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The Global Health Licensing Program: A New Model for Humanitarian Licensing at the University Level

Published online by Cambridge University Press:  06 January 2021

Beirne Roose-Snyder  and
Megan K. Doyle
Beirne Roose-Snyder
Affiliation:
Georgetown University Law Center; Drinker Biddle & Reath LLP
Megan K. Doyle
Affiliation:
Georgetown University Law Center; Johns Hopkins University; Hogan & Hartson LLP
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Extract

Disparities in health outcomes and access to the essential medicines that affect health outcomes are two of the most pressing issues facing the world today. The lack of adequate health care in developing countries is rooted in a number of systemic problems, including insufficient health infrastructure, lack of medical personnel, government corruption and incompetence, and the high price of pharmaceuticals. These problems are not mutually exclusive. Instead, they are mutually reinforcing, particularly in least developed and developing countries.

The high cost of drugs and vaccines is undoubtedly one of the driving forces in disparate health outcomes, and partial solutions to poor health in the developing world rightly focus on lowering the cost of health products, while preserving the financial incentive for innovation. The high cost of many medicines is largely due to the international patent system, codified by the Trade Related Intellectual Property Rights (TRIPS) Agreement, which grants a monopoly to the innovator and allows it to completely control pricing for a period of years. The result is an access gap, whereby patients in low- and middle-income countries (LMI) cannot afford expensive patented drugs, while patients in wealthy countries can afford and do have access to such treatments.

Type
Article
Information
American Journal of Law & Medicine , Volume 35 , Issue 2-3 , June 2009 , pp. 281 - 309
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2009

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References

1 See, e.g., Gostin, Lawrence O., Meeting Basic Survival Needs of the World's Least Healthy People: Toward a Framework Convention on Global Health, 96 Geo. L.J. 331, 333 (2008)Google Scholar; World Health Org. [WHO], WHO Policy Perspectives on Medicines - Equitable Access to Essential Medicines: A Framework for Collective Action, (2004), available at http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.4.pdf (last visited Apr. 1, 2009).

2 Gostin, supra note 1, at 333-35; Jonathan D. Quick, Essential Medicines Twenty-five Years On: Closing the Access Gap, 18 Health Pol’y & Plan. 1, 1-3 (2003).

3 Amy Kapczynski et al., Addressing Global Health Inequities: An Open Licensing Approach for University Innovations, 20 Berkeley Tech. L.J. 1031, 1048-49 (2005) (“MSF has concluded that ‘the most significant factor in lowering prices is the introduction of generic sources in a country,’ and Oxfam International has called generic competition the single most important tool to remedy the access gap.”); Knowledge Ecology International, IGWG Submission on Collective Management of Intellectual Property – The Use of Patent Pools to Expand Access to Needed Medical Technologies, presentation to the World Health Organization Inter-governmental Working Group on Collective Management of Intellectual Property 2-3, (Sept. 30, 2007) [hereinafter KEI submission], http://www.who.int/phi/public_hearings/second/contributions_section2/Section2_ManonRess-PatentPool.pdf (last visited Apr. 5, 2008); Samantha Chaifetz et al., “Closing the Access Gap for Health Innovations: An Open Licensing Proposal for Universities,” BioMedCentral, 2 (2007), available at www.essentialmedicine.org/wordpress/wpcontent/ uploads/2007/04/Globalization&Health/pdf; Oxfam International, Generic Competition, Price and Access to Medicines: The Case of Antiretrovirals in Uganda 2 (2002), http://www.oxfam.org.uk/resources/policy/health/downloads/bp26_generic.pdf; Oxfam International, Save the Children, and VSO, Beyond Philanthropy: The Pharmaceutical Industry, Corporate Social Responsibility, and the Developing World 15 (2002), http://www.oxfam.org.uk/resources/policy/health/downloads/beyondphilanthropy.pdf.

4 Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy 51 (2002), available at http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf (last visited Apr. 1, 2009).

5 MSF/UNAIDS/WHO, Surmounting Challenges: Procurement of Anti- Retroviral Medicines in Low- and Middle-Income Countries 2-8 (2003), available at http://www.who.int/medicinedocs/en/d/Js4892e (last visited Apr. 1, 2009).

6 Gostin, supra note 1; Andrea Gerlin, Poor Women Should Get HPV Vaccine, Health Leaders Say, Bloomberg News, Dec. 12, 2006, http://www.bloomberg.com/apps/news?pid=20601082&sid=azZjNl2Egni0&refer=canada.

7 Kevin Outterson & Aaron S. Kesselheim, Market-Based Licenses for HPV Vaccines in Developing Countries, 27 Health Affairs 130, 132-137 (2008).

8 Staff of Joint Econ. Comm., 106th Cong. The Benefits of Medical Research and the Role of the NIH, (2000).

9 The Association of University Technology Managers, AUTM Licensing Survey: FY 2003 (2003), available at http://www.autm.net/events/File/Surveys/03_Abridged_Survey.pdf (last visited Apr. 1, 2009).

10 See, e.g., Press Release, Georgetown University, Georgetown Working to Address Global Health Issues (Feb. 16, 2007), http://explore.georgetown.edu/news/?ID=22753; Press Release, Georgetown University, Georgetown President Outlines Vision of Engagement: DeGioia Stresses Academic Involvement in Local & Global Issues (Jan. 22, 2007), http://explore.georgetown.edu/news/?ID=22158.

11 See Universities Allied for Essential Medicines, http://www.essentialmedicine.org/ (last visited Apr. 1, 2009); Chokshi, Dave A. & Rajkumar, Rahul, Leveraging University Research to Advance Global Health, 298 JAMA 1934, 1934-36 (2007)CrossRefGoogle ScholarPubMed.

12 April E. Effort & Ashley J. Stevens, Using Academic License Agreements to Promote Global Social Responsibility, 43 Les Nouvelles: J. Licensing Executives Soc’y 85 (2008).

13 See, e.g., Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices 123 (Anatole Krattiger et al. eds., 2007), http://www.iphandbook.org (hereinafter Handbook of Best Practices); Effort & Stevens, supra note 12.

14 Anatole Krattiger, The Use of Nonassertion Covenants: A Tool to Facilitate Humanitarian Licensing, Manage Liability & Foster Global Access, in Handbook of Best Practices, supra note 13, at 1739.

15 Id.

16 Id.

17 Id.

18 Alan B. Bennett, Reservation of Rights for Humanitarian Uses, in Handbook of Best Practices, supra note 13, at 41-43.

19 Id.

20 Lorelei Ritchie de Larena, The Price of Progress: Are Universities Adding to the Cost?, 43 Hous. L. Rev. 1373, 1413-17 (2007).

21 Id.

22 See, e.g. Amanda L. Brewster et al., Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation, 1 Innovation Strategy Today 202, 211 (2005), http://www.biodevelopments.org/innovation/index.htm; Ashley J. Stevens, Valuation & Licensing in Global Health, in Handbook of Best Practices, supra note 13, at 86 (2007); PowerPoint presentation, Mark L. Rorbaugh, National Institutes of Health: Improving Public Health Through Public Private Partnerships, available at http://www.who.int/intellectualproperty/events/en/Mark.Rohrbaugh.pdf.

23 See Brewster et al., supra note 22, at 211.

24 See Stevens, supra note 22, at 97; see also Rorbaugh, supra note 22.

25 Bennett, supra note 18, at 41-44.

26 Kapczynski et al., supra note 3.

27 Katherine M. Nolan-Stevaux, Open Source Biology: A Means to Address the Access & Research Gaps?, 23 Santa Clara Computer & High Tech. L.J. 271 (2007) Anatole Krattiger & Stanley P. Kowalski, Facilitating Assembly of and Access to Intellectual Property: Focus on Patent Pools and a Review of Other Mechanisms, in Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, supra note 13, at 1137; KEI submission, supra note 3.

28 Nolan-Stevaux, supra note 27, at 306; KEI submission, supra note 27.

29 Nolan-Stevaux, supra note 27.

30 Id.

31 Id.

32 See Krattiger & Kowalski, supra note 27.

33 See Nolan-Stevaux, supra note 27, at 306.

34 BiOS, http://www.bios.net/daisy/bios/home.html (last visited Apr. 5, 2008).

35 BiOS, BiOS-compatible Agreement Listing, http://www.bios.net/daisy/bios/licenses/2997.html (last visited Apr. 5, 2008).

36 Knowledge Ecology International, EMILA Working Plan (June 1, 2007), available at http://www.keionline.org/index.php?option=com_content&task=view&id=64&Itemid=44 (last visited Apr. 5, 2008).

37 Knowledge Ecology International, The Essential Medical Inventions Licensing Agency (2007), http://www.keionline.org/misc-docs/emila.pdf.

38 See Brewster et al., supra note 22.

39 Id.

40 U.S. Patent No. 7,279,306 (issued Oct, 9, 2007).

41 See Kapczynski, supra note 3; Universities Allied for Essential Medicines, Model Provisions for an “Equitable Access and Neglected Disease License”, http://www.essentialmedicine.org/EAL.pdf (last visited Apr. 5, 2008).

42 Id.

43 Id.

44 Id.

45 Id.

46 Id.

47 See Nolan-Stevaux, supra note 27; Stevens, supra note 22; Effort & Stevens, supra note 13.

48 See Nolan-Stevaux, supra note 27, at 298-99.

49 See Nolan-Stevaux, supra note 27.

50 See Stevens, supra note 22, at 981.

51 See Nolan-Stevaux, supra note 27, at 301.

52 Id.

53 See Stevens, supra note 22; Effort & Stevens, supra note 13.

54 Lita Neisen and Anatole Krattiger, Ensuring Developing-Country Access to New Inventions: The Role of Patents and the Power of Public Sector Research Institutions, in Handbook of Best Practices, supra note 13, at 123; Robert Eiss et al., Ensuring Global Access through Effective IP Management: Strategies of Product-Development Partnerships, in Handbook of Best Practices, supra note 13, at 163; Brewster et al., supra note 22.

55 See Brewster et al., supra note 22.

56 See Eiss et al., supra note 53.

57 Id.

58 Id.

59 Id.

60 See supra note 53; Stewart supra note 22; Joachim Oehler, Using Milestones in Healthcare Product Licensing Deals to Ensure Access in Developing Countries, MIHR Handbook of Best Practices, 119 (2007).

61 See Oehler, supra note 59.

62 Id.

63 Id.

64 Id.

65 Id.

66 Id. at 104-07; see supra note 53.

67 See Brewster et al., supra note 53; Neisen, supra note 53.

68 Id.

69 Id.

70 Id.

71 Amy Kapczynski, Access to Essential Medicines and University Research: Building Best Practices, Yale University Center for Interdisciplinary Research on AIDS: Policy Update, (2003).

72 Experts may be found in other universities’ licensing offices, from the Association of University Licensing Managers (AUTM), and from non-profit groups such as Knowledge Ecology International (KEI), Universities Allied for Essential Medicines (UAEM), Essential Action, Medecins Sans Frontieres, and the Essential Medicines Consortium.

73 Kapczynski, supra note 70.

74 Id.

75 Id.

76 Mark Anderson, Making drugs available at affordable prices: How Universities’ Technology Transfer Offices Can Help Developing Countries, 2 J. of Intell. Prop. L. & Prac. 145, 151 (2007).

77 See Eiss et al., supra note 53, at 163.

78 See Kapczynski, supra note 3, at 1048-49 (“MSF has concluded that ‘the most significant factor in lowering prices is the introduction of generic sources in a country,’ and Oxfam International has called generic competition the single most important tool to remedy the access gap”); KEI Submission, supra note 3, at 2-3; Chaifetz et al., supra note 3, at 2; Oxfam International, Save the Children, and VSO, Beyond Philanthropy: The Pharmaceutical Industry, Corporate Social Responsibility, and the Developing World, 15 (2002).

79 See Stevens, supra note 21.

80 Universities Allied for Essential Medicines, personal communication, Apr. 8, 2008.