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Why are Generic Drugs Being Held up in Transit? Intellectual Property Rights, International Trade, and the Right to Health in Brazil and beyond

Published online by Cambridge University Press:  01 January 2021

Mônica Steffen Guise Rosina  and
Lea Shaver
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Extract

Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have witnessed more than 100-fold price reduction for antiretroviral (ARV) drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 2 , Summer 2012 , pp. 197 - 205
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

Quental, C. et al. , “Medicamentos genéricos no Brasil: Impactos das políticas públicas sobre a indústria nacional,” Ciência e saúde coletiva 13 (2008): 619–628, at 621.CrossRefGoogle Scholar
Federal Drug Administration, “Facts and Myths about Generic Drugs,” 2011, available at <http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm> (last visited May 21, 2012).+(last+visited+May+21,+2012).>Google Scholar
Park, C. Jayadev, A., “Access to Medicines in India: A Review of Recent Concerns,” in Subramanian, R. Shaver, L., eds., Access to Knowledge in India: New Research on Intellectual Property, Innovation and Development (London: Bloomsbury Academic, 2011): At 78.Google Scholar
MSF 2007; Bazzle, T., “Pharmacy of the Developing World: Reconciling Intellectual Property Rights in India with the Right to Health: TRIPS, India's Patent System and Essential Medicines,” Georgetown Journal of Intenational Law 42, no. 3 (2011): 785–815, at 785; id. (Park and Jayadev), at 78.Google Scholar
In all of these cases authorities seized the shipments in accordance with the European Community's Council Regulation No 1383/2003.Google Scholar
Xavier, S., Border Measures Concerning Goods Allegedly Infringing Intellectual Property Rights: The Seizures of Generic Medicines in Transit, Working Paper, International Centre for Trade and Sustainable Development, 2009, at 01.Google Scholar
World Trade Organization, European Union and a Member State – Seizure of Generic, Drugs in Transit, DS408, 2010, available at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds408_e.htm> (last visited May 21, 2012); see also World Trade Organization, European Union and a Member State – Seizure of Generic Drugs in Transit, DS409, 2010, available at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds409_e.htm> (last visited May 21, 2012).+(last+visited+May+21,+2012);+see+also+World+Trade+Organization,+European+Union+and+a+Member+State+–+Seizure+of+Generic+Drugs+in+Transit,+DS409,+2010,+available+at++(last+visited+May+21,+2012).>Google Scholar
The treaties are known as the Anti-Counterfeiting Trade Agreement (ACTA) and the Trans-Pacific Partnership (TPP). The details of these negotiations are discussed later in this article.Google Scholar
For more detailed information on the dynamics of the Brazilian public health system, see Guise, M. S. Wang, D. W. L. de Campos, T. C., “Access to Medicines: Pharmaceutical Patents and the Right to Health,” in Shaver, L., Access to Knowledge in Brazil: New Research on Intellectual Property, Innovation and Development (London: Bloomsbury, 2010).Google Scholar
Instituto Brasileiro de Geografia e Estatística, “Censo 2010,” 2011, available at <http://www.ibge.gov.br/home/> (last visited May 21, 2012).+(last+visited+May+21,+2012).>Google Scholar
Unlike the generic drugs sold in Brazil today, similar drugs were not required to provide proof of bioequivalence. Today, the pharmaceutical market in Brazil is comprised of reference, similar and generic drugs.Google Scholar
Two main programs were aimed at assisting the generics pharmaceutical industry: (1) support for production and registration of medicines; and (2) support for the importation of equipments. National companies were the ones who mostly benefited from BNDES' finance lines. Medley, EMS Sigma Pharma, and Eurofarma e Biosintética are examples of companies that made full usage of such programs, renovating their plants and enhancing technical capacity (see Quental, et al. , supra note 1, at 621).Google Scholar
Cunha, A. M. et al. , Relatório de acompanhamento setorial: Complexo da saúde - indústria farmacêutica, Vol. I. ABDI and UNICAMP 2008, (translation: Sectoral monitoring report: Health complex – pharmaceutical industry): At 14.Google Scholar
Farmanguinhos, Ministério da Saúde e Fundação Oswaldo Cruz, “Mais de 1 bilhão de medicamentos por ano para a população brasileira,” 2011, available at <http://www2.far.focruz.br/farmanguinhos/> (last visited May 21, 2012) (translation: More than 1 billion drugs per year for the Brazilian population).+(last+visited+May+21,+2012)+(translation:+More+than+1+billion+drugs+per+year+for+the+Brazilian+population).>Google Scholar
Gadelha, C. A. Quental, C. Fialho, B. C., “Saúde e inovação: Uma abordagem sistêmica das indústrias da saúde,” Cadernos de Saúde Pública 19, no. 1 (2003): 47–59, available at <http://www.scielosp.org/pdf/csp/v19n1/14904.pdf> (last visited Jan 12, 2010) (translation: Health and innovation: A systemic approach to the health industries). For similar data, see Radaelli, V. Andrade, C. Furtado, J., Trajectory of Development Based Innovation: The Pharmaceutical Sector in Brazilian Industrial Policy, 2011, available at <www.merit.unu.edu/MEIDE/papers/2009/1236001150_VR.pdf> (last visited March 10, 2011); and L. Hasenclever, Diagnóstico da indústria farmacêutica brasileira (Brasília: United Nations Economic, Social, and Cultural Organization/Rio de Janeiro: Universidade Federal do Rio de Janeiro, 2002) (translation: Diagnosis of the Brazilian pharmaceutical industry).CrossRefGoogle Scholar
Id. (Radaelli et al.) at 34.Google Scholar
See Quental, Gadelha, Fialho, , supra note 15.Google Scholar
Id., at 52.Google Scholar
Capanema, L. X. L. Palmeira Filho, P. L., “A cadeia farmacêutica e a política industrial: Uma proposta de inserção do BNDES,” BNDES Setorial, 19, (2004): 23–48, available at <http://www.bndes.govol.br/SiteBNDES/export/sites/default/bndes_pt/Galerias/Arquivos/conhecimento/bnset/set1902.pdf> (last visited July 15, 2010) (translation: The pharmaceutical chain and industrial policy, a BNDES proposal): At 36.Google Scholar
Rosina, M. S. G., A regulamentação internacional das patentes e sua contribuição para o processo de desenvolvimento do Brasil: Análise da produção nacional de novos conhecimentos no setor farmacêutico, Tese (Doutorado em Direito Internacional e Comparado) — Faculdade de Direito, Universidade de São Paulo, São Paulo, 2011, at 203–210.Google Scholar
See Cunha, et al. , supra note 13, at 10; Oliveira, E. A. Bermudez, J., “A produção pública de medicamentos no Brasil: Uma visão geral,” Cadernos de Saúde Pública 22, no. 1 (2006): 2379–2389 (translation: Public drug production in Brazil: A general overiew): At 2381.Google Scholar
De Souza Antunes, A. M. Canongia, C., “Prospecção tecnológica da indústria farmacêutica nacional: Fármacos e medicamentos da RENAME com potencial de inovação,” in Buss, P. M. da Rocha Carvalheiro, J. Romero, C. P. (Org.) Casas, Medicamentos no Brasil: Inovação e acesso (Rio de Janeiro: Ed. Fio Cruz, 2008): 145–165, at 149–155.Google Scholar
The issuance of this compulsory license was based on national public health concerns. At the time, Efavirenz alone took took up a large share of the Ministry of Health's total budget. For further details, see Guise, et al. , supra note 9.Google Scholar
At the time, the Ministry of Health alleged lack of technological capacity for immediate local production. The drug is currently produced in Brazil through a partnership between public laboratories and a few private generic companies.Google Scholar
Grabois Gadelha, C. A. de V. Maldonado, J. M. S., “O papel da inovação na indústria farmacêutica: Uma janela de oportunidade no âmbito do complexo industrial da saúde,” in Buss, et al. , supra note 22, at 41–59, 43.CrossRefGoogle Scholar
See Guise, et al. , supra note 9.Google Scholar
Kumar, S. P., “Border enforcement of intellectual property rights against in transit generic pharmaceuticals: An analysis of character and consistency,” European Intellectual Property Review and SSRN Research Paper 2009, at 9, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1383067>..>Google Scholar
Art.135, Council Regulation n. 450/2008.Google Scholar
See Kumar, , supra note 27, at 05.Google Scholar
See Xavier, , supra note 6, at 02.Google Scholar
Abbott, F. M., “Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare,” World Intellectual Property Organization Journal 1, no. 1 (2009): 43–50.Google Scholar
This was not the case for Brazil. See Guise, et al. , supra note 9, for further information on pipeline protection.Google Scholar
UNITAID is an international drug purchasing facility that provides medicine and treatment against HIV/AIDS, malaria, and tuberculosis for the poorest people of developing countries who otherwise could not afford them. It is hosted and administered by the World Health Organization (WHO). For further information, see <http://www.unitaid.eu/> (last visited May 21, 2012).+(last+visited+May+21,+2012).>Google Scholar
Ruse-Khan, H. G., Trade Agreement Creating Barriers to International Trade? ACTA Border Measures and Goods in Transit, Max Planck Institute for Intellectual Property, Competition & Tax Law, Research Paper Series n. 10–10, 2011, at 06.Google Scholar
See WTO, DS408, supra note 7.Google Scholar
Ministério da Saúde, Nota informativa: subsídios do Ministério da Saúde frente ao tema e às apreensões holandesas de medicamentos genéricos, Mimeo, 2010.Google Scholar
See WTO DS408, supra note 7.Google Scholar
WT/DS408/1, May 19, 2010; WT/DS/409/1, May 19, 2010.Google Scholar
GATT art. 5 (2): “There shall be freedom of transit through the territory of each contracting party, via the routes most convenient for international transit, for traffic in transit to or from the territory of other contracting parties.”Google Scholar
TRIPS Preamble: “Members, desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade”; and art. 41: “These procedures [enforcement of intellectual property rights] shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.”Google Scholar
Knowledge Ecology International, available at <http://keion-line.org/node/1091> (last visited May 21, 2012).+(last+visited+May+21,+2012).>Google Scholar
Drug-safety testing data is another issue regulated by the agreement that would hinder access to generics worldwide.Google Scholar
Art. 14.4 Each Party shall provide ex officio border measures with respect to imported, exported, or in-transit merchandise, or merchandise in free trade zones, that is suspected of being counterfeit or confusingly similar trademark goods, or pirated copyright goods.Google Scholar
See Abbott, , supra note 31.Google Scholar
Helfer, L. R. Graeme, A., Human Rights and Intellectual Property: Mapping the Global Interface (Cambridge: Cambridge University Press, 2011).CrossRefGoogle Scholar
Sell, S. K., “TRIPS and the Access to Medicines Campaign,” Wisconsin International Law Journal 20, no. 20 (2002): 418–522.Google Scholar
Marceau, G., “WTO Dispute Settlement and Human Rights,” European Journal of International Law 13, no. 13 (2002): 753–814; Hestermeyer, H., Human Rights and the WTO: The Case of Patents and Access to Medicines, Oxford, 2007.CrossRefGoogle Scholar
Id. (Hestermeyer).Google Scholar
Langford, M., ed., Social Rights Jurisprudence: Emerging Trends in International and Comparative Law, 2009.CrossRefGoogle Scholar
Helfer, L. R., “The New Innovation Frontier? Intellectual Property and the European Court of Human Rights,” Harvard International Law Journal 49, no. 1 (2008): 1–52.Google Scholar
Charter of Fundamental Rights of the European Union, December 7, 2000, Official Journal of the European Communities, December 18, 2000 (2000/C 364/01), available at <http://www.unhcr.org/refworld/docid/3ae6b3b70.html> (last visited June 16, 2012).+(last+visited+June+16,+2012).>Google Scholar
See Helfer, , supra note 51.Google Scholar
Forman, L., “‘Rights’” and Wrongs: What Utility for the Right to Health in Reforming Trade Rules on Medicines?” Critical Concepts 10, no. 10 (2008): 37–52.Google Scholar