title: [Consequences of the judicialization of health policies: the cost of medicines for mucopolysaccharidosis].
abstract: This study analyzes expenditures backed by court rulings to ensure the public provision of medicines for treatment of mucopolysaccharidosis (MPS), a rare disease that requires high-cost drugs not covered by the Brazilian government's policy for pharmaceutical care and which have disputed clinical efficacy. The methodology included a review of files from 196 court rulings ordering the Brazilian Ministry of Health to provide the medicines, in addition to Ministry of Health administrative records. According to the analysis, the "judicialization" of the health system subjected the Brazilian government to a monopoly in the distribution of medicines and consequently the loss of its capacity to manage drug purchases. The study also indicates that the imposition of immediate, individualized purchases prevents obtaining economies of scale with planned procurement of larger amounts of the medication, besides causing logistic difficulties in controlling the amounts consumed and stored. In conclusion, litigation results from the lack of a clear policy in the health system for rare diseases in general, thereby leading to excessive expenditures for MPS treatment.
authors.affiliation: Instituto de Bioética Direitos Humanos e Gênero, Brasília, Brazil. d.diniz@gmx.com
authors.forename: Debora
authors.initials: D
authors.lastname: Diniz
authors.forename: Marcelo
authors.initials: M
authors.lastname: Medeiros
authors.forename: Ida Vanessa D
authors.initials: IV
authors.lastname: Schwartz
mesh_terms: D001938:Brazil; D016527:Drug Costs / Q000331:legislation & jurisprudence*; D018954:Drugs, Essential / Q000191:economics* / Q000600:supply & distribution; D005102:Health Expenditures / Q000331:legislation & jurisprudence; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence; D006801:Humans; D007066:Iduronate Sulfatase / Q000191:economics / Q000600:supply & distribution; D009083:Mucopolysaccharidoses / Q000188:drug therapy*; D020051:N-Acetylgalactosamine-4-Sulfatase / Q000191:economics / Q000600:supply & distribution; D017150:Public Sector; D035583:Rare Diseases / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000191:economics / Q000600:supply & distribution
chemical_list: D018954:Drugs, Essential; D011994:Recombinant Proteins; D020051:N-Acetylgalactosamine-4-Sulfatase; D007066:Iduronate Sulfatase