Center for Global Health & Development/Department of International Health, Boston University School of Public Health, Boston, MA, USA.
Health Policy. 2012 Aug;106(3):211-24. doi: 10.1016/j.healthpol.2012.04.015. Epub 2012 Jun 12.
Review the literature on the impact of policies designed to enhance uptake of generic medicines in low and middle income countries (LMICs).
We searched for publications related to generic medicines policies (January 2000-March 2010) and did a bibliometric, descriptive analysis of the dataset in addition to an analysis of studies evaluating the impact of pro-generic policies. We repeated a subset of this larger search in January 2012.
Of the 4994 articles screened, 315 (6.3%) full-text publications were related to generic medicines policies. Of these 315, 236 (75%) dealt with generic medicine policies in high-income countries, and 79 (25%) with policies in LMICs. In total, we found only 10 evaluation studies looking at the impact of competition, trade, pricing and prescribing policies on generic medicine price and/or volume. Key barriers to implementing generic medicine policies in LMICs are negative perceptions of stakeholders (e.g., generics are of lower quality) plus perverse private sector financial incentives to sell products with the highest profit margin. Other relevant barriers are legal/regulatory, such as the absence of generic substitution regulations. There also exists a general difficulty in promoting generics due to a lack of transparency in the pharmaceutical supply and distribution system, for example, a lack of price information provided by health care provider organizations to physicians.
There is little policy evaluation to determine which pro-generic policies increase generic medicines utilization in LMICs. Ensuring a functioning medicines regulation authority, creating a reasonably robust market of generic medicines and aligning incentives for physicians, consumers and drug sellers are necessary prerequisites for increasing the uptake and use of generic medicines.
综述旨在提高中低收入国家（LMICs）仿制药使用率的政策的影响。
我们检索了 2000 年 1 月至 2010 年 3 月期间与仿制药政策相关的出版物，并对数据集进行了文献计量和描述性分析，此外还分析了评估促进仿制药政策的影响的研究。我们在 2012 年 1 月重复了这一更大规模检索的一部分。
在所筛选的 4994 篇文章中，有 315 篇（6.3%）全文出版物与仿制药政策相关。在这 315 篇中，236 篇（75%）涉及高收入国家的仿制药政策，79 篇（25%）涉及 LMICs 的政策。总的来说，我们只发现了 10 项评估研究，研究了竞争、贸易、定价和处方政策对仿制药价格和/或数量的影响。在 LMICs 中实施仿制药政策的主要障碍是利益相关者的负面看法（例如，仿制药质量较低）以及私营部门销售利润率最高产品的不当财务激励。其他相关障碍包括法律/监管方面的障碍，例如缺乏仿制药替代法规。由于药品供应和分销系统缺乏透明度，例如医疗机构向医生提供的价格信息缺乏，也普遍难以推广仿制药。
几乎没有政策评估来确定哪些促进仿制药的政策可以增加 LMICs 中仿制药的使用率。确保有一个运作良好的药品监管机构，创建一个合理健全的仿制药市场，并调整医生、消费者和药品销售商的激励机制，是提高仿制药的采用和使用的必要前提。
