Policies to promote use of generic medicines in low and middle income countries: a review of published literature, 2000-2010.

OBJECTIVE Review the literature on the impact of policies designed to enhance uptake of generic medicines in low and middle income countries (LMICs). METHODS 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. RESULTS 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. CONCLUSION 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.