Promoting and regulating generic medicines: Brazil in comparative perspective

• Main Authors: Elize Massard da Fonseca, Kenneth C. Shadlen
• Format: Article in Journal/Newspaper
• Language: English; Spanish; Portuguese
• Published: Pan American Health Organization 2017
• Subjects: Drugs; generic; therapeutic equivalency; generic drug policy; Brazil; Medicine; R; Arctic medicine. Tropical medicine; RC955-962; Public aspects of medicine; RA1-1270; Arctic
• Online Access: https://doaj.org/article/30124c8011254af0922acc614ce032dd

ABSTRACT Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.