Studies published in indexed journals on lawsuits for medicines in Brazil: a systematic review

Gomes, Vanessa Santana; Amador, Tânia Alves

doi:10.1590/0102-311X00219113

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Review • Cad. Saúde Pública 31 (3) • Mar 2015 • https://doi.org/10.1590/0102-311X00219113 copy

Studies published in indexed journals on lawsuits for medicines in Brazil: a systematic review

Estudios publicados en revistas indexadas acerca de decisiones judiciales para el acceso a los medicamentos en Brasil: una revisión sistemática

Authorship SCIMAGO INSTITUTIONS RANKINGS

The aim of this systematic review was to identify and characterize articles in indexed scientific journals with quantitative data surveys on administrative or legal proceedings for access to medicines. The SciELO, LILACS, MEDLINE via PubMed, Embase, and Scopus databases were used. We identified 45 articles, of which 17 were selected. The larger studies, each covering between 2,000 and 2,927 lawsuits, were done in the states of São Paulo, Rio de Janeiro, and Santa Catarina, Brazil. Eleven studies specified the type of legal representation, of which six examined cases with public attorneys and five with private attorneys. Only two studies reported whether the lawsuit was individual or class action, and in both the claims were individual. Since the majority of the medicines requested in the lawsuits were medium to high-cost, the review indicates that lawsuits contributed to the incorporation of these drugs into current pharmaceutical care in Brazil.

Judicial Decisions; Pharmaceutical Services; Right to Health

Information on publications	n	%
Year of publication
2013-2012	5	29.4
2011-2010	8	47.0
2009-2008	2	11.8
2007-2006	1	5.9
2005	1	5.9
Scope
Federal Government	1	5.9
São Paulo State	5	29.4
Rio de Janeiro State	4	23.5
Minas Gerais State	2	11.8
Rio Grande do Sul State	2	11.8
Santa Catarina State	2	11.8
Pernambuco State	1	5.9
Language of publication
Portuguese	16	94.1
English	1	5.9
Country of publication
Brazil	16	94.1
United States	1	5.9
Journal
Ciência & Saúde Coletiva	2	11.8
Revista de Saúde Pública	8	47.0
Cadernos de Saúde Pública	5	29.4
Health and Human Rights	1	5.9
Revista do Direito Sanitário	1	5.9
Study design
Quantitative/descriptive	14	82.3
Mixed descriptive (theoretical/quantitative)	3	17.7
Number of lawsuits (sample size)
≤ 500	8	47.0
500-1,000	2	11.8
1,000-1,500	2	11.8
1,500-2,000	0	0.0
2,000-2,500	3	17.6
2,500-3,000	2	11.8

Data source (type of document and location)	n	%
Documents
Preliminary rulings on lawsuits and reports on drug costs	1	5.9
Files on lawsuits for medicines, Ministry of Health	1	5.9
Court proceedings	14	82.3
File on financial authorizations for purchase of drugs	1	5.9
Data collection site
Municipal Health Secretariats *	2	11.8
State Health Secretariats	7	41.2
Ministry of Health, print and electronic files	1	5.9
Website, Court of Justice	2	11.8
Office of the State Attorney (PGE)	2	11.8
System for Registration of Court Proceedings (SCJ)	3	17.6

Legal variables	n	%
Plaintiffs’ legal representation (public, private, free legal aid)	11	64.7
Plaintiffs’ allegations, and judges’ reasons for ruling in favor of claims	4	23.5
Nature of lawsuit (individual or class-action)	2	11.8
Petition for advance relief or other injunctions	3	17.6
Defendants (Federal, state, or municipal government or a combination thereof)	4	23.5

Authors	Therapeutic indications	Most frequently requested drugs	Health services	% without ANVISA	Presenças em listas oficiais	Ano de publicação
Stamford et al. 5 (n = 105)	Inclusion on government distribution lists	Year of publication	NA	NA	NA	2012
Campos Neto et al. 10	NA	Antineoplastic drugs and immune modulators	NA	NA	NA	2012
Campos Neto et al. 10 (n = 2,412)	Rheumatoid arthritis, type I diabetes mellitus, chronic obstructive pulmonary disease, and ankylosing spondylitis.	Adalimumab, etanercept, ursodeoxycholic acid, infliximab, and insulin glargine.	NA	NA	NA	2012
Sartoni Junior D et al. 6 (n = 13)	Rheumatoid arthritis, type I diabetes mellitus, chronic obstructive pulmonary disease, and ankylosing spondylitis.	Adalimumab, etanercept, ursodeoxycholic acid, infliximab, and insulin glargine.	NA	NA	NA	2012
Diniz et al. 19	Fabry’s disease *	Alpha-galactosidase **	Private	0%	NA	2012
(n = 196)	Type IV mucopolysaccharidosis ***	Galsulphase **	NA	NA	NA	2012
Machado et al. ⁸ (n = 827)	NA	Adalimumabe, etanercepte, insulina glargina, omeprazol, aripiprazol	Privado	5%	19,6% presente na RENAME, 11,1% essenciais pela lista da Organização Mundial da Saúde; 24,3% alto custo; 10,9% atenção básica, 3,5% estratégico. 56,7% fora de lista	2011
Sant’ Ana et al. ⁹ (n = 27)	NA	Furosemida; digoxina; clonazepam; ácido acetilsalicílico; enalapril e bromazepam.	50% privado, 50% público	0,9%	45,2% RENAME; 13,9% excepcionais	2011
Borges & Ugá ¹² (n = 2062)	NA	NA	NA	NA	52% presentes em listas do Ministério da Saúde	2010
Chieffi & Barata ¹⁶ (n = 2.927)	NA	Insulina glargina e lispro, adalimumabe, etanercepte, infliximabe	NA	NA	NA	2010
Lopes et al ¹⁷ (n = 1.220)	Câncer ^#	Bevacizumabe, capecitabina, cetuximabe, erlotinibe, imatinibe, rituximabe, temozolomida	Privado	2006: 14% 2007: 10% ^##	NA	2010
Stamford et al. ⁵ (n = 105)	NA	Antineoplastic drugs and immune modulators	NA	NA	NA	2012
Campos Neto et al. ⁷ (n = 2,412)	Rheumatoid arthritis, type I diabetes mellitus, chronic obstructive pulmonary disease, and ankylosing spondylitis	Adalimumab, etanercept, ursodeoxycholic acid, infliximab, and insulin glargine	NA	NA	NA	2012
Sartoni Junior et al. ⁶ (n = 13)	Fabry’s disease *	Alpha-galactosidase **	Private	0%	NA	2012
Diniz et al. ¹⁹ (n = 196)	Type IV mucopoly- saccharidosis ***	Galsulphase **	NA	NA	NA	2012
Biehl et al. ² (n = 1,080)	Essential hypertension, diabetes mellitus, chronic viral hepatitis, ischemic heart disease, and chronic obstructive pulmonary disease	Teriparatide, clopidogrel, insulin glargine, rituximab, infliximab	Public	NA	Essential drugs 28%; exceptional drugs 27%; special drugs 11%; one strategic action; 56% not on list	2012
Macedo et al. ¹³ (n = 81)	NA	NA	NA	NA	14.3% primary care and 19.5% exceptional	2011
Machado et al. ⁸ (n = 827)	NA	Adalimumab, etanercept, insulin glargine, omeprazole, aripiprazole	Private	5%	19.6% on RENAME list; 11.1% WHO essential drugs; 24.3% high-cost; 10.9% primary care, 3.5% strategic. 56.7% not on list	2011
Sant’ Ana et al. ⁹ (n = 27)	NA	Furosemide; digoxin; clonazepam; acetyl-salicylic acid; enalapril and bromazepam	50% private, 50% public	0.9%	45.2% RENAME; 13.9% exceptional	2011
Borges & Ugá ¹² (n = 2,062)	NA	NA	NA	NA	52% on Ministry of Health lists	2010
Chieffi & Barata ¹⁶ (n = 2,927)	NA	Insulin glargine and lispro, adalimumab, etanercept, infliximab	NA	NA	NA	2010
Lopes et al ¹⁷ (n = 1,220)	Cancer ^#	Bevacizumab, capecitabine, cetuximab, erlotinibe, imatinibe, rituximab, temozolomide	Private	2006: 14% 2007: 10% ^##	NA	2010
Pepe et al. ¹⁰ (n = 185)	Hypertension, diabetes mellitus, degenerative diseases of the nervous system, chronic lower airway diseases, and end-stage renal disease	NA	NA	NA	35.8% of drugs on RENAME list and 48.1% on government distribution lists	2010
Pereira et al. ²⁰ (n = 622)	Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, hepatitis C, ischemic heart disease, hypertension, cancer, and diabetes	Infliximab, leflunomide, etanercept, adalimumab, propatyl nitrate, clopidogrel, enalapril,carvedilol, simvastatin, insulin glargine	Private	1,4%	Exceptional/high-cost drugs 26.4%; primary pharmaceutical care 2.4%; mental health 1.5%; strategic 1.4%; cystic fibrosis 1%	2010
Chieffi & Barata ¹⁴ (n = 2,927)	NA	NA	Public	3%	23% supplied by SUS,;13% belonged to Program for Dispensing Exceptional Drugs;	2009
Leite et al. ¹⁸ (n = 2,426)	NA	NA	NA	NA	32% of requested drugs were part of standard distribution in the SUS	2009
Vieira & Zucchi ¹⁵ (n = 170)	Diabetes mellitus, cancer, comorbidities related to hypertension and diabetes	NA	Public	2 without registration	62% part of REMUME – São Paulo, or the list of the Program for Dispensing Exceptional Drugs (High-Cost)	2007
Messeder et al. ¹¹ (n = 389)	Until 1998: HIV. 2000: Crohn’s disease, chronic hepatitis C, and kidney disease 2001 and 2002: essential hypertension and chronic ischemic heart disease	2000: botulin toxin type A, riluzole and olanzapine. 2001: cyproterone acetate and goserelin acetate. 2002: sevelamer hydrochloride and mesalazine	Public	NA	31.4 % exceptional, 18.2% strategic, 14/08% primary care, 19% mental health, 3.7% state, 30.8% with no definition of funding	2005

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[1] Correspondence T. A. Amador Programa de Pós-graduação em Assistência Farmacêutica, Universidade Federal do Rio Grande do Sul. Av. Ipiranga 2752, sala 602A, Porto Alegre, RS 90610-000, Brasil. tania.alves@ufrgs.br