TRIPS and the global pharmaceutical market: Can the pharmaceutical industry make drugs available to developing countries without compromising its research incentive?

Health Affairs

Volumn 23, Issue 3, 2004, Pages 146-154

  Barton, John H ^a  

^a STANFORD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVELOPING COUNTRY; DRUG CHOICE; DRUG COST; DRUG INDUSTRY; DRUG MARKETING; FINANCIAL MANAGEMENT; FOREIGN WORKER; HEALTH CARE ACCESS; HEALTH CARE ORGANIZATION; HEALTH CARE QUALITY; PHARMACEUTICAL CARE; POLITICAL SYSTEM; PROSPECTIVE PRICING; PURCHASING; REVIEW; UNITED STATES;

BIOMEDICAL RESEARCH; DEVELOPING COUNTRIES; DRUG INDUSTRY; HEALTH SERVICES ACCESSIBILITY; INTERNATIONAL COOPERATION;

EID: 2442519268     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.23.3.146     Document Type: Review

References (20)

1. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
2. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
3. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
4. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
5. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
6. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
7. See U.K. Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (London: CIPR, September 2002), especially Chapter 2. For the NGO perspective, see Médecins sans Frontières, "Drug Patents under the Spotlight," May 2003; and Campaign for Access to Essential Medicines, www.accessmed-msf.org/index.asp (3 January 2004). For the industry perspective, see the International Federation of Pharmaceutical Manufacturers Associations, www.ifpma.org (3 January 2004). For more academic perspectives, see B. Pécoul et al., "Access to Essential Drugs in Poor Countries: A Lost Battle?" Journal of the American Medical Association 281, no. 4 (1999): 361-367; and A. Attaran and L. Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (2001): 1886-1892. The proceedings of the important WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs, at Hosbjor, Norway, in April 2001, are at www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/ hosbjor_presentations_ e.htm (13 February 2004).
8. World Trade Organization, "Declaration on the TRIPS Agreement and Public Health," 20 November 2001, www.wto.org/english/thewto_e/minist_e/ min01_e/mindecl_trips_e.htm (17 February 2004).
9. Article 31(f) of TRIPS requires that manufacture of products under compulsory license be predominantly for the domestic market. Thus, a small sub-Saharan African country that clearly has the right to grant a compulsory license may have no local industry able to manufacture the product. If it asks a foreign firm to manufacture the product, that firm might be manufacturing the product primarily for export - a result that would violate TRIPS.
10. See WTO, "DOHA Development Agenda: Decision Removes Final Patent Obstacle to Cheap Drug Imports," 30 August 2003, www.wto.org/english/ news_e/pres03_e/pr350_e.htm (13 February 2004).
11. UNAIDS, Accelerating Action against AIDS in Africa (Geneva: UNAIDS, 1 September 2003), available for download at www.unaids.org.
12. World Health Organization, The Three by Five Initiative (three million patients by 2005), www.who.int/3by5/en (13 February 2003).
13. F.M. Scherer and J. Watal, "Post-TRIPs Options for Access to Patented Medicines in Developing Countries," January 2001, www.cmhealth.org/docs/wg4_paperl.pdf (13 February 2004).
14. See, for example, International Federation of Pharmaceutical Manufacturers Associations, "African Comprehensive HIV-AIDS Partnership," 2004, www.ifpma.org/Health/hiv/health_achap_hiv.aspx (13 February 2004).
15. S. Jarrett (UNICEF Supply Division), "Vaccine Purchasing," www.unicef.org/immunization/expert_ purchase.html (13 February 2004).
16. Bill C-56, An Act to Amend the Patent Act and the Food and Drug Act, First Reading, 6 November 2003.
17. M. Kremer, "Creating Markets for New Vaccines: Part I: Rationale, and Part II: Design Issues," in Innovation Policy and the Economy, vol. 1, ed. A.B. Jaffe, J. Lerner, and S. Stern (Cambridge, Mass.: MIT Press, 2001); and J. Barton, "Financing of Vaccines," Lancet 355, no. 9211 (2000): 1269-1270.
18. M. Kremer, "Creating Markets for New Vaccines: Part I: Rationale, and Part II: Design Issues," in Innovation Policy and the Economy, vol. 1, ed. A.B. Jaffe, J. Lerner, and S. Stern (Cambridge, Mass.: MIT Press, 2001); and J. Barton, "Financing of Vaccines," Lancet 355, no. 9211 (2000): 1269-1270.
19. See Speech by Mark B. McClellan (then FDA commissioner) before the First International Colloquium on Generic Medicine, 25 September 2003, www.fda.gov/oc/speeches/2003/genericdrug0925.html (13 February 2004).
20. 42 U.S. Code sec. 1860D-11(i), as inserted by P.L. 108-173, sec. 101 (2003).