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The Brazilian Pharmaceutical Industry: Actors, Institutions, and Policies

Published online by Cambridge University Press:  29 December 2023

Julia Paranhos ,
Lia Hasenclever  and
Fernanda S. Perin
Julia Paranhos
Affiliation:
FEDERAL UNIVERSITY OF RIO DE JANEIRO (IE/UFRJ), BRAZIL
Lia Hasenclever
Affiliation:
CANDIDO MEDNES UNIVERSITY (UCAM-CAMPOS), BRAZIL
Fernanda S. Perin
Affiliation:
BIRMINGHAM CITY UNIVERSITY (BCU), UNITED KINGDOM
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Abstract

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

Keywords

Pharmaceutical IndustryDevelopment PoliciesInstitutional FrameworkBrazil
Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue S1: Rethinking Pharmaceutical Policies in Latin America and the Caribbean , Fall 2023 , pp. 126 - 135
Copyright
© 2023 The Author(s)

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References

Sindicato da Indústria de Produtos Farmacéuticos, “Relatório Anual de Atividades 2019,” 2020, available at <https://sindusfarma.org.br/uploads/Publicacoes/RAA_2020_pdf_01mar20.pdf> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Currency exchange BRL/USD = 5.04 (02 July 21).Google Scholar
ANVISA, “Anuário Estatístico Do Mercado Farmacêutico,” Brasília: ANVISA, 2018, available at <http://portal.anvisa.gov.br/documents/374947/3413536/Anu%C3%A1rio+Estat%C3%ADstico+do+Mercado+Farmac%C3%AAutico+-+2017/3179a522-1af4-4b4c-8014-cc25a90fb5a7> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Ministery of Economy, Secretary of Labour, “Annual List of Social Information,” Database, 2020, available at <http://pdet.mte.gov.br> (last visited July 24, 2023); IBGE, “Monthly Industrial Survey 2003-2020,” Database, Brazilian Institute of Geography and Statistics (IBGE), 2021, available at <https://sidra.ibge.gov.br/tabela/3653> (last visited July 24, 2023).+(last+visited+July+24,+2023);+IBGE,+“Monthly+Industrial+Survey+2003-2020,”+Database,+Brazilian+Institute+of+Geography+and+Statistics+(IBGE),+2021,+available+at++(last+visited+July+24,+2023).>Google Scholar
Id. Google Scholar
Brazilian Institute of Geography and Statistics (IBGE) “Annual Industrial Survey (PIA-Empresa),” 2020, available at <https://sidra.ibge.gov.br/pesquisa/pia-empresa/quadros/brasil/2019> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
API is any substance or combination of substances used in a finished pharmaceutical product with the intention of providing pharmacological activity or otherwise having a direct effect on healing.Google Scholar
Mnistry of Economy/Brazil, “COMEX Stat. Exports and Imports Dataset,” 2020, available at <http://comexstat.mdic.gov.br/pt/home> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Brazilian National Confederation of Industry, “Trade Coefficients,” Database, 2018, available at <https://static.portaldaindustria.com.br/media/filer_public/1a/10/1a10608b-0dc1-40b1-abf6-3d2d0eeb4133/coeficientesdeaberturacomercial_serie-recente_precosconstantes_numero1_2019_v1.xlsx> (last visited June 21, 2021; file protected).+(last+visited+June+21,+2021;+file+protected).>Google Scholar
Id. Google Scholar
CEPAL, “Perspectivas Del Comercio Internacional de América Latina y El Caribe 2021: En Busca de Una Recuperación Resiliente y Sostenible,” ECLAC - Economic Commission for Latin America and the Caribbean, 2021, available at <https://www.cepal.org/es/publicaciones/47535-perspectivas-comercio-internacional-america-latina-caribe-2021-busca> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
IEDI, “Exportações industriais no 3o trim/22: resiliência da média-alta e média-baixa tecnologia,” Carta IEDI 1179. Carta IEDI, 2023, available at <https://www.iedi.org.br/cartas/carta_iedi_n_1179.html> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Hasenclever, L., Fialho, B., Klein, H., and Zaire, C., Economia industrial de empresas farmacêuticas, 1st ed. (Rio de Janeiro: E-Papers, 2010).Google Scholar
J. Paranhos and F. Steiner Perin, “The COVID-19 Pandemic and the Call for Innovation Policies in the Health Sector,” UNIDO - Department of Policy Research and Statistics, 2021, available at <https://www.unido.org/stories/covid-19-pandemic-and-call-innovation-policies-health-sector#story-start> (last visited July 24, 2023); Paranhos, J., Mercadante, E., and Hasenclever, L., “Os esforços inovativos das grandes empresas farmacêuticas no Brasil: o que mudou nas duas últimas décadas?” Revista Brasileira de Inovação 19 (2020): e0200015–e0200015; V. Radaelli, Trajetórias Inovativas Do Setor Farmacêutico No Brasil: Tendências Recentes e Desafios Futuros, Ph.D. thesis, 2012, Campinas, Brazil: University of Campinas (Unicamp); L. Hasenclever, M.Auxiliadora Oliveira, J. Paranhos, and G. Costa Chaves, eds., 2018. Produção pública de medicamentos no Brasil: Capacitação tecnológica e acesso a medicamentos, 1st ed., (Rio de Janeiro: E-Papers, 2018), available at <http://www.e-papers.com.br/produtos.asp?codigo_produto=3055> (last visited July 24, 2023); M.A. Oliveira, J.A. Zepeda Bermudez, G. Costa Chaves, and G. Velásquez, “Has the Implementation of the TRIPS Agreement in Latin America and the Caribbean Produced Intellectual Property Legislation That Favours Public Health?” Bulletin of the World Health Organization 82, no. 11 (2004): 815-821.CrossRefGoogle Scholar
Caliari, T. and Machado Ruiz, R., “Brazilian Pharmaceutical Industry and Generic Drugs Policy: Impacts on Structure and Innovation and Recent Developments,” Science and Public Policy 41, no. 2 (2014): 245–56.CrossRefGoogle Scholar
On May 12, 2021, the Federal Supreme Court (STF) ruled for the unconstitutionality of the sole paragraph of article 40 of the Law 9.279/1996 (Direct Action of Unconstitutionality 5529).Google Scholar
Oliveira, et al., supra note 14; Hasenclever, L., Lopes, R., Costa Chaves, G., Reis, R., and Vieira, M., ‘O instituto de patentes Pipeline e o acesso a medicamentos: aspectos econômicos e jurídicos deletérios à economia da saúde,” Revista de Direito Sanitário 11, no. 2 (2010): 164–88; B.N. Sampat and K.C. Shadlen, “TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India,” Studies in Comparative International Development 50, no. 2 (2015): 228-57; E. Mercadante and J. Paranhos, “Pharmaceutical Patent Term Extension and Patent Prosecution in Brazil (1997-2018),” Cadernos De Saude Publica 38, no. 1 (2022): e00043021; K.C. Shadlen, Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America. (Oxford: Oxford University Press, 2017).CrossRefGoogle Scholar
Currently recognized as the main health regulatory institution in Latin America and respected worldwide. Since 2016, Anvisa has become a regular member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), world’s leading forum for the harmonization of technical requirements composed of regulatory authorities and the pharmaceutical industry.Google Scholar
Bioavailability refers to the extent that an administered drug reaches its intended biological destination. Bioequivalence is a term used to assess the pharmaceutical equivalence between products presented in the same pharmaceutical form, containing identical qualitative and quantitative composition of active principles, and that have comparable bioavailability.Google Scholar
For information about price regulation in Brazil before 2003, see Miranda, C., Paranhos, J., and Hasenclever, L., “Drug Price Regulation Experiences in Selected Countries: Lessons for Brazil,” Vigilância Sanitária Em Debate: Sociedade, Ciência & Tecnologia 9 (2021): 14–22.Google Scholar
Kornis, G.E.M., Braga, M.H., Fagundes, M., and Baumgratz de Paula, P.A., “A regulação em saúde no Brasil: um breve exame das décadas de 1999 a 2008,” Physis: Revista de Saúde Coletiva 21 (2011): 1077–1102; Hasenclever, Fialho, et al., supra note 13.CrossRefGoogle Scholar
Ministry of Development, Industry and Foreign Trade, “Acompanhamento Da Política Industrial, Tecnológica e de Comércio Exterior,” 2005, available at <https://old.abdi.com.br/Paginas/estudo.aspx?f=Monitoramento,%20gest%C3%A3o%20e%20avalia%C3%A7%C3%A3o%20do%20PITCE> (last visited July 24, 2023); Ministry of Development, Industry and Foreign Trade, ‘Inovar e Investir Para Sustentar o Crescimento,” 2008, available at <https://old.abdi.com.br/Paginas/estudo.aspx?f=Monitoramento,%20gest%C3%A3o%20e%20avalia%C3%A7%C3%A3o%20da%20PDP> (last visited July 24, 2023); Ministry of Development, Industry and Foreign Trade, “Plano Brasil Maior: 2011/2014,” 2011, available at <https://www.gov.br/agricultura/pt-br/assuntos/camaras-setoriais-tematicas/documentos/camaras-setoriais/carne-bovina/anos-anteriores/plano-brasil-maior.pdf> (last visited July 24, 2023).+(last+visited+July+24,+2023);+Ministry+of+Development,+Industry+and+Foreign+Trade,+‘Inovar+e+Investir+Para+Sustentar+o+Crescimento,”+2008,+available+at++(last+visited+July+24,+2023);+Ministry+of+Development,+Industry+and+Foreign+Trade,+“Plano+Brasil+Maior:+2011/2014,”+2011,+available+at++(last+visited+July+24,+2023).>Google Scholar
Ministry of Science and Technology, Brazil, “Ciência, Tecnologia e Inovação Para o Desenvolvimento Nacional: Plano de Ação 2007-2010,” 2007, available at <https://livroaberto.ibict.br/bitstream/1/725/1/Ciencia%2C%20tecnologia%20e%20inova%C3%A7%C3%A3o%20para%20o%20desenvolvimento%20nacional.pdf> (last visited July 24, 2023); Ministry of Science, Technology and Innovation, Brazil, ‘Estratégia Nacional de Ciência, Tecnologia e Inovação 2012–2015: Balanço Das Atividades Estruturantes,” 2011, available at <https://livroaberto.ibict.br/218981.pdf> (last visited July 24, 2023).+(last+visited+July+24,+2023);+Ministry+of+Science,+Technology+and+Innovation,+Brazil,+‘Estratégia+Nacional+de+Ciência,+Tecnologia+e+Inovação+2012–2015:+Balanço+Das+Atividades+Estruturantes,”+2011,+available+at++(last+visited+July+24,+2023).>Google Scholar
Brasília: Ministry of Health, Department of Science, Technology and Strategic Supplies, “Política Nacional de Ciência, Tecnologia e Inovação Em Saúde,” at 2, 2008, available at <https://bvsms.saude.gov.br/bvs/publicacoes/Politica_Portugues.pdf> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Massard da Fonseca, E., Shadlen, K., and Inácio Bastos, F., “Integrating Science, Technology and Health Policies in Brazil: Incremental Change and Public Health Professionals as Agents of Reform,” Journal of Latin American Studies 51, no. 2 (2019): 357–77.CrossRefGoogle Scholar
Brazilian Company of Research and Industrial Innovation, “Institutional,” 2022, available at <https://embrapii.org.br/en/> (last visited December 28, 2022).+(last+visited+December+28,+2022).>Google Scholar
Non-reimbursable funds were offered by FINEP through public calls. Reimbursable resources and loans were offered by FINEP and BNDES based on risk analysis. In this sense the chances of nepotism, political interference and corruption are very low due to the selection criteria and the obligation for companies to present projects to obtain both types of financing.Google Scholar
J. Paranhos, F. Steiner Perin, M. Vaz, D. Falcão, and L. Hasenclever “Articulação de políticas e instrumentos de produção e inovação para o Complexo Industrial da Saúde no Brasil, 2003-2017: os casos do Inova Saúde e do Profarma,” 2021, Partial research report, Rio de Janeiro, Federal University of Rio de Janeiro/Open Society Foundations.Google Scholar
J. Paranhos, H. Menezes, R. Torres, and L. Hasenclever, “Avaliação Dos Impactos Da Exclusividade Sobre Dados de Testes de Registro de Medicamentos Sobre a Inovação e o Sistema de Saúde Brasileiro,” 2021, Relatório de pesquisa — convênio UFRJ/IE/PNUD, GEI/IE/UFRJ, Rio de Janeiro: Federal University of Rio de Janeiro/Open Society Foundations.Google Scholar
Paranhos, et al., supra note 28.Google Scholar
Ministry of Science, Technology, Innovation and Communication, Brazil, 2016, “Estratégia Nacional de Ciência, Tecnologia e Inovação 2016–2022: Ciência, Tecnologia e Inovação Para o Desenvolvimento Econômico e Social,” available at <http://www.finep.gov.br/images/a-finep/Politica/16_03_2018_Estrategia_Nacional_de_Ciencia_Tecnologia_e_Inovacao_2016_2022.pdf> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Brasil, Casa Civil da Presidência da República, 2017, Decreto n. 9245, de 20 de Dezembro de 2017, Institui a Política Nacional de Inovação Tecnológica Na Saúde, Diário Oficial Da União, available at <https://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2017/Decreto/D9245.htm> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
F. De Negri and P. Koeller, “Políticas públicas para pesquisa e inovação em face da crise da COVID-19,” Nota Técnica 64, Instituto de Pesquisa Econômica Aplicada (Ipea); Santos Servo, L.M., Borges dos Santos, M.A., Sulpino Vieira, F., and Pucci de Sá e Benevides, R., “Financiamento do SUS e Covid-19: histórico, participações federativas e respostas à pandemia,” Saúde em Debate 44 (August 2021): 114–129; M. Tuffani, “Governo Tem Proposta Para Passar Fundo de Ciência Da FINEP Para o BNDES,” Direto Da Ciência, Chamadas & Destaques, September 30, 2019, available at <https://www.diretodaciencia.com/2019/09/30/governo-tem-proposta-para-passar-fundo-de-ciencia-da-finep-para-o-bndes/>.CrossRefGoogle Scholar
D. Junqueira, “Farmacêuticas receberam o menor investimento da década sob Bolsonaro,” Repórter Brasil, April 20, 2020, sec. Conteúdo original em português, available at <https://reporterbrasil.org.br/2020/04/coronavirus-expoe-fragilidade-das-farmaceuticas-que-receberam-menor-investimento-da-decada-sob-bolsonaro/> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Paranhos and Perin, supra note 14.Google Scholar
Internationalization is the process by which the company conducts some operation of its value chain outside its domestic market, such as sales, distribution networks, R&D centers, or manufacturing.Google Scholar
F. Perin and J. Paranhos, “Policies to Support the Internationalisation of Latecomer Science-Based Firms: The Experience of Large Brazilian Pharmaceutical Companies,” Multinational Business Review (2023).CrossRefGoogle Scholar
Paranhos, J., Mercadante, E., and Hasenclever, L., “Os esforços inovativos das grandes empresas farmacêuticas no Brasil: o que mudou nas duas últimas décadas?” Revista Brasileira de Inovação 19 (2020): e0200015–e0200015.CrossRefGoogle Scholar
Mitidieri, T.L., Paiva Pimentel, V., de Azevedo Braga, C., and Paulo Pieroni, J., “Há espaços competitivos para a indústria farmoquímica brasileira?: reflexões e propostas para políticas públicas,” BNDES Setorial no. 41 (March 2015): 43–78.Google Scholar
Malerba, F. and Orsenigo, L., “The Evolution of the Pharmaceutical Industry,” Business History 57, no. 5 (2015): 664–87.CrossRefGoogle Scholar
Caliari, T. and Machado Ruiz, R., “Brazilian Pharmaceutical Industry and Generic Drugs Policy: Impacts on Structure and Innovation and Recent Developments,” Science and Public Policy 41, no. 2 (2014): 245–256.CrossRefGoogle Scholar
IBGE, “Brazilian Innovation Survey (PINTEC) 2008-2017,” 2020, available at <https://sidra.ibge.gov.br/pesquisa/pintec> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Bell, M. and Pavitt, K., “Technological Accumulation and Industrial Growth: Contrasts Between Developed and Developing Countries,” Industrial and Corporate Change 2, no. 2 (1993): 157–210.CrossRefGoogle Scholar
Carlsson, B., “Internationalization of Innovation Systems: A Survey of the Literature,” Research Policy 35, no. 1 (2006): 56–67.CrossRefGoogle Scholar
J. Paranhos, Julia, H. Menezes, R. Torres, and L. Hasenclever, “Avaliação Dos Impactos Da Exclusividade Sobre Dados de Testes de Registro de Medicamentos Sobre a Inovação e o Sistema de Saúde Brasileiro,” 2021, Relatório de pesquisa — convênio UFRJ/IE/PNUD, GEI/IE/UFRJ, Rio de Janeiro: Federal University of Rio de Janeiro/Open Society Foundations.Google Scholar
F.J.R. Paumgartten, “Pharmaceutical Lobbying in Brazil: A Missing Topic in the Public Health Research Agenda,” Revista de Saúde Pública 50 (December 2016); D. Junqueira and R. Chaves, “With Donations of 13 Million BRL, the Pharmaceutical Industry Wins a Seat and Expands the Lobby in the New Congress,” Repórter Brasil, June 17, 2020, sec. English - original content, available at <https://reporterbrasil.org.br/2020/06/with-donations-of-13-million-brl-the-pharmaceutical-industry-wins-a-seat-and-expands-the-lobby-in-the-new-congress/> (last visited July 24, 2023).+(last+visited+July+24,+2023).>Google Scholar
Gomes, C.A., Chaves, J.G., and Ninomya, T., “Os Laboratórios Farmacêuticos Oficiais e a Produção Pública de Medicamentos,” in Medicamentos No Brasil: Inovação e Acesso, Buss, P. M., Carvalheiro, J. R., and Casas, C.P. (Rio de Janeiro: Fiocruz, 2008); Ministry of Health, Brazil, “Assistência Farmacêutica,” 2019, available at <http://www.saude.gov.br/assistencia-farmaceutica/laboratorios-oficiais> (last visited July 24, 2023).Google Scholar
Hasenclever, L., Fialho, B., Klein, H., and Zaire, C., Economia industrial de empresas farmacêuticas, 1st ed. (Rio de Janeiro: E-Papers, 2010).Google Scholar
Torres, R.L. and Hasenclever, L., “Technological Capability Building in the Brazilian Pharmaceutical Industry,” Latin American Business Review 17, no. 3 (2016): 223–44; L. Hasenclever, M. Auxiliadora Oliveira, J. Paranhos, and G. Costa Chaves, eds., Produção pública de medicamentos no Brasil: Capacitação tecnológica e acesso a medicamentos, 1st ed. (Rio de Janeiro: E-Papers, 2018), available at <http://www.e-papers.com.br/produtos.asp?codigo_produto=3055> (last visited July 24, 2023).CrossRefGoogle Scholar
Id. (Hasenclever, et al.).Google Scholar
V.P. Pimentel, Parcerias Para o Desenvolvimento Produtivo de Medicamentos No Brasil Sob a Ótica Das Compras Públicas Para Inovação: 2009-2017, 2018, Master thesis, Rio de Janeiro, Brasil: Postgraduate Program in Public Policy, Strategy and Development, Institute of Economics, Federal University of Rio de Janeiro.Google Scholar
Paranhos and Perin, supra note 14.Google Scholar
P.B. Tigre, C.V. Machado França do Nascimento, and L. Silveira Costa, “Windows of Opportunities and Technological Innovation in the Brazilian Pharmaceutical Industry,” Cadernos de Saúde Pública 32 (November 2016).CrossRefGoogle Scholar
In 2023, Luiz Inácio Lula da Silva new government took office and there are new perspectives to resume the articulation of the production and innovation policies with the health policies to reduce Brazil’s dependence on pharmaceutical production. The Executive Group of the Economic-Industrial Health Complex (GECEIS) was recreated in April 2023, but no other policies or concrete actions were taken so far.Google Scholar
G. Dutrénit and V. Arza, “Channels and Benefits of Interactions between Public Research Organisations and Industry: Comparing Four Latin American Countries,” Science and Public Policy 37 (2010): 541-53.CrossRefGoogle Scholar
CEPAL, supra note 11Google Scholar