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

Quental C. , “Medicamentos genéricos no Brasil: Impactos das políticas públicas sobre a indústria nacional,” Ciência e saúde coletiva 13 (2008): 619–628, at 621.

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).

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.

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.

In all of these cases authorities seized the shipments in accordance with the European Community's Council Regulation No 1383/2003.

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.

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).

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.

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).

Instituto Brasileiro de Geografia e Estatística, “Censo 2010,” 2011, available at <http://www.ibge.gov.br/home/> (last visited May 21, 2012).

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.

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 , supra note 1, at 621).

Cunha A. M. , 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.

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).

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).

Id. (Radaelli et al.) at 34.

See Quental Gadelha Fialho , supra note 15.

Id., at 52.

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.

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.

See Cunha , 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.

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.

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 , supra note 9.

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.

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 , supra note 22, at 41–59, 43.

See Guise , supra note 9.

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>.

Art.135, Council Regulation n. 450/2008.

See Kumar , supra note 27, at 05.

See Xavier , supra note 6, at 02.

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.

This was not the case for Brazil. See Guise , supra note 9, for further information on pipeline protection.

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).

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.

See WTO, DS408, supra note 7.

Ministério da Saúde, Nota informativa: subsídios do Ministério da Saúde frente ao tema e às apreensões holandesas de medicamentos genéricos, Mimeo, 2010.

See WTO DS408, supra note 7.

WT/DS408/1, May 19, 2010; WT/DS/409/1, May 19, 2010.

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.”

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.”

See Ruse-Khan , supra note 34, and B. K., ACTA: Risk of Third Party Enforcement for Access to Medicines, Program on Information, Justice and Intellectual Property. Research paper n. 1, American University Washington College of Law, 2010; Flynn S. , ACTA's Constitutional Problem: The Treaty That Is Not a Treaty (Or an Executive Agreement), PIJIP Research Paper no. 19., American University Washington College of Law, Washington, D.C., 2011, at 10, reports that: […] as the text of ACTA was gradually leaked, and then officially released, during the last year of the negotiation, the substance of ACTA came under broad criticism. In June 2010, nearly 650 international intellectual property experts and public interest organizations from six continents adopted a sharply worded public statement criticizing the proposal as ‘a threat to numerous public interests,’ including to freedom on the internet, basic civil liberties including privacy and free expression, free trade in generic medicines, and to the policy balances between protection and acces that lie at heart of all intellectual property doctrines.

Knowledge Ecology International, available at <http://keion-line.org/node/1091> (last visited May 21, 2012).

Drug-safety testing data is another issue regulated by the agreement that would hinder access to generics worldwide.

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.

See Abbott , supra note 31.

Helfer L. R. Graeme A. , Human Rights and Intellectual Property: Mapping the Global Interface (Cambridge: Cambridge University Press, 2011).

Sell S. K. , “TRIPS and the Access to Medicines Campaign,” Wisconsin International Law Journal 20, no. 20 (2002): 418–522.

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.

Id. (Hestermeyer).

Langford M. , ed., Social Rights Jurisprudence: Emerging Trends in International and Comparative Law, 2009.

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.

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).

See Helfer , supra note 51.

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.