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Delivering Drugs to the Poor: Will the TRIPS Amendment Help?

Published online by Cambridge University Press:  06 January 2021

Graham Dutfield
Graham Dutfield*
Affiliation:
School of Law, University of Leeds
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Extract

Many of the diseases and health conditions that account for a large part of the disease burden in low- and middle-income countries are far less common in high-income countries. These burdens are primarily associated with infectious diseases, reproductive health, and childhood illnesses. Just eight diseases and conditions account for 29 percent of all deaths in low- and middle-income countries: TB, HIV/AIDS, diarrheal diseases, vaccine-preventable diseases of childhood, malaria, respiratory infections, maternal conditions, and neonatal deaths.

Approximately 17.6 million people in low- and middle-income countries die each year from communicable diseases and maternal and neonatal conditions. Both the occurrence of and the death rates from such diseases and conditions are far lower in all high-income countries.

Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people’s lives. High-profile pandemics like HIV/AIDS understandably attract considerable attention. Millions of people have died of this terrible disease - 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively. As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 2-3 , June 2008 , pp. 107 - 124
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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References

1 Jamison, Dean T. et al., Cost-Effective Strategies for the Excess Burden of Disease in Developing Countries, in Priorities in Health 59, 59 (2006)Google Scholar, http://files.dcp2.org/pdf/PIH/PIH04.pdf.

2 UNAIDS Joint U.N. Programme on HIV/AIDS, 2006 Report on the Global AIDS Epidemic 13 (2006), available at http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/Default.asp.

3 “Concerning access, patents are not the issue but the overwhelming poverty of individuals, absence of state healthcare financing, lack of medical personnel, transport and distribution infrastructure plus supply chain charges which can make affordable originator or generic products unaffordable. In many countries, medicines are unaffordable from whatever source, price or patent status.” Trevor Jones, Commentary, in Public Health Innovation and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation and Public Health 202 (World Health Organization ed., 2006), available at http://www.who.int/intellectualproperty/documents/thereport/en/index.html.

4 Kaufer, Erich, The Economics of the Patent System 6 (1989)Google Scholar.

5 Giulio Mandich, Patent Law of Venice (1450-1550), 30 J. Pat. Off. Soc’y 157, 176 (F.D. Prager trans., 1948) (quoting Sen. Terra reg. 7 p. 32).

6 Id. at 177 (quoting Sen. Terra reg. 7 p. 32).

7 Dutfield, Graham, Patent Systems As Regulatory Institutions, 54 Indian Econ. J., 62, 65 (2006)Google Scholar.

8 This point applies to those developing countries that have attained a reasonable capacity to adopt and benefit from such technologies. Countries with very limited capacity have far less to gain from free access to technologies. However, the relationship between technology transfer and levels of intellectual property protection is extremely complicated and generalizations should be made with extreme caution, if at all. See Maskus, Keith E., The Role of Intellectual Property Rights in Encouraging Foreign Direct Investment and Technology Transfer, 9 Duke J. Comparative Int’l L. 109 (1998)Google Scholar.

9 European Community Patent Convention, 1989 O.J. (L 401) .

10 Patents Act, 1977, c. 37, § 60(5) (Eng.).

11 Id.

12 See, e.g., Inhale Therapeutic Systems Inc. v. Quadrant Healthcare Plc, [2002] R.P.C. 21 (Eng. Pat. Ct.).

13 Cornish, William R., Experimental Use of Patented Inventions in European Community States, 29 Int’l Rev. Indus. Prop. & Copyright L. 735, 735-36 (1998)Google Scholar.

14 Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. 2002).

15 For examples of how basic research carried out in universities, hospitals and government research agencies contributed to major biomedical revolutions, see Graham Dutfield, Intellectual Property Rights and the Life Science Industries: A Twentieth Century History (2003) [hereinafter Dutfield, Life Science].

16 Madey, 307 F.3d at 1362,

17 Id.

18 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. (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter the TRIPS Agreement].

19 Panel Report, Canada – Patent Protection of Pharmaceutical Products WT/DS114/R, (Mar. 17, 2000).

20 Graham Dutfield & Uma Suthersanen, Global Intellectual Property Law, (forthcoming Sept. 2008).

21 Dutfield, Life Science, supra note 15, at 56-60.

22 Paris Convention for the Protection of Industrial Property, Mar. 20, 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305.

23 Id. art. 5(4).

24 Jerome Reichman & Catherine Hasenzahl, United Nations Conference on Trade and Development (UNCTAD) & International Centre for Trade and Sustainable Development (ICTSD), UNCTAD-ICTSD Project on IPRS and Sustainable Development, Issue Paper No. 5: Non-voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice in Canada and the United States of America, at 1 ( 2003).

25 Id. at 12.

26 Id. at 4.

27 Id. at 19.

28 Id.

29 Id. at 19-20.

30 Gilbert, David, Walley, Tom, & Bill New, Lifestyle Medicines, 321 Brit. Med. J. 1341, 1341-44 (2000)Google ScholarPubMed; Weintraub, Arlene, Are Pharmas Addicted to Lifestyle Drugs?, BusinessWeek June 15, 2007, at 40–41Google Scholar.

31 Médicins Sans Frontières (MSF) and Drugs for Neglected Diseases (DND) Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases 10 (MSF and DND Working Group, 2001).

32 Orbinski, James, Health, Equity, and Trade: A Failure in Global Governance, in The Role of the World Trade Organization in Global Governance 223, 230-31 (Sampson, Gary P. ed., 2001)Google Scholar.

33 World Health Organization (WHO), Investing in Health Research and Development: Report of the Ad Hoc Committee on Health Research Relating to Future Intervention Options 102 (WHO, 1996).

34 For two critical perspectives on this issue and the industry more generally, see Marcia Angell, The Truth about the Drug Companies: How They Deceive Us and What to Do about It (2004); Merrill Goozner, The $800 Million Pill: The Truth Behind the Cost of New Drugs (2004).

35 As James Le Fanu puts it:

[t]he pharmaceutical industry has also had no alternative, in the absence of new and lucky drug discoveries, other than to keep hammering away. This takes several forms of which the most obvious is the ‘better mousetrap’ – new and more costly variants of drugs already available. These may well be ‘better’ in the sense of being easier to take and having fewer side-effects, but they are no more effective therapeutically, Alternatively, when there is no effective remedy for a disease the drug companies have adopted the ‘useless mousetrap’ on the grounds that patients and relatives want to be doing ‘something’. Thus new drugs for Alzheimer's and multiple sclerosis are increasingly widely prescribed even though their efficacy is scarcely detectable.

James Le Fanu, The Rise and Fall of Modern Medicine 396 (1999).

36 Moynihan, Ray & Henry, David, The Fight Against Disease Mongering: Generating Knowledge for Action, PLoS Medicine, Apr. 2006, at 425CrossRefGoogle Scholar; see also Ray Moynihan & Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies are Turning us all into Patients (2005); Lynne Payer, Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick (1992).

37 See Dutfield, Life Science, supra note 15, at 25-26.

38 Sell, Susan K., Private Power, Public Law: The Globalization of Intellectual Property Rights 55–56 (2003)CrossRefGoogle Scholar.

39 See the TRIPS Agreement, supra note 18.

40 Id. art. 27.1.

41 Id.

42 Trebilcock, Michael J. & Howse, Robert, The Regulation of International Trade 430 (3d. ed. 2005)Google Scholar.

43 This is particularly well evidenced by the annual Special 301 Reports of the Office of the United States Trade Representative. 301 Reports dating back to 2002 are available on the website of the Office of the U.S. Trade Representative at http://www.ustr.gov/Document_Library/Reports_Publications/Section_Index.html. See generally Office of the U.S. Trade Representative, 2007 Special 301 Report (2007), available at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2007/2007_Special_301_Review/asset_upload_file230_11122.pdf.

44 See Matthews, Duncan, Globalising Intellectual Property Rights: The TRIPS Agreement 18–19 (2002)CrossRefGoogle Scholar; Sell, supra note 38, at 48-49; Drahos, Peter, Global Property Rights in Information: The Story of TRIPS at the GATT, Prometheus, June 1995, 6–7CrossRefGoogle Scholar.

45 Graham Dutfield, ‘To Copy is to Steal’: TRIPS, (Un)free Trade Agreements & the New Intellectual Property Fundamentalism, 1 J. Info. L. & Tech. (Special Issue) 1 (2006), http://www2.warwick.ac.uk/fac/soc/law/elj/jilt/2006_1/dutfield/dutfield.pdf.

46 The basis for such an argument is Article 12 of the International Covenant on Economic, Social and Cultural Rights:

The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

  • (a) the provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

  • (b) the improvement of all aspects of environmental and industrial hygiene;

  • (c) the prevention, treatment and control of epidemic, endemic, occupational and other diseases;

  • (d) the creation of conditions which would assure to all medical service and medical attention in the event of sickness.

International Covenant on Economic, Social, and Cultural Rights, Dec. 16, 1966, 993 U.N.T.S. 4, 8.

47 Keith Bradsher, Bayer Agrees to Charge Government a Lower Price for Anthrax Medicine, N.Y. Times, Oct. 25, 2001 at B8.

48 Id.

49 Correa, Carlos M., Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, in Negotiating Health: Intellectual Property and Access to Medicines 81, 91 (Roffe, Pedro, Tansey, Geoff & Vivas-Eugui, David eds. 2006)Google Scholar [hereinafter Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products].

50 See Matthews, supra note 44, at 115.

51 Id.

52 See id. According to a key World Bank publication of the time, “while it may be a heavy dose of regulation, South Africa's law is probably consistent with TRIPS.” The World Bank, Global Economic Prospects and the Developing Countries 2002: Making Trade Work for the World's Poor 138 (The World Bank, 2001).

53 But having made this point, drug companies can be very creative and aggressive in using legal means to prevent generic producers from entering the market even when the patents protecting the drug have expired. See Dutfield, Life Science, supra note 15, at 109-11.

54 Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, § 101(B)(ii), 98 Stat. 1585, 1586 (1984) (codified as amended at 21 U.S.C. § 355).

55 Id.

56 Council Directive 2004/27, art. 10, 2004 O.J. (L 136) 34 (EC).

57 Id.; Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products, supra note 49, at 94; Meir Perez Pugatch, Intellectual Property, Data Exclusivity, Innovation and Market Access. in Negotiating Health: Intellectual Property and Access to Medicines, supra note 49, at 97, 101-10.

58 TRIPS Agreement, supra note 18, art. 39.3.

59 Id.

60 Id.

61 Id. art. 39.1.

62 UNCTAD-ICTSD, Project on IPRs and Sustainable Development: Resource Book on TRIPS and Development 531 (2005).

63 Id.

64 United States-Chile Free Trade Agreement, U.S.-Chile, art. 17.10.1, Jan. 1, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Bilateral/Chile_FTA/Final_Texts/asset_upload_file912_4011.pdf. [hereinafter U.S.-Chile FTA].

65 Id.

66 Central America-Dominican Republican Free Trade Agreement, art. 15.10.1, May 28, 2004, available at http://www.ustr.gov/assets/Trade_Agreements/Regional/CAFTA/CAFTADR_Final_Texts/asset_upload_file934_3935.pdf. [hereinafter DR-CAFTA].

67 Id.

68 Id.

69 For more detailed explanations of the data protection-related problems with US-DR-CAFTA and other FTAs, see Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products, supra note 49; Frederick Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreement, (Quaker United Nations Office, Occasional Paper No. 14, 2004), available at http://www.quno.org/geneva/pdf.economic/Occassional/TRIPS-Public-Health-FTAs.pdf.

70 Christopher Garrison, Exceptions to Patent Rights in Developing Countries, Issues Paper 17, UNCTAD-ICTSD Project on IPRs and Sustainable Development (2006).

71 TRIPS Agreement, supra note 18, art. 31(b)

72 Curiously this clause is rarely discussed in debates on access to medicines. The reason may be that many developing countries have deficient competition regulations.

73 Scherer, F.M. & Watal, Jayashree, The Economics of TRIPS Option for Access to Medicines, in The Economics of Essential Medicines 32, 37–38 (Granville, B. ed. 2002)Google Scholar.

74 World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746, (2002) available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf. [hereinafter the Doha Declaration].

In November 2005, the TRIPS Council extended the deadline for LDCs to fully implementing TRIPS by a further seven and a half years to 1 July 2013. Press Release, World Trade Organization, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), available at http://www.wto.org/English/news_e/pres05_e/pr424_e.htm.

75 Doha Declaration, supra note 74, ¶ 5(b).

76 Id. ¶ 5(c).

77 Id. ¶ 5(d).

78 This is known as “international exhaustion.” It may be contrasted with “national exhaustion” according to which rights are exhausted only in the case of first sale in that country. With national exhaustion regimes, parallel importation is not permitted. Fredrick M. Abbott, Parallel Importation: Economic and social welfare dimensions 5 (2007), http://www.iisd.org/pdf/2007/parallel_importation.pdf.

79 See TRIPS Agreement, supra note 18, art. 28.

80 Decision by the General Council for TRIPS, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 (Aug. 30, 2003), available at http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm

81 Id. ¶ 1(b).

82 Id. ¶ 2.

83 Id. ¶ 2(a).

84 Id. ¶ 2(b).

85 Id. ¶ 3 (emphasis added).

86 Id. at n. 3.

87 Id. ¶ 6(i).

88 Decision by General Council for TRIPS, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 6, 2005), available at http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm

89 As of 20 Feb. 2008.

90 Communication from Rwanda's Government for the Treatment & Research on AIDS (TRAC), Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/9/RWA/1 (July 19, 2007), available at http://docsonline.wto.org/DDFDocuments/t/IP/N/9RWA1.doc.

91 Id.

92 See Rwanda and Canada: Leading the Implementation of the August 2003 Decision for Import/Export of Pharmaceuticals Produced Under Compulsory License, Intell. Prop. Q. Update, Third Quarter 2007, at 5, available at http://www.ciel.org/Publications/IP_Update_3Q07.pdf.

93 See id. at 5-7.