title: The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America.
abstract: Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation in five Latin American (LA) countries that have made strides in this regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on the success of orphan drug legislation in the EU and US, LA countries should strive to adopt similar strategies with regard to rare diseases and drug development. With the implementation of new targeted regulations, reimbursement strategies, and drug approvals, accessibility to treatment will be improved for people afflicted with rare diseases in these developing countries.
authors.affiliation: Department of Preventive Medicine, Mount Sinai School of Medicine, New York, NY, 10029-6574, USA ; Arnold Consultancy & Technology, New York, NY, 10023-3458, USA ; Quorum Consulting, Inc., San Francisco, CA, 94104, USA.
authors.forename: Renée J G
authors.initials: RJ
authors.lastname: Arnold
authors.affiliation: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.
authors.forename: Lida
authors.initials: L
authors.lastname: Bighash
authors.affiliation: HEORT, Bogotá, Colombia.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Bryón Nieto
authors.affiliation: AxiaBio Life Sciences, São Paulo City, Brazil.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Tannus Branco de Araújo
authors.affiliation: T.I. Salud, Col. Juárez, 06600, Mexico.
authors.forename: Juan Gabriel
authors.initials: JG
authors.lastname: Gay-Molina
authors.affiliation: Institute for Clinical Effectiveness and Health Policy & Professor of Public Health, Universidad de Buenos Aires, Ciudad de Buenos Aires, C1414CPT, Argentina.
authors.forename: Federico
authors.initials: F
authors.lastname: Augustovski
keywords: Latin America; market access; orphan drugs; rare disease
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