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

Health Policy

Volumn 106, Issue 3, 2012, Pages 211-224

  Kaplan, Warren A ^a   Ritz, Lindsay Sarah ^b   Vitello, Marie ^c   Wirtz, Veronika J ^d  

^a BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c BOSTON CHILDREN S HOSPITAL   (United States)

^d INSTITUTO NACIONAL DE SALUD PÚBLICA   (Mexico)

Author keywords

Generic medicines; Low and middle income countries; Pharmaceutical policy; Regulation

Indexed keywords

GENERIC DRUG;

BIBLIOMETRICS; BRAZIL; COMPETITION; DEVELOPING COUNTRY; DRUG COST; DRUG INDUSTRY; DRUG INFORMATION; DRUG USE; FUNDING; HEALTH CARE POLICY; LOWEST INCOME GROUP; MEDICAL SOCIETY; PATENT; PERSONNEL MANAGEMENT; PHYSICIAN; PRESCRIPTION; PROFIT; REVIEW; SOUTH AFRICA; THAILAND;

DEVELOPING COUNTRIES; DRUGS, GENERIC; HEALTH POLICY; HUMANS; PHYSICIAN'S PRACTICE PATTERNS;

EID: 84863778492     PISSN: 01688510     EISSN: 18726054     Source Type: Journal    
DOI: 10.1016/j.healthpol.2012.04.015     Document Type: Review

References (71)

1. Cameron A., Ewen M., Ross-Degnan D., Ball D., Laing R. Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet 2009, 373:632-635.
2. Cameron A, Laing R. Cost savings of switching private sector consumption from originator brand medicines to generic equivalents. Background Paper 35, Geneva: World Health Organization; 2010. Available at: [18.04.12]. http://www.who.int/healthsystems/topics/financing/healthreport/35MedicineCostSavings.pdf.
3. Dylst P., Simoens S. Generic medicine pricing policies in Europe: current status and impact. Pharmaceuticals 2010, 3:471-481.
4. Kanavos P., Costa-Font J., Seeley E. Competition in off-patent drug markets: issues, regulation and evidence. Economic Policy 2008, 55:500-544.
5. Aaserud M., Austvoll-Dahlgren A., Kösters J.P., Oxman A.D., Ramsay C., Sturm H. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database of Systematic Reviews 2006, 2:CD005979.
6. Godman B., Shrank W., Andersen M., Berg C., Bishop I., Burkhardt T., et al. Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications. Expert Review Pharmacoeconomics and Outcomes Research 2010, 10:707-722.
7. King D.R., Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croatian Medical Journal 2002, 43:462-469.
8. Tobar F. Economy of generic drugs in Latin America. Revista Panamericana De Salud Publica 2008, 23:59-67.
9. World Bank. How we classify countries. Washington, DC; 2011. [accessed 18.12.11]. http://data.worldbank.org/about/country-classifications.
10. GRADE Working Group. Grading of recommendations assessment, development and evaluation; 2010. [accessed 17.12.11]. http://www.gradeworkinggroup.org/publications/index.htm.
11. Waning B., Kaplan W., King A.C., Lawrence D.A., Leufkens H.G., Fox M.P. Global strategies to reduce the price of antiretroviral medicines: evidence from transactional databases. Bulletin of the World Health Organization 2009, 87:520-528.
12. Ford N., Wilson D., Costa Chaves G., Lotrowska M., Kijtiwatchakul K. Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil and Thailand. AIDS 2007, 21(Suppl. 4):S21-S29.
13. Akaleephan C., Wibulpolprasert S., Sakulbumrungsil R., Luangruangrong P., Jitraknathee A., Aeksaengsri A., 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, 91:174-182.
14. Kessomboon N., Limpanonant J., Kulsomboon V., Maleewong U., Eksaengri A., Paothong P. Impact on access to medicines from TRIPS-plus: a case study of Thai-US FTA. Southeast Asian Journal of Tropical Medicine and Public Health 2010, 41:667-677.
15. Rovira J., Abbas I., Cortes M. Guide to the intellectual property rights impact aggregate model 2009, International Centre for Trade and Sustainable Development, Geneva, [accessed 18.04.12]. http://ictsd.org/downloads/2010/03/guide-to-the-ipria-model.pdf.
16. Supakankunti S., Janjaroen W.S., Tangphao O., Ratanawijitrasin S., Kraipornsak P., Pradithavanij P. Impact of the World Trade Organization TRIPS agreement on the pharmaceutical industry in Thailand. Bulletin of the World Health Organization 2001, 79:461-470.
17. Rothberg A.D., Blignault J., Serfontein C.B., Valodia B., Eekhout S., Pels M.L. Experience of a medicines reference-pricing model. South African Medical Journal 2004, 94:183-188.
18. Holmes C.B., Coggin W., Jamieson D., Mihm H., Granich R., Savio P., et al. Use of generic antiretroviral agents and cost savings in PEPFAR treatment programs. Journal of the American Medical Association 2010, 304:313-320.
19. Bevilacqua G., Farias M.R., Blatt C.R. Procurement of generic medicines in a medium size municipality. Revista De Saude Publica 2011, 45:583-589.
20. Meyer J.C., Summers R.S., Moeller H. Randomized, controlled trial of prescribing training in a South African province. Medical Education 2001, 35:833-840.
21. Homedes N., Ugalde A. Multisource drug policies in Latin America: survey of 10 countries. Bulletin of the World Health Organization 2005, 83:64-70.
22. Lim D., Emery J., Luis J., Sunderland B.V. A systematic review of the literature comparing the practices of dispensing and non-dispensing doctors. Health Policy 2009, 92:1-9.
23. World Health Organization World Health Report Health systems financing: the path to universal coverage 2011, WHO, Geneva.
24. Ensor T., Cooper S. Overcoming barriers to health service access: influencing the demand side. Health Policy and Planning 2009, 19:69-79.
25. Ranson M.K., Chopra M., Atkins S., Dal Poz M.R., Bennett S. Priorities for research into human resources for health in low- and middle-income countries. Bulletin of the World Health Organization 2010, 88:435-443.
26. Kumaranayake L., Lake S., Mujinja P., Hongoro C., Mpembeni R. How do countries regulate the health sector? Evidence from Tanzania and Zimbabwe. Health Policy and Planning 2000, 15:357-367.
27. Hongoro C., Kumaranayake L. Do they work? Regulating for-profit providers in Zimbabwe. Health Policy and Planning 2000, 15:368-377.
28. LeGrand A., Hogerzeil H., Haaijer-Ruskamp F. Intervention research in rational use of drugs: a review. Health Policy and Planning 1999, 14:89-102.
29. Ratanawijitrasin S., Soumerai S.B., Weerasuriya K. Do national medicinal medicine policies and essential medicine programs improve medicine use? A review of experiences in developing countries. Social Science and Medicine 2001, 53:831-844.
30. Gilson L., Raphaely N. The terrain of health policy analysis in low and middle income countries: a review of published literature 1994-2007. Health Policy Planning 2008, 23:294-307.
31. Waber R.L., Shiv B., Carmon Z., Ariely D. Commercial features of placebo and therapeutic efficacy. Journal of the American Medical Association 2008, 299:1016-1017.
32. Rao A.R., Monroe K.B. The effect of price, brand name, and store name on buyers' perceptions of product quality. Journal of Marketing Research 1989, 26:351-357.
33. Rizzo J.A., Zeckhauser R. Generic script share and the price of brand-name medicines: the role of consumer choice. International Journal of Health Care Finance and Economy 2009, 9:291-316.
34. Lofgren H. Generic drugs: international trends and policy developments in Australia. Australian Health Review 2004, 27:39-48.
35. Ratanawijitrasin S., Wondemagegnehu E. Effective drug regulation: a multicountry study 2002, World Health Organization, Geneva.
36. Kaplan W.A., Laing R. Paying for pharmaceutical registration in developing countries. Health Policy and Planning 2003, 18:237-248.
37. Cockburn R., Newton P.N., Agyarko E.K., Akunyili D., White N.J. The global threat of counterfeit drugs: why industry and governments must communicate the dangers. PLoS Medicine 2005, 2:e100.
38. World Health Organization. Medicines: spurious/falsely-labelled//counterfeit (SFFC) medicines. Fact sheet No. 275. [accessed 18.04.12]. http://www.who.int/mediacentre/factsheets/fs275/en/.
39. Kelesidis T., Kelesidis I., Rafailidis P., Falagas M.E. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. Journal of Antimicrobial Chemotherapy 2007, 60:214-236.
40. Faden L., Vialle-Valentin C., Ross-Degnan D., Wagner A. 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, 100:134-143.
41. Infarmed (Portuguese Ministry of Health and Medicines Agency) Information campaigns 2007, 2009 and 2010 2011, INFARMED, Lisboa.
42. Walt G., Shiffman J., Schneider H., Murray S.F., Brugha R., Gilson L. 'Doing' health policy analysis: methodological and conceptual reflections and challenges. Health Policy and Planning 2008, 23:308-317.
43. Babovic S., Wasan K.M. 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, 100:816-821.
44. Chaves G.C., Oliveira M.A. A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement. Bulletin of the World Health Organization 2007, 85:49-56.
45. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) [codified as amended 21 U.S.C. §355 (1994)].
46. European Generic Medicines Association How to increase patient access to generic medicines in European healthcare systems 2009, EGA Health Economics Committee, [18.04.12]. http://www.egagenerics.com/doc/ega_increase-patient-access_update_072009.pdf.
47. LaFond A, Brown L. A guide to monitoring and evaluation of capacity-building interventions in the health sector in developing countries. MEASURE Evaluation Manual Series, No. 7. New Orleans, LA: Tulane University; 2003. [accessed 18.04.12]. http://www.cpc.unc.edu/measure/publications/pdf/ms-03-07.pdf.
48. Yin R.K. Case study research: design and methods. Applied social research methods series 2003, Sage Publications, Thousand Oaks, CA. 3rd ed.
49. Shukla N., Sangal T. Generic drug industry in India: the counterfeit spin. Journal of Intellectual Property Rights 2009, 14:236-240.
50. Gonzalez C.P.V., Fitzgerald J., Rovira J. Generics in Latin America: trends and regulation. Journal of Generic Medicines 2008, 6:43-56.
51. Timmermans K. Harmonization, regulation, and trade: interactions in the pharmaceutical field. International Journal of Health Services 2004, 34:651-661.
52. Morin J.-F. Tripping Up TRIPS Debates IP and Health in Bilateral Agreements. International Journal of Intellectual Property Management 2006, 1:37-53.
53. Jayaranam K. Patent threat in emerging economies shifts to biotech. Nature Biotechnology 2008, 26:481-483.
54. Konigbauer I. Advertising and generic market entry. Journal of Health Economics 2007, 26:286-305.
55. Correa C.M. Ownership of knowledge-the role of patents in pharmaceutical R&D. Bulletin of the World Health Organization 2004, 82:784-787.
56. Carradinha H. Tendering short-term pricing policies and the impact on patients, governments and the sustainability of the generic medicines industry. Journal of Generic Medicines 2009, 6:351-361.
57. Chong C.P., Hassali M.A., Bahari M.B., Shafie A.A. Evaluating community pharmacists' perceptions of future generic substitution policy implementation: a national survey from Malaysia. Health Policy 2009, 94:68-75.
58. din Babar Z.U., Awaisu A. Evaluating community pharmacists' perceptions and practices on generic medicines: a pilot study from Peninsular Malaysia. Journal of Generic Medicines 2008, 5:315-330.
59. Maiga F.I., Haddad S., Fournier P., Gauvin L. Public and private sector responses to essential drugs policies: a multilevel analysis of drug prescription and selling practices in Mali. Social Science & Medicine 2003, 57:937-948.
60. Kisa S. Factors that influence prescribing decisions among Turkish physicians. Clinical Research and Regulatory Affairs 2006, 23:177-189.
61. Lee C.F., Liou W.S., Hsieh C.C. 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, 11:A133-A134.
62. Salde V.C., Uema S., Paraje M.G. Application of the in force legislation related to prescribing and dispensing drugs using their generic name. Latin American Journal of Pharmacy 2008, 27:440-445.
63. Rumel D., Nishioka S.D., dos Santos A.A.M. Drug interchangeability: clinical approach and consumer's point of view. Revista De Saude Publica 2006, 40:921-927.
64. Nsimba S.E.D. Assessing the performance, practices and roles of drug sellers/dispensers and mothers'/guardians' behaviour for common childhood conditions in Kibaha district, Tanzania. Tropical Doctor 2007, 37:197-201.
65. Gossell-Williams M. Generic substitutions: a 2005 survey of the acceptance and perceptions of physicians in Jamaica. West Indian Medical Journal 2007, 56:458-463.
66. Jamshed S.Q., Babar Z.U.D., Ibrahim M.I.M., Hassali M.A.A. Generic medicines as a way to improve access and affordability: a proposed framework for Pakistan. Journal of Clinical and Diagnostic Research 2009, 3:1596-1600.
67. Trap B., Hansen E.H., Hogerzeil H.V. Prescription habits of dispensing and non-dispensing doctors in Zimbabwe. Health Policy and Planning 2002, 17:288-295.
68. James C.D., Peabody J., Solon O., Quimbo S., Hanson K. An unhealthy public-private tension: pharmacy ownership, prescribing, and spending in the Philippines. Health Affairs 2009, 28:1022-1033.
69. Al-Gedadi N.A., Hassali M.A.A. Pharmacists' views on generic medicines: a review of the literature. Journal of Generic Medicines 2009, 5:209-218.
70. Russo G., McPake B. Medicine prices in urban Mozambique: a public health and economic study of pharmaceutical markets and price determinants in low-income settings. Health Policy and Planning 2009, 25:70-84.
71. Malkawi B.H. Patent protection and the pharmaceutical industry in Jordan. Asian Journal of WTO and International Health Law and Policy 2009, 4:93-127.