ReviewPolicies to promote use of generic medicines in low and middle income countries: A review of published literature, 2000–2010
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.
References (71)
- et al.
Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: analysis of the effect of TRIPS-plus proposal
Health Policy
(2009) - et al.
A systematic review of the literature comparing the practices of dispensing and non-dispensing doctors
Health Policy
(2009) - et al.
Do national medicinal medicine policies and essential medicine programs improve medicine use? A review of experiences in developing countries
Social Science and Medicine
(2001) - et al.
Active pharmaceutical management strategies of health insurance systems to improve cost-effective use of medicines in low- and middle-income countries: a systematic review of current evidence
Health Policy
(2011) - et al.
Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals
Journal of Pharmaceutical Sciences
(2011) Advertising and generic market entry
Journal of Health Economics
(2007)- et al.
Public and private sector responses to essential drugs policies: a multilevel analysis of drug prescription and selling practices in Mali
Social Science & Medicine
(2003) - et al.
The change of prices and expenditures of the original and generic drugs of fluoxetine—a longitudinal analysis on reimbursement database of the national health insurance
Value in Health
(2008) - et al.
Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis
Lancet
(2009) - Cameron A, Laing R. Cost savings of switching private sector consumption from originator brand medicines to generic...
Generic medicine pricing policies in Europe: current status and impact
Pharmaceuticals
Competition in off-patent drug markets: issues, regulation and evidence
Economic Policy
Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies
Cochrane Database of Systematic Reviews
Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications
Expert Review Pharmacoeconomics and Outcomes Research
Encouraging the use of generic medicines: implications for transition economies
Croatian Medical Journal
Economy of generic drugs in Latin America
Revista Panamericana De Salud Publica
Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases
Bulletin of the World Health Organization
Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil and Thailand
AIDS
Impact on access to medicines from TRIPS-plus: a case study of Thai–US FTA
Southeast Asian Journal of Tropical Medicine and Public Health
Guide to the intellectual property rights impact aggregate model
Impact of the World Trade Organization TRIPS agreement on the pharmaceutical industry in Thailand
Bulletin of the World Health Organization
Experience of a medicines reference-pricing model
South African Medical Journal
Use of generic antiretroviral agents and cost savings in PEPFAR treatment programs
Journal of the American Medical Association
Procurement of generic medicines in a medium size municipality
Revista De Saude Publica
Randomized, controlled trial of prescribing training in a South African province
Medical Education
Multisource drug policies in Latin America: survey of 10 countries
Bulletin of the World Health Organization
Health systems financing: the path to universal coverage
Overcoming barriers to health service access: influencing the demand side
Health Policy and Planning
Priorities for research into human resources for health in low- and middle-income countries
Bulletin of the World Health Organization
How do countries regulate the health sector? Evidence from Tanzania and Zimbabwe
Health Policy and Planning
Do they work? Regulating for-profit providers in Zimbabwe
Health Policy and Planning
Intervention research in rational use of drugs: a review
Health Policy and Planning
The terrain of health policy analysis in low and middle income countries: a review of published literature 1994–2007
Health Policy Planning
Cited by (103)
Product patents and access to innovative medicines
2021, Social Science and MedicineKnowledge and Attitude of Physicians Towards the Cost of Commonly Prescribed Medicines: A Case Study in Three Nigerian Healthcare Facilities
2020, Value in Health Regional IssuesCitation Excerpt :Effective management of NCDs such as hypertension and DM are compromised by the inability of patients to pay for their medication, leading to concerns with adherence and potentially poorer outcomes for patients.13,17,18 Encouragingly, we are beginning to see pharmaceutical companies improving access to medicines for both infectious and NCDs by making them available at lower costs,6,19,20 In addition, there has been appreciable promotion of generic medicines to help lower costs for both patients and healthcare systems; there are, however, concerns with the quality of generics among physicians in LMICs.21 One of the core components of rational prescribing are cost considerations, along with the effectiveness and safety of different treatment approaches.22,23
Supply chain agility and firm performance: testing serial mediations in pharmaceutical industry
2023, Business Process Management JournalTackling reimbursement challenges to fair access to medicines–introduction to the topic
2023, Expert Review of Pharmacoeconomics and Outcomes ResearchA leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
2022, Journal of Pharmaceutical Policy and Practice