. (1996). Dicionário jurídico: Academia Brasileira de Letras Jurídicas (4th ed.). Rio de Janeiro: Forense Universitária.Google Scholar

Copyright information

© The Author(s) 2019

Authors and Affiliations

  • Eduardo Guimarães
    • 1
    • 2
  1. 1.Pedro II’s SchoolRio de JaneiroBrazil
  2. 2.Institute of Social MedicineRio de Janeiro State UniversityRio de JaneiroBrazil

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