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Intellectual Property and Development at WHO and WIPO

Published online by Cambridge University Press:  06 January 2021

Jack Lerner
Jack Lerner*
Affiliation:
University of Southern California Gould School of Law; USC Intellectual Property and Technology Law Clinic; Samuelson Law, Technology & Public Policy Clinic, UC-Berkeley School of Law
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Extract

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (“WIPO”) recently approved a historic “Development Agenda” – a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (“WHO”) has launched its own development agenda of sorts – an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) that is tasked with preparing “a global strategy and plan of action” aimed at “securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 2-3 , June 2008 , pp. 257 - 277
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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References

1 See generally World Intellectual Property Organization [WIPO], http://www.wipo.int.

2 William New, WIPO Launches New Agenda On IP And Development, Intell. Prop. Watch, Sept. 29, 2007, http://www.ip-watch.org/weblog/index.php?p=762.

3 See generally World Health Organization [WHO], http://www.who.int.

4 Public Health, Innovation, Essential Health Research and Intellectual Property Rights: Towards a Global Strategy and Plan of Action, World Health Assembly Res. WHA59.24 ¶ 3 (May 27, 2006), available at http://www.who.int/gb/ebwha/pdf.files/WHA59/A59_R24-en.pdf [hereinafter WHA, Public Health Innovation].

5 For example, the World Trade Organization is engaged in an ongoing process of amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) to make it easier for developing countries to obtain less expensive, generic versions of patented medicines. The United Nations Conference on Trade and Development, together with the International Centre for Trade and Sustainable Development, is implementing a Capacity Building Project on Intellectual Property Rights (IPRs) and Sustainable Development that conducts research designed to improve understanding of the implications of the TRIPS Agreement for developing countries and to “strengthen the analytical and negotiating capacity of developing countries so that they are better able to participate in IPR-related negotiations in an informed fashion in furtherance of their sustainable development objectives.” See Capacity Building Project on Intellectual Property Rights, http://www.iprsonline.orgunctadictsd/description.htm. The United Nations Development Programme (“UNDP”) has launched a capacity building project designed help developing countries provide access to HIV/AIDS drugs in the context of the flexibilities and safeguards within TRIPS, through technical assistance and facilitation. See UNDP, Intellectual Property Rights, http://www.undp.org/poverty/intel.htm; see also Press Release, UNDP, Fostering Appropriate National Responses to Intellectual Property and Access to Medicine (Oct. 26, 2006), http://content.undp.org/go/newsroom/?categoryID=349428&lang=en.

6 WIPO, Proposal by Argentina and Brazil for the Establishment of a Development Agenda for WIPO, WIPO Doc. WO/GA/31/11 (Aug. 7, 2004), available at http://www.wipo.int/documents/en/document/govbody/wo_gb_ga/pdf.wo_ga_31_11.pdf [hereinafter WIPO, Proposal].

7 Id. at II.

8 Id. at V-VII.

9 WIPO, General Report Adopted by the Assemblies of the Member States of WIPO, ¶ 334, WIPO Doc. A/43/16 (Nov. 12, 2007), available at http://www.wipo.int/edocs/mdocs/govbody/en/a_43/a_43_16-main1.pdf. [hereinafter WIPO, General Report].

10 See id.

11 See id.

12 Id. Annex A, ¶¶ 1-14.

13 Id.

14 Id. Annex A, ¶¶ 15-23.

15 Id.

16 Id. Annex A, ¶ 22.

17 Id. Annex A, ¶¶ 24-32.

18 See Michel Kostecki, Int’l Ctr. for Trade And Sustainable Dev. (ICTSD), Programme on IPRs and Sustainable Development, Issue Paper No. 12: Intellectual Property and Economic Development: What Technical Assistance to Redress the Balance in Favour of Developing Nations? (2006).

19 WIPO, General Report, supra note 9, Annex A, ¶¶ 33-38.

20 Id. Annex A, ¶¶ 39-44.

21 Id.

22 Id.

23 Posting of Dr. Sisule Musungu, to Thoughts In Colours, available at http://thoughtsincolours.blogspot.com/2007/07/wipo-development-agenda-as-dust.html (July 9, 2007, 01:10 EST).

24 WIPO, Proposal, supra note 6.

25 Note, however, that the WHO is mentioned in Proposal 40 of WIPO's General Report, which calls for intensified cooperation on IP issues with various UN agencies. WIPO, General Report, supra note 9, at 16 (“To request WIPO to intensify its cooperation on IP related issues with United Nations agencies, according to Member States’ orientation, in particular UNCTAD, UNEP, WHO, UNIDO, UNESCO and other relevant international organizations, especially the WTO in order to strengthen the coordination for maximum efficiency in undertaking development programs”).

26 The Secretary-General, Intellectual Property Rights, Innovation, and Public Health, ¶ 3, delivered to the Fifty-Sixth World Health Assembly, U.N. Doc. A56/17 (May 12, 2003), available at http://www.who.int/gb/ebwha/pdf.files/WHA56/ea5617.pdf.

27 Id.

28 Id. ¶ 23.

29 Intellectual Property Rights, Innovation, and Public Health, World Health Assembly Res. 56.27, at 2, U.N.Doc. WHA56/27 (May 28, 2003) [hereinafter WHA 56.27].

30 WHO, Comm’n on Intellectual Prop. Rights, Innovation, & Pub. Health, Public Health, Innovation, and Intellectual Property Rights, at iii (Apr. 25, 2006), available at http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf. [hereinafter CIPIH Report].

31 Id.

32 Id at x.

33 Id. For a broad overview of CIPIH's findings, see CIPIH, Frequently Asked Questions, http://www.who.int/intellectualproperty/documents/thereport/questions/en/index.html. (last visited Apr. 17, 2008) [hereinafter CIPIH, FAQ].

Id. passim. The report's conclusions are summarized by CIPIH as follows:

Intellectual property rights are a general incentive provided by governments to promote innovation in all fields. In respect of public health, they are embedded in a set of other incentives which influence the pattern of innovation. They need to be looked at as part of a bigger picture.

In particular, because of the small and uncertain market demand for diagnostics, vaccines and medicines needed to address health problems mainly affecting developing countries, the incentive effect of intellectual property rights may be limited or non-existent.

Because intellectual property rights may not be an effective incentive in this area, there is a need for other incentives and financial mechanisms to be put in place and for collaborative efforts between different stakeholders. Without access to the products of innovation, there can be no public health benefits. Defining the conditions by which products can be accessed is therefore an important aspect of the report.

There has been significant progress in recent years, in particular initiatives taken by different stakeholders to promote innovation in health-care products e.g. increased funding by foundations and the formation of public-private partnerships for product development.

This momentum for change is welcome but is insufficient. More needs to be done. There are unsettled and debated issues in intellectual property for example the effectiveness of the recent amendment to TRIPS in increasing access to medicines in countries without manufacturing capacity, the impact of data exclusivity laws and the impact of intellectual property provisions in bilateral trade agreements.

And there is a need to ensure enhanced financing on a sustainable basis of innovation and access and promote synergy between the different partners. Ultimately it is a responsibility that governments must accept if these objectives are to be achieved.

It is appropriate that WHO should now take the lead in promoting a more sustainable and better-funded effort and addressing unresolved issues. WHO should accordingly develop a Global Plan of Action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries.

35 For example, Professors Carlos Correa and Pakdee Pothisiri suggested, among other things, that more attention should have been paid to what they called a “drastic decline in the capacity of the pharmaceutical industry to innovate” and called for additional analysis on the negative effects of TRIPS-plus provisions in free trade agreements. CIPIH Report, supra note 30, at 201. Trevor Jones questioned the report's connection between patents and pricing and disagreed with the report's call for further reform of the patent system, among other things. Id. at 202.

36 Id.

37 Id. at 104 (proposal 4.1).

38 Id. at 55 (proposal 2.10).

39 Id. at 120 (proposals 4.13-4.15).

40 See, e.g. Carlos M. Correa, Note on the CIPIH Report, Commentaries by Commissioners, CIPIH, http://www.who.int/intellectualproperty/documents/thereport/CCcommentary.pdf. (last visited June 1, 2008).

41 Id. at 83-96.

42 Id. at 89-90 (proposals 3.5 and 3.6).

43 CIPIH, FAQ, supra note 33.

44 World Health Assembly, Public Health Innovation, supra note 4..

45 Id.

46 Riaz K. Tayob, WHO Working Group on IPR and Innovation Finishes Week of Work, to Meet Again in April 2008, Third World Network, Nov. 13, 2007, http://www.twnside.org.sg/title2/health.info/twnhealthinfo021107.htm.

47 WHO, Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property: Progress to Date in Drafting Groups A and B, A/PHI/IGWG/2/Conf. Paper No. 1. Rev. 1 and Annex, Dec. 14, 2007, available at http://www.who.int/gb/phi/pdf.igwg2/PHI_IGWG2_CP1Rev1-en.pdf [hereinafter December 14, 2007 Progress Report].

48 Id.

49 Id. ¶ 7.

50 Id. ¶¶ 8, 9.

51 Id. ¶ 12.

52 Id. ¶ 6.

53 Id. ¶ 13.

54 Id. ¶ 14 b). As specified by the Commission on Marcroeconomics and Health and discussed in the CIPIH Report, Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each. Type II diseases are incident in both rich and poor countries, but with a substantial proportion of the cases in poor countries. Type III diseases are those that are overwhelmingly or exclusively incident in developing countries. Id. at n. 1.

55 Id. at n.1.

56 Id. at n.1.

57 Id. ¶ 14 e). This sub-paragraph corresponds with what is referred to later in the draft global strategy as Element 5.

58 Id.

59 Id. ¶¶ 15-26. These twelve principles originated with a draft global strategy submitted in September 2007 by fourteen developing countries. WHO, Sub-regional Meeting Consensus Document: Draft Global Strategy on Public Health, Innovation and Intellectual Property submitted by Argentina, Brazil, Bolivia, Chile, Costa Rica, Cuba, Ecuador, El Salvador, Honduras, Mexico, Peru, Suriname, Uruguay and Venezuela, A/PHI/IGWG/2/2 Annex, Sept. 3-5 2007, available at http://www.who.int/phi/public_hearings/second/regional_consultations/Sub-regional_Consensus_Document.pdf.

60 December 14, 2007 Progress Report, supra note 47, ¶ 15.

61 Id. ¶ 16.

62 Id. ¶ 17.

63 Id. ¶ 20.

64 Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C, art. 8(1), Apr. 15, 1994,33 I.L.M. 81, available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf. [hereinafter the TRIPS Agreement] (Marrakesh Agreement Establishing the World Trade Organization).

65 December 14, 2007 Progress Report, supra note 47, ¶ 25.

66 Id. ¶ 18.

67 Id. ¶ 27, 28

68 Id. ¶ 28 (1.3).

69 Id. ¶ 29

70 Id.

71 Id. ¶ 30.

72 Id.

73 Id. ¶ 30(2.4)(d).

74 Id. ¶ 30(2.4)(e).

75 Id. ¶ 30(2.3)(c) (“encourage further exploratory discussions on the utility of possible intruments [sic] or mechanisms for essential health and biomedical R&D, including inter alia, a essential health and biomedical R&D treaty”).

76 Id. ¶ 32(3.1)(a)

77 Id. ¶ 32(3.2)(a).

78 Id. ¶ 32(3.2)(b). Consensus has not been reached on this proposed action. Id.

79 Id. ¶ 32(3.4).

80 Id. ¶ 32(3.5).

81 Id. ¶ 34.

82 Id. ¶ 34(4.1)(a).

83 Id. ¶ 34(4.1)(b). Consensus has not been reached on this proposed action. Id.

84 Id. ¶ 34(4.1)(c).

85 Id. ¶ 34(4.2)(c).

86 Id. ¶ 34.

87 Id. ¶ 34(4.3).

88 Id. ¶ 34(4.3)(a).

89 Id. ¶ 34(4.3)(b).

90 Id. ¶ 34(4.3)(c).

91 Id. ¶¶ 35-36.

92 Id.

93 Id. ¶ 36(5.1)(b).

94 Id. ¶ 36(5.1)(c) and (f), respectively.

95 Id. ¶ 36(2.3)(f).

96 Id. ¶ 37.

97 Id. ¶ 38(6.1).

98 Id. ¶ 38(6.2).

99 Id. ¶ 39(6.2)(e).

100 Id. ¶ 39(6.2)(g). The issue of “linkage” between regulatory authorities and intellectual property has been particularly controversial, and over the last few years such provisions have been agreed upon in several bilateral trade agreements with the United States. See, e.g., Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements, Occasional Paper 14, Quaker United Nations Office (2004) (arguing that the rules set up by the Agreements are generally prohibitively complicated for individuals operating in the real world); Rafael Pastor, The Impact of Free Trade Agreements on Intellectual Property Standards in a Post-TRIPS World n.48-52, bilaterals.org, April 4, 2006, http://www.bilaterals.org/article.php3?id_article=4311.

101 December 14, 2007 Progress Report, supra note 47, ¶ 39(6.3).

102 Id. ¶ 39(6.3)(d).

103 Id. ¶ 39(6.3)(g) (first alternative).

104 Id. ¶ 39(6.3)(g) (second alternative).

105 Id. ¶ 39(6.3)(e).

106 Id. ¶¶ 39(6.3)(a), (h), (i), 39(6.4).

107 Id. ¶ 39(6.3)(c).

108 Id. ¶¶ 40-42.

109 Id. ¶ 42(7.1)(a).

110 Id. ¶ 42(7.3).

111 Id. ¶¶ 43-44.

112 Id. ¶ 43.

113 Id. ¶ 26.

114 See William New, WHO Board Sets Course On IP, Avian Flu, Tighter Publication Policy, Intell. Prop. Watch, Feb. 4, 2008, http://www.ip-watch.org/weblog/index.php?p=909.

115 See generally December 14, 2007 Progress Report, supra note 47, ¶¶ 35-37.

116 U.N. World Intellectual Property Organization [WIPO], Assemblies of the Member States of WIPO, Forty-Third Series of Meetings, Report of the Provision Committee on Proposals Related to a WIPO Development Agenda (PCDA), Annex, ¶¶ 2, 3, Doc. A/43/13 Rev. (September 17, 2007) (prepared by the Secretariat) [hereinafter WIPO Development Agenda], available at http://www.wipo.int/edocs/mdocs/govbody/en/a_43/a_43_13_rev.doc; December 14, 2007 Progress Report, supra note 47, ¶¶ 42(7.2), 42(7.3).

117 See, e.g., WIPO Development Agenda, supra note 116, ¶ 4; December 14, 2007 Progress Report, supra note 47, ¶¶ 28(1.2), 30(2.1).

118 See, e.g., WIPO Development Agenda, supra note 116, ¶¶ 7, 23, 32; December 14, 2007 Progress Report, supra note 47, ¶¶ 36(5.3), 39(6.3).

119 See, e.g., WIPO Development Agenda, supra note 116, at Cluster A: Technical Assistance and Capacity Building; December 14, 2007 Progress Report, supra note 47, at Element 3: Building and improving innovative capacity.

120 See, e.g., WIPO Development Agenda, supra note 116, ¶ 8; December 14, 2007 Progress Report, supra note 47, ¶ 36.

121 See, e.g., WIPO Development Agenda, supra note 116, ¶¶ 14, 17; December 14, 2007 Progress Report, supra note 47, ¶ 36(5.2).

122 See, e.g., WIPO Development Agenda, supra note 116, ¶¶ 28, 29, 31; December 14, 2007 Progress Report, supra note 47, at Element 4: Transfer of technology.

123 See, e.g., WIPO Development Agenda, supra note 116, ¶¶ 34, 35 (proposing studies on constraints to and impact of IP); December 14, 2007 Progress Report, supra note 47, ¶ 28(1.1) (proposing to map global R&D with a view to identifying gaps that disproportionately affect developing countries), and ¶ 42(7.1) (proposing task force to study financing mechanisms).

124 WIPO Development Agenda, supra note 116, ¶ 33.

125 December 14, 2007 Progress Report, supra note 47, at Element 8: Establishing monitoring and reporting systems.

126 Id.

127 WIPO Development Agenda, supra note 116, ¶ 39.

128 December 14, 2007 Progress Report, supra note 47, ¶ 2.3(c).

129 WIPO Development Agenda, supra note 116, at 18.

130 See, e.g., id. at Proposals 30, 40; December 14, 2007 Progress Report, supra note 47, at Proposed Actions 5.1, 5.2, 2.3, 8.2.

131 WIPO Development Agenda, supra note 116, at Proposal 30.

132 Id. at Proposal 40.

133 December 14, 2007 Progress Report, supra note 47, ¶ 5.1(e).

134 Id. ¶ 5.2(a).

135 Id. ¶ 2.3(f) (to be considered within Element 5).

136 Id. ¶ 8.2(b).

137 Id. ¶ 5.3.

138 Id.

139 Sixtieth World Health Aassembly, Public Health Innovation and Intellectual Property: Agenda Item 12.20 (May 24, 2007), http://www.who.inte/gb/ebwhat.pdf.files/WHA60/A60_R30-en.pdf.

140 See generally Love, James & Hubbard, Tim, The Big Idea: Prizes to Stimulate R&D for New Medicines, 82 Chi.-Kent L. Rev. 1519, 1550 (2007)Google Scholar.

141 See discussion supra Parts II.A., II.B.

142 See generally WIPO Development Agenda, supra note 116; December 14, 2007 Progress Report, supra note 47.

143 Note the language of Cluster E of the Development Agenda: WIPO, General Report, supra note 9, Annex A, ¶¶ 39-44.

144 During the last IGWG meeting, a United States-based NGO released a report analyzing organizations that submitted comments in advance of IGWG public hearings conducted earlier in 2007. The report showed that comments from groups with links to the pharmaceutical industry outnumbered those from independent groups by more than 2 to 1. See Essential Action, Pharmaceutical Links of NGOs Contributing to the World Health Organization's Second Public Hearing on Public Health, Innovation and Intellectual Property, Nov. 7, 2007, http://www.essentialaction.org/access/uploads/igwg.contributorlinks.rtf; see also William New, Report Finds Significant Industry Affiliation in IGWG ‘NGO’ Comments, Intell. Prop. Watch, Nov. 8, 2007, http://lists.essential.org/pipermail/ip-health/2007-November/thread.html beginning with http://lists.essential.org/pipermail/ip-health/2007-November/011884.html.

145 See List of Experts and Concerned Entities for the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, http://www.who.int/gb/phi/pdf.igwg2/listofexpert-en.pdf (last visited Apr. 26, 2008). The “concerned public and private entities” permitted to attend were: The Bill & Melinda Gates Foundation; Biotechnology Industry Organization (BIO); Directorate of Science, Technology and Industry, Organization for Economic Cooperation and Development (OECD); Drugs for Neglected Diseases Initiative (DNDi); Global Forum for Health Research; Médecins Sans Frontières (MSF); Access to Essential Medicines Campaign; and Facilité Internationale d'Achat de Médicaments (UNITAID). Id.

146 See Essential Action, supra note 144.

147 WIPO Development Agenda, supra note 116, at 31.

148 Id. at 28.

149 See id. at 16-21.

150 See Tenu Avafia et al., The Ability of Select Sub-Sahara African Countries to Utilise TRIPs Flexibilities and Competition Law to Ensure a Sustainable Supply of Essential Medicines: A Study of Producing and Importing Countries § 1 (2006), http://www.iprsonline.org/unctadictsd/docs/Trade%20and%20Competition%2030%203%2006%20final%20Edit1%20_2_%20_2_.pdf. William New, supra note 2; Raghavan Chakravarthi, ‘No!’ to ‘TRIPS-plus’ IP standards, Third World Network, http://www.twnside.org.sg/title2/twr171d.htm.

151 A recent ICTSD project illustrates the challenges facing developing country governments in setting IP policy. The ICTSD recently developed a Diagnostic Toolkit to aid the assessment of needs for IP technical and financial assistance in least-developed countries. See Mart Leesti & Tom Pengelly, Technical and Financial Co-operation Needs for Implementation of the WTO TRIPS Agreement in Sierra Leone: Final Report of Needs Assessment ix (2007), http://www.iprsonline.org/ictsd/docs/Sierra_Leone%20final%20report%20with%20logos%20November%202007.pdf. This document outlines several steps necessary merely to assess a country's priority needs for technical and financial assistance, which include assessment of: the national development context; existing IP policy and legal framework; existing arrangements for IP administration; existing arrangements for IP enforcement and regulation; and existing arrangements for promoting use of the IP system for development and promoting innovation, technology transfer, and creativity. Id.

152 See generally Drahos, Peter, Developing Countries and International Intellectual Property Standard-Setting, 5 J. World Intell. Prop. 765 (2002)Google Scholar.

153 WIPO Development Agenda, supra note 116, ¶ 35.

154 Kostecki, supra note 18, at vii; Leesti & Pengelly, supra note 151, at ix.

155 See discussion supra Part II A-B.

156 See discussion supra Part II A.

157 WIPO Development Agenda, supra note 116, at Cluster A Proposal 1.

158 Id. at Proposals 1-14.

159 Id. at Proposal 6.

160 Id. at Proposal 9.

161 See Kostecki, supra note 18, at ix. .

162 December 14, 2007 Progress Report, supra note 47, at § 11(2.1).

163 Id. at § 13 (3.1)-(3.2).

164 Id. at § 17(5.1)(a).

165 Id. at § 17(5.2).

166 WIPO Development Agenda, supra note 116, at Proposal 1.

167 E-mail from James Love to Senate Finance Committee (Nov. 2, 2007), lists.essential.org/pipermail/ip-health/2007-November/011872.html. See also William New, WHO Session On IP And Health Clashes On Vision, Practicalities, Intell. Prop. Watch, Nov. 9, 2007, http://www.ip-watch.org/weblog/index.php?p=818; Tove Iren S. Gerhardsen, US Advises Developing Country FTA Partners Not To Follow WHO Plan, Intell. Prop. Watch, Dec. 11, 2006, http://www.ip-watch.org/weblog/index.php?p=485. As Professor Outterson discusses in his article in this Symposium, the United States presented similar, highly technical arguments in earlier Comments to the IGWG. See Outterson, Kevin, Should Access to Medicines And TRIPS Flexibilities Be Limited To Specific Diseases?, 34 Am. J.L. & Med. 279 (2008)Google Scholar.

168 Const. World Health Org. art. 1 ( “The objective of WHO shall be the attainment by all peoples of the highest possible level of health.”), available at http://www.who.int/governance/eb/who_constitution_en.pdf. see also WHO website, http://www.who.int (last visited Apr. 27, 2008).

169 December 14, 2007 Progress Report, supra note 47, at Annex ¶ 15.

170 See Raustiala, Kal & Victor, David G., The Regime Complex for Plant Genetic Resources, 58 Int’l Org. 277 (2004)Google Scholar.

171 WHO, Public Health Innovation and Intellectual Property, http://www.who.int/phi/en (last visited June 8, 2008); WIPO, Development Agenda for WIPO, http://www.wipo.int/ipdevelopment/en/agenda (last visited June 8, 2008).