Patents, biomedical research, and treatments: Examining concerns, canvassing solutions

Hastings Center Report

Volumn 37, Issue 1, 2007, Pages

  Johnston, Josephine ^a   Wasunna, Angela A ^a  

^a NONE

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[No Author keywords available]

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EID: 33846994704     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (186)

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10. Ibid.
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27. National Science Board, Science and Engineering Indicators 2006 (Arlington, Va.: National Science Foundation, 2006).
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30. The authors defined gene patents as patents that claim "human protein-encoding nucleotide sequences." K. Jensen and F. Murray, "Intellectual Property Landscape of the
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32. Ibid.
33. Organisation for Economic Co-operation and Development, "Patents and Innovation"; J. Johnston, "Health-Related Academic Technology Transfer: Rethinking Patenting and Licensing Practices," International Journal of Biotechnology, forthcoming.
34. Organisation for Economic Co-operation and Development, "Turning Science into Business: Patenting and Licensing at Public Research Organisations" (Paris, France: Organisation for Economic Co-operation and Development, 2003).
35. U.S. Code, title 35, Part II, chapter 18, Sec. 202.
36. The Stevenson-Wydler Technology Innovation Act of 1980 and the Federal Technology Transfer Act of 1986.
37. Office of Technology Transfer, National Institutes of Health, "Statistics," December 2004, http://ott.od.nih.gov/about_nih/ statistics.html (accessed June 7, 2006).
38. National Science Board, Science and Engineering Indicators 2006.
39. Mowery et al., Ivory Tower and Industrial Innovation.
40. Ibid.
41. Organisation for Economic Co-operation and Development, "Patents and Innovation."
42. Ibid.
43. Parke-Davis & Co. v. H.K. Mulford & Co., 196 F. 496 (2d Cir. 1912).
44. Diamond v. Chakrabarty, 447 U.S. 303 (1980), p. 151.
45. Harvard College v. Canada (Commissioner of Patents) [2002] 4 S.C.R. 45, 2002 SCC 76.
46. L.B. Andrews and J. Paradise, "Gene Patents: The Need for Bioethics Scrutiny and Legal Change," Yale Journal of Health Policy, Law, and Ethics 5, no. 1 (2005): 403-412, at 405.
47. Nuffield Council on Bioethics, "The Ethics of Patenting DNA: A Discussion Paper" (London: Nuffield Council on Bioethics, 2002).
48. J. Paradise, L. Andrews, and T. Holbrook, "Patents on Human Genes: An Analysis of Scope and Claims," Science 307, no. 5715 (2005): 1566-67.
49. United Nations Educational, Scientific and Cultural Organization, "Universal Declaration on the Human Genome and Human Rights," 1997, http://portal.unesco.org/shs/en/ev.php-URL_ID=1881&URL_DO= DO_TOPIC&URL_SECTION = 201.html; Nuffield Council on Bioethics, "The Ethics of Patenting DNA."
50. Diamond v. Chakrabarty.
51. European Patent Office, "Convention on the Grant of European Patents" (European Patent Convention), 12th ed., April 2006, article 53, http://www.european-patent-office.org/legal/epc/e/ma1.html#CVN.
52. The European Parliament and The Council of the European Union, "European Directive on the Legal Protection of Biotechnological Inventions," 1998, article 6, http://europa.eu/eur-lex/pri/en/oj/dat/1998/ l_213/l_ 21319980730en00130021.pdf.
53. Nuffield Council on Bioethics, "The Ethics of Patenting DNA."
54. E.R. Gold and T.A. Caulfield, "The Moral Tollbooth: A Method That Makes Use of the Patent System to Address Ethical Concerns in Biotechnology," Lancet 359, no. 9325 (2002): 2268-70.
55. Working Group on Research Tools, National Institutes of Health, "Report of the National Institutes of Health (NIH) Working Group on Research Tools," 1998, http://www.nih.gov/news/researchtools/.
56. M.A. Heller and R.S. Eisenberg, "Can Patents Deter Innovation? The Anticommons in Biomedical Research," Science 280 (1998): 698-701, at 700.
57. Commission on Intellectual Property Rights, "Integrating Intellectual Property Rights and Development Policy," http://www. iprcommission.org/graphic/documents/final_report.htm (2002, accessed June 7, 2006).
58. Working Group on Research Tools, "Report of the National Institutes of Health Working Group on Research Tools."
59. Department of Health and Human Services, National Institutes of Health, "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice," Federal Register 64, no. 246 (December 23, 1999): 72090-72096.
60. Department of Health and Human Services, National Institutes of Health, "Best Practices for the Licensing of Genomic Inventions," Federal Register 69, no. 223 (November 19, 2004): 67747-67748.
61. Organisation for Economic Co-operation and Development, "Guidelines for the Licensing of Genetic Inventions" (Paris, France: Organisation for Economic Co-operation and Development, 2006).
62. J.P. Walsh, C. Cho, and W.M. Cohen, "View from the Bench: Patents and Material Transfers," Science 309, no. 5743 (2005): 2002-2003, at 2002.
63. Ibid.
64. S. Hansen, A. Brewster, and J. Asher, "Intellectual Property in the AAAS Scientific Community: A Descriptive Analysis of the Results of a Pilot Survey on the Effects of Patenting on Science" (Washington, D.C.: American Association for the Advancement of Science, 2005).
65. Walsh, Cho, and Cohen, "View from the Bench."
66. Committee on Assessing Integrity in Research Environments, Institute of Medicine and National Research Council of the National Academies, "Integrity in Scientific Research" (Washington, D.C.: The National Academies Press, 2002).
67. Madey v. Duke University, 266 F. Supp. 2d 420 (MDNC 2001).
68. C. Dent et al., "Research Use of Patented Knowledge: A Review" (Paris, France: Organisation for Economic Co-operation and Development, 2006).
69. UNAIDS/WHO, "AIDS Epidemic Update: December 2005," Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO), Geneva, Switzerland 2005, http://www.unaids.org/epi/ 2005/doc/ EPIupdate2005_pdf_en/epi-update2005_en.pdf.
70. S. Rosen et al., "The Cost of HIV/AIDS to Businesses in Southern Africa," AIDS 18 (2004): 317-24.
71. R. Bonnel, "HIV/AIDS: Does it Increase or Decrease Growth in Africa?" http://siteresources.worldbank.org/INTAFRREGTOPHIVAIDS/Resources/ Growth_in_ Africa.pdf.
72. M. Ainsworth and A.M. Over, "The Economic Impact of AIDS in Africa," in AIDS in Africa, ed. M. Essex et al. (New York: Raven, 1994);
73. J.M. Seghal, The Labour Implications of HIV/AIDS (Geneva, Switzerland: International Labour Organisation, 1999).
74. R. Park, "The International Drug Industry: What the Future Holds for South Africa's HIV/AIDS Patients," Minnesota Journal of Global Trade 11, no. 1 (2002): 125-54.
75. See World Health Organization, "Antiretroviral Treatments for HIV/AIDS," 1997, http://www.who.int/inf-fs/en/fact163.html.
76. The three drugs are didanosine (ddI), zalcitabine (D4T) and idovudine (AZT). See P. Boulet, C. Garrison, and E. 't Hoen, "Drug Patents under the Spotlight: Sharing Practical Knowledge about Pharmaceutical Patents" (Geneva, Switzerland: Médecins Sans Frontières, May 2003).
77. World Health Organization, "Coordinates 2002, Charting Progress Against AIDS, TB and Malaria" (2002), 1, http://whqlibdoc.who.int/hq/2002/ WHO_CDS_2002.11.pdf.
78. The Pharmaceutical Manufacturers Association and Others v. The President of the Republic of South Africa and Others, case no: 4183/98, High Court of South Africa (Transvaal Provincial Division);
79. H. Sun, "The Road to Doha and Beyond: Some Reflections on the TRIPS Agreement and Public Health," European Journal of International Law 15, no. 1 (2004): 123-50.
80. M. Heywood, "Debunking 'Conglomotalk': A Case Study of the Amicus Curiae as an Instrument for Advocacy, Investigation and Mobilisation" (presentation at "Health, Law and Human Rights: Exploring the Connections: An International Cross-Disciplinary Conference Honoring Jonathan M. Mann," September 29 to October 1, 2001, Philadelphia, Pa.).
81. See Médecins Sans Frontières, "Campaign Accomplishments for 2001, Campaign for Access to Effective Medicines" (Brussels, Belgium: Médecins Sans Frontières, April 23, 2001).
82. A. Stoppard, "Drug Companies Drop Lawsuit against South Africa," MIsanet.com http://www.afrol.com/News2001/sa021_drugcase_dropped. htm (accessed February 14, 2005).
83. P. Basu, "International Patent Law: Boon or Bane of Biotech?" Nature Biotechnology 23, no. 1 (2005): 13-15.
84. World Trade Organization, "Declaration on the TRIPS Agreement and Public Health, Ministerial Conference" (Doha declaration, adopted November 14, 2001), http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_e.htm, at para.2-4.
85. C. Correa, "Integrating Public Health Concerns into Patent Legislation in Developing Countries" (Geneva, Switzerland: The South Center, 2000).
86. F.M. Scherer and J. Watal, "Post-TRIPS Options for Access to Patented Medicines in Developing Nations," Journal of International Economic Law 5, no. 4 (2002): 913-39.
87. F. Abbott and R.V. Van Puymbroeck, "Compulsory Licensing for Public Health: A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision" (World Bank Working Paper No. 61, The World Bank, Global AIDS Program, 2005).
88. Sun, "The Road to Doha and Beyond."
89. World Trade Organization, Doha declaration, Para. 5 (c).
90. John Barton, "TRIPS and the Global Pharmaceutical Market," 151.
91. World Trade Organization, Doha declaration, Para 5 (d). See also H. Sun, "The Road to Doha and Beyond."
92. "Treatment Access: Patent Mailbox Opened in India," HIV Treatment Bulletin 6, no. 4 (April 2005), http://www.i-base.info/htb/v6/htb6-4/ Patent.html.
93. S. Kontic, "An Analysis of the Generic Pharmaceutical Industries in Brazil and China in the Context of TRIPS and HIV/AIDS," (2005), http://www.law.utoronto.ca/documents/ihrp/HIV_kontic.doc; see also S. Basheer, "India's New Patent Regime: Aiding 'Access' or Abetting 'Genericide'?" International Journal of Biotechnology, forthcoming. However, generic production of second-line drugs such as ritonavir, lopinavir plus ritonavir, and nelfinavir may be granted patent protection if the mailbox system accepts applications for drugs that have pre-1995 filing dates but were not marketed prior to 1995.
94. World Trade Organization, TRIPS agreement, Article 66.2 http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm.
95. Doha declaration, Paragraph 6.
96. F. Abbott, "The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner in WTO," Journal of International Economic Law 5, no. 2 (2002): 469-505.
97. See B. Condon and T. Sinha, "Global Diseases, Global Patents and Differential Treatment in WTO Law: Criteria for Suspending Patent Obligations in Developing Countries," Northwestern Journal of International Law and Business 26, no. 1 (2005): 1-42.
98. Ibid.
99. Ibid., at 11-12.
100. Y. Nkrumah and P. Osewe, "TRIPS Compliance and Public Health: Opportunities and Obstacles for African Countries," International Journal of Biotechnology, forthcoming.
101. Sun, "The Road to Doha and Beyond," at 147. See also Joint Oxfam-MSF Press Release, August 30, 2003, http://www.oxfam.org.
102. S. O'Carroll, "Importing Indian Generic Drugs Following TRIPS: Case Studies of Zambia and Kenya," (2005) http://www.law. utoronto.ca/documents/ ihrp/IV_Ocarroll.doc. See also C. Grace, "The Effect of Changing Intellectual Property Protection on the Pharmaceutical Industry Prospects in India and China: Considerations for Access to Medicines" (London: Department for International Development Health Systems Resource Centre, Issues Paper-Access to Medicines, 2004, http://www.dfid.gov.uk/pubs/files/ indiachinadomproduce.pdf); and N. Druce, "Access to Medicines in Underserved Markets: What Are the Implications of Changes in Intellectual Property Rights, Trade and Drug Registration Policy?" (London: Department for International Development Health Systems Resource Centre, 2004, http://www.dfidhealthrc.org/Shared/publications/Issues_papers/ATM/ DFID_synthesis_aw.pdf).
103. J.H. Reichman, "Taking the Medicine, with Angst: An Economist's View of the TRIPS Agreement," Journal of International Economic Law 4, no. 4 (2001):795-807.
104. See R. Bate, R. Tren, and J Urbach, "Taxed to Death" (Washington D.C.: AEI-Brooking Joint Center for Regulatory Studies, 2005, http://www.fightingmalaria.org/pdfs/taxed_to_death1.pdf).
105. A. Wasunna, "Brinkmanship and Compulsory Licensing: Policy Lessons from Brazil," International Journal of Biotechnology, forthcoming, and Nkrumah and Osewe, "TRIPS Compliance and Public Health."
106. Sun, "The Road to Doha and Beyond."
107. Ibid., at 146. See the U.S.-Singapore Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/Bilateral/Singapore_FTA/ Section_Index.html and the U.S.-Chile Free Trade Agreement, http://www.ustr.gov/Trade_Agreements/ Bilateral/Chile_FTA/Section_Index.html.
108. See the Free Trade Area of the Americas, http://www.ustr.gov/ Trade_Agreements/Regional/FTAA/Section_Index.html. See also D. Vivas-Eugui, "Regional and Bilateral Agreements in a TRIPS-plus World: The Free Trade Area of the Americas (FTAA)" (Geneva, Switzerland: Quarter United National Office, 2003), http://www.quno.org/geneva/pdf/economic/Issues/FTAs-TRIPS-plus- English.pdf.
109. Park, "The International Drug Industry."
110. C. Correa, "Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement" (Geneva, Switzerland: The South Center, 2002).
111. Ibid.
112. Ibid.
113. T.G. Field, "Intellectual Property: The Practical and Legal Fundamentals?" Idea. 35 (1994): 79-128.
114. E.R. Gold et al., "The Unexamined Assumptions of Intellectual Property: Adopting an Evaluative Approach to Patenting Biotechnological Innovation," Public Affairs Quarterly 18 (2004): 299-344, at 316.
115. World Health Organization, "Constitution of the World Health Organization," http://www.who.int/about/en/; United Nations Office of the High Commissioner for Human Rights, "International Covenant on Economic, Social and Cultural Rights," http://www.unhchr.ch/html/menu3/b/a_cescr. htm.113. World Intellectual Property Office, "What Is Intellectual Property?" http://www.wipo.int/about-ip/en/.
116. M. Kirby, "Report of the IBC on Ethics, Intellectual Property and Genomics" (Paris, France: United Nations Educational, Scientific and Cultural Organization, International Bioethics Committee, 2002), 2.
117. Gold et al., "The Unexamined Assumptions of Intellectual Property."
118. The SNP Consortium, "About the SNP Consortium," http://snp.cshl.org/about/ (accessed December 13, 2006).
119. Mowery et al., Ivory Tower and Industrial Innovation.
120. Commission on Intellectual Property Rights, "Integrating Intellectual Property Rights and Development Policy," 114.
121. M.F. Schultz and D.B. Walker, "How Intellectual Property Became Controversial: NGOs and the New International IP Agenda," Engage 6, no. 2 (2005), 82-98.
122. See Consumer Project on Technology, "Medical Research and Development Treaty," http://www.cptech.org/workingdrafts/rndtreaty4.pdf.
123. Ibid.
124. P. Stevens, "International Policy Network, Diseases of Poverty and the 10/90 Gap" (London: International Policy Network, 2004), http://www.fightingdiseases.org/pdf/Diseases_of_Poverty_FINAL.pdf.
125. World Health Organization, "The WHO Report on Infectious Diseases 1999: Removing Obstacles to Healthy Development," (Geneva, Switzerland: WHO, 1999). See also Schultz and Walker, "How Intellectual Property Became Controversial."
126. R. Glennerster and M. Kremer, "A Better Way to Spur Medical Research and Development," Regulation 23, no.2 (2000): 34-39.
127. Ibid. See also M. Kremer, "Pre-Commitments to Purchase New Vaccines: Rationale," 1999, http://adfdell.pstc.brown.edu/ classes/readings/kre99a. pdf.
128. Ibid.
129. P. Shetty, "More Creative Thinking Needed on Drug R&D," Sci-DevNet, May 3, 2005.
130. Glennerster and Kremer, "A Better Way to Spur Medical Research and Development," at 38. See also WA. Masters, "Research Prizes: A New Kind of Incentive for Innovation in African Agriculture," International Journal of Biotechnology 7, nos 1, 2, 3 (2005): 195-211.
131. Glennerster and Kremer, "A Better Way to Spur Medical Research and Development."
132. M. Kremer, "Creating Markets for New Vaccines," in Innovation Policy and the Economy, vol. 1, ed. J. Adam, L. Joshua, and S. Scott (Cambridge, Mass.: The MIT Press, 2001).
133. A. Hollis, "An Efficient Reward System for Pharmaceutical Innovation" (unpublished paper, http://econ.ucalgary.ca/fac-iles/ah/ drugprizes.pdf, accessed December 6, 2006), 3.
134. M. Kremer, "Patent Buy-Outs: A Mechanism for Encouraging Innovation," Quarterly Journal of Economics 113, no. 4 (1998): 1137-67.
135. S. Shavell and T. Van Ypersele, "Rewards vs. Intellectual Property Rights, "Journal of Law and Economics 44 (2001): 525-47; Hollis, "An Efficient Reward System for Pharmaceutical Innovation."
136. R.C. Guell and M. Fischbaum, "Toward Allocative Efficiency in the Prescription Drug Industry," Milbank Quarterly 73 (1995): 213-29.
137. M. Abramowicz, "Perfecting Patent Prizes," Vandtrbilt Law Review 56 (2003): 115-236.
138. Shetty, "More Creative Thinking Needed on Drug R & D."
139. T. Pogge, "A New Approach to Pharmaceutical Innovation," ON LINE Opinion http://www.onlineopinion.com.au.print.asp?article=3559.
140. D.B. Ridley, H.G. Grabowski, and J.L. Moe, "Developing Drugs for Developing Countries," Health Affairs 25, no. 2 (2006): 313-23.
141. W.A. Kaplan and R. Laing, "Local Production: Industrial Policy and Access to Medicines: An Overview of Key Concepts, Issues and Opportunities for Future Research" (health and nutrition discussion paper prepared for World Bank meeting on the role of generics and local industry in attaining the millennium development goals in pharmaceutical and vaccines, Washington, D.C., June 24, 2003).
142. Ibid.
143. J. Tybout, "Manufacturing Firms in Developing Countries: How Well Do They Do, and Why?" (World Bank, Washington, D.C., policy research working paper no. 1965, 1998).
144. Ibid.
145. Scherer and Watal, "Post-TRIPS Options for Access to Patented Medicines in Developing Nations," at 928.
146. The above draws from K. Outterson, "Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets," Yale Journal of Health Policy, Law, and Ethics 5, no. 1 (2005): 195-291.
147. Ibid.
148. See Médecins Sans Frontières, "Untangling the Web of Price Reductions: A Pricing Guide for the Purchase of ARVs for Developing Countries," 8th ed., (Geneva, Switzerland: Médecins Sans Frontières, 2004).
149. Outterson, "Pharmaceutical Arbitrage."
150. Director General Trade (Unit F4), "Tiered Pricing for Medicines Exported to Developing Countries, Measures to Prevent Their Re-Importation into the EC Market and Tariffs in Developing Countries" (Brussels, Belgium: European Commission, 2002). See also Outterson, "Pharmaceutical Arbitrage," at 252.
151. Department for International Development, "Increasing Access to Essential Medicines in the Developing World: U.K. Government Policy and Plans" (London: Department for International Development, 2004), http://www.dfid.gov.uk/pubs/files/accessmedicines.pdf.
152. M.R. Morgan, "Medicines for the Developing World: Promoting Access and Innovation in the Post-TRIPS Environment," University of Toronto Faculty of Law Review 64, no. 1 (2006): 45-111. See also http://www.clinton-foundation.org.
153. DFID, "Increasing Access to Essential Medicines in the Developing World."
154. Department of Commerce, United States Patent and Trademark Office, "Utility Examination Guidelines," Federal Register 66, no. 4 (January 5, 2001): 1092-1099.
155. Andrews and Paradise, "Gene Patents," 405.
156. A.K. Rai and R.S. Eisenberg, "The Public Domain: Bayh-Dole Reform and the Progress of Biomedicine," Law and Contemporary Problems 66 (2003): 289-314.
157. L. Nelson, "The Role of University Technology Transfer Operations in Assuring Access to Medicines and Vaccines in Developing Countries," Yale Journal of Health Policy, Law, and Ethics 3, no. 2 (2003): 301-308.
158. Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002).
159. P. Pressman et al., "The Licensing of DNA Patents by U.S. Academic Institutions: An Empirical Survey," Nature Biotechnology 24, no. 1 (2006): 31-39.
160. See A. Kapczynski et al., "Addressing Global Health Inequities: An Open Licensing Approach for University Innovations," Berkeley Technology Law Journal 20, no. 2 (2005): 1032-1114, at 1031.
161. For more on voluntary licensing strategies, see A. Brewster et al., "Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation," Innovation Strategy Today 1, no. 3 (2005): 203-216. See also an independent working group convened by Universities Allied for Essential Medicines, "Model Provisions for an 'Equitable Access and Neglected Disease License,'" (New Haven, Conn.: Universities Allied for Essential Medicines), http://www.essentialmedicine.org/EAL.pdf, (accessed December 13, 2006).
162. Brewster et al., "Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation."
163. Ibid.
164. Ridley, Grabowski, and Moe, "Developing Drugs for Developing Countries."
165. Ibid.
166. R.M. Schefler and V. Pathania, "Medicines and Vaccines for the World's Poorest: Is There Any Prospect for Public-Private Cooperation?" Globalization and Health 1 (2005): 10.
167. Rockefeller Foundation, "Partnering to Develop New Products for Diseases of Poverty: One Donor's Perspective," (New York: The Rockefeller Foundation, 2004) http://prelive.rockfound.org/Library/ Partnering_to_Develop_New_Products_for_Diseases_of_Poverty.pdf.
168. http://www.pfizer.com/pfizer/subsites/philanthropy/access/global.health. hiv.diflucan.jsp.
169. http://www.merck.com/cr/enabling_access/developing world_mectizan/.
170. Some of the above is from S. Nishtar, "Public-Private Partnerships in Health: A Global Call to Action," Health Research Policy and Systems 2 (2004): 5.
171. Brewster et al., "Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation."
172. Pressman et al., "The Licensing of DNA Patents by U.S. Academic Institutions."
173. Ibid.
174. Brewster et al., "Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation," 212.
175. Walsh, Cho, and Cohen, "View from the Bench."
176. Johnston, "Health-Related Academic Technology Transfer."
177. U.S. Code, title 35, Part II, chapter 18, Sec. 202.
178. See policies in Japan, Italy, Germany, Sweden, New Zealand, and Australia.
179. Kapczynski et al., "Addressing Global Health Inequities"; R.K. Merton, "The Normative Structure of Science," in The Sociology of Science, ed. R.K. Merton and N.W. Storer (Chicago, 111.: University of Chicago Press, 1973): 267-78.
180. Johnston, "Health-Related Academic Technology Transfer"; R.K. Merton, "The Normative Structure of Science," in The Sociology of Science, 267-78.
181. K.D.Jackson, "Global Distributive Justice and the Corporate Duty to Aid," Journal of Business Ethics 12, no. 7 (1993): 547-51;
182. A. Ho, "Pharmaceutical Corporations and the Duty to Aid in HIV/AIDS Epidemic," Business and Professional Ethics Journal, forthcoming.
183. Brewster et al., "Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation," 208.
184. Callahan and Wasunna, Medicine and the Market.
185. M. Herder and J. Dyck Brian, "Canada's Stem Cell Corporation: Aggregate Concerns and the Question of Public Trust," Journal of Business Ethics, forthcoming.
186. Johnston, "Health-Related Academic Technology Transfer.''