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Table 2 National Laws on Rare Diseases in 6 Latin American Countries

From: A civil society view of rare disease public policy in six Latin American countries

CountryLaw/OrdinanceDate EnactedDescription
ArgentinaLaw 26,689June 29, 2011Defines rare diseases in Argentina as those that affect 1 of every 2000 persons and dictates comprehensive care and coverage for rare disease patients. It mandates national patient- and disease-specific data registries, centers of excellence, interdisciplinary care for rare disease patients, expanded newborn screening programs, and research and development of health technologies to address rare diseases. Of note, in Argentina rare diseases are referred to in Spanish as “diseases of low prevalence” given the negative connotation of the word “rare.”
BrazilOrdinance 199January 30, 2014Ordinance 199 is an administrative act (not passed by Congress). It calls for greater public awareness, improving diagnosis, increasing education and training among health professionals, expanding reference centers, and developing clinical protocols for prioritized rare diseases. Ordinance 199 expands a 2009 policy on clinical genetics [10].
ChileLaw 20.850June 1, 2015The Financial Protection System for High Cost Diagnostics and Treatments (Ricarte Soto Law) creates a program for diagnostic and treatment coverage for select high-cost diseases and, as such, facilitates access for some rare disease patients. The law originated with a focus on rare diseases, but is not specific to rare diseases [11].
ColombiaLaw 1392July 2, 2010Mandates social protection for all with rare diseases and measures to address in a comprehensive manner the needs of these patients in all dimensions and in all relevant phases of disease awareness, diagnosis, prevention, treatment, and ongoing management. The law guarantees access to medicines and diagnosis, calls for health professional training in rare diseases, a data/information collection system, centers of excellence, and rare disease research networks [6].
MexicoArticle 224 bis and bis 1 of the General Health LawJanuary 30, 2012Defines orphan medicines for rare diseases that affect < 5 individuals in 10,000 and mandates the nation’s Secretary of Health consider any and all means necessary to make these medicines available to the Mexican population [8].
PeruLaw 29698June 4, 2011Declares of national interest the prevention, diagnosis, and comprehensive treatment for persons with rare diseases. Calls on the Ministry of Health to adopt mechanisms to ensure orphan drugs are available to patients, develop a rare disease patient registry, build a national action plan, seek measures to improve diagnosis, and include rare diseases in medical education and training curricula. The law considers rare disease services and treatments in Peru a priority for annual health budgeting and resource allocation purposes [7].