Negociando a saúde e autonomia: exclusividade de dados, políticas de saúde e acesso a inovações farmacêuticas

Autores

Palavras-chave:

Propriedade intelectual, exclusividade de dados, ensaio clínico, acesso a medicamentos, acesso a tecnologias.

Resumo

O artigo analisa a disputa pela difusão internacional da exclusividade de dados como forma de proteção a dados de testes clínicos. Essa é uma demanda crítica para as empresas farmacêuticas, que buscam maiores parcelas de mercado e mais longos períodos de monopólio visando recuperar os investimentos em pesquisa e desenvolvimento e maior lucratividade. Entretanto, trata-se de matéria sensível, com repercussões econômicas e sociais para países de menor renda que adotam esse regime de proteção. Esse artigo se fundamenta em questões críticas para a economia política da inovação e apresenta uma revisão de estudos empíricos que mostram, em síntese, que a exclusividade de dados atrasa a entrada de medicamentos genéricos no mercado, aumentando preços e reduzindo o acesso, ao passo que não se encontram benefícios da sua adoção, porque não há efeitos positivos sobre a inovação tecnológica interna, redução do “International drug lag” e o desenvolvimento de medicamentos para demandas epidemiológicas específicas.

Referências

ACQUAH, D. (2014). Extending the limits of protection of pharmaceutical patents and data outside the EU - Is there a need to rebalance? IIC International Review of Intellectual Property and Competition Law, v. 45, n. 3, p. 256–286.

ADAMINI, S. et al. (2009). Policy making on data exclusivity in the European Union: from industrial interests to legal realities. Journal of Health Politics, Policy and Law, v. 34, n. 6, p. 979–1010.

AKALEEPHAN, C. et al. (2009). Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: Analysis of the effect of TRIPs-Plus proposal. Health Policy, v. 91, n. 2, p. 174–182.

ARRIVILLAGA, L. R. (2003). An International Standard of Protection for Test Data Submitted to Authorities to Obtain Marketing Authorization for Drugs: TRIPS Article 39.3. The Journal of World Intellectual Property, v. 06, p. 139–154.

BAGLEY, M. (2013). Patent Term Restoration and Non-Patent Exclusivity in the United States. In. DREXL, J.; LEE, N. (Org.). Pharmaceutical Innovation, Competition and Patent Law: a Trilateral Perspective. Edward Elgar, p. 111–140.

BEALL, R. F. et al (2019). How will recent trade agreements that extend market protections for brand-name prescription pharmaceuticals impact expenditures and generic access in Canada? Health Policy, v. 123, n. 12, p. 1251–1258.

CALIARI, T.; RUIZ, R. M. (2014). Brazilian pharmaceutical industry and generic drugs policy: Impacts on structure and innovation and recent developments. Science and Public Policy, v. 41, n. 2, p. 245–256.

CARVALHO, N. P (2008). The TRIPS regime of antitrust and undisclosed information. Kluwer Law International BV.

CHAVES, G. C.; GASPAR, W. B.; VIEIRA, M. F. (2017) Mercosur-EU Free Trade Agreement: Impact analysis of TRIPS-plus measures proposed by the EU on public purchases and domestic production of HIV and Hepatitis C medicines in Brazil. Ministerio da Saúde, Brazil.

CORIAT, B. et al (2023). Health and Access to care: why it is necessary and urgent to switch from global public good to commons based approach. Laboratory of Economics and Management (LEM), Sant'Anna School of Advanced Studies, Pisa, Italy.

CORREA, C. (2009). Intellectual Property Rights and Inequalities in Health Outcomes. In. LABONTE, R. (Org.). Globalization and Health: pathways, evidence and policy. London: Routledge.

______. (2011). Test Data protection: rights conferred under the TRIPS Agreement and some effects of FTA TRIPS-plus standards. In. DREYFUSS, R. (Org.). The Law and Theory of Trade Secrecy: a handbook of contemporary research. Cheltenham: Edward Elgar Publishing Limited.

DIEPENDAELE, L. et al (2017). Raising the Barriers to Access to Medicines in the Developing World - The Relentless Push for Data Exclusivity. Developing World Bioethics, v. 17, n. 1, p. 11–21.

DREYFUSS, Rochelle. (2010). TRIPS and essential medicines: must one size fit all? Making the WTO responsive to the global health crisis. In. POGGE, THOMAS; RIMMER, MATTHEW; RUBENSTEIN, K. (Org.). Incentives for Global Public Health: patent law and access to essential medicines. Cambridge: Cambridge University Press.

GAMBA, M; RODRIGUEZ, J.; CORNEJO, D. (2009). Estudio de impacto acceso a medicamentos en el TLC EU: impacto sobre el precio y consumo de medicamentos del Acuerdo Comercial (TLC) con la Unión Europea para Perú y Colombia. Instituto IFARMA, 2009.

GAMBA, M; BUENAVENTURA, F.; SERRANO, M. (2012). Impacto de 10 años de Proteccíon de Datos en Medicamentos en Colombia. Instituto IFARMA.

GLESSON, D.; LOPERT, R.; MOIR, H. (2014) Proposals for extending data protection forbiologics in theTPPA: Potential consequences for Australia. Submission to the Department of Foreign Affairs and Trade. [S.l.]: [s.n.].

GRABOWSKI, H.; LONG, G.; MORTIMER, R. (2011). Data exclusivity for biologics. Nature Publishing Group, v. 10, p. 15–16.

HERNANDEZ-GONZALEZ, G; VALVERD, M.; MURILLO, C. (2009). Evaluación del Impacto delas Disposiciones de ADPIC+ en el Mercado Institucional de Medicamentos de Costa Rica. Programa de ICTSD sobre Propiedad Intelectual y Desarrollo Sostenible.

JACINTO, J.; CORNEJO, E.; GAMBA, M. (2013). Impacto de la protección de datos de prueba a productos biotecnológicos, en el acceso a medicamentos. Lima

KHAN, K. et al. (2001). Undertaking Systematic Reviews of Research on Effectiveness: CRD’s Guidance for those Carrying Out or Comissioning Reviews. New York: NHS Centre for Reviews and Dissemination.

MASKUS, K.; REICHMAN, J. (2005). The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods. In. MASKUS, K.; REICHMAN, J. (Org.). International Public Goods and Transfer of Technology under a globalized intellectual property rights regime. Cambridge: Cambridge University Press.

MENEZES, H. Z. (2015). A Estratégia Norte-Americana de Forum Shifting para Negociação de Acordos TRIPS-Plus com Países da América Latina. Contexto Internacional, v. 37, n. 2, p. 435–468.

MERCURIO, B. (2018). Drugs, Patents and Policy: A Contextual Study of Hong Kong. Cambridge: Cambridge University Press.

MORIN, J. F.; GOLD, E. R. (2014), An Integrated Model of Legal Transplantation: The Diffusion of Intellectual Property Law in Developing Countries. International Studies Quarterly. v. 58, n. 4, p. 781–792.

MUZAKA, V. (2011). The Politics of Intellectual Property Rights and Access to Medicines. 1st. ed. London: Palgrave Macmillan.

OGUAMANAM, C. (2010). Patents and Pharmaceutical R&D: Consolidating Private-Public Partnership Approach to Global Public Health Crises. The Journal of World Intellectual Property, vol. 13, n. 04.

PACUD, Z. (2019). Patents, supplementary protection certificates and data exclusivity at the service of pharmaceuticals. In. FRANKEL, S. (Org.). The Object and Purpose of Intellectual Property. Cheltenham: Edward Elgar Publishing, p. 2018–239.

PALMEDO, M. (2023). Evaluating the Impact of Data Exclusivity on the Price per Kilogram of Pharmaceutical Imports. Journal of Globalization and Development https://doi.org/10.1515/jgd-2021-0016

PETTICREW, M.; ROBERTS, H. (2006). Systematic reviews in the social sciences: A practical guide. Oxford: Blackwell Publishing.

PIANETTI, G. A.; CÉSAR, I. (2016). Registro e autorização: atendimento aos requisitos mínimos de qualidade, eficácia e segurança. Organização Pan-Americana da Saúde/Organização Mundial da Saúde (OPAS/OMS), v. 1, n. 6, p. 1–8.

QUENTAL, C.; FILHO, S. S. (2006). Ensaios clínicos: Capacitação nacional para avaliação de medicamentos e vacinas. Revista Brasileira de Epidemiologia, v. 9, n. 4, p. 408–424.

RAGAVAN, S. (2017a). The Significance of the Data Exclusivity and Its Impact on Generic Drugs. Intellectual Property Studies, v. 01, n. 01, p. 131–141.

______. (2017b). Data exclusivity: a tool to sustain market monopoly. Jindal Global Law Review, v. 8, n. 2, p. 241–260.

REICHMAN, J. (2006). The International Legal Status of Undisclosed Clinical Trial Data: from private to public goods? In. ROFFE, P.; TANSEY, G.; VIVAS-EUGUI, D. (Org.). Negotiating Health: intellectual property and access to medicines. Geneva: International Center for Trade and Sustainable Development.

ROVIRA, J.; ABBAS, I.; CORTÉS, M. (2009). Guide to the IPRIA (Intellectual Property Rights Impact Aggregate) Model.

RUMEL, D.; NISHIOKA, S. SANTOS, A. (2006). Intercambialidade de medicamentos: abordagem clínica e o ponto de vista do consumidor. Revista de Saúde Pública, v. 40, n. 5, p. 921–927.

SELL, S. K. (2007). TRIPS-plus free trade agreements and access to medicines. Liverpool Law Review, v. 28, n. 1, p. 41–75.

______. (2010). TRIPS was never enough: vertical forum shifting, FTAS, ACTA, and TPP. J. Intell. Prop. L, v. 18, n. 2, p. 458.

SHAFFER, E. R.; BRENNER, J. (2009). Trade Agreement’s Impact on Access to Generic Drugs. Health Affairs, set, v. 28, n. 5.

SHAIKH, O. H. (2016). Access to Medicine Versus Test Data Exclusivity: safeguarding flexibilities under international Law. Berlin: Springer.

SKILLINGTON, G. L.; SOLOVY, E. M. (2003). The Protection of Test and Other Data Required by Article 39.3 of the TRIPS Agreement. Northwestern Journal of International Law & Business, v. 24, n. 1, p. 1–52.

SPINA ALI, G. (2019). Sweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity. Asia Pacific Journal of Health Law & Ethics, v. 12, n. 02, p. 1–51.

STORPIRTIS, S. et al. (2004). Equivalência Farmacêutica no Contexto da Intercambialidade Entre Medicamentos Genéricos e de Referência: Bases Técnicas e Científicas. Infarma. v. 16, n. 9/10, p. 9–10.

WATAL, J. (2001). Intellectual Property Rights in the WTO and Developing Countries. Alphen aan den Rijn: Kluwer Law International.

WEISSMAN, R. (2006). Data Protection: options for implementation. In. ROFFE, P.; TANSEY, G.; VIVAS-EUGUI, D. (Org.). Negotiating Health: intellectual property and access to medicines. Geneva: International Center for Trade and Sustainable Development.

WILEMAN, H.; MISHRA, A. (2010). Drug Lag and Key Regulatory Barries in the Emerging Markets. Perspectives in Clinical Research, v. 01, n. 02, p. 51–56.

YU, P. K. (2019). Data exclusivities and the limits to TRIPS harmonization. Florida State University Law Review, v. 46, n. 3, p. 641–708.

Downloads

Publicado

2023-07-18

Edição

Seção

Artigos e Ensaios