The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America [

ARNOLD RJ, ; BIGHASH L, ; BRYÓN NIETO A,; TANNUS BRANCO DE ARAÚJO G,; GAY-MOLINA JG,; AUGUSTOVSKI F.

F1000RESEARCH

F1000RESEARCH

Año: 2015

2046-1402

Compared to a decade ago, nearly three times as many drugs for rare diseasesare slated for development. This article addresses the market access issuesassociated with orphan drug status in Europe and the United States in contrastto the legislation in five Latin American (LA) countries that have made strides inthis regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on thesuccess of orphan drug legislation in the EU and US, LA countries should striveto adopt similar strategies with regard to rare diseases and drug development.With the implementation of new targeted regulations, reimbursementstrategies, and drug approvals, accessibility to treatment will be improved forpeople afflicted with rare diseases in these developing countries.