Pesquisa e Desenvolvimento (P&D) no Setor Farmacêutico
avanços, limitações, seletividade e negligência
DOI:
https://doi.org/10.5216/teri.v14i1.79594Palavras-chave:
Setor Farmacêutico, Pesquisa e Desenvolvimento (P&D), Investimentos, Crescimento, LimitaçõesResumo
Com o objetivo de contribuir para os estudos e debates acerca do processo de Pesquisa e Desenvolvimento (P&D) no setor farmacêutico, este trabalho realizou uma extensa coleta, organização e análise de dados sobre o tema, explorando os avanços, limitações, seletividade e negligência nesse âmbito. Revelou-se que o setor farmacêutico representa o segundo maior investidor em P&D, registrando gastos globais de 238 bilhões de dólares em 2021. A busca por lucros decorrentes de medicamentos de sucesso motivou um crescimento significativo no número de empresas farmacêuticas focadas em P&D, resultando em 5.416 corporações que testam mais de 20 mil fármacos em várias fases de pesquisa e desenvolvimento. No entanto, este estudo também aponta para as limitações dos produtos derivados de P&D farmacêutico, observando que muitos medicamentos recém-aprovados não apresentam vantagens significativas sobre os já existentes e tendem a priorizar a manutenção de franquias rentáveis ou a competição de mercado, em detrimento do bem-estar populacional. Além disso, destaca-se a seletividade e negligência nos investimentos em P&D, com determinadas doenças recebendo maior atenção devido a uma variedade de interesses, incluindo aspectos socioeconômicos.
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ABBVIE - Annual Reports (2010 2022). North Chicago, Illinois, EUA: AbbVie, 2023. Available: https://investors.abbvie.com/annual-report-proxy. Accessed on: 23 dec. 2023.
ANGELL, Marcia. The Truth about the Drug Companies: how they deceive us and what to do about it. illustrated edition (2005). New York City, NY, United States: Random House Trade, 2005. 319 p.
ARONSON, Jeffrey K.; GREEN, A. Richard. Me‐too pharmaceutical products: history, definitions, examples, and relevance to drug shortages and essential medicines lists. British Journal of Clinical Pharmacology, [S.L.], v. 86, n. 11, p. 2114-2122, 13 may 2020. http://dx.doi.org/10.1111/bcp.14327.
BRANCH, Sarah K.; AGRANAT, Israel. “New Drug” Designations for New Therapeutic Entities: new active substance, new chemical entity, new biological entity, new molecular entity. Journal of Medicinal Chemistry, [S.L.], v. 57, n. 21, p. 8729-8765, 4 sep. 2014. http://dx.doi.org/10.1021/jm402001w.
CAMARGO JR., Kenneth Rochel de. O grande investimento da indústria farmacêutica nos últimos anos foi para disfunção erétil, não para malária. [Entrevista concedida a Raquel Júnia]. EPSJV/Fiocruz (Escola Politécnica de Saúde Joaquim Venâncio), [Online], nov. 2016. Available: https://www.epsjv.fiocruz.br/noticias/entrevista/o-grande-investimento-da-industria-farmaceutica-nos-ultimos-anos-foi-para. Accessed on: 25 mar. 2024.
CITELINE. Pharma Intelligence. Pharma R&D: annual review 2022. London (England): Pharma Intelligence, 2022. 55 p. Available: https://pharmaintelligence.informa.com/. Accessed on: 22 oct. 2023.
COHEN, Deborah. Cancer drugs: high price, uncertain value. Bmj, [S.L.], p. 1-4, 4 oct. 2017. http://dx.doi.org/10.1136/bmj.j4543.
DAVIS, Courtney et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. Bmj, [S.L.], p. 1-13, 4 oct. 2017. http://dx.doi.org/10.1136/bmj.j4530.
DIMASI, Joseph A. et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics, [S.L.], v. 47, p. 20-33, may. 2016. Elsevier BV. http://dx.doi.org/10.1016/j.jhealeco.2016.01.012.
EFPIA - The European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures. Belgium (Europe): EFPIA, 2022. 28 p. Available: https://www.efpia.eu/. Accessed on: 10 out. 2023.
FDA - Food and Drug Administration (FDA). The Drug Development Process. Federal agency of the Department of Health and Human Services (USA). Silver Spring, Maryland, U.S. 2018. Available: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process. Accessed on: 16 oct. 2023.
GLOY, Viktoria et al. The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020. International Journal of Cancer, [S.L.], v. 152, n. 12, p. 2474-2484, 24 feb. 2023. http://dx.doi.org/10.1002/ijc.34473.
GYAWALI, Bishal et al. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. Jama Internal Medicine, [S.L.], v. 179, n. 7, p. 906, 1 jul. 2019. http://dx.doi.org/10.1001/jamainternmed.2019.0462.
HILAL, Talal et al. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration. Jama Internal Medicine, [S.L.], v. 180, n. 8, p. 1108, 1 aug. 2020. http://dx.doi.org/10.1001/jamainternmed.2020.2250.
HOTEZ, Peter J et al. Rescuing the bottom billion through control of neglected tropical diseases. The Lancet, [S.L.], v. 373, n. 9674, p. 1570-1575, may. 2009. http://dx.doi.org/10.1016/s0140-6736(09)60233-6.
KESSELHEIM, Aaron S. et al. Determinants of Market Exclusivity for Prescription Drugs in the United States. Jama Internal Medicine, [S.L.], v. 177, n. 11, p. 1658, 1 nov. 2017. http://dx.doi.org/10.1001/jamainternmed.2017.4329.
KIM, Chul; PRASAD, Vinay. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival. Jama Internal Medicine, [S.L.], v. 175, n. 12, p. 1992, 1 dec. 2015. http://dx.doi.org/10.1001/jamainternmed.2015.5868.
LIGHT, Donald. W.; LEXCHIN, Joel. R. Pharmaceutical research and development: what do we get for all that money?. Bmj, [S.L.], v. 345, n. 071, p. 1-5, 7 aug. 2012. http://dx.doi.org/10.1136/bmj.e4348.
MALERBA, Franco; ORSENIGO, Luigi. The evolution of the pharmaceutical industry. Business History, [S.L.], v. 57, n. 5, p. 664-687, 3 jun. 2015. http://dx.doi.org/10.1080/00076791.2014.975119.
MORGAN, Steven G et al. “Breakthrough” drugs and growth in expenditure on prescription drugs in Canada. Bmj, [S.L.], v. 331, n. 7520, p. 815-816, 2 sep. 2005. http://dx.doi.org/10.1136/bmj.38582.703866.ae.
NACI, Huseyin et al. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis. Bmj, [S.L.], p. 1-17, 18 sep. 2019. http://dx.doi.org/10.1136/bmj.l5221.
PEDRIQUE, Belen et al. The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment. The Lancet Global Health, [S.L.], v. 1, n. 6, p. 371-379, dec. 2013. http://dx.doi.org/10.1016/s2214-109x(13)70078-0.
PRASAD, Vinay et al. The high price of anticancer drugs: origins, implications, barriers, solutions. Nature Reviews Clinical Oncology, [S.L.], v. 14, n. 6, p. 381-390, 14 mar. 2017. http://dx.doi.org/10.1038/nrclinonc.2017.31.
RAJKUMAR, S. Vincent. The high cost of prescription drugs: causes and solutions. Blood Cancer Journal, [S.L.], v. 10, n. 6, p. 1-5, 23 jun. 2020. http://dx.doi.org/10.1038/s41408-020-0338-x.
SOMO - investigates multinationals. Public health over pharmaceutical profit. 2024. Available: https://www.somo.nl/our-work/sectors/pharmaceutical-industry/. Accessed on: 25 mar. 2024.
STACCIARINI, João Henrique Santana. Drug advertising in Brazil. Sociedade & Natureza, [S.L.], v. 36, n.1, p. e72114, 2024b. http://dx.doi.org/10.14393/sn-v36-2024-72114x.
STACCIARINI, João Henrique Santana. (article in press). O Setor Farmacêutico Global: Números e Dinâmicas. Caminhos de Geografia, [S.L.], 2024a. PPUFU - Portal de Periódicos da Universidade Federal de Uberlândia.
STACCIARINI, João Henrique Santana. The Consolidation of the Pharmaceutical Sector in the Global Economy: growth, influence, deviations, and marketing. 2023. 145 p. PhD Thesis - Geography, Universidade Federal de Goiás, Goiânia (Brazil), 2023. https://doi.org/10.5281/zenodo.10377840.
STATISTA - Insights and facts across 170 industries and 150 countries. Research and development worldwide: Statistics & Facts. Hamburg, Germany. 2022a. Available: https://www.statista.com/topics/6737/research-and-development-worldwide/. Accessed on: 28 oct. 2023.
STATISTA - Insights and facts across 170 industries and 150 countries. Total global spending on pharmaceutical research and development from 2014 to 2028. Hamburg, Germany. 2022b. Available: https://www.statista.com/statistics/309466/global-r-and-d-expenditure-for-pharmaceuticals/. Accessed on: 29 out. 2023.
STATISTA - Insights and facts across 170 industries and 150 countries. Percentage of global research and development spending in 2021, by industry. Hamburg, Germany. 2023. Disponível em: https://www.statista.com/statistics/270233/percentage-of-global-rundd-spending-by-industry/. Acesso em: 29 out. 2023.
TROUILLER, Patrice et al. Drug development for neglected diseases: a deficient market and a public-health policy failure. The Lancet, [S.L.], v. 359, n. 9324, p. 2188-2194, jun. 2002. http://dx.doi.org/10.1016/s0140-6736(02)09096-7.
VAN LUIJN, Johan C. F. et al. Superior efficacy of new medicines? European Journal Of Clinical Pharmacology, [S.L.], v. 66, n. 5, p. 445-448, 12 mar. 2010. http://dx.doi.org/10.1007/s00228-010-0808-3.
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