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Table 3 National Regulations for Rare Diseases in 6 Latin American Countries

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

CountryRegulation(s)Date EnactedDescription
ArgentinaResolution 2329December 22, 2014Creates national program for rare diseases and congenital anomalies. For rare diseases, specifies developing a list of these and a national patient registry. All other provisions such as advisory board, public awareness, training of public health professionals, and a national network of diagnosis and care centers apply to both rare diseases and congenital anomalies [17].
Decree 794May 11, 2015Specifically regulates the national rare diseases law with provisions such as a national advisory board, studies to determine the existing care infrastructure, and minimum coverage standards. Most of the specific mandates in the national law are left “unregulated” in the decree [18].
Resolution 271/19February 13, 2019Establishes the Advisory Board for Rare Diseases and Congenital Anomalies to be led by the Ministry of Health and to include representatives from several hospitals, one medical society, and five patient-based organizations. Mandates the Board create rare diseases list for Ministry approval [19].
BrazilN/ASee Ordinance 199
ChileN/ASee Law 20.850
ColombiaDecree 1954September 19, 2012Describes the data collection mechanism on number of rare diseases in Colombia [20].
Resolution 430February 20, 2013Lists 1940 different rare diseases in the country [21]
Resolution 3681September 19, 2013Specifies how the government would collect information on rare disease patients via the high-cost account. Data from the one-time census of patients in 2013 was made public via the Ministry’s SISPRO system capturing data on just over 13,000 patients, including their age, gender, type of rare disease, and geographic residence [22]
Resolution 123January 21, 2015Mandates the continued reporting of hemophilia and related coagulopathies to the high-cost account. These were the only diseases mandated for continued reporting beyond the one-time census of rare disease patients in 2013 [23]
Resolution 2048June 9, 2015Updates the number of rare diseases in Colombia to 2149 with each assigned a number code (1–2149). The coding is important for use in health system settings with the goal of improving surveillance of rare diseases over time and nationwide [24]
Resolution 651March 1, 2018Outlines the processes, standards, and criteria for health centers to become officially recognized rare disease reference centers for diagnosis, treatment, and management. Also defines how these reference centers would then link to each other in networks and sub-networks to cover all of Colombia [25].
MexicoN/A
PeruDecree 004-2019-SAFebruary 22, 2019Mandates national plan, rare disease patient registry, scientific and medical research, health personnel training, and coordinated care regardless of coverage status or source of medical care. Also mandates budget impact and other economic evaluation studies for high-cost rare disease diagnostic tests and medicines to be carried out by a new health technology evaluation agency called RENETSA. Main public payers are to establish consultative councils to review rare disease cases to recommend when treatment is warranted, but final decisions will be made by each payer depending on a budget impact analysis and funds availability [26].