The DNDi’s HCV Programme and the intellectual property system: a public health approach to the Hepatitis C epidemic
DOI:
https://doi.org/10.18593/ejjl.21865Keywords:
DNDi, Hepatitis C, Intellectual property system, Pharmaceutical patents, Empirical legal researchAbstract
The exclusivity guaranteed by intellectual property rights seems to be, paradoxically, at the same time, one of the most important justifications for innovation for the pharmaceutical industry and one of the main mechanisms for blocking access to innovation in this sector. Consequently, this paper aims to understand empirically how the research and development program for new treatments for hepatitis C, led by the Drugs for Neglected Diseases initiative (DNDi), relates to the current intellectual property rights system. Therefore, the research was carried out stemming from a holistic, descriptive, single case study on the subject, according to the definitions elaborated by Robert Yin and the theoretical propositions formulated by Susan Sell. As the main result of this investigation, it is possible to theorize that, through the intellectual property rights policy adopted and the prioritization of public health needs, both the program conducted by DNDi and the institution's own institutional model seem to function as a means of bypassing the structures and the institutions currently supported by the intellectual property rights system.
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ABECASSIS, Philippe et al. DNDi, a distinctive illustration of commons in the area of public health. AFD Research Papers Series, n. 2019-93, Feb. 2019. Disponível em: https://www.afd.fr/en/dndi-distinctive-illustration-commons-area-public-health. Acesso em: 25 jul. 2019.
ANDRIEUX-MEYER, Isabelle et al. Safety and efficacy of ravidasvir plus sofosbuvir for 12 weeks in non-cirrhotic and 24 weeks in cirrhotic patients with hepatitis C virus genotypes 1, 2, 3 and 6: the STORM-C-1 phase II/III trial stage 1 results. In: THE INTERNATIONAL LIVER CONGRESS, 1., 2018, Paris. Proceedings [...]. Paris: European Association For The Study Of The Liver, 2018. Pôster. Disponível em: https://www.dndi.org/wp-content/uploads/2018/03/Andrieux-Meyer_STORM-C-1_phase_II_III_trial_EASL_ILC_2018.pdf. Acesso em: 24 jul. 2019. DOI: https://doi.org/10.1016/S0168-8278(18)30459-8
BARBEITAS, Mady. The innovation system for leishmaniasis therapy in Brazil. In: CASSIER, Maurice; CORREA, Marilena (ed.). Health innovation and social justice in Brazil. Cham: Palgrave Macmillan, 2019. p. 109-134. Disponível em: https://www.palgrave.com/gp/book/9783319768335. Acesso em: 25 jul. 2019. DOI: https://doi.org/10.1007/978-3-319-76834-2_5
CASSIER, Maurice; CORREA, Marilena. A consortium in times of crisis: producing Brazilian sofosbuvir? In: CASSIER, Maurice; CORREA, Marilena (Ed.). Health innovation and social justice in Brazil. Cham: Palgrave Macmillan, 2019. p. 109-134. Disponível em: https://www.palgrave.com/gp/book/9783319768335. Acesso em: 25 jul. 2019.
CENTER FOR DRUG EVALUATION AND RESEARCH. Application number: 209195Orig1s000. 2017. Disponível em: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209195Orig1s000lbl.pdf. Acesso em: 24 jul. 2019.
CLEARY, Ekaterina Galkina et al. Contribution of NIH funding to new drug approvals 2010–2016. Proceedings of The National Academy of Sciences, [S. l.], v. 115, n. 10, p. 2329-2334, 12 fev. 2018. Disponível em: https://www.pnas.org/content/pnas/115/10/2329.full.pdf. Acesso em: 30 jul. 2019. DOI: https://doi.org/10.1073/pnas.1715368115
COLLIER, Roger. Drug development cost estimates hard to swallow. Canadian Medical Association Journal, [S. l.], v. 180, n. 3, p. 279-280, 3 fev. 2009. Disponível em: http://www.cmaj.ca/content/180/3/279.full. Acesso em: 30 jul. 2019. DOI: https://doi.org/10.1503/cmaj.082040
COSTANTINI, Sydney; WALENSKY, Rochelle P. The costs of drugs in infectious diseases: branded, generics, and why we should care. The Journal Of Infectious Diseases, Oxford: Oxford University Press, p. 1-7, 19 mar. 2019. Disponível em: https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiz066/5385524. Acesso em: 30 jul. 2019. DOI: https://doi.org/10.1093/infdis/jiz066
CRESSEY, Tim R. et al. Ravidasvir pharmacokinetics and ARV drugs interactions in HCV+/-HIV infected adults. In: CONFERENCE ON RETROVIRUSES AND OPPORTUNISTIC INFECTIONS, 1., 2018, Boston. Proceedings [...]. Boston: Croi Foundation, 2018. Pôster. Disponível em: http://www.croiconference.org/sessions/ravidasvir-pharmacokinetics-and-arv-drugs-interactions-hcv-hiv-infected-adults. Acesso em: 25 jul. 2019.
DIMASI, Joseph A.; GRABOWSKI, Henry G.; HANSEN, Ronald W. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal Of Health Economics, [S. l.]: Elsevier, v. 47, p. 20-33, maio 2016. Disponível em: https://www.sciencedirect.com/science/article/abs/pii/S0167629616000291?via%3Dihub. Acesso em: 23 jul. 2019. DOI: https://doi.org/10.1016/j.jhealeco.2016.01.012
DIRECTOR-GENERAL OF HEALTH MALAYSIA. Press Statement Minister of Health 20th September 2017 – Implementation of the Rights of Government for Sofosbuvir Tablet to Increase Access for Hepatitis C Treatment in Malaysia. 2017. Disponível em: https://kpkesihatan.com/2017/09/20/press-statement-minister-of-health-20th-september-2017-implementation-of-the-rights-of-government-for-sofosbuvir-tablet-to-increase-access-for-hepatitis-c-treatment-in-malaysia/. Acesso em: 23 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. An innovative approach to r&d for neglected patients: ten years of experience & lessons learned by DNDi. Geneva: Drugs For Neglected Diseases Initiative, 2014. 24 p. Disponível em: https://www.dndi.org/wp-content/uploads/2009/03/DNDi_Modelpaper_2013.pdf. Acesso em: 30 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. 2016 Annual report: Progress through Partnership. Genebra: Drugs For Neglected Diseases Initiative, 2017. 76 p. Disponível em: https://www.dndi.org/about-dndi/annual-reports/annualreport2016/. Acesso em: 10 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Compañías farmacéuticas y organizaciones sin fines de lucro colaboran para proporcionar un tratamiento para que la Hepatitis C sea accesible para pacientes de América Latina. 2018a. Disponível em: https://www.dndial.org/es/2018/comunicacion-e-informacion/es-press-releases/companias-farmaceuticas-y-organizaciones-colaboran-para-proporcionar-tratamiento-para-hepatitis-c-sea-accesible-america-latina/. Acesso em: 10 jul. 2019
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Iniciativa Medicamentos para Doenças Negligenciadas e farmacêutica Pharco testam tratamento de baixo custo para hepatite C com apoio dos governos da Malásia e Tailândia. 2016. Disponível em: https://www.dndi.org/2016/media-centre/langues-press-releases/dndi-pharco-hepc-malaysia-thailand-pt/. Acesso em: 10 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Intellectual Property Policy: DNDi policies. 2019a. Disponível em: https://www.dndi.org/wp-content/uploads/2018/03/DNDi_Intellectual_Property_Policy.pdf. Acesso em: 10 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Modelo de Negócios. 2019b. Disponível em: https://www.dndial.org/parcerias-estrategicas/modelo-negocios/. Acesso em: 10 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Parceiros. 2019c. Disponível em: https://www.dndial.org/parcerias-estrategicas/parceiros/. Acesso em: 10 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE; PHARCO; PHARMANIAGA. Pharmaniaga, Pharco and DNDi sign agreement to provide affordable hepatitis C treatment in Malaysia. 2017. Disponível em: https://www.dndi.org/2017/media-centre/press-releases/pharmaniaga-pharco-dndi-agreement-affordable-hep-c-treatment-malaysia/. Acesso em: 23 jul. 2019.
DRUGS FOR NEGLECTED DISEASES INITIATIVE. Uma abordagem de saúde pública para a epidemia de hepatite C: levando o tratamento da hepatite C aos pacientes negligenciados. Genebra: Drugs For Neglected Diseases Initiative, 2018b. 15 p. Disponível em: https://www.dndi.org/wp-content/uploads/2018/11/DNDi_HCV_2018_POR.pdf. Acesso em: 25 jul. 2019.
ESMAT, Gamal et al. Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis C genotype-4. Journal Of Hepatology, [S. l.]: Elsevier BV, v. 68, n. 1, p. 53-62, set. 2017. Disponível em: https://www.ncbi.nlm.nih.gov/pubmed/28935432. Acesso em: 24 jul. 2019. DOI: https://doi.org/10.1016/j.jhep.2017.09.006
EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER. EASL Recommendations on Treatment of Hepatitis C 2018. Journal of Hepatology, [S. l.]: Elsevier BV, v. 69, n. 2, p. 461-511, ago. 2018. Disponível em: https://www.journal-of-hepatology.eu/article/S0168-8278(18)31968-8/pdf. Acesso em: 24 jul. 2019. DOI: https://doi.org/10.1016/j.jhep.2018.03.026
FERES, Marcos Vinício Chein; SILVA, Alan Rossi; MOREIRA, Thaís Miranda. A DNDi e a política de propriedade intelectual: a zona intermediária da legalidade. In: SEMINÁRIO INTERNACIONAL DE DIREITOS HUMANOS E EMPRESAS, 2., 2015, Juiz de Fora. Anais [...]. Juiz de Fora: UFJF, 2015. p. 1-18. Disponível em: https://seminariosinternacionaisdireitoshumanoseempresas.files.wordpress.com/2015/10/artigo-completo-grupo-de-trabalho-ii-a-dndi-e-a-polc3adtica-de-propriedade-intelectual-a-zona-intermedic3a1ria-da-legalidade.pdf. Acesso em: 10 jul. 2019.
FONG, Loh Foon. Hope for hepatitis C patients. The Star Online, Kuala Lumpur, 2 mar. 2018. Disponível em: https://www.thestar.com.my/news/nation/2018/03/02/hope-for-hepatitis-c-patients-18-state-hospitals-offering-treatment-through-affordable-medicine/. Acesso em: 23 jul. 2019.
GILEAD SCIENCES INC. Chronic hepatitis C treatment expansion: generic manufacturing for developing countries. 2015. Disponível em: https://www.gilead.com/~/media/%20files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615%20.pdf?la=en. Acesso em: 25 jul. 2019.
GILEAD SCIENCES INC. Epclusa® Registration In The Developing World. 2019. Disponível em: https://www.gilead.com/-/media/files/pdfs/aoem-registrations/epclusa_registeration.pdf?la=en&hash=83CDB4E0C2D7FBF3DE87E9E5F5C60BE6. Acesso em: 24 jul. 2019.
GILEAD SCIENCES INC. License agreement. 2014. Disponível em: https://www.gilead.com/~/media/files/pdfs/other/2014_original_hcv_licensing_agreement.pdf?la=en. Acesso em: 25 jul. 2019.
HATCH, Orrin G.; WYDEN, Ron. The price of sovaldi and its impact on the U.S. health care system. Washington: U.S. Government Publishing Office, 2015. 134 p. Disponível em: https://www.finance.senate.gov/imo/media/doc/1%20The%20Price%20of%20Sovaldi%20and%20Its%20Impact%20on%20the%20U.S.%20Health%20Care%20System%20(Full%20Report).pdf. Acesso em: 30 jul. 2019.
HILL, Andrew et al. Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C. Journal Of Virus Eradication, London, v. 2, n. 1, p. 28-31, jan. 2016. Disponível em: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946692/pdf/jve-2-28.pdf. Acesso em: 25 jul. 2019. DOI: https://doi.org/10.1016/S2055-6640(20)30691-9
INTERNATIONAL TREATMENT PREPAREDNESS COALITION. A step back for millions of people with hepatitis C. 2015. Disponível em: http://itpcglobal.org/a-step-back-for-millions-of-people-with-hepatitis-c/. Acesso em: 25 jul. 2019
IWAMOTO, Momoko et al. Identifying the optimal care model for HCV care in Cambodia, and overcoming barriers to decentralization and scale-up: Médecins Sans Frontières’ (MSF) pilot program. In: WORLD HEPATITIS SUMMIT, 1., 2017, São Paulo. Proccedings [...]. São Paulo: World Hepatitis Summit, 2017. Pôster. Disponível em: http://www.worldhepatitissummit.org/docs/default-source/posters/49a_momokoiwamoto.pdf?sfvrsn=2. Acesso em: 24 jul. 2019.
LAZONICK, William et al. How Stock Buybacks Make Americans Vulnerable to Globalization. The Academic-industry Research Network, Cambridge, v. 2, n. 1, p. 1-16, 2016. Disponível em: http://www.theairnet.org/v3/backbone/uploads/2016/03/Lazonick.BuybacksAndGlobalization_AIR-WP16-0301.pdf. Acesso em: 30 jul. 2019.
LOVE, James. Pharmaceutical global R&D was 7.9 percent of sales in 2010. 2011. Disponível em: https://www.keionline.org/21592. Acesso em: 30 jul. 2019.
MACHADO, Maíra Rocha. O estudo de caso na pesquisa em direito. In: MACHADO, Maíra Rocha (org.). Pesquisar empiricamente o direito. São Paulo: Rede de Estudos Empíricos em Direito, 2017. p. 357-389. Disponível em: http://reedpesquisa.org/publicacoes/volume-2-no-1-2014/. Acesso em: 30 jul. 2019.
MAXMEN, Amy. Busting the billion-dollar myth: how to slash the cost of drug development. Nature, [S. l.], v. 536, n. 7617, p. 388-390, ago. 2016. Disponível em: https://www.nature.com/news/busting-the-billion-dollar-myth-how-to-slash-the-cost-of-drug-development-1.20469. Acesso em: 23 jul. 2019. DOI: https://doi.org/10.1038/536388a
MEDICINES PATENT POOL. El Medicines Patent Pool y Pharco Pharmaceuticals firman una licencia para el ravidasvir, un medicamento prometedor para la hepatitis C. 2017. Disponível em: https://medicinespatentpool.org/uploads/2018/01/2017.04.El-Medicines-Patent-Pool-y-Pharco-Pharmaceuticals-firman-una-licencia-para-el-ravidasvir.pdf. Acesso em: 23 jul. 2019.
MÉDECINS SANS FRONTIÈRES. Lives on the edge: time to align medical research and development with people’s health needs. Geneva: Médecins Sans Frontières, 2016. 52 p. Disponível em: https://msfaccess.org/lives-edge-time-align-medical-research-and-development-peoples-health-needs. Acesso em: 23 jul. 2019.
MÉDECINS SANS FRONTIÈRES. MSF secures lower price for generic hepatitis C treatment. 2017. Disponível em: https://www.msf.org/msf-secures-lower-price-generic-hepatitis-c-treatment. Acesso em: 23 jul. 2019.
MOSER, Petra. Patents and innovation in economic history. National Bureau of Economic Research, [S. l.], p. 1-34, fev. 2016. Disponível em: https://www.nber.org/papers/w21964.pdf. Acesso em: 30 jul. 2019.
MSF ACCESS CAMPAIGN. Spotlight on: Trans-Pacific Partnership Agreement. 2018. Disponível em: https://msfaccess.org/spotlight-trans-pacific-partnership-agreement. Acesso em: 30 jul. 2019.
NG, Eric. Chinese biotech firm Ascletis first to apply for Hong Kong IPO under new rules. South China Morning Post, [S. l.], 8 maio 2018. Disponível em: https://www.scmp.com/business/companies/article/2145082/chinese-biotech-firm-ascletis-first-apply-hong-kong-ipo-under-new. Acesso em: 23 jul. 2019.
¬¬PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA. Advocacy: intellectual property. 2019. Disponível em: https://www.phrma.org/advocacy/intellectual-property. Acesso em: 30 jul. 2019.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA. 2015 biopharmaceutical research industry profile. Washington: Pharmaceutical Research And Manufacturers of America, 2015. 67 p. Disponível em: http://phrma-docs.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf. Acesso em: 30 jul. 2019.
POLARIS OBSERVATORY HCV COLLABORATORS. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. The Lancet Gastroenterology & Hepatology, [S. l.]: Elsevier, v. 2, n. 3, p. 161-176, 2017. Disponível em: https://www.thelancet.com/action/showPdf?pii=S2468-1253%2816%2930181-9. Acesso em: 17 jul. 2019.
REUTERS. Insurers worry that $84,000 hepatitis C drug sovaldi could break the bank. Newsweek, [S. l.], p. 1-2, 28 maio 2014. Disponível em: https://www.newsweek.com/insurers-worry-84000-hepatitis-c-drug-sovaldi-could-break-bank-252539. Acesso em: 30 jul. 2019.
SELL, Susan K. Private power, public law: the globalization of intellectual property rights. Nova Iorque: Cambridge University Press, 2003. 242 p. DOI: https://doi.org/10.1017/CBO9780511491665
STATISTA. Ranking of the 20 companies with the highest spending on research and development in 2018 (in billion U.S. dollars). 2019. Disponível em: https://www.statista.com/statistics/265645/ranking-of-the-20-companies-with-the-highest-spending-on-research-and-development/. Acesso em: 30 jul. 2019.
SWANSON, Ana. Big pharmaceutical companies are spending far more on marketing than research. The Washington Post, Washington, 11 fev. 2015. Disponível em: https://www.washingtonpost.com/news/wonk/wp/2015/02/11/big-pharmaceutical-companies-are-spending-far-more-on-marketing-than-research/?noredirect=on&utm_term=.80bf0f4c5ab4. Acesso em: 30 jul. 2019.
TIRRELL, Meg. Gilead to buy pharmasset for $11 billion to win in hepatitis. Bloomberg, [S. l.], 2014. Disponível em: https://www.bloomberg.com/news/articles/2011-11-21/gilead-to-acquire-pharmasset-for-11-billion-to-add-hepatitis-c-medicines. Acesso em: 30 jul. 2019.
TRESSE, Vitor Schettino. Doenças negligenciadas e patentes de fármacos: uma análise da garantia ao direito à saúde através do novo paradigma colaborativo. 2015. 109 f. Dissertação (Mestrado em Direito) – Universidade do Estado do Rio de Janeiro, Rio de Janeiro, 2015.
UNITED STATES GOVERNMENT ACCOUNTABILITY OFFICE. Drug industry: profits, research and development spending, and merger and acquisition deals. Washington: United States Government Accountability Office, 2017. 78 p. Disponível em: https://www.gao.gov/assets/690/688472.pdf. Acesso em: 30 jul. 2019.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Prescription drugs: innovation, spending, and patient access. Washington: U.S. Department Of Health And Human Services, 2016. 147 p. Disponível em: https://delauro.house.gov/sites/delauro.house.gov/files/Prescription-Drugs-Innovation-Spending-and-Patient-Access-12-07-16.pdf. Acesso em: 30 jul. 2019.
WORLD HEALTH ORGANIZATION. Essential medicines and health products: prequalification of medicines. 2019. Disponível em: https://extranet.who.int/prequal/. Acesso em: 24 jul. 2019.
WORLD HEALTH ORGANIZATION. Global hepatitis report 2017. Geneva: World Health Organization, 2017. 68 p. Disponível em: https://www.afro.who.int/sites/default/files/2017-06/9789241565455-eng.pdf. Acesso em: 30 jul. 2019.
WORLD HEALTH ORGANIZATION. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection. Geneva: World Health Organization, 2018a. 108 p. Disponível em: https://apps.who.int/iris/bitstream/handle/10665/273174/9789241550345-eng.pdf?ua=1. Acesso em: 24 jul. 2019.
WORLD HEALTH ORGANIZATION. Progress report on access to hepatitis C treatment: focus on overcoming barriers in low – and middle-income countries. Geneva: World Health Organization, 2018b. 68 p. Disponível em: https://apps.who.int/iris/bitstream/handle/10665/260445/WHO-CDS-HIV-18.4-eng.pdf;jsessionid=9AC16EC2FB8CFE75BD77EC8DF69E417D?sequence=1. Acesso em: 24 jul. 2019.
WORLD TRADE ORGANIZATION. Acordo sobre Aspectos dos Direitos de Propriedade Intelectual Relacionados ao Comércio. 1994. Disponível em: http://www.inpi.gov.br/legislacao-1/27-trips-portugues1.pdf. Acesso em: 20 ago. 2019.
YIN, Robert K. Estudo de caso: planejamento e método. 5. ed. Porto Alegre: Bookman, 2015.
ZAMPIERI, Natália. A problemática dos monopólios das indústrias de medicamentos e o direito à saúde: o caso glivec. Espaço Jurídico Journal Of Law [EJJL], São Miguel do Oeste: Universidade do Oeste de Santa Catarina, v. 16, n. 1, p. 201-220, jun. 2015. Disponível em: https://portalperiodicos.unoesc.edu.br/espacojuridico/article/view/2822. Acesso em: 31 jul. 2019. DOI: https://doi.org/10.18593/ejjl.v16i1.2822
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