Fonseca Elize Massard da
Business Administration School of São Paulo, Center for Public Administration and Government Studies, Fundação Getulio Vargas, São Paulo, SP, Brazil.
Rev Panam Salud Publica. 2015 Feb;37(2):113-7.
The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.
世界卫生组织（WHO）推行使用通用药物政策，以促进制药行业的竞争、降低药品价格并增加治疗药物的可及性。然而，对于各国如何实施这些政策却知之甚少。本文描述了发展中国家（包括拉丁美洲国家）的国家监管机构用于界定通用药品与专利药品的不同术语，以及在应用WHO指南时出现的挑战，如标签问题。作者得出结论，这些国家通用药物术语的差异是制度背景（即公共部门环境以及该国存在的法律法规体系）和政策遗留问题（如知识产权制度）的结果，并强调需要进一步分析药品法规，以更好地理解通用药物政策的障碍和政治影响。
