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Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases?

Published online by Cambridge University Press:  06 January 2021

Kevin Outterson
Kevin Outterson*
Affiliation:
Boston University School of Law
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Extract

The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006, the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH Report), finding this concern to be significant:

In the context of our work one of the important points is that, where the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market.

On this issue, the WHO CIPIH Report was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Médecins Sans Frontières, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology).

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 2-3 , June 2008 , pp. 279 - 301
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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Footnotes

†

Editor’s Note: This symposium was held at Boston University in February 2008. In May 2008, the 61st World Health Assembly met in Geneva and adopted a Global Health Strategy on Public Health, Innovation and Intellectual Property, following the final meeting of the Inter-Govermental Working Group (IGWG 2) on May 3, 2008. This paper was circulated in draft form at IGWG 2, but has not been modified to account for the final resolution. In general, the WHA final resolution is supportive of the approach taken in this article, due to the efforts of many delegations and observers.

References

1 World Health Organization, Report of the Commission on Intellectual Property Rights, Innovation and Public Health 22 (2006) [hereinafter WHO CIPIH Report].

2 See, e.g., Médecins Sans Frontières, A Guide to the Post-2005 World: TRIPS, R&D and Access to Medicines (2005), http://www.msf.org/msfinternational/invoke.cfm?component=article&objectid=88694E5B-0FED-434A-A21EDA1006002653&method=full_html.

3 See Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C art. 8(1), Apr. 15, 1994,3 3 I.L.M. 81, available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf. (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter TRIPS or TRIPS Agreement].

4 For a longer treatment on this balance, see Outterson, Kevin, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale J. Health Pol’y, L. & Ethics 193–286 (2005)Google ScholarPubMed, available at http://www.ssrn.com/abstract=567742 [hereinafter Pharmaceutical Arbitrage].

5 See e.g., Ryan, Michael P., Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property (Brookings Institution Press 1998)Google Scholar; Matthews, Duncan, Globalizing Intellectual Property Rights (Higgott, Richard ed., Routledge 2002)Google Scholar; Drahos, Peter with Braithwaite, John, Information Feudalism: Who Owns the Knowledge Economy? (The New Press 2002)Google Scholar; Sell, Susan K., Power and Ideas: North-South Politics of Intellectual Property and Antitrust (Rosenau, James N., ed., State University of New York Press 1998)Google Scholar; Sell, Susan K., Private Power, Public law: The Globalization of Intellectual Property Rights (Smith, Steve, ed., Cambridge University Press 2003)CrossRefGoogle Scholar; Helfer, Laurence R., Regime Shifting: The TRIPS Agreement and New Dynamics of International Intellectual Property Lawmaking, 29 Yale J. Int’l L. 1 (2004)Google Scholar. For a report that ranks pharmaceutical companies based upon their commitment to access initiatives, see Access to Medicine Index, http://www.atmindex.org (last visited Mar. 24, 2008).

6 WHO CIPIH Report, supra note 1, at 121.

7 See infra Section III; see also U.S. Gen. Accounting Office, GAO Report 07-1198, U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarification 15, 19, 23 (Sept. 2007) [hereinafter, GAO Trade Policy Report].

8 Pharmaceutical Arbitrage, supra note 4, at 193-286; Outterson, & Kesselheim, , Market-Based Licensing for HPV Vaccines in Developing Countries, 27 Health Aff. 131, 131 (2008)Google Scholar; GAO Trade Policy Report, supra note 7, at 24; WHO CIPIH Report, supra note 1, at 111-12. For a recent example of the conventional view, see Danzon, Patricia M., At What Price?, 449 Nature 176 (2007)Google Scholar.

9 Many LMICs have not taken advantage of the flexibilities permitted under TRIPS. William New, Disparities Seen In Developing Countries’ TRIPS Implementation (Dec. 11, 2007), available at http://www.ip-watch.org/weblog/index.php?p=865. TRIPS permitted many developing countries to implement its provisions on a delayed basis. TRIPS Agreement, supra note 3, at arts. 65-66. After extensions, most developing countries must have implemented the TRIPS Agreement by January 1, 2005, but the thirty “least developed countries” may defer full implementation for pharmaceutical products until 2016. World Trade Organization, Doha Ministerial Declaration on the TRIPS Agreement and Public Health of 20 Nov. 2001, WT/MIN(01)/DEC/2, ¶ 7 (2001) [hereinafter Doha Declaration]. Despite these concessions, all but three of Africa's Least Developed Countries (LDCs) have already adopted patent laws for pharmaceuticals. Phil Thorpe, Study on the Implementation of the TRIPS Agreement by Developing Countries 1 (Comm. on Intellectual Prop. Rights, Study Paper 7) (2004). Similarly, Latin America has not fully availed itself of TRIPS flexibilities, with varying levels of sensitivity between countries. Gabriela Costa Chaves and Maria Auxiliadora Oliveira, A Proposal For Measuring The Degree of Public Health-Sensitivity of Patent Legislation In The Context of the WTO TRIPS Agreement, 85 Bull. World Health Org. (Jan. 2007). The TRIPS Agreement merely sets minimum periods of IP protection; the United States can still unilaterally extend patent protection, and has done so with copyright. WTO Members are also free to negotiate so-called “TRIPS-plus” agreements with additional provisions requiring protections in excess of the TRIPS Agreement's minimum standards. The U.S. has done so with a number of bilateral and multilateral treaties. Médecins Sans Frontières, MSF Briefing note, Access to Medicines at Risk Across the Globe: What To Watch Out For in Free Trade Agreements with the United States 4-6 (2004). For an explanation of why most developing country patent offices have not taken full advantage of TRIPS flexibilities, see Drahos, Peter, “Trust Me”: Patent Offices in Developing Countries, 34 Am. J.L. & Med. 151 (2008)Google Scholar.

10 GAO Trade Policy Report, supra note 7, at 23.

11 Doha Declaration, supra note 9, at para. 1.

12 Id. at para. 5(c).

13 Id. at para. 4, 5(b), 5(c), 5(d); GAO Trade Policy Report, supra note 7, at 11-26.

14 Doha Declaration, supra note 9, at para. 4.

15 The Jean Chretien Pledge to Africa Act, 2004 S.C., ch. 23 (Can.), available at http://www.canlii.org/ca/as/2004/c23/part2620%2Ehtml. [hereinafter Canadian Access to Medicines Regime or CAMR]. The law created a positive list of drugs eligible for compulsory licensure, a procedural hurdle not required by the WTO. Id at Sched. 1.

16 Jillian C. Cohen-Kohler et al., Canada's Implementation of the Paragraph 6 Decision: Is It Sustainable Public Policy?, 3 Globalization & Health (2007), available at http://www.globalizationandhealth.com/content/3/1/12.

17 The off-patent drugs include: amphotericin B, azithromycin, beclomethasone/beclometasone, ceftazidime, ceftriaxone, ciclosporin(e), ciprofloxacin, daunorubicin, doxorubicin, enalapril, erythromycin, etoposide, ibuprofen, isoniazid + pyrazinamide, insulin, ivermectin, levodopa + carbidopa, lithium carbonate, metoclopramide, metronidazole, morphine, nifedipine, nitrofurantoin, ofloxacin, potassium chloride, rifampin, salbutamol/albuterol, timolol. Patent status was taken from the U.S. FDA Orange Book. See Electronic Orange Book, Approved Drug Products with Therapeutic Equivalents, http://www.fda.gov/cder/ob/default.htm (last visited Mar. 24, 2008).

18 Apiradee Treerutkuarkul, Talks With Pharma-Giants Collapse, Bangkok Post, Dec. 18, 2007; Savoie, Brent, Thailand's Test: Compulsory Licensing In An Era of Epidemiologic Transition, 48 Va. J. Int’l L. 211 (2007)Google Scholar; Outterson & Kesselheim, supra note 8, at 133.

19 Editorial, Bangkok's Drug War Goes Global, Wall St. J., Mar. 7, 2007; M. Vaughan, In Clash with Activists, Critics Charge Thailand Violation of Trade Rules, Intell. Prop. Watch, Mar. 19, 2007.

20 Press Release, Médecins Sans Frontières, Abbott Should Reconsider its Unacceptable Decision to Not Sell New Medicines in Thailand (March 23, 2007), available at http://www.worldaidscampaign.info/index.php/en/campaigns/in_country_campaigns/asia/abbott_should_reconsider_its_unacceptable_decision_to_not_sell_new_medicines_in_thailand.

21 Office of the U.S. Trade Representative, 2007 Special 301 Report 27 (2007) [hereinafter Special 301 Report].

22 Indeed, as the GAO reports, the USTR itself concedes the point. See GAO Trade Policy Report, supra note 7, at 48-49. The USTR stated that the decision to place Thailand on the Special 301 “priority watch list” was based “not solely on [Thailand’s] compulsory license decision.” Id. at 49.

23 For my most recent defense of equitable access in the face of diversion, see generally Outterson & Kesselheim, supra note 8. For an earlier defense set in a broader theoretical context, see Pharmaceutical Arbitrage, supra note 4, at 261-68. In the context of adaptive innovation leading to the creation of a distinctive product, diversion is much less likely.

24 For more information about ebola hemorrhagic fever, see The Centers for Disease Control and Prevention, Special Pathogens Branch (2006) available at http://www.cdc.gov/ncidod/dvrd/spb/mnpages/dispages/ebola.htm.

25 See generally Magnusson, Roger S., Non-Communicable Diseases and Global Health Governance: Enhancing Global Processes to Improve Health Development, 3 Globalization & Health (May 22, 2007)CrossRefGoogle Scholar available at http://www.globalizationandhealth.com/content/3/1/2.

26 Institute of Medicine, Cancer Control Opportunities in Low- and Middle- Income Countries (National Academies Press 2007).

27 See generally Gaziano, Thomas A., Reducing The Growing Burden of Cardiovascular Disease in the Developing World, 26 Health Aff. 13 (2007)Google Scholar; The Center for Global Health and Economic Development, A Race Against Time: The Challenge of Cardiovascular Disease in Developing Economies (Columbia University, 2004).

28 World Health Organization Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, Draft Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, A/PHI/IGWG/2/2 (July 31, 2007), available at http://www.who.int/gb/phi/pdf.igwg2/PHI_IGWG2_2-en.pdf [hereinafter WHO IGWG]. An early form of this article was submitted to the WHO IGWG Public Hearing in September, 2007, available at http://www.who.int/phi/public_hearings/second/contributions_section1/Section1_Kevin_Outterson_Boston_Uni_Full_Contribution.pdf.

29 Hubbard, Tim & Love, James, A New Trade Framework for Global Healthcare R&D, 2 PLoS Biology 147 (Feb. 2004)Google Scholar. Other proposals for separating these markets have been recently summarized in Nathan, Carl, Aligning Pharmaceutical Innovation With Medical Need, 13 Nat. Med. 304–308 (2007)CrossRefGoogle Scholar. The WHO CIPIH Report recommended further investigation of this proposal. WHO CIPIH Report, supra note 1, at 178 (Recommendation 3.6). For a philosophical approach, see Pogge, Thomas, Harnessing the Power of Pharmaceutical Innovation, in The Power of Pills: Social, Ethical, and Legal Issues in Drug Development, Marketing, and Pricing 142-49 (Cohen, Jillian Claire et al. eds., 2006)CrossRefGoogle Scholar.

30 Scherer, F.M., A Note on Global Welfare in Pharmaceutical Patenting, 27 World Econ. 1127, 1141 (2004)Google Scholar; Pharmaceutical Arbitrage, supra note 4, at 193; Steinbrook, Robert, Closing the Affordability Gap for Drugs in Low-Income Countries, 357 New Eng. J. Med. 1996-99 (2007)CrossRefGoogle Scholar.

31 Paul Hunt, Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, 19 Sept. 2007, at 1 (Draft for Consultation), available at http://www2.essex.ac.uk/human_rights_centre/rth/docs/PH%20draft%20guidelines%2019%20sept%202007.doc; see also Oxfam, Oxfam Briefing Paper 109: Investing For Life: Meeting Poor People's Needs for Access to Medicines Through Responsible Business Practices, Nov. 2007, at 2, available at http://www.oxfam.org/en/files/bp109_investing_for_life_0711.pdf. download.

32 See, e.g., Médecins Sans Frontières, MSF Campaign Brochure 5 (2004), http://www.msf.org.au/education/resources/access-brochure.pdf. (“Medicines aren't just any consumer goods.”); Knowledge Ecology International, IGWG Submission on Collective Management of Intellectual Property – The Use of Patent Pools to Expand Access to Needed Medical Technologies, Sept. 30, 2007, http://www.who.int/phi/public_hearings/en/; Oxfam, supra note 31.

33 WHO CIPIH Report, supra note 1, at 20.

34 IMS Health estimates the global pharmaceutical market at $643 billion in 2006. Press Release, IMS Health, IMS Health Reports Global Pharmaceutical Market Grew 7.0 Percent in 2006, to $643 Billion (Mar. 20, 2007), available at http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_3665_80560241,00.html. Companies do not typically break out their financial results by high-income v. low- and medium-income categories, but the World Health Assembly estimated that approximately 90% of drug sales are in developed countries. Intellectual Property Rights, Innovation, and Public Health, World Health Assembly Res. WHA56.27 10th plen. mtg., (May 28, 2003). My estimates also confirm that 90% or more of the patent-based drug companies’ profits derive from high-income countries. Kevin Outterson, Patent Buy-Outs For Global Disease Innovations For Low- and Middle-Income Countries, 32 Am. J. L. & Med. 159, 160 (2006). For Merck, approximately 7.5% of its global revenues come from developing countries. Outterson & Kesselheim, supra note 8, at 134. In its 2006 Form 10-K filed with the U.S. Securities and Exchange Commission, Merck derived more than half of its global revenue from the United States in 2006. The “other” category accounted for 10.6% of global revenues, but this category included Australia and New Zealand while excluding Africa and the Middle East. Merck & Co. Inc., Annual Report (Form 10-K), at 120 n.20 (2007).

35 U.S. Department of Commerce, Pharmaceutical Price Controls in OECD Countries: Implications For U.S. Consumers, Pricing, Research and Development, and Innovation 3 (2004), available at http://www.ita.doc.gov/td/chemicals/drugpricingstudy.pdf. (last visited Mar. 27, 2008) [hereinafter OECD Pricing Report]; see also Kevin Outterson, Testimony Before the Committee on Health, Education, Labor, & Pensions, United States Senate, Hearing on: Drug Importation: Would the Price Be Right? (Feb. 17, 2005) (critique of the Department of Commerce Report), available at ssrn.com/abstract=706849.

36 OECD Pricing Report, supra note 35, at viii-ix.

37 Catlin, Aaron et al., National Health Spending In 2005: The Slowdown Continues, 26 Health Aff. 142, 143 exhibit 1 (2007)Google Scholar.

38 Centers for Medicare and Medicaid Services, National Health Expenditures By Type of Service and Source of Funds: Calendar Years 2006-1960, available for download at http://www.cms.hhs.gov/NationalHealthExpendData/02_NationalHealthAccountsHistorical.asp#TopOfPage (see Prescription Drugs figures at Line 394 in Excel Document) [hereinafter Expenditures].

39 Congressional Budget Office, The Budget and Economic Outlook: Fiscal Years 2008 to 2017, 58-59, Box 3-2 (Jan. 2007). The figure cited is the gross cost, which is a more appropriate measure of government subsidy of prescription drug purchases.

40 Hwang, Wenke et al., Out-of-Pocket Medical Spending for Care of Chronic Conditions, 20 Health Aff. 267, 267 (2001)Google Scholar; Soumerai, S.B. et al., Effects of Medicaid Drug-Payment Limits on Admission to Hospitals and Nursing Homes 325 N. Engl. J. Med. 1072 (1991)Google Scholar; Stuart, Bruce et al., Riding the Rollercoaster: The Ups and Downs In Out-Of-Pocket Spending Under The Standard Medicare Drug Benefit, 24 Health Affairs 1022 (2005)Google Scholar; and Chien-Wen, Tseng, et al., Elderly Patients’ Preferences and Experiences with Providers in Managing Their Drug Costs, 55 J. Am. Ger. Soc. 1974, 1974 (2007)Google Scholar.

41 Expenditures, supra note 38.

42 U.S. Gov't Accountability Office, GAO-05-690, Expenditures Represent a Substantial Federal Commitment and Need to Be Examined 34 tbl. 2 (2005).

43 Expenditures, supra note 38. The OECD estimate is higher, at 12.5% but includes other nondurable medical goods. OECD Health Data: 2007, available at http://www.oecd.org/document/16/0,3343,en_2825_495642_2085200_1_1_1_1,00.html. (pharmaceuticals and other nondurable medical as a percentage of total health expenditures).

44 Global Forum for Health Research, Monitoring Financial Flows for Health Research 35 (2006).

45 Id. at 39.

46 Public Citizen's Congress Watch, Rx R&D Myths: The Case Against The Drug Industry's R&D “Scare Card” 7 (July 2001) (critiquing the success of pharmaceutical innovation, including a description of the role of public investment); but see Ernst & Young LLP, Pharmaceutical Industry R&D Costs: Key Findings about the Public Citizen Report (Aug. 8, 2001) (industry-funded response). For a recent proposal concerning publicly funded R&D, see Bouchard, Ron A., Balancing Public and Private Interests in the Commercialization of Publicly Funded Medical Research: Is There a Role for Compulsory Government Royalty Fees?, 13 B.U. J. Sci. & Tech. L. 120 (2007)Google Scholar (calling for compulsory government royalties on publicly funded medical research in order to reallocate the benefits and burdens of this public expenditure).

47 NIH Budget 2007, available at http://www.nih.gov/about/budget.htm.

48 Moses, Hamilton III et al., Financial Anatomy of Biomedical Research, 294 J. Am. Med. Ass’n. 1333-42 (2005)CrossRefGoogle Scholar; European Science Foundation, EMRC White Paper: Present Status and Future Strategy for Medical Research in Europe 16-19 (2007) available at http://www.esf.org.

49 OECD, Science, Technology and Industry Scoreboard 36-7 (2007).

50 Bill & Melinda Gates Foundation, 2006 Annual Report 14 (2006).

51 Global Forum for Health Research, supra note 44, at 36.

52 Accenture, The Pursuit of High Performance through Research and Development: Understanding Pharmaceutical Research and Development Cost Drivers 4 fig. 2.1.1 (2007).

53 Merrill Goozner, The $800 Million Pill: The Truth Behind the Cost of New Drugs (2004); Public Citizen's Congress Watch, supra note 46; but see Ernst & Young LLP, supra note 46.

54 Global Forum for Health Research, supra note 44, at 39. The Global Forum statistics are derived from the OECD, which itself uses the PhRMA figures for U.S. R&D. George Messinis, R&D Price Inflation, Real BERD and Innovation: Pharmaceuticals, OECD 1980-2000 (Working Paper No. 18) (May 2004) available at http://www.cfses.com/documents/pharma/18-Inflation_Real_BERD_&_%20Innovation_Messinis.pdf. For estimates of U.S. R&D spending for health, see Moses III et al., supra note 48, at 1333-42. These figures include only direct expenditures, and exclude tax expenditures.

55 Personal written communication from Hamilton Moses III (Dec. 7, 2007 ) (on file with author). See Moses III et al., supra note 48.

56 26 U.S.C. sec. 41 (2007). The U.S. Treasury estimates the R&D tax credit was $4.630 billion in FY 2004, but did not separately report the portion awarded to the pharmaceutical industry. U.S. Gov't Accountability Office, supra note 42, at 100.

57 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 STAT. 2296 (codified at 21 U.S.C. § 355a).

58 Orphan Drug Act, Pub. L. No. 97-414, 96 Stat. 2049 (1982) (codified as amended as 21 U.S.C. §§ 360aa-360ee (1994), 26 U.S.C. § 45C (Supp. 11 1994), 42 U.S.C. § 236 (1994)). Rohde, David Duffield, The Orphan Drug Act: An Engine of Innovation? At What Cost?, 55 Food & Drug L.J. 125, 131 (2000)Google Scholar. Loughnot, David, Potential Interactions of the Orphan Drug Act and Pharmacogenomics: A Flood of Orphan Drugs and Abuses?, 31 Am. J.L. & Med. 365, 365 (2005)Google Scholar. The orphan drug tax credit amounts to approximately $180 to $200 million per year. U.S. Gov't Accountability Office, supra note 42, at 105 tbl. 4, app. III.

59 Holik, Daniel S., U.S. Possessions Corporations Returns, 2003, Statistics of Income Bulletin 113, 115 fig. C (2006)Google Scholar (the “pharmaceuticals and medicines” industrial group accounted for 53.1%).

60 Merck's Possessions Tax Credit for 2006 was only $87 million. Merck & Co. Inc., Annual Report (Form 10-K), at 114 (Feb. 28, 2007).

61 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 346a(i)(1) (2007).

62 Food and Drug Administration Modernization Act of 1997 § 111.

63 Orphan Drug Act § 527.

64 Two recent estimates have been made; the lower of the two projected a $7.7 billion cost for a single two year “wild card” transferable patent extension. Spellberg, B. et al., Societal Costs Versus Savings from Wild-Card Patent Extension Legislation to Spur Critically Needed Antibiotic Development, 35 Infection 167, 167 (2007)Google Scholar; Outterson, Kevin et al., Will Longer Antimicrobial Patents Improve Global Public Health? 7 Lancet Infectious Diseases 559, 561 (2007)Google Scholar.

65 In its comments to the WHO IGWG, the U.S. Government called for additional “tax credits to encourage research and development into medicines related to neglected or orphan diseases.” U.S. Government Comments on Annexes I and II of the World Health Organization (WHO) Secretariat's Elements of a Global Strategy and Plan of Action, at 8, Doc. A /PHI/IGWG/1/5, available at http://www.who.int/phi/submissions/USA-Comments.pdf. [hereinafter, U.S. Comments].

66 Global Forum for Health Research, supra note 44, at 39 tbl 2.1.

67 Brazil has fully subsidized the price of AIDS medications as part of its aggressive treatment and prevention program. The high price had prevented Brazil from making similar commitments across other treatment categories. WHO CIPIH Report, supra note 1, at 97-100 fig. 4.3; Outterson & Kesselheim, supra note 8, at 133. Brazil's threatened compulsory licenses may have saved US$1 billion in AIDS treatment costs between 2001 and 2005. Nunn, Amy S., et al., Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment, 4 PLoS Med. 1804, 1809 (2007)Google Scholar.

68 Paul Hunt, supra note 31, at 1; WHO CIPIH Report, supra note 1, at 23; see also Oxfam, supra note 31, at 2.

69 Oxfam, supra note 31, at 13.

70 See, e.g., Roger S. Magnusson, Non-Communicable Diseases and Global Health Governance: Enhancing Global Processes to Improve Health Development, 3 Globalization & Health (May 22, 2007) available at http://www.globalizationandhealth.com/content/3/1/2.

71 Global Forum for Health Research, 2 Global Forum Update on Research for Health 1, 10-11 (2005); see also Lopez, Alan & Mathers, Colin, Inequities in Health Status: Findings From the 2001 Global Burden of Disease Study, 4 Global Forum Update on Research for Health 163, 164 (2007)Google Scholar.

72 Global Forum for Health Research, supra note 71, at 11 fig. 3.

73 Id. at 11; for more information on DALY see Disability Adjusted Life Years (DALY), http://www.who.int/healthinfo/boddaly/en/.

74 Lopez & Mathers, supra note 71, at 169 tbl. 2.

75 Ebrahim, Shah & Smeeth, Liam, Non-Communicable Diseases in Low and Middle-Income Countries: A Priority or a Distraction?, 34 Int’l. J. Epidemiology 961, 962 tbl. 2 (2005)Google Scholar.

76 Lopez & Mathers, supra note 71, at 171-72 tbls. 7 & 8.

77 See, e.g. the special issue of The Lancet in December 2007 devoted to the burden of chronic diseases, with several articles focusing upon LMICs. Abegunde, Dele O et al., The Burden and Costs of Chronic Diseases in Low-Income and Middle-Income Countries, 370 The Lancet 1929 (2007)Google Scholar; Lim, Stephen S et al., Prevention of Cardiovascular Disease in High-Risk Individuals in Low-Income and Middle-Income Countries: Health Effects and Costs, 370 The Lancet 2054 (2007)Google Scholar; Beaglehole, Robert et al., Prevention of Chronic Diseases: A Call To Action, 370 The Lancet 2152 (2007)Google Scholar. For a somewhat contrarian view, see Ebrahim & Smeeth, supra note 76; but see Strong, Kathleen et al., Preventing Chronic Disease: A Priority For Global Health, Int’l. J. Epidemiology 492 (2006)Google Scholar (letter responding to the Ebrahim & Smeeth article). The WHO CIPIH Report strongly noted the growing rate of noncommunicable disease. WHO CIPIH Report, supra note 1, at 2-5, 44.

78 Lopez & Mathers, supra note 71, at 172.

79 WHO CIPIH Report, supra note 1, at 13.

80 See Condon, Bradly & Sinha, Tapen, Global Diseases, Global Patents and Differential Treatment in WTO Law: Criteria for Suspending Patent Obligations in Developing Countries, 26 Nw. J. Int’l L. & Bus. 1, 25–28 (2005)Google Scholar.

81 WHO CIPIH Report, supra note 1, at 14 tbl. 1.3.

82 Kamangar, F. et al., Patterns of Cancer Incidence, Mortality, and Prevalence Across Five Continents: Defining Priorities to Reduce Cancer Disparities in Different Geographic Regions of the World, 24 J. Clin. Oncology 2137 (2006)Google Scholar.

83 Mathers, C.D. et al., Global Burden of Disease and Risk Factors 52 tbl. 3.1 (Oxford/World Bank, 2006)Google ScholarPubMed.

84 See Harper, Diane M. et al., Sustained Efficacy Up To 4.5 Years of a Bivalent L1 Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18: Follow-Up From a Randomised Control Trial, 367 The Lancet 1247 (2006)Google Scholar.

85 Outterson & Kesselheim, supra note 8.

86 Id.

87 Press Release, Bill and Melinda Gates Foundation, Cervical Cancer Vaccine Project (Oct. 2006), available at http://www.path.org/files/RH_cc_vacc_proj_fs_update.pdf.

88 Press Release, Merck, Merck To Donate Three Million Doses of Gardasil, its Cervical Cancer Vaccine, to Support Vaccination Programs in Lowest Income Nations (Sept. 26, 2007). Three million doses will vaccinate one million women, a very small percentage of the need.

89 WHO CIPIH Report, supra note 1, at 22 (“[A]s is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market.”); see also Nathan, Carl, Aligning Pharmaceutical Innovation With Medical Need, 13 Nature Med. 304 (2007)Google Scholar. For a review of the literature, see Pharmaceutical Arbitrage, supra note 4, at 244-50.

90 See, e.g., Médicins Sans Frontiéres, Access to Essential Medicines Campaign & Drugs for Neglected Diseases Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases (2001).

91 Mary Moran et al., The New Landscape of Neglected Disease Drug Development (2005), available at http://www.wellcome.ac.uk.

92 Kremer, Michael & Glennerster, Rachel, Strong medicine: Creating incentives for pharmaceutical research on neglected diseases 119 (Princeton University Press 2004)Google Scholar.

93 Aiden Hollis, An Efficient Reward System For Pharmaceutical Innovation 1 (Oct. 6, 2004), available at http://www.who.int/intellectualproperty/news/en/Submission-Hollis6-Oct.pdf.

94 See Hubbard & Love, supra note 29; but see Joseph A. DiMasi & Henry G. Grabowski, Patents and R&D Incentives: Comments on the Hubbard and Love Trade Framework For Financing Pharmaceutical R&D 2 (June 25, 2004), available at http://www.who.int/intellectualproperty/news/en/Submission3.pdf.

95 Sykes, Alan O., TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution, 3 Chi. J. Int’l. L. 47, 56 (2002)Google Scholar; Neglected Diseases: Towards Policies Without Borders, 262 OECD Observer (July 2007), available at http://www.oecdobserver.org/news/fullstory.php/aid/2282/Neglected_diseases.html.

96 Jean O. Lanjouw & William Jack, Trading Up: How Much Should Poor Countries Pay to Support Pharmaceutical Innovation?, 4 Ctr. For Global Development Brief, Nov. 2004, at 1, available at http://www.cgdev.org/content/publications/detail/2842/.

97 WHO CIPIH Report, supra note 1, at 22; Pharmaceutical Arbitrage, supra note 4, at 244-50.

98 Mathers et al., supra note 83, at 52 tbl. 3.1.

99 WHO CIPIH Report, supra note 1, at 3-4 tbls. 1.1 & 1.2.

100 See, e.g., Nathan, supra note 29, at 304-08.

101 WHO CIPIH Report, supra note 1, at 14.

102 UNAIDS, Fact Sheet: Key Facts by Region – 2007 AIDS Epidemic Update (Nov. 2007), http://data.unaids.org/pub/EPISlides/2007/2007_epiupdate_en.pdf (estimating that 2.1 million people are living with HIV in 2007 in North America, Western and Central Europe).

103 Gardiner Harris, Figures on H.I.V. Rate Expected to Rise, N.Y. Times, Dec. 2, 2007 (reporting that estimates on U.S. infection rates may be 50% higher than previously thought).

104 WHO CIPIH Report, supra note 1, at 16-19, 44.

105 Outterson & Kesselheim, supra note 8.

106 Pharmaceutical Arbitrage, supra note 4, at 234.

107 Munoz, Nubia et al., Against Which Human Papillomavirus Types Shall We Vaccinate and Screen? The International Perspective, 111 Int’l. J. Cancer 278, 281-84 (2004)Google Scholar.

108 WHO, Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property: Progress to Date in Drafting Groups A and B 4-5, A/PI/IGWG/2/Conf.Paper No.1 Rev.1 (Dec. 14, 2007) [hereinafter WHO Draft Global Strategy (2007)].

109 WHO CIPIH Report, supra note 1, at 45.

110 WHO Draft Global Strategy (2007). An earlier draft is WHO, Elements of a Global Strategy and Plan of Action, A/PHI/IGWG/1/5 (Dec. 8, 2006) [hereinafter WHO Elements of a Global Strategy (2006)].

111 WHO Draft Global Strategy (2007), at 3-5 ¶¶ 3, 4, 13, 14(a), 14(b).

112 WHO CIPIH Report, supra note 1.

113 World Health Assembly [WHA] Res. 59.24 (May 27, 2006).

114 U.S. Comments, supra note 65, at 2.

115 WHO CIPIH Report, supra note 1, at 48 (Recommendation 2.4).

116 Id. at 22.

117 WHA Res. 59.24, supra note 113, at § 2 ¶ 4.

118 WHO Elements of a Global Strategy (2006), supra note 110, at 6-8.

119 U.S. Comments, supra note 65, at 4-6, ¶¶ 7-8. The U.S. Comments suggest that the WTO and WIPO are the better fora.

120 Id. at 5 ¶ 6.

121 Id. at 5 ¶ 7.

122 WHO CIPIH Report, supra note 1, at 172.

123 See infra Part IV.C.

124 See, e.g., Klein, Elli et al., Hospitalizations and Deaths Caused By Methicillin-Resistant Staphylococcus aureus, United States, 1999-2005, 13 Emerging Infectious Diseases 1840 (2007)Google Scholar; Monina Klevens, R. et al., Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States, 298 J. Am. Med. Ass’n. 1763 (2007)Google Scholar.

125 WHO CIPIH Report, supra note 1, at 180-82.

126 Id. at 180.

127 WHA Res. 59.24, supra note 113, at § 2 ¶ 3.