{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T04:25:51Z","timestamp":1768623951158,"version":"3.49.0"},"reference-count":46,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T00:00:00Z","timestamp":1589846400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"DOI":"10.3389\/fphar.2020.00752","type":"journal-article","created":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T05:18:46Z","timestamp":1589865526000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":8,"title":["The High \u201cCost\u201d of Experimental Drugs Obtained Through Health Litigation in Brazil"],"prefix":"10.3389","volume":"11","author":[{"given":"Ricardo Eccard da","family":"Silva","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisangela da Costa","family":"Lima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Rita C. G.","family":"Novaes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia G. S.","family":"Osorio-de-Castro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2020,5,19]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1080\/14737167.2018.1485098","article-title":"Immunosuppressants in Brazil: underlying drivers of spending trends 2010-2015","volume":"18","author":"Alves","year":"2018","journal-title":"Expert Rev. Pharmacoeconom. Outcomes Res."},{"key":"B2","article-title":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. Sistema de Produtos e Servi\u00e7os sob Vigil\u00e2ncia Sanit\u00e1ria (Datavisa), para verificar a exist\u00eancia do registro, e tanto no Sistema de Controle de Pesquisa Cl\u00ednica (SCPC) como no Sistema de Notifica\u00e7\u00e3o de Eventos Adversos Graves em Ensaios Cl\u00ednicos (NotivisaEC) para verifica\u00e7\u00e3o dos eventos adversos","year":"2018"},{"key":"B3","unstructured":"Resolu\u00e7\u00e3o do Conselho Nacional de Sa\u00fade n. 466 de 12 de dezembro de 2012, que aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos2012"},{"key":"B4","unstructured":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. Resolu\u00e7\u00e3o RDC n. 38\/2013, que aprova o regulamento para os programas de acesso expandido, uso compassivo e fornecimento de medicamento p\u00f3s-estudo2013"},{"key":"B5","year":"2013"},{"key":"B6","unstructured":"Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa). Resolu\u00e7\u00e3o RDC n. 9 de 20 de fevereiro de 2015. Dispo\u00f5e sobre o Regulamento para a realiza\u00e7a\u00e3o de ensaios cli\u00ednicos com medicamentos no Brasil2015"},{"key":"B7","article-title":"LEI N\u00b0 13.411, DE 28 DE DEZEMBRO DE 2016. Altera a Lei n. 6.360, de 23 de setembro de 1976, que disp\u00f5e sobre a vigil\u00e2ncia sanit\u00e1ria a que ficam sujeitos os medicamentos, as drogas, os insumos farmac\u00eauticos e correlatos, cosm\u00e9ticos, saneantes e outros produtos, e d\u00e1 outras provid\u00eancias, e a Lei n\u00b0 9.782, de 26 de janeiro de 1999, que define o Sistema Nacional de Vigil\u00e2ncia Sanit\u00e1ria, cria a Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria, e d\u00e1 outras provid\u00eancias, para dar transpar\u00eancia e previsibilidade ao processo de concess\u00e3o e renova\u00e7\u00e3o de registro de medicamento e de altera\u00e7\u00e3o p\u00f3s-registro","year":"2016"},{"key":"B8","unstructured":"Governo Federal. Sistema Eletr\u00f4nico do Servi\u00e7o de Informa\u00e7\u00e3o ao Cidad\u00e3o2019"},{"key":"B9","doi-asserted-by":"publisher","first-page":"147","DOI":"10.17566\/ciads.v7i2.496","article-title":"Efeitos do gasto com a judicializa\u00e7\u00e3o da sa\u00fade no or\u00e7amento da Secretaria Estadual de Sa\u00fade do Distrito Federal entre 2013 e 2017","volume":"7","author":"Chagas","year":"2018","journal-title":"Cad. Ibero-Amer. Dir. Sanit."},{"key":"B10","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1186\/s12913-017-2430-x","article-title":"Legal access to medications: a threat to Brazil's public health system","volume":"17","author":"Chieffi","year":"2017","journal-title":"BMC Health Serv. Res."},{"key":"B11","unstructured":"The Intellectual Property and Science business of Thomson Reuters2018"},{"key":"B12","unstructured":"Insulinas an\u00e1logas de a\u00e7\u00e3o r\u00e1pida para Diabetes Mellitus Tipo 12019"},{"key":"B13","unstructured":"Insulinas an\u00e1logas de a\u00e7\u00e3o prolongada para o tratamento de diabetes mellitus tipo II. Relat\u00f3rio de Recomenda\u00e7\u00e3o N\u00b0 434 Fevereiro\/20192019"},{"key":"B14","unstructured":"Recomenda\u00e7\u00f5es sobre as tecnologias avaliadas em 2014. Relat\u00f3rio T\u00e9cnico Alfataliglicerase para o tratamento da doen\u00e7a de Gaucher2019"},{"key":"B15","article-title":"Judicializa\u00e7\u00e3o da Sa\u00fade no Brasil: Perfil das demandas, causas e propostas de solu\u00e7\u00e3o. Relat\u00f3rio Anal\u00edtico Propositivo","year":"2019"},{"key":"B16","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1056\/NEJMhle1409465","article-title":"Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs","volume":"372","author":"Darrow","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"B17","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1007\/s40258-013-0073-6","article-title":"Insulin Glargine in a Brazilian State: Should the Government Disinvest? An Assessment Based on a Systematic Review","volume":"12","author":"De Souza","year":"2014","journal-title":"Appl. Health Econ. Health Policy"},{"key":"B18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1590\/S1679-45082016AO3363","article-title":"Evidence-Based Medicine in judicial decisions concerning right to healthcare","volume":"14","author":"Dias","year":"2016","journal-title":"Einstein"},{"key":"B19","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1590\/1413-81232014192","article-title":"A judicializa\u00e7\u00e3o da sa\u00fade no Distrito Federal","volume":"19","author":"Diniz","year":"2014","journal-title":"Cien. Saude Colet."},{"key":"B20","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1590\/S0103-73312010000100007","article-title":"Um enfoque sanit\u00e1rio sobre a demanda judicial de medicamentos","volume":"20","author":"Figueiredo","year":"2010","journal-title":"Physis: Rev. Sa\u00fade Coletiva"},{"key":"B21","doi-asserted-by":"publisher","first-page":"S159","DOI":"10.1590\/0102-311X00161812","article-title":"Evidence-based process for decision-making in the analysis of legal demands for medicines in Brazil","volume":"29","author":"Figueiredo","year":"2013","journal-title":"Cad. Sa\u00fade P\u00fablica"},{"key":"B22","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1590\/S1020-49892008000300007","article-title":"O uso de drogas ainda experimentais em assist\u00eancia: extens\u00e3o de pesquisa, uso compassivo e acesso expandido","volume":"23","author":"Goldim","year":"2008","journal-title":"Rev. Panam. Salud. Publica\/Pan Am. J. Public Health"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1590\/0102-311X00070018","article-title":"Added therapeutic value of new drugs approved in Brazil from 2004 to 2016","volume":"35","author":"Hoefler","year":"2019","journal-title":"Cad. Sa\u00fade P\u00fablica"},{"key":"B24","article-title":"International Conference on Harmonisation of Techinical Requirements for Registration of Pharmaceuticals For Human Use","year":"2003"},{"key":"B25","unstructured":"\u00cdndice Nacional de Pre\u00e7os ao Consumidor Amplo. Instituto Brasileiro de Geografia e Estat\u00edstica \u2013 IBGE2019"},{"key":"B26","doi-asserted-by":"publisher","first-page":"705","DOI":"10.1177\/2168479016656030","article-title":"Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period","volume":"50","author":"Jarow","year":"2016","journal-title":"Ther. Innov. Regul. Sci."},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0167039","article-title":"Budget Impact of Long-Acting Insulin Analogues: The Case in Brazil","volume":"11","author":"Laranjeira","year":"2016","journal-title":"PloS One"},{"key":"B28","doi-asserted-by":"publisher","first-page":"620","DOI":"10.1590\/S0034-89102010000400005","article-title":"Rational use of anticancer drugs and patient lawsuits in the state of S\u00e3o Paulo, Southeastern Brazil","volume":"44","author":"Lopes","year":"2010","journal-title":"Rev. Sa\u00fade P\u00fablica"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0174616","article-title":"Trends in medicines procurement by the Brazilian federal government from 2006 to 2013","volume":"12","author":"Luz","year":"2017","journal-title":"PloS One"},{"key":"B30","unstructured":"Fundo Nacional de Sa\u00fade. Minist\u00e9rio da Sa\u00fade vai disponibilizar software para controlar a\u00e7\u00f5es judiciais em sa\u00fade2018"},{"key":"B31","unstructured":"Ministro da Sa\u00fade discute acesso da popula\u00e7\u00e3o \u00e0 sa\u00fade p\u00fablica2018"},{"key":"B32","unstructured":"Minist\u00e9rio da Sa\u00fade adota medidas para garantir oferta de medicamentos para doen\u00e7as raras2018"},{"key":"B33","unstructured":"Liminar aponta \u201cafronta a concorr\u00eancia\u201d em compra para doen\u00e7as raras2018"},{"key":"B34","doi-asserted-by":"publisher","first-page":"e57","DOI":"10.26633\/RPSP.2019.57","article-title":"Normatiza\u00e7\u00e3o de programas de acesso expandido e uso compassivo de medicamentos na Am\u00e9rica do Sul [Regulations on expanded access and compassionate use of medicines in South AmericaRegulaci\u00f3n de los programas de acceso ampliado y uso compasivo de medicamentos en Am\u00e9rica del Sur]","volume":"43","author":"Mosegui","year":"2019","journal-title":"Rev. Panameric. Salud Publica Pan Am. J. Public Health"},{"key":"B35","unstructured":"Organiza\u00e7\u00e3o Pan-Americana da Sa\u00fade. Acesso aos medicamentos de alto custo nas Am\u00e9ricas2009"},{"key":"B36","doi-asserted-by":"publisher","first-page":"1807","DOI":"10.1590\/0102-311XPE010915","article-title":"The 21st Century Cures Act: can the regulatory framework survive the \u201ccures","volume":"31","author":"Osorio-de-Castro","year":"2015","journal-title":"Cad. Sa\u00fade P\u00fablica"},{"key":"B37","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1590\/1414-462X201700020022","article-title":"Qual \u00e9 o custo da prescri\u00e7\u00e3o pelo nome de marca na judicializa\u00e7\u00e3o do acesso aos medicamentos","volume":"25","author":"Paim","year":"2017","journal-title":"Cad. Sa\u00fade Colet."},{"key":"B38","first-page":"145","article-title":"Drugs in 2017: a brief review","volume":"38","year":"2018","journal-title":"Rev. Prescrire"},{"key":"B39","unstructured":"Supremo Tribunal Federal. Decis\u00e3o do STF desobriga Estado de fornecer medicamento sem registro na Anvisa2019"},{"key":"B40","doi-asserted-by":"publisher","first-page":"741","DOI":"10.1590\/s0103-73312016000300002","article-title":"O caso da fosfoetanolamina sint\u00e9tica e a preocupante flexibiliza\u00e7\u00e3o das normas sanit\u00e1rias no Brasil","volume":"26","author":"Teodoro","year":"2016","journal-title":"Physis: Rev. Sa\u00fade Coletiva"},{"key":"B41","doi-asserted-by":"publisher","first-page":"607","DOI":"10.1080\/14737167.2017.1311209","article-title":"Federal procurement of unlicensed medicines in Brazil; findings and implications","volume":"17","author":"Teodoro","year":"2017","journal-title":"Expert Rev. Pharmacoecon. Outcomes Res."},{"key":"B42","doi-asserted-by":"publisher","first-page":"2539","DOI":"10.1590\/1413-81232017228.07982017","article-title":"The lawsuits to antineoplastic drugs: the tip of an iceberg","volume":"22","author":"Vidal","year":"2017","journal-title":"Cien. Saude Colet."},{"key":"B43","unstructured":"International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)2016"},{"key":"B44","volume-title":"World Health Organization. Adverse Reaction Terminology WHO-ART","year":"2018"},{"key":"B45","unstructured":"The WHO-UMC system for standardised case causality assessment2018"},{"key":"B46","unstructured":"The Anatomical Therapeutic Chemical Classification System with Defined Daily Doses (ATC\/DDD)2019"}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/article\/10.3389\/fphar.2020.00752\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T05:18:54Z","timestamp":1589865534000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/article\/10.3389\/fphar.2020.00752\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,19]]},"references-count":46,"alternative-id":["10.3389\/fphar.2020.00752"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2020.00752","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,19]]},"article-number":"752"}}