The impact of globalization on vaccine development and availability

Health Affairs

Volumn 25, Issue 4, 2006, Pages 1061-1069

  Milstien, Julie B ^a,c   Kaddar, Miloud ^b   Kieny, Marie Paule ^b  

^a University of Maryland School of Medicine Center for Vaccine Development   (United States)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c WHO Initiative for Vaccine Research ^*

Author keywords

[No Author keywords available]

Indexed keywords

VACCINE;

COMMERCIAL PHENOMENA; DEVELOPING COUNTRY; DRUG INDUSTRY; ECONOMICS; HUMAN; INTERNATIONAL COOPERATION; LEGAL ASPECT; MANAGEMENT; ORGANIZATION AND MANAGEMENT; PATENT; PUBLIC HEALTH; QUALITY CONTROL; REVIEW;

COMMERCE; DEVELOPING COUNTRIES; DRUG INDUSTRY; HUMANS; INTERNATIONAL AGENCIES; INTERNATIONALITY; OWNERSHIP; PATENTS; POLICY MAKING; PUBLIC HEALTH; QUALITY CONTROL; VACCINES;

EID: 33746927104     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.25.4.1061     Document Type: Review

References (45)

1. J. Delbrück, "Globalization of Law, Politics, and Markets - Implications for Domestic Law - A European Perspective," Indiana Journal of Global Legal Studies 1, no. 1 (1993): 9-36.
2. D. Woodward et al., "Globalization, Global Public Goods, and Health," in Trade in Health Services: Global, Regional and Country Perspectives, ed. C. Viera and N. Drager (Washington: Pan American Health Organization, 2002).
3. See, for example, R.M. Scheffler and V. Pathania, "Medicines and Vaccines for the World's Poorest: Is There Any Prospect for Public-Private Cooperation?" Globalization and Health 1 (21 July 2005): 10, http://www.globalizationandhealth.com/content/1/1/10 (accessed 5 May 2006).
4. "Epidemics of Meningococcal Disease, African Meningitis Belt, 2001," Weekly Epidemiological Record 76, no. 37 (2001): 282-288;
5. and "Meningococcal Disease, Serogroup W135, Burkina Faso: Preliminary Report, 2002," Weekly Epidemiological Record 77, no. 18 (2002): 152-154.
6. World Health Organization, "International Health Regulations (IHR)," 23 May 2005, http://www.who.int/csr/ihr/en (accessed 12May 2006).
7. WHO and World Trade Organization, "WTO Agreements and Public Health: A Joint Study by the WHO and the WTO Secretariat" (Geneva: WHO, 2002).
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, "Welcome to the Official Web Site for ICH," http://www.ich.org/cache/compo/1478-272-1.html (accessed 19 March 2006).
9. World Bank, "Immunization at a Glance," November 2001, http://siteresources.worldbank.org/INTPHAAG/Resources/AAGImmuniz.pdf (accessed 18 May 2006).
10. WHO, "Estimates of Disease Burden and Cost-Effectiveness," http://www.who.int/immunization_monitoring/burden/estimates_burden/en (accessed 12 May 2006).
11. World Bank, "Immunization at a Glance."
12. L. Roberts, "Polio: Health Workers Scramble to Contain African Epidemic," Science 305, no. 5680 (2004): 24-25.
13. Measles deaths decreased from 600,000 to 395,000; see WHO, The World Health Report 2005: Make Every Mother and Child Count (Geneva: WHO, 2005), 101, Annex Table 3.
14. "The Trouble with Cheap Drugs," Economist, 29 January 2004, http://www.economist.com/displaystory.cfm?story_id=2388708 (accessed 20 April 2006).
15. F.T. Cutts et al., "Efficacy of Nine-Valent Pneumococcal Conjugate Vaccine against Pneumonia and Invasive Pneumococcal Disease in the Gambia: Randomised, Double-Blind, Placebo-Controlled Trial," Lancet 365, no. 9465 (2005): 1139-1146.
16. B.C. Buckland, "The Process Development Challenge for a New Vaccine," Nature Medicine 11, no. 4 Supp. (2005): S16-S19.
17. M.M. Struck, "Vaccine R&D Success Rates and Development Times," Nature Biotechnology 14, no. 5 (1996): 591-593.
18. F.E. André, "How the Research-based Industry Approaches Vaccine Development and Establishes Priorities," Developments in Biologicals 110 (2002): 25-29.
19. S. Davey, ed., The 10/90 Report on Health Research 2001-2002 (Geneva: Global Forum for Health Research, 2002).
20. I. Serdobova and M.P. Kieny, "Assembling a Global Vaccine Development Pipeline for the Developing World," American Journal of Public Health 96, no. 9 (forthcoming).
21. S.Warner, "The Return of Vaccines," Scientist 19, no. 22 (2005): 28.
22. To put this in context, it is estimated that the United States spends $3 billion per year on antidepressants (Post Trauma Treatment Advanced Neuro Therapy, "The Cost of Depression," referencing articles published in the 1990s, at http://www.post-trauma.com/artcl_CostOfDepression. html, accessed 19 March 2006),
23. while the antihypertensive market was estimated at almost $30 billion in the seven major markets in 2003 (Datamonitor, Antihypertensives: Can Manufacturers Maintain Value? October 2004, as quoted at http://www.piribo.com/ publications/diseases_conditions/antihypertensives.html, accessed 19 March 2006).
24. Datamonitor, Commercial Insight: Vaccines - Reaching Adulthood, 30 July 2004, http://www.datamonitor.com/~7c7d0c547a1246d5b008cb14af6a98f6~/industries/ research/?pid=DMHC2018&type=Report (accessed 5 June 2006).
25. UNICEF Supply Division, personal communication, 2005;
26. and WHO, "Draft Report, Expert Committee Consultation to Develop a Fast Track Mechanism for the Licensing of Vaccines Procured through UN Agencies, New Delhi, 13-15 September 2005" (Geneva: WHO, 2005).
27. J. Milstien and B. Candries, "Economics of Vaccine Development and Implementation: Changes over the Past Twenty Years," Jordan Report Twentieth Anniversary: Accelerated Development of Vaccines 2002 (Bethesda, Md.: National Institute of Allergy and Infectious Diseases, 2002), 73-79.
28. B. Bloom, D. Canning, and M. Weston, "The Value of Vaccination," World Economics 6, no. 3 (2005): 15-39.
29. B. Bloom, D. Canning, and M. Weston, ," World Economics 2005): no. 3 (6, Ibid., 39.
30. WHO, "The GAVI Financial Sustainability Planning Process," http://www.who.int/immunization_financing/analyses/fsp/process/en (accessed 8 January 2006).
31. GAVI, "Update on the International Finance Facility for Immunization (IFFIm)," http://www.vaccinealliance.org/resources/16brd_19._IFFIm_update. pdf (accessed 28 December 2005).
32. M.M. Phillips, "G-8 Nations Shape Plan to Fight Disease," Wall Street Journal, 14 February 2006.
33. J.B. Milstien, "Regulation of Vaccines: Strengthening the Science Base," Journal of Public Health Policy 25, no. 2 (2004): 173-189.
34. WHO Expert Committee on Biological Standardization, "Regulation and Licensing of Biological Products in Countries with Newly Developing Regulatory Authorities," Technical Report Series 858, Annex 1, adopted 1994 (Geneva: WHO, 1994);
35. and WHO Expert Committee on Biological Standardization, "Guidelines for National Authorities on Quality Assurance for Biological Products," Technical Report Series 822, Annex 2, adopted 1991 (Geneva:WHO, 1991).
36. J. Milstien and L. Belgharbi, "Regulatory Pathways for Vaccines for Developing Countries," Bulletin of the World Health Organization 82, no. 2 (2004): 128-133.
37. SeeWHO, "Developing Countries' Vaccine Regulators Network (DCVR)," 13 January 2005, http://www.who.int/vaccines-access/ vaccine_regulation/dcvr.htm (accessed 9 January 2006).
38. Commission on Intellectual Property Rights, Innovation, and Public Health, "WHO Workshop on Intellectual Property Rights and Vaccines in Developing Countries" (Report on a WHO meeting, 19-20 April 2004), http://www.who.int/intellectualproperty/events/vaccines_meeting/en/index.html (accessed 2 March 2006).
39. M. Ayass, Trip Report, Mission to India, Consultant Report for WHO, 2005.
40. Boston Consulting Group, World Bank, and WHO, "Draft Study Report: Global Vaccine Supply: the Changing Role of Suppliers" (Study commissioned for GAVI, 2005).
41. R.T. Mahoney, A. Pablos-Mendez, and S. Ramachandran, "The Introduction of New Vaccines into Developing Countries, III: The Role of Intellectual Property," Vaccine 22, nos. 5-6 (2004): 786-792.
42. J. Milstien and M. Kaddar, "Managing the Effect of TRIPS on Availability of Priority Vaccines," Bulletin of the World Health Organization 84, no. 5 (2006): 360-365.
43. K. Stohr and M. Esveld, "Public Health: Will Vaccines Be Available for the Next Influenza Pandemic?" Science 306, no. 5705 (2004): 2195-2196.
44. Warner, "The Return of Vaccines."
45. Arent Fox, "The Arent Fox BioShield Initiative," http://www.arentfox.com/legal_updates/content1006.htm (accessed 9 January 2006).