Center for Global Health and Development, Boston University School of Public Health, Boston, Massachusetts, United States of America ; World Health Organization Collaborating Centre for Pharmaceutical Policy, Boston University, Boston, Massachusetts, United States of America.
PLoS One. 2013 Sep 30;8(9):e74399. doi: 10.1371/journal.pone.0074399. eCollection 2013.
This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.
这项观察性研究调查了拉丁美洲、亚洲和中东/南非 19 个低收入和中等收入国家（LMICs）的私营部门零售药品市场，分析了 2001 年至 2011 年期间通用和原研药品的市场份额之间的关系。超过 5000 种不同的药品被分为通用（无品牌通用、品牌通用药品）和原研药类别，每个国家都包括美国作为比较国。在 9 个选定的 LMIC 中，与时间推移相比，那些原研药的市场份额降幅最大的药物与它们对应的通用版本的市场份额进行了比较。在这些 LMICs 的私营部门中，通用药品（品牌通用加无品牌通用）占市场份额的 70%至 80%，超过了大多数欧洲国家。在这三个地区，品牌通用药品的市场份额都高于无品牌通用药品，而在美国则相反。尽管从原研药转换为其通用版本可以节省资金，但在个别药品层面，这种说法实际上很复杂。在一些国家，市场行为表明，一些原研药的市场份额在时间上下降最多，它们转换为通用版本。而在其他国家，如中东/南非和亚洲，这些原研药的损失并没有伴随着其等效通用版本的市场份额发生任何变化。对于那些通用药品市场份额显著增加和/或有全面“转换”为通用版本证据的国家，特别是在拉丁美洲，有必要在药品政策和通用药品的采用之间建立因果关系。在其他国家，通用药品市场份额没有变化，这表明至少通用药品没有得到大力推广。
