Innovation and access to medicines for neglected populations: Could a treaty address a broken pharmaceutical R&D system?

PLoS Medicine

Volumn 9, Issue 5, 2012, Pages

  Moon, Suerie ^a,b   Bermudez, Jorge ^c   't Hoen, Ellen ^d  

^a HARVARD UNIVERSITY   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c INSTITUTO OSWALDO CRUZ   (Brazil)

^d UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; DRUG;

ARTICLE; COST; DRUG INDUSTRY; DRUG RESEARCH; FINANCIAL MANAGEMENT; FUNDING; HEALTH CARE ACCESS; HEALTH CARE POLICY; HEALTH CARE QUALITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INVESTMENT; LOWEST INCOME GROUP; MEDICINE; PATENT; WORLD HEALTH ORGANIZATION; DRUG DEVELOPMENT; HEALTH; HEALTH CARE DELIVERY; HEALTH CARE DISPARITY; INTERNATIONAL COOPERATION; MEDICAL RESEARCH; NEGLECTED DISEASE;

BIOMEDICAL RESEARCH; DRUG DISCOVERY; HEALTH SERVICES ACCESSIBILITY; HEALTHCARE DISPARITIES; HUMANS; INTERNATIONAL COOPERATION; NEGLECTED DISEASES; PHARMACEUTICAL PREPARATIONS; WORLD HEALTH;

EID: 84861547905     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001218     Document Type: Article

References (67)

1. The Commission on Health Research for Development (1990) Health research: Essential link to equity in development. Available: http://www.cohred.org/downloads/open_archive/ComReports_0.pdf. Accessed 11 April 2012.
2. United Kingdom Commission on Intellectual Property Rights (CIPR) (2002) Integrating intellectual property rights and development policy. Available: http://www.iprcommission.org/graphic/documents/final_report.htm. Accessed 11 April 2012.
3. Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) (2006) Public health, innovation and intellectual property rights. Available: http://www.who.int/intellectualproperty/report/en/index.html. Accessed 11 April 2012.
4. World Health Assembly (WHA) (2008) Global strategy and plan of action on public health, innovation and intellectual property. Resolution 61.21(Sixty-first). Available: http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf. Accessed 11 April 2012.
5. The World Bank (2012) The World Bank-data. Available: http://data.worldbank.org/. Accessed 5 February 2012.
6. WHO Consultative Expert Working Group on Research and Development (CEWG): Financing and Coordination (2012) Research and development to meet health needs in developing countries: Strengthening global financing and coordination. Available: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf. Accessed 11 April 2012.
7. World Intellectual Property Organization (WIPO) (1988) Existence, scope and form of generally internationally accepted and applied Standards/Norms for the protection of intellectual property- note prepared by the international bureau of WIPO-revision. MTN.GNG/NG11/W/24/Rev.1.
8. Watal J, (2001) Intellectual property rights in the WTO and developing countries The Hague Kluwer Law International.
9. World Trade Organization (WTO) (2001) Declaration on the TRIPS agreement and public health. WT/MIN(01)/DEC/2.
10. David PA, (1993) Intellectual property institutions and the panda's thumb: Patents, copyrights, and trade secrets in economic theory and history. In: Wallerstein MB, Mogee ME, Schoen RA, editors. Global dimensions of intellectual property rights in science and technology Washington (D.C.) The National Academies Press.
11. Moon S, (2009) Medicines as global public goods: The governance of technological innovation in the new era of global health. Global Health Governance 2 (2).
12. Drahos P, Braithwaite J, (2002) Information feudalism: Who owns the knowledge economy? New York The New Press.
13. Sell SK, (2003) Private power, public law: The globalization of intellectual property rights New York Cambridge University Press.
14. The World Bank (2012) Data: GNI per capita, Atlas method (current US$). Accessed 1 February 2012.
15. Strom S, Fleischer-Black M, (2003) Drug maker's vow to donate cancer drug falls short. The New York Times. Available: http://www.nytimes.com/2003/06/05/business/05DRUG.html. Accessed 11 April 2012.
16. Kurian P, (2012) In the matter of Natco Pharma Limited and Bayer Corporation. Compulsory License Application No. 1 of 2011. Available: http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf. Accessed 11 April 2012.
17. World Health Organization, Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations Children's Fund (2011) Progress report 2011: Global HIV/AIDS response. Available: http://www.who.int/hiv/pub/progress_report2011/en/index.html. Accessed 11 April 2012.
18. 't Hoen E, Berger J, Calmy A, Moon S, (2011) Driving a decade of change: HIV/AIDS, patents, and access to medicines. J Int AIDS Soc 14: 15.
19. Moran M, Guzman J, Abela-Oversteegen L, Liyanage R, Omune B, et al. (2011) G-FINDER report 2011: Neglected disease research and development: Is innovation under threat? Available: http://www.policycures.org/downloads/g-finder_2011.pdf. Accessed 11 April 2012.
20. Butler D, (2010) Vaccine offers meningitis hope. Nature 468: 143.
21. Moon S, (2011) Pharmaceutical production and related technology transfer Geneva World Health Organization (WHO).
22. UNITAID (2011) UNITAID annual report 2010. Available: http://www.unitaid.eu/images/NewWeb/documents/AR10/unitaid_ar2010_web.pdf. Accessed 11 April 2012.
23. GAVI Alliance Secretariat (2010) Advance market commitment for pneumococcal vaccines: Annual report 12 June 2009-31 March 2010.
24. US Food and Drug Administration (2008) Guidance for industry: Tropical disease priority review vouchers. Available: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0530-gdl.pdf. Accessed 11 April 2012.
25. Wilson P, Palriwala A, (2011) Prizes for global health technologies. Available: http://www.resultsfordevelopment.org/sites/resultsfordevelopment.org/files/resources/R4D-PrizesReport.pdf. Accessed 11 April 2012.
26. Crager SE, Price M, (2009) Prizes and parasites: Incentive models for addressing Chagas disease. J Law Med Ethics 37 (2): 292-304.
27. Love J, Hubbard T, (2009) Prizes for innovation of new medicines and vaccines. Annals of Health Law 18: 155-186.
28. Governments of Bangladesh, Barbados, Bolivia and Suriname (2009) Chagas disease prize fund for the development of new treatments, diagnostics and vaccines. Available: http://www.who.int/phi/Bangladesh_Barbados_Bolivia_Suriname_ChagasPrize.pdf. Accessed 11 April 2012.
29. Wei M, (2007) Should prizes replace patents? A critique of the Medical Innovation Prize Act of 2005. Boston University Journal of Science and Technology Law (Working Paper).
30. Finkelstein SN, Temin P, (2008) Reasonable Rx: Solving the drug price crisis Upper Saddle River, N.J. FT Press/Pearson Education.
31. Banerjee A, Hollis A, Pogge T, (2010) The health impact fund: Incentives for improving access to medicines. Lancet 375 (9709): 166-169.
32. Travis J, (2008) Research funding. Prizes eyed to spur medical innovation. Science 319 (5864): 713.
33. Bermudez J, 't Hoen E, (2010) The UNITAID patent pool initiative: Bringing patents together for the common good. Open AIDS J 4: 37-40.
34. Serafino D, (2007) Survey of patent pools demonstrates variety of purposes and management structures. KEI Research Note 6.
35. World Intellectual Property Organization (2011) WIPO re:Search. Retrieved 5 February 20120. Available: http://www.wipo.int/research/en/. Accessed 11 April 2012.
36. Open Source Drug Discovery (2012) Open source drug discovery. Available: http://www.osdd.net/home. Accessed 11 April 2012.
37. Munos B, (2010) Can open source drug R&D repower pharmaceutical innovation? Clin Pharmacol Ther 87: 534-536.
38. Travis J, (2008) Science and commerce. Science by the masses. Science 319 (5871): 1750-1752.
39. Moran M, (2005) A breakthrough in R&D for neglected diseases: New ways to get the drugs we need. PLoS Med 2 (9): e302 doi:10.1371/journal.pmed.0020302.
40. Ziemba E, (2005) Public-private partnerships for product development: Financial, scientific, and managerial issues as challenges to future success. Research report for the WHO Commission on Intellectual Property Rights, Innovation, and Public Health.
41. Drugs for Neglected Diseases initiative (DNDi) (2011) Financing & incentives for neglected disease R&D: Opportunities and challenges: Comments to the WHO consultative expert working group (CEWG) on research & development: Financing and coordination - June 2011. DNDi Outlook 3.
42. Medicines for Malaria Venture (2012) How cost effective is MMV? Available: http://www.mmv.org/about-us/faqs/how-cost-effective-mmv. Accessed 11 April 2012.
43. DiMasi JA, Grabowski HG, (2007) The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28 (4-5): 469-479.
44. Goozner M, (2004) The $800 million pill: The truth behind the cost of new drugs Berkeley University of California Press.
45. Light DW, Warburton R, (2011) Demythologizing the high costs of pharmaceutical research. BioSocieties pp. 1-17.
46. Kaitin KI, DiMasi JA, (2011) Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther 89 (2): 183-188.
47. Jack A, (2006) Novartis chief in warning on cheap drugs. The Financial Times. Available: http://www.ft.com/intl/cms/s/0/6cfd37e8-5020-11db-9d85-0000779e2340.html. [Requires free registration]. Accessed 11 April 2012.
48. Fink S, Rabinowitz R, (2011) The UN's battle with NCDs: How politics, commerce, and science complicated the fight against an "invisible epidemic". Foreign Affairs (September).
49. World Health Organization (2008) The global burden of disease: 2004 update. Available: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/index.html. Accessed 11 April 2012.
50. Burke MA, Matlin SA, eds. (2008) Global forum for health research, monitoring financial flows for health research 2008 Geneva Global Forum for Health Research.
51. Heller MA, Eisenberg RS, (1998) Can patents deter innovation? The anticommons in biomedical research. Science 280 (5364): 698-701.
52. Jaffe AB, Lerner J, (2004) Innovation and its discontents: How our broken patent system is endangering innovation and progress, and what to do about it Princeton, N.J. Princeton University Press.
53. Massum H, Harris R, (2011) Open source for neglected diseases: Magic bullet or mirage? Available: http://www.resultsfordevelopment.org/sites/resultsfordevelopment.org/files/Open%20Source%20for%20Neglected%20Diseases.pdf. Accessed 11 April 2012.
54. Angell M, (2004) The truth about the drug companies: How they deceive us and what to do about it New York Random House.
55. Hubbard T, Love J, (2004) A new trade framework for global healthcare R&D. PLoS Biol 2 (2): e52 doi:10.1371/journal.pbio.0020052.
56. Governments of Bangladesh, Barbados, Bolivia, and Suriname (2009) Proposal for WHO discussions on a biomedical R&D treaty. Available: http://www.who.int/phi/Bangladesh_Barbados_Bolivia_Suriname_R_DTreaty.pdf. Accessed 11 April 2012.
57. Dentico N, Ford N, (2005) The courage to change the rules: A proposal for an essential health R&D treaty. PLoS Med 2 (2): e14 doi:10.1371/journal.pmed.0020014.
58. Health Action International Global, Initiative for Health and Equity in Society, Knowledge Ecology International, Medecins Sans Frontieres, Third World Network (2011) An essential health & biomedical treaty. Available: http://www.who.int/phi/news/phi_1_joint_submission_en.pdf. Accessed 11 April 2012.
59. Chen LC, Evans TG, Cash RA, (1999) Health as a global public good. In: Kaul I, Grunberg I, Stern MA, editors. Global Public Goods: International Cooperation in the 21st Century Oxford and New York Oxford University Press pp. 284-304.
60. DiMasi J, Grabowski H, (2004) Patents and R&D incentives: Comments on the Hubbard and Love trade framework for financing pharmaceutical R&D. Available: http://www.who.int/intellectualproperty/news/en/Submission3.pdf. Accessed 11 April 2012.
61. Fehr A, Thurmann P, Razum O, (2011) Expert Delphi survey on research and development into drugs for neglected diseases. BMC Health Services Research 11 (1): 312.
62. Love J, Hubbard T, Khor M, Sulston J, Stoppa-Lyonet D, et al. (2005) Letter to WHA executive board: Request to evaluate proposal for new global medical R&D treaty. Available: http://www.who.int/intellectualproperty/submissions/CPTech.pdf. Accessed 11 April 2012.
63. Velasquez G, Seuba X, (2011) Rethinking global health: A binding convention for R&D for pharmaceutical products. Research Note 42. Available: http://www.southcentre.org/index.php?option=com_content&view=article&id=1651%3Arethinking-global-health-a-binding-convention-for-rad-for-pharmaceutical-products&Itemid=335&lang=en. Accessed 11 April 2012.
64. World Health Organization (2006) Constitution of the World Health Organization. Basic Documents, Forty-fifth edition, Supplement, October 2006. Available: http://www.who.int/governance/eb/who_constitution_en.pdf. Accessed 11 April 2012.
65. Hein W, Moon S, (Forthcoming) Informal norms in global governance: Negotiating global intellectual property rules, human rights, and access to medicines Aldershot Ashgate In press.
66. Nikogosian H, (2010) WHO framework convention on tobacco control: A key milestone. Bull World Health Organ 88 (2): 83.
67. Pharmaceutical Research and Manufacturers of America (PhRMA) (2011) Pharmaceutical industry profile 2011. Available: http://www.phrma.org/sites/default/files/159/phrma_profile_2011_final.pdf. Accessed 11 April 2012.