Elsevier

Health Policy

Volume 106, Issue 3, August 2012, Pages 211-224
Health Policy

Review
Policies to promote use of generic medicines in low and middle income countries: A review of published literature, 2000–2010

https://doi.org/10.1016/j.healthpol.2012.04.015Get rights and content

Abstract

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.

Introduction

With the rising costs of healthcare and the uncertain global economic situation, governments and payers in many countries will require the increased usage of generic medicines. Data from price surveys in 36 low and middle-income countries (LMICs) show that in the private sector, prices of the lowest cost generic medicines were on average 2.6 times less expensive than the corresponding originator medicines [1]. By using generic medicines, potential savings can be quite large [2]. For example, in the private sector of 17 countries, the average percentage savings for individual medicines (n = 4–12 medicines) ranged from 9% to 89% if private sector purchasers would switch from originator brands to the lowest-priced generic equivalents [2]. Savings would not, however, be confined to the private sector. For example, in public hospitals in China, over US$86 million (2008 dollars) could be saved from switching only 4 medicines, saving patients an average of 65% [2].

Given the actual and perceived need for increased usage and promotion of low-price, assured-quality generic medicines, it is important for countries to gather evidence as to what pro-generic medicines policies actually work in their countries’ context. There is a large body of research on pro-generic medicine pharmaceutical policies in the United States and Europe, see e.g., [3], [4], [5], [6]. In contrast, impact evaluation of pro-generic medicine interventions in LMICs appears much less systematized.

Therefore, the objective of this study was to inquire into the nature, extent and strength of the evidence for successful implementation of pro-generic medicines policies in LMICs. We further attempt to characterize barriers to increasing the uptake of generic medicines in LMICs that are related to “supply side” (e.g., trade, competition, pricing, regulation, intellectual property, reimbursement) and “demand side” (physician, dispenser, consumer) policies. Finally, we attempt to also identify a minimum set of pro-generic medicine “enabling” policies that most LMICs could implement to help policy makers prioritize actions.

Section snippets

Search strategies

To the extent possible, the literature review followed the PRIMSA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The study protocol is available upon request from the authors. We searched the following databases for publications between 1 January 2000 to 31 March 2010 in English, French, Spanish and Portuguese: PubMed via the US National Library of Medicine, Excerpta Medica Database (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL),

Bibliometric analysis

Of the 4994 articles screened, 686 references (13.7%) contained “generic” in the title or in the abstract (Fig. 1). Out of those 686 references, we identified 313 full text publications (45.9%) whose overall subject matter was related to generic medicines and pro-generic medicines policies in high-income and LMICs.

Many geographic regions and countries were represented in these references, but the top ten most common countries/regions (representing n = 233 references) are shown in Table 1. More

Bibliometric analysis

One key message is that a large majority (81.9%) of the literature in our database is directed toward pro-generic medicines policies in high-income countries. Of the LMIC literature, the primary countries of focus are Brazil and India with particular emphasis on trade and intellectual property-related issues. Nonetheless, this literature is primarily descriptive.

A second point is that certain policy areas in the LMIC literature (see Table 2) are not well represented. There are fewer references

Conclusions

Overall, the literature on the impact of pro-generic medicines policies in LMICs suffers in comparison with the literature in high-income countries, with the possible exceptions of Brazil and India regarding trade policies. There are certain policy domains relevant for generic medicines policies that are clearly underrepresented in LMICs, notably regulation and the “demand side” of the medicine value chain, i.e., the dispensers and consumers.

On the basis of our findings from the literature we

Funding

The present document was not directly funded. A related and as yet unpublished document was prepared under a WHO/Health Action International (HAI) consultancy to two of the authors (W.A.K., V.W.).

Conflict of interest

None.

Author contributions

WAK and VJW developed the concept and design followed by drafting of the manuscript and then critically reviewed it for important intellectual content. Both WAK, VJW, LSR and MV carried out the bibliometric analysis. All authors contributed to interpretation of the data. WAK supervised the study.

Acknowledgements

We wish to acknowledge the members of the Health Action International Technical Advisory Group on Medicines for their invaluable comments on an earlier version of this manuscript.

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