Basic Survival Needs and access to Medicines — Coming to Grips with TRIPS: Conversion + Calculation

UN Office for the Coordination of Humanitarian Affairs, Togo: Moving Past HIV , January 22, 2009, Irinnews website, at 1, available at <http://www.irinnews.org> (last visited June 23, 2010) [hereinafter cited as Togo: Moving Past HIV].

UN Office for the Coordination of Humanitarian Affairs, Togo: Haphazard Supply of AIDS Drugs Endangers Lives , December 5, 2007, Irinnews website, at 1, available at <http://www.irinnews.org> (last visited June 23, 2010) [hereinafter cited as Togo: Haphazard Supply of AIDS Drugs Endangers Lives].

See Togo: Moving Past HIV, supra, note 1, at 1.

See Togo: Haphazard Supply of AIDS Drugs Endangers Lives , supra, note 2, at 1. See generally Gostin L. O. , “Meeting the Survival Needs of the World's Least Healthy People: Toward a Framework Convention on Global Health,” Georgetown Law Journal. 96, no. 2 (January 2008): 364–374.

UN Office for the Coordination of Humanitarian Affairs, Togo: ARVs Free, and in Stock, At Last, January 21, 2009, Irinnews website, at 1, available at <http://www.irinnews.org> (last visited June 23, 2010).

See, e.g., England R. , “Are We Spending Too Much on HIV?” BMJ 334, no. 7589 (February 17, 2007): At 344, and Garrett L. , “The Challenge of Global Health,” Foreign Affairs 86, no. 1 (January/February 2007): 14–38. But cf. Farmer P. , “Intelligent Design,” Foreign Affairs 86, no. 2 (March/April 2007): 155–159.

United Nations Conference on Trade and Development, The Least Developed Countries Report 2008, at xii, United Nations, 2008.

The World Bank classifies economies for operational and analytical purposes on the basis of gross national income (GNI) per capita as follows: Low income (2007 GNI/capita of US$935 or less) and middle income (2007 GNI/capita of US$11,455 or less). Within the latter category, a distinction is made between lower-middle income (US$936-US$3,705) and upper-middle income (US$3,706-US$11,455). The World Bank's classification is updated annually. World Bank, “Country Classification,” available at <http://web.worldbank.org/wbsite/external/datastatistics> (last visited December 5, 2008) [hereinafter World Bank].

Data P. , “New Cancer Drugs Can Work Wonders, but Who Can Afford Them?” Times of India, October 23, 2008, at 1, posted by Ramos J. , Cancer Resources & Advocacy, to <ip-health@lists.essential.org> on October 28, 2008.

2,200,000 to be exact, <http://www.google.com> (last visited June 23, 2010).

WHO, Public Health, Innovation and Intellectual Property Rights 11–12, Report of the Commission on Intellectual Property Rights, Innovation and Public Health, 2006 [hereinafter Report of the Commission on Intellectual Property Rights, Innovation and Public Health]; Committee on Economic, Social and Cultural Rights, General Comment No. 14 (2000): The Right to the Highest Attainable Standard of Health (art. 12 of the International Covenant on Economic, Social and Cultural Rights), available at <http://www.ohchr.org> (last visited June 23, 2010) [hereinafter Committee on Economic, Social and Cultural Rights].

See Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra, note 11, at 1112.

See MDG Gap Task Force, Delivering on the Global Partnership for Achieving the Millennium Development Goals , Preface, available at <http://www.un.org/esa/policy/mdggap> (last visited June 23, 2010) [hereinafter MDG Gap Task Force].

Id., at 35.

UNDP, “Millennium Development Goals: A Compact among Nations to End Human Poverty,” Human Development Report 2003 (Oxford and New York: Oxford University Press, 2003): At 3.

See MDG Gap Task Force, supra, note 13, at 35.

Id. These indicators were developed by WHO to measure progress on Strategic Objective 11 of its medium-term strategic plan (“To ensure improved access, quality and use of medical products and technologies”), see Appendix to Access to Affordable Essential Medicines (available at <http://www.un.org/esa/policy/mdggap>).

Now known as Knowledge Ecology International (www.keionline.org).

WHA Resolution 54.11 (2001), available at <http://www.who.int> (last visited June 23, 2010). WHO/Health Action International, Measuring Medicine Prices, Availability Affordability and Price Components, 2nd ed., 2008 [hereinafter WHO/HAI].

Id., at sections 1.2.1 through 1.2.3.

General Assembly Resolution S-26/2, annex, para 20, available at <http://www.un.org/ga> (last visited June 23, 2010).

WHO/UNAIDS/UNICEF, “Toward Universal Access: Scaling Up Priority HIV/AIDS Interventions in the Health Sector,” Progress Report 2008, WHO, 2008, at 11 [hereinafter WHO/UNAIDS/UNICEF].

See WHO and Committee on Economic, Social and Cultural Rights, supra, note 11.

See WHO/UNAIDS/UNICEF, supra, note 22, at 9.

Id., at 15–35. More detailed information on prices is available from MSF, “Untangling the Web of Antiretroviral Price Reductions,” 11th ed., July 2008 (updated periodically, latest update January 27, 2009), available at <www.msfaccess.org> (last visited June 23, 2010).

See MDG Gap Task Force, supra, note 13, at 35.

See, e.g., Gostin L. O. , Public Health Law: Power, Duty, Restraint (Berkeley: University of California Press, The Milbank Memorial Fund, 2008): At 270–283; see Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra, note 11, at 9–11. See also Hestermeyer H. , Human Rights and the WTO: The Case of Patents and Access to Medicines (New York: Oxford University Press, paperback edition 2008): 76–136.

See MDG Gap Task Force, supra, note 13, at 35.

Id., at 42.

WHO has issued a Model List, which is periodically updated, available at <http://www.who.int/medicines/publications/essentialmedicines/en/index.html> (last visited June 23, 2010) [hereinafter WHO Model List of Essential Medicines]. It is composed of a “core list” of minimum medicines needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions and a “complementary list” for which specialized facilities, care, or treatment are necessary. A medicine may also be listed on the complementary list because of higher cost or lower cost-effectiveness considerations.

See MDG Gap Task Force, supra, note 13, at 36.

See, generally WHO, “Medicines Policy,” available at <http://www.who.int/medicines/areas/policy/en/index.html> (last visited June 23, 2010).

See MDG Gap Task Force, supra, note 13, at 42.

Id., at 41.

Id., at 36–37.

Id., at 38–39. The international reference price for a product is typically the median generic price for medicines offered to low-income and middle-income countries by non-profit suppliers and international tender prices. See Cameron A Ewen M. Ross-Degnan D. Ball D. Laing R. , “Medicines Prices, Availability, and Affordability in 36 Developing and Middle-Income Countries: A Secondary Analysis,” The Lancet Online, December, 1, 2008, at 3, available at <www.thelancet.com> (last visited June 23, 2010).

See Gap Task Force, supra, note 13, at 39.

See WHO/HAI, supra, note 19, section 1.2.3. The survey results are available at <http://www.haiweb.org/medicineprices> (last visited June 23, 2010).

See Cameron , supra, note 36, at 1.

Id., at 1 (emphasis added).

Id., at 9.

Id.

The TRIPS Agreement is Annex 1C to the Agreement Establishing the World Trade Organization, annexed to the Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, signed at Marakkesh, Morocco, on April 15, 1994. The agreement is available at <http://www.wto.org> (last visited June 23, 2010) [hereinafter TRIPS Agreement].

Primo Braga C. A. , Trade-Related Intellectual Property Issues: The Uruguay Round Agreement and Its Economic Implications 32, 45–47, paper presented at the Uruguay Round and the Developing Economies, a World Bank conference, January 26–27, 1995; copy on file with the author.

WHO, “IPR, Innovation, Human Rights and Access to Drugs: An Annotated Bibliography,” WHO, Health Economics and Drugs, EDM Series No. 14 (2001).

A Google search for “TRIPS, access to medicines” yielded over eight million entries (8,220,000 to be exact) (last visited March 10, 2009).

“…patents shall be available for any inventions, whether products or processes, in all fields of technology ….” See TRIPS Agreement, supra, note 43, at Art. 27.1 (emphasis added). Besides patents, the TRIPS Agreement sets standards for copyright (and related rights), trademarks, geographical indications, industrial designs, and lay-out designs of integrated circuits. It also lays down standards, within the context of unfair competition, for protection of certain undisclosed information and for control of anticompetitive practices in contractual licenses, and with respect to measures to control anticompetitive practices in contractual licenses. See TRIPS Agreement, Part II (Sections 1 through 8).

Sell S. , Private Power, Public Law: The Globalization of Intellectual Property Rights (Cambridge, U.K.: Cambridge University Press, 2003): At 12; see also, e.g., Correa C. M. , Trade Related. Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement (New York: Oxford University Press, 2007): At 271; Khor M. , “Rethinking Intellectual Property Rights and TRIPS,” in Drahos P. Mayne R. , eds., Global Intellectual Property Rights: Knowledge, Access and Development (Hound-smills, U.K.: Palgrave McMillan and New York: Oxfam, 2002): 151–213, at 205–206; see Braga Primo , supra, note 44, at 32.

See Correa , supra, note 48, at 271; Sell , supra, note 48, at 49–50 and 96–120.

See Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra, note 11, at 84 (India); Auxiliadora Oliveira M. Costa Chaves G. Epsztejn R. , “Brazilian Intellectual Property Legislation,” in Bermudez J. A. Z. Auxiliadora Oliveira M. , Intellectual Property in the Context of the WTO TRIPS Agreement: Challenges for Public Health (Brazil: ENSP/WHO – Oswaldo Cruz Foundation – FIOCRUZ – Jorge AZ. Bermudez, 2004): 151–160, at 152.

See TRIPS Agreement, supra, note 43, at Art. 27.1. For a detailed explanation of patentable subject matter, see Correa , supra, note 48, at 271–281.

See TRIPS Agreement, supra, note 43, at Art. 28.

Id., at Art. 33.

Id., at Art. 29.1.

Id.

Id., at Art. 29.2.

WHO defines a generic drug as a pharmaceutical product “usually intended to be interchangeable with the innovator product, which is usually manufactured with a license from the innovator company and marketed after expiry of the patent or other exclusivity rights.” WHO, Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for a Drug Regulatory Authority 35, 1999. WHO prefers the term “multisource pharmaceutical product” over the term “generic product” in order to avoid confusion as there is no universally agreed upon definition of the term “generic.” Id. See also Section I.B (“The role of generic medicines”) in Abbott F. M. , “The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO,” Journal of International Economic Law 5, no. 2 (2002): 469–505. A concise overview is provided in Gable L. Gamharter K. Gostin L. O. Hodge J. G. Jr. Van Puymbroeck R. V. , Legal Aspects of HIV/AIDS: A Guide for Policy and Law Reform 189–91, World Bank, 2007.

See TRIPS Agreement, supra, note 43, at Art. 31 (b).

Id., at Art. 31 (a) (“authorization for such use shall be considered on its individual merits”).

Id., at Art. 31 (b).

Id.

“A Gathering Storm. Drugs Companies' Patents Are Under Attack. Will This Really Help the Poor?” The Economist, June 9, 2007, at 71.

See TRIPS Agreement, supra, note 43, at Art. 31 (f).

Id. The EU regulation on the Doha Declaration Paragraph 6 decision (see text infra) also requires prior efforts to obtain a voluntary license, but specifies that the period can be as short as 30 days. Regulation (EC) No. 816/2006 of the European Parliament, available at <http://europaeu/scadplus/leg/en/lvb/I21172.htm> (last visited November 22, 2008).

Doha Declaration on the TRIPS Agreement and Public Health, para 5(b), WTO document WT/MIN(01)/DEC/2, available at <http://www.wto.org> (last visited June 23, 2010).

The British terminology for a government-use authorization is “Crown use.” Tayler Y. , ed., Battling HIV/AIDS: A Decision Maker's Guide to the Procurement of Medicines and Related Supplies (Annex B: Intellectual Property Rights: How They Affect Procurement and What Steps Can Be Taken), World Bank, Washington D.C., 2004, at 119.

See TRIPS Agreement, supra note 43, at Art. 31(d).

Id., at Art. 31(h).

Id., at Art. 3l(i), (j).

Id., at Part III (Articles 41–61).

See Braga Primo , supra, note 44, at 27.

Criminal sanctions may be applied with respect to patents but are not required. See TRIPS Agreement, supra note 43, at Art. 61.

Id., at Art. 42, footnote 11.

While this was not a WTO Dispute Settlement case, the lead plaintiff in the famous, or, rather, infamous South Africa Medicines Act case (PMA and others versus President of South Africa and others, High Court of South Africa, Transvaal Provincial Division, Case No. 4183/98) was the Pharmaceutical Manufacturers Association of South Africa (In this lawsuit the pharmaceutical industry sought to overturn legislation that would have allowed, among other things, parallel importing under the doctrine of international exhaustion of intellectual property rights. After considerable local and international pressure, the industry eventually withdrew the suit.)

See TRIPS Agreement, supra, note 43, at Part II, Section 7, Art. 39.

“For the purposes of this Agreement, the term ‘intellectual property’ refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.” Id., at Art. 1.2.

The TRIPS Agreement requires WTO members to comply with Articles 1 through 12 and Article 19 of the Paris Convention. Id., at Art. 2.1.

Correa C. M. , Protection of Data Submitted for the Registration of Pharmaceuticals (South Centre, in collaboration with WHO, 2nd edition, 2004): At 1–3.

Id., at 6–7; see Correa, supra, note 48, at 374. It may be noted that two important pieces of earlier U.S. legislation that provide for periods of marketing exclusivity as an incentive/reward for pharmaceutical innovation and competition, and that may have served as inspiration for what became Art. 32. 3 of TRIPS, do not rely on an intellectual property argument. Orphan Drug Act, Pub. L. No. 97–414, codified, at 21 U.S.C. Sec. 360aa et seq.; Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), PUB. L. No. 98–417, codified as amended at 21 U.S.C. Secs. 355 and 360cc and 35 U.S.C. Secs. 156, 271, 272.

Correa C. M. , Integrating Public Health Concerns into Patent Legislation in Developing Countries 7 et seq., (South Centre, 2000): At 7; Musungu S. F. Villaneuva S. Blasetti R. , Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks, South Centre, Geneva 2004.

See WTO document WT/MIN(01)/DEC/2, supra, note 65. While this declaration is commonly referred to as the Doha Declaration, it should not be confused with the Ministerial Declaration adopted on November 14, 2001 at Doha, Qatar launching the Doha Round of Multilateral Trade Negotiations (also referred to as the Doha Development Round), WTO document WT/MIN(01)/DEC/1, available at <http://www.wto.org> (last visited June 23, 2010).

See Doha Declaration on the TRIPS Agreement and Public Health, supra, note 65, para 5(b).

Id., at para 5 (c).

Id., para 5 (d).

Id., at para 4.

A detailed look at the struggle and accomplishments of the developing countries in the work leading up to the Doha Declaration, and a commentary on the Declaration's provisions, is provided in Abbott , supra, note 57.

See TRIPS Agreement, supra, note 43, at Art. 1.1 The same sub-article also recognizes that members may provide “more extensive protection than is required by this Agreement,” in other words, that the TRIPS standards are minimum standards and that countries may, but are not required, to adopt higher standards of protection.

Id., at Art. 27.1.

World Bank, Global Economic Prospects 2002: Making Trade Work for the World's Poor , 2002, at 141 [hereinafter Global Economic Prospects 2002].

See authorities cited supra, note 80; Correa , supra, note 48.

See TRIPS Agreement, supra, note 43, at Art. 27.2.

Id., at Art. 27.3(a).

Id., at Art. 27.3(b). (But plant varieties must be able to be patented or be protected by a sui generis system, or a combination of the sui generis system and the patent system.)

See Correa , supra, note 48, at 302–311.

TRIPS Agreement, supra, note 43, Art. 7 (“Objectives”).

See Correa , supra, note 48, at 99–101; see, generally Hestermeyer , supra, note 27, at 76–136 and 207–292.

Macroeconomics and Health: Investing in Health for Economic Development (WHO: Report of the Commission on Macroeconomics and Health, 2001): 21–29.

Nussbaum M. C. , Women and Human Development: The Capabilities Approach (Cambridge, U.K.: Cambridge University Press, 2000): At 78; Sen A , Development as Freedom (New York: Alfred A Knopf, 1999): At 49.

Daniels N. , Just Health: Meeting Health Needs Fairly (New York: Cambridge University Press, 2008): At 30.

Dworkin R. , Sovereign Virtue: The Theory and Practice of Equality (Cambridge: Harvard University Press, 2002): At 6.

See Correa , supra, note 48, at 103.

Id., at 103–110.

Id., at 112.

Id., at 111. Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy (October 2003), available at <www.ftc.gov>. (last visited June 23, 2010).

Hazel Tau et al. v. GlaxoSmithKline South Africa (PTY) Ltd. et al., In the Competition Commission of South Africa (copy of the complaint on file with author); Callahan D. Wasunna A. A. , Medicine and the Market: Equity v. Choice (Baltimore: Johns Hopkins University Press, 2004): At 193.

Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, August 30, 2003, WTO document IP/C/W/405, available at <http://www.wto.org> (last visited June 23, 2010).

See Doha Declaration on the TRIPS Agreement and Public Health, supra, note 65, para 6.

For fuller information on the decision and how to implement it, see Abbott F. M. Van Puymbroeck R.V. , 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, 2005) and Abbott F. M. , “The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health,” American Journal of International Law 99, no. 2 (April 2005): At 317–358.

Tremblay J.-F. , “Supplying Drugs to the World's Poor: WTO Process Enables Poor Countries to Get Patented Drugs at Reduced Prices, But It's Seldom Used,” Chemical & Engineering News, April 28, 2008, at 32.

See <http://www.wto.org> (last visited June 24, 2010).

The average GDP/capita of Thailand, Brazil, and the Philippines in 1994 was US$2,309. Author's calculation with data from The Complete World Developments Reports 1978–2009 , World Development Indicators Database, DVD, World Bank 2009.

World Bank, Global Economic Prospects 2008: Technology Diffusion in the Developing World (“Nurturing technological adaptive capacity”), 2008, at 127–142.

Pursuant to Art. 65.4 of the TRIPS Agreement, developing countries were not required to apply the substantive patent provisions to pharmaceutical products until January 1, 2005. Under paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, Least-Developed Countries were granted another extension until January 1, 2016.

See Global Economic Prospects 2002, supra note 89, at 134.

See Khor , supra note 48, at 206.

See Sell , supra note 48, at 13.

Stiglitz J. E. , Making Globalization Work (New York: W.W. Norton & Company, 2007): At 105.

Id.

See Global Economic Prospects 2002, supra note 89, at 133 (Table 5.1).

Finger J. M. , The Doha Agenda and Development: A View from the Uruguay Round , Asian Development Bank, Washington, D.C., 2002, at 14, available at <http://www.adb.org> (last visited June 24, 2010); see Global Economic Prospects 2002, supra note 89, at 133.

See Global Economic Prospects 2002, supra note 89, at 147.

Id., at 136.

Id. Up-front costs to upgrade intellectual property protection systems were estimated by the World Bank at US$1.5 to US$2 million in 2002, with indications that they could be far higher. Id.

Fink C. Maskus K. E. , eds., Intellectual Property and Development: Lessons from Recent Economic Research (New York and Washington, D.C.: Oxford University Press and World Bank, 2005): At 2–3.

Id., at 2.

See Global Economic Prospects 2002, supra note 89, at 129–150, at Chapter 5, “Intellectual Property: Balancing Incentives with Competitive Access”; World Bank, Global Economic Prospects 2005: Trade, Regionalism, and Development , 2005, at 97–111.

See Global Economic Prospects 2005, supra note 126, at 111. See also Maskus K. E. , Intellectual Property Rights in the Global Economy , Institute for International Economics, 2000, at 235–241.

See Stiglitz , supra, note 117, at 105–117; Grinols E. L. Henderson J. W. , “Replace Pharmaceutical Patents Now,” Pharmacoeconomis 25, no. 5 (2005): 355–363.

Boldrin M. Levine D. K. , Against Intellectual Monopoly 68 (New York: Cambridge University Press, 2008): At 68.

Id., at 69–70.

PhRMA, Press Release, May 14, 2007, available at <http://www.phrmaorg/news_room/press_releases> (last visited December 10, 2008).

See TRIPS Agreement, supra, note 43, at Art. 31.

Scherer and Watal point out that: (1) the U.S. Department of Defense used to procure patented pharmaceuticals under government-use licenses during the 1950s and 1960s at substantially reduced prices from producers, such as Italy, that did not provide patent protection for pharmaceuticals; and (2) that the United States leads the world in judicial grants of compulsory licenses to restore competition upon breaches of the antitrust laws (or in the negotiated settlement of these cases). Scherer F. M. Watal J. , “Post-TRIPS Options for Access to Patented Medicines in Developing Nations,” Journal of International Economic Law 5, no. 4 (2002): 913–939, at 916.

Attaran and Gillespie-White make the same point with respect to AIDS drugs: “The economics and profitability of antiretroviral drug research (unlike that of, say, malaria) are driven by consumption of drugs by AIDS patients in the lucrative North American and European markets.” Attaran A Gillespie-White L. , “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?” JAMA 286, no. 15 (October 17, 2001): 1886–1892, at 1890.

See Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra note 11, at 15.

IMS Global Pharmaceutical and Therapy Forecast for 2009, released October 29, 2008, available at <http://www.imshealth.com> (last visited June 24, 2010).

As Boldrin and Levine note, the question really is: How much profit is “enough”? See Boldrine Levine , supra note 129, at 70. Boldrine and Levine's discuss relevant factors at 212–242 (“The Pharmaceutical Industry”).

Global Forum for Health Research, The 10/90 Gap (on file with author).

Id.

Report of the Commission on Intellectual Property, Innovation and Public Health, supra note 11, at 70–78; see generally Reich M. R. , ed., Public-Private Partnerships for Public Health (Cambridge: Harvard University Press, 2002): 1–18.

Grubb P. W. , Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy, 4th ed. (Oxford: Oxford University Press, 2004): At 47.

See Attaran Gillespie-White , supra note 134, at 1886.

Attaran A , “How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?” Health Affairs 23, no. 3 (2004): At 155–166.

Médecins Sans Frontières, Drug Patents Under the Spotlight, 2003, at 23 [hereinafter MSF].

Id.

Id., at 7 (“Case study: Patents may hamper the development of new fixed dose combinations”).

See WHO Model List of Essential Medicines, supra note 30.

See Making Globalization Work, supra note 117, at 128.

WTO, Handbook on Accession to the WTO, available at <http://www.wto.org> (last visited June 24, 2010).

Deere C. , The Implementation Game: The TRIPS Agreement and the Global Politics of Intellectual Property Reform in Developing Countries (Oxford: Oxford University Press, 2009): At 155–156; See generally Abbott F. M. Correa C. M. , World Trade Organization Accession Agreements: Intellectual Property Issues , Quaker United Nations Office, 2007, available at <http://www.quno.org> (last visited June 24, 2010).

WTO, Report of the Working Party on the Accession of Cambodia, para 204, WTO Doc. WT/ACC/KHM/21, August 15, 2003, available at <http://www.wto.org> (last visited June 24, 2010) [hereinafter Report of the Working Party on the Accession of Cambodia]. “Working party Completes Cambodia's Membership Negotiation,” WTO News, July 23, 2003, available at <http://www.wto.org/english/news> (last visited January 29, 2009). Cambodia became a member on October 14, 2004. At the time of Cambodia's formal accession to membership the WTO Deputy Director-General issued a statement confirming that the country, as a Least-Developed Country, would have access to the benefits of the Doha Declaration on the TRIPS Agreement and Public Health. See Abbott Correa , supra note 150, at 7. Subsequently, Cambodia passed a law to apply the January 1, 2016 deadline as granted under the Doha Declaration. Oxfam International, How the Law of the Jungle Is Applied to One of the World's Poorest Countries, June 14, 2004, available at <http://www.ngoforum.org.kh/development/docs/Cambodia> (last visited March 16, 2009) [hereinafter Oxfam International]. See also Deere , supra, note 150, at 155.

See Report of the Working Party on the Accession of Cambodia, supra note 151, para 205.

See generally Oxfam International, supra note 151.

Available at <http://www.ustr.gov> (last visited June 24, 2010).

Smith R. D. Correa C. Oh C. , “Trade, Trips, and Pharmaceuticals,” The Lancet Online 373, no. 373 (January 22, 2009): 684–691; Fink C. Reichmiller P. , “Tightening TRIPS: Intellectual Property Provisions of U.S. Free Trade Agreements),” in Newfarmer R. , ed., Trade, Doha, and Development: A Window into the Issues , World Bank, 2006.

For example, the agreements with the Central American countries, Morocco, and Bahrain.

See Fink Reichmiller , supra note 155, at 291. See also Abbott F. , The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements , Quaker United Nations Office, Occasional Paper 14, available at <http://www.quno.org> (last visited June 24, 2010).

Available at <http://www.ustr.gov> (last visited June 24, 2010).

See also KEI Statement on IPR/Health Aspects of Bipartisan “New Trade Policy,” May 14, 2007, available at <http://www.keionline.org> (last visited June 24, 2010).

Wilson D. Cawthorne P. Ford N. Aongswang S. , “Global Trade and Access to Medicines: AIDS Treatments in Thailand,” The Lancet 354, no. 354 (November 27, 1999): At 1894.

Kwa A , Dying for Free Trade, available at <http://www.twnside.org.sg/title/twr131o.htm> (last visited June 24, 2010).

Id.

Id.

Id.

't Hoen E. F.M. , The Global Politics of Pharmaceutical Monopoly Power (AMB Publishers 2009): At 23, available at <www.mfsaccess.org> (last visited June 24, 2010).

Id.

Id., at 24. Another source puts the then-monthly cost of the Pfizer product at US$136. See Wilson , supra, note 160, at 1894.

Thailand's GNI/capita was US$2,120 in 1998. See Word Development Indicators Database, supra, note 111.

See Wilson , supra, note 160, at 1893.

See MSF, Patents Under the Spotlight, supra, note 144, at 20.

See Wilson , supra, note 160, at 1894; MSF, supra, note 144, at 20.

Id.

Ford N. Wilson D. Bunjumnong O. von Schoen Angerer T. , “The Role of Civil Society in Protecting Public Health over Commercial Interests: Lessons from Thailand,” The Lancet 363, no. 363 (2004): 560–563, at 560.

See 't Hoen , supra, note 165, at 24.

Id.

See MSF, Patents in the Spotlight, supra, note 144. BMS's formulation patent was later declared invalid by the Thai Central Intellectual Property and International Trade Court. Id. ('t Hoen), supra, note 165, at 24.

See Ford , supra, note 173, at 560.

See Wilson , supra, note 160, at 1894.

Id.

Didanosine together with zidovudine formed the standard duotherapy. Revenga A Over M. Masaki E. Peerapatanapokin W. Gold J. Tangcharoensathien V. Thanprasertsuk S. , The Economics of Effective AIDS Treatment: Evaluating Policy Options for Thailand (World Bank, 2006): At 28.

Id., at 31.

Id., at 41.

Id., at 42. Public budgetary resources accounted for 65 to 80 percent of HIV/AIDS expenditures during the period 2000–2003. Id.

See 't Hoen , supra note 165, at 47.

See Revenga , supra note 180, at 169.

“Bangkok,” Washington Post , December 1, 2006 at A25; Love J. P. , Recent Examples of Compulsory Licensing of Patents , KEI Research Note 2007:2, at 12, available at <www.keiaccess.org> (last visited March 3, 2009). Steinbrook R , “Thailand and the Compulsory Licensing of Efavirenz,” New England Journal of Medicine 356, no. 6 (February 8, 2007): 544–546. The text of the government-use license is available at <www.cptech.org/ip/health> (Announcement of the Department of Disease Control, Ministry of Public Health, Thailand on the Public Use of patent for Pharmaceutical Products, November 29, 2006).

MSF, “The Battle for Lopinavir/Ritonavir,” Access News, at 4, available at <www.msfaccess.org>.

See 't Hoen , supra, note 165, at 47.

Condon B. J. Sinha T. , Global Lessons from the AIDS Pandemic: Economic, Financial, Legal and Political Implications (Heidelberg, Germany: Springer, 2008): At 51.

See 't Hoen , supra note 165, at 47–48. Abbott did not patent and register Aluvia in Thailand so as to avoid a compulsory license on its patent for the superior product. Condon, supra n. 189, at 51. The text of the licenses is available at <www.cptech.org/ip/health> (Decree of Department of Disease Control, Ministry of Public Health, Regarding Exploitation of Patent on Drugs & Medical Supplies by the Government on Combination Drug between Lopinavir & Ritonavir, January 29, 2007; Ministry of Public Health Announcement Regarding Exploitation of Patents on Drugs and Medical Supplies for Clopidogrel, January 25, 2007).

See 't Hoen , supra, note 165, at 49; USTR Special 301 Report 2007, GPO 2007.

Scheutter D. , “Abbott Excludes Thailand from New Drugs,” Reuters, March 14, 2007, available at <http://www.actupny.org/reports/abbottgreed.html> (last visited June 25, 2010); see MSF, The Battle for Lopinavir/Ritonavir, supra, note 187, at 4. Avoiding the need for refrigeration is a major advantage in a hot or tropical country. In the cited publication, MSF gives the example of a woman named Somying who lives in the slums of Bangkok. Too poor to be able to afford the purchase of a refrigerator, Somying must buy ice each day to prevent her AIDS medicines from spoiling in the heat. It costs her one quarter of her monthly budget.

Jinks B. Amin H. , “Thailand Buying Three Generic AIDS, Heart Drugs from India,” Bloomberg, June 22, 2007, available at <http://www.bloomberg.com/apps/news> (last visited August 21, 2007).

Id.

See t'Hoen , supra note 165, at 49.

Letter from U.S. Ambassador to Thai Prime Minister on Compulsory Licenses, provided by Kannikar Kijtiwatchakul (August 22, 2007), MSF Belgium-Thailand Mission, to <ip-health@lists.essential.org> on August 22, 2007.

See 't Hoen , supra note 165, at 49; The Director-General reportedly called Health Minister Mongkol to assure him of the legitimacy of his actions. ten Kate D. , “Thailand's Drug-Company Stare-Down Faces an Uncertain Future,” The Asia Sentinel, November 23, 2007, posted by Sarah Rimmington, Essential Action, to <ip-health@lists.essential.org> on November 25, 2007.

See 't Hoen , supra note 165, at 49–50.

Letter made available by Alexandra Heumber, MSF EU Liaison Officer, to <ip-health@lists.essential.org> on September 10, 2007.

Id. ACT UP, AIDS Activists Confront Magic Johnson at Abbott Forum, available at <http://www.actupny.org/reports/abbottgreed.html> (last visited June 25, 2010).

Thai civil society joins forces with international NGOs to denounce the EU Trade Commissioner and the U.S. Ambassador for their interference in Thailand's CL decision (reporting on a joint press conference given on August 22, 2007 by the Thai Network of People Living with HIV/AIDS, the Social Network for Cancer Patients, AIDS Access Foundation, Foundation for Consumers, MSF, and OXFAM), posted by Kannikar Kijtiwatchakul, MSF Belgium-Thailand Mission, to <ip-health@lists.essential.org>, August 22, 2007; Oxfam-MSF Joint Letter to Commissioner Mandelson on Thailand CL Issue, August 27, 2007, made available by Alexandra Heumber, MSF, to <ip-health@lists.essential.org> on August 27, 2007.

Letter dated June 20, 2007 (on file with author).

Treerutkuarkul A , “Talks with Pharma-Giants collapse, CL Seems a Certainty,” Bangkok Post, December 18, 2007, posted by Weissman Robert , Essential Action, to <ip-health@lists.essential.org> on December 19, 2007.

The Ministry of Public Health and The National Health Security Office (Thailand), The 10 Burning Questions on the Government Use of Patents on the Four Anti-Cancer Drugs in Thailand, at 2, February 2008, available at <http://www.cptech.org/ip/health/c/thailand> (last visited June 25, 2010).

Id., at 3.

The four cancer medicines were: Docetexel, sold by Sanofi-Aventis under the brand name Taxotere; letrozole, sold by Novartis under the brand name Femara; imatinib, sold by Novartis under the brand name Glivec; and erlotinib, sold by Roche under the brand name Tarceva Id.

Id.

Id., at 5

Id., at 5–6.

Phusadee Arunmas, Pharma Amps Up Pressure on Thailand, Bangkok Post, January 31, 2008, posted by Robert Weissman, Essential Medicines, to <ip-health@lists.essential.org> on January 31, 2008.

Letter from Lila Feisee, Managing Director Intellectual Property, Biotechnology Industry Organization to Jennifer Choe Groves, Office of the United States Trade Representative (February 11, 2008), posted by Thiru Balasubramaniam, KEI to <ip-health@lists.essential.org> on February 15, 2008.

Silverman E. , Thailand Minister to Review Compulsory Licensing , Pharmalot , available at <http://www.pharmalot.org/2008> (last visited on November 19, 2009).

Business Groups Seek to Engage New Thai Ministry on Compulsory Licensing, BNA WTO Reporter, February 20, 2008, at A-11, posted by Sarah Rimmington, Essential Action, to <ip-health@lists.essential.org> on February 20, 2008.

The mission produced a report “Improving Access to Medicines in Thailand: The Use of TRIPS Flexibilities” (available at <www.keionline.org>) that provided general statements on methods to improve access to medicines but did not directly evaluate the government's recent actions. Some commentators saw it as an endorsement of government policy (“Industry Publication Reports That WTO Says Thai's Patent Policy Is Legal,” posted by Rimmington Sara , Essential Action, to <ip-health@lists.essential.org> on February 20, 2008) but the former Minister of Public Health was not so sanguine ( Na Songkla M. , “Health Before Profits? Learning from Thailand's Experience,” The Lancet 373, no. 373 (February 7, 2009): At 441–442.

Pratruangkrai P. Sarnsamak P. , “US on Verge of Legal Action, Thai Officials Say They Are Ready If Washington Takes Case to the WTO,” The Nation (Bangkok), February 21, 2008, posted by Rimmington Sarah , Essential Action, to <ip-health@lists.essential.org> on February 20, 2008.

“Heart Pills Supply Cut, Indian company Stops Exports over Confusion with Govt Policy,” The Nation (Thailand), February 22, 2008, posted by Weissman Robert , Essential Action, to <ip-health@lists.essential.org> on February 22, 2008.

“Thai Chief Drug Price Negotiator Removed from Post,” Reuters, February 26, 2008, posted by Rimmington Sarah , Essential Action, to <ip-health@lists.essential.org> on February 26, 2008.

“Head of Thailand's FDA Resigns After One Week,” Associated. Press, March 3, 2008), posted by Sanjuan Judit Rius , Knowledge Ecology International, to <ip-health@lists.essential.org> on March 3, 2008.

Treerutkuarkul A , “Health Ministry to Push for Discounts,” Bangkok Post, March 8, 2008.

Sarnsamak P. , “Health Minister Does a Licensing About-Turn As Pressure Mounts,” The Nation (Bangkok), March 12, 2008; Sarnsamak P. , “Soliciting of Signatures to Remove Health Minister Continues,” The Nation (Bangkok), March 12, 2008, posted by Rimmington Sarah , Essential Action, to <ip-health@lists.essential.org> on March 13, 2008.

Ashayagachat A , USTR: No CL Complaint,” Bangkok Post, March 8, 2008, posted to <ip-health@lists.essential.org>, March 7, 2008.

“Cancer Patients' Lifeline, Chaiya Backs Down on Licensing,” The Nation, March 11, 2008, posted by Weissman Robert , Essential Action, to <ip-health@lists.essential.org> on March 10, 2008.

“Thailand Says Will Keep Generic Drugs for Cancer Treatment,” AFP (Bangkok), March 11, 2008, posted by Sarah Rimmington, Essential Action, to <ip-health@lists.essential.org> on March 13, 2008.

Id.

The Chairman of the Rural Doctors Society is reported to have declared after the policy reversal by the Health Minister that his organization could collect the necessary 200,000 signatures within two weeks and that he intended to continue the drive to oust the Health Minister. See Sarnsamak , supra note 220.

“Thai Health Minister to Maintain Compulsory Licenses Issued by Country,” March 12, 2008, Network Kaiser , available at <www.kaisernetwork.org> (last visited June 25, 2010).

Gauri V. Beyrer C. Vaillancourt D. , “From Human Rights Principles to Public Health Practice: HIV/AIDS Policy in Brazil,” in Beyrer C. Pizer H. F. , eds., Public Health and Human Rights: Evidence-Based Approaches (Baltimore: Johns Hopkins University Press, 2007): At 289.

Le Loup G. Pereira de Assis A. Costa-Couto M. H. Thoenig J.-C. Fleury S. Rochel de Camargo K. Jr. Larouzé B. , “The Brazilian Experience of ‘Scaling-up’: A Public Policy Approach,” in Coriat Benjamin , ed., The Political Economy of HIV/AIDS in Developing Countries: TRIPS, Public Health Systems and Free Access (Cheltenham: Edward Elgar, 2008): At 114.

Id.; Between 1996 and 2002, mortality dropped by 70 percent and morbidity by 80 percent, with a 70 percent decrease in hospitalizations. de Albuquerque Possas C. , “Compulsory Licensing in the Real World: The Case of ARV Drugs in Brazil,” in Coriat , supra note 228, at 152.

See 't Hoen , supra note 165, at 44–45.

Biehl J. , “Pharmaceutical Governance,” in Petryna A. Lakoff A. Kleinman A. , eds., Global Pharmaceuticals: Ethics, Markets, Practices (Durham and London: Duke University Press, 2006): At 210.

Henrique Cardoso F. , The Accidental President of Brazil: A Memoir (New York: Public Affairs, 2006): At 214.

Id. In fact, in 2002, about 600,000 people were infected. Id., at 17.

See Biehl , supra note 231, at 209.

Id., at 210.

Rochel de Camargo K. , “Celebrating the 20th Anniversary of Ulysses Guimaraes' Rebirth of Brazilian Democracy and Creation of Brazil's Health Care System,” American Journal of Public Health 99, no. 1 (January 2009): At 30; see Le Loup , supra note 228, at 108.

See Le Loup , supra note 228, at 111 and authorities there cited.

Constitutions of the Countries of the World, Vol. III, The Federative Republic of Brazil, Art. 196 (Oceana: Oxford University Press, 2008) [hereinafter Constitution of the Federative Republic of Brazil].

Law 7670 of 1988; see Biehl , supra, note 231, at 211.

Id., at 214. AZT (zidovudine) was the first antiretroviral drug in the treatment of HIV/AIDS. It was off-patent in Brazil and manufactured locally. See 't Hoen , supra note 165, at 45.

See Biehl , supra note 231, at 214.

See Le Loup , supra note 228, at 109.

See Biehl , supra note 231, at 210.

See Le Loup , supra note 228, at110–111; Biehl , supra note 231, at 212–213.

See Condon Sinha , supra note 189, at 38–39; Auxiliadora Oliveira M. Esher A. , “Acesso Universal ao Tratamento para as Pessoas Vivendo com HIV e AIDS no Brasil,” in Bermudez J. A. Z. Auxiliadora Oliveira M. Esher A. , Acceso a Medicamentos: Derecho Fundamental, Papel del Estado [Access to Medicines: Fundamental Right, Role of the State] (Brazil: ENSP/OPS/OMS-Fiocruz, Ministerio de Salud 2004): At 233–250.

See Biehl , supra note 231, at 216.

See Le Loup , supra note 228, at 113.

Id.

See Cardoso , supra note 232, at 214.

Id., at 215.

Id.

See Condon Sinha , supra note 189, at 39; Possas , supra note 229, at 152; Biehl , supra note 231, at 214–216; Le Loup , supra note 228, at 114.

“You provide patent protection in your country, the logic goes, and we, the investors, feel confident in investing there, which translates to more foreign investment and development for you.” See Biehl , supra note 231, at 219.

Id.

See Possas , supra note 229, at 152. In 1987 the U.S. had started an investigation under its trade law into the adequacy of intellectual property rights protections in Brazil with respect to pharmaceuticals which led to the imposition of broad trade sanctions in late 1988. In 1990 the Brazilian president announced that he would comply with U.S. demands for legislative change. Drahos P. , “Negotiating Intellectual Property Rights: Between Coercion and Dialogue,” in Drahos Mayne , supra, note 48, at 171.

See Oliveira Auxiliadora Costa Chaves Epsztejn , supra note 50, at 153.

See Biehl , supra note 231, at 218.

See Oliveira Auxiladora Chaves Costa Epsztejn , supra note 50, at 152.

Id., at 153–155. The cost to the government of the pipeline provision alone has been estimated at US$519 million (compared to the price for the drugs involved paid by MSF) during the period 2001–2007. See Possas , supra, note 229, at 155.

See Possas , supra note 229, at 154.

See Biehl , supra note 231, at 226.

Given the extreme budget stringency and an upcoming devalution, it was the only way of keeping the universal access program going, said the then-Minister of Health. Id., at 228.

See 't Hoen , supra note 165, at 45.

Cassier M. Correa M. , “Scaling-Up and Reverse Engineering: Acquisition of Industrial Knowledge by Copying Drugs in Brazil,” in Coriat , supra note 228, at 132–135.

Id., at 140 et seq.

WTO, WT/DS199/1, Brazil. - Measures Affecting Patent Protection, dated June 8, 2000, available at <www.wto.org> (last visited June 25, 2010).

See Deere , supra note 150, at 166.

See Condon Sinha , supra note 189, at 40.

But Brazil had to commit that in the future it would hold talks with the U.S. government prior to granting compulsory licenses. WTO, WT/DS/199/4, Brazil. - Measures Affecting Patent Protection: Notification of Mutually Agreed Solution, dated July 19, 2001 available at <www.wto.org> (last visited June 25, 2010).

See Cardoso , supra note 232, at 217.

Ford N. Wilson D. Costa Chaves G. Lotrowska M. Kijtiwatchakul K. , “Sustaining Access to Antiretroviral Therapy in the Less-Developed World: Lessons from Brazil and Thailand,” AIDS 21, suppl. 4 (2007): 521–529.

See Oliveira , supra note 256, at 155–156. The regulatory review exception, also referred to as the Bolar exception, permits use of a patented invention in order to prepare a submission to a national regulatory authority. It is allowed under Art. 30 of the TRIPS Agreement. See Canada - Patent Protection of Pharmaceutical Products, WT/DS 114/R, March 17, 2000, available at <http://docsonline.wto.org> (last visited June 25, 2010).

See Ford , supra note 271, at S25.

See Possas , supra note 229, at 156. The four drugs were: Efavirenz (Merck), nelfinavir (Roche), lopinavir/ritonavir (Abbott), and tenofovir (Gilead).

Id.

See Ford , supra note 271, at S26.

Id.; see Possas , supra note 229, at 157.

See Ford , supra note 271, at S26. More than one-third of all Brazilian patients on antiretroviral treatment use efavirenz in their treatment regime. Open Society Institute, Playing by the Rules: Using Intellectual Property Law and Policy to Improve Access to Essential Medicines (July 2008): At 19.

See Ford , supra note 271, at S26.

Id.

See Possas , supra note 225, at 158.

Nunn A Fonseca E. Bastos F. Gruskin S. Salamon J. , “Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment,” PLoS Medicine 4, no. 11 (2007): 1804–1816, at 1804.

Id.

Id.

Unless otherwise noted, the account of Pfizer's misadventure with its patented brand Norvasc in the Philippines is based upon the Open Society's report Playing by the Rules: Using Intellectual Property Law and Policy to Improve Access to Essential Medicines, supra note 278.

Another source reported the importation of only 80 samples. Cahile-Magkilat B. , “PITC asks IPO to Cancel Pfizer's Patent on Drug,” Manila Bulletin, May 9, 2007, available at <http://www.pitc.gov.ph/archives/ipo_cancel.html> (last visited June 25, 2010).

Id.

Pfizer, Inc. v. Apotex, Inc., U.S. Court of Appeals for the Federal Circuit, Case 2006–1261, decided March 22, 2007, available at <cafc.uscourts.gov/opinions/06–1261.pdf> (last visited March 1, 2009). The Court invalidated the patent on grounds of obviousness (lack of inventive step in TRIPS terminology, TRIPS Agreement, supra note 43, at Art. 27.1, footnote 5).

Acosta R. de Leon M. , Government Fires First Salvo in Big IP Case vs. Pfizer , Business Mirror, May 9, 2007, available at <http://www.pitc.gov.ph/archives/1st_salvo.html> (last visited June 25, 2010).

Republic Act No. 9502, An Act Providing for Cheaper and Quality Medicines, Amending for the Purpose Republic Act No. 8293 or the Intellectual Property Code, Republic Act No. 6675 or the Generics Act of 1988, and Republic Act No. 5921 or the Pharmacy Law, and for Other Purposes, available at <http://www.senate.gov.ph/republic_acts/> (last visited March 1, 2009).

State of the Phillippines, 14th Congress, Senate Bill No. 1458, available at <http://www.senate.gov.ph/lis/bill_res.aspx?congress=14&q=SBN-1658> (last visited June 25, 2010).

See Republic Act No. 9502, supra note 290, Sec. 2.

Id., at § 3.

Id., at § 5.

Id., at § 6.

Id., at § 7; Id., at § 8; Id., at § 10.

Id., at §§ 17–30.

E.g., strengthening of the Bureau of Food and Drugs and of quality assurance standards (§§ 31, 32), facilitation of generic prescription (Sec. 38), required production of unbranded generic counterparts of locally produced branded drugs (Sec. 39), and a drive to educate the public about generic drugs (§ 40).

On the average, essential medicines are available in less than 35 percent of public sector outlets. See text “The Facts on the Ground.”

Private sector prices are 9 to 25 times higher than international reference prices for lowest-priced generic products and more than 20 times higher than international reference prices for originator products. See text “The Facts on the Ground.”

See WHO/HAI, supra note 19, § 1.1.

See text “The Facts on the Ground.”

Id.

Figures are for 2007. See text “The Facts on the Ground.”

See World Bank, supra note 8.

See MSF, supra note 25, at 5–6.

See Cameron , supra note 36.

WHO, Commission on Social Determinants of Health, Closing the Gap in a Generation: Health Equity Through Action on the Social Determinants of Health , 2008, at 102 [hereinafter Closing the Gap in a Generation].

See Constitution of the Federative Republic of Brazil, supra note 238, at Arts. 196 and 198.

See Biehl , supra note 231, at 216.

Id., at 211.

“To critics of globalization, the fight over intellectual property is a fight over values.” See Stiglitz , supra note 117, at 105.

SEe Biehl , supra note 231, at 216.

See WHO Medicines Strategy 2008–2013, Draft 8, June 13 2008, at 5, available at <http://www.who.int> (last visited June 25, 2010).

See Closing the Gap in a Generation, supra note 310, at 139.

Taking its direction from the second preambular clause of its constitution (“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”), WHO has done consistently fine and pioneering work in the application of human rights thinking to health. Among relevant recent publications are: Human Rights, Health and Poverty Reduction Strategies, WHO and OHCHR, Health and Human Rights Publications Series, Issue No. 5 (December 2008); The Right to Health, OHCHR and WHO, Fact Sheet No. 31 (June 2008); Hoherzeil H. V. Samson M. Vidal Casanova J. , Ruling for Access: Summaries of Leading Court Cases on Access to Essential Medicines as Part of the Fulfillment of the Right to Health , WHO, 2004; Hoherzeil H. V. Samson M. Vidal Casanova J. , IPR, Innovation, Human Rights and Access to Drugs: An Annotated Bibliography, WHO EDM Series No. 14 (2003); and Nygren-Krug H. , 25 Questions & Answers on Health & Human Rights, WHO, Health & Human Rights Publication Series Issue No. 1 (July 2002).

See Gostin , supra note 27, at 278.

Contributions of these organizations have been noted throughout this essay. The body of work of Paul Hunt, the former Special Rapporteur for the Right to Health, should also be noted, available at <http://www2.essex.ac.uk/human_rights_centre/rth/> and <http://www.ohchr.org> (both last visited June 24, 2010).

WHA61.21 dated 24 May 2008 and Annex, available at <http://www.who.int> (last visited June 25, 2010).

See Biehl , supra note 231, at 225.

See 't Hoen , supra note 165, at 45.

See Biehl , supra note 231, at 216.

Type I diseases are diseases that are incident in both high-income and low-income countries, affecting a sizeable number in both sets of countries; Type II diseases are also incident in rich and poor countries, but a substantial proportion of the cases are in the low-income countries. See Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra note 11, at 13.

See Stiglitz , supra note 117, at 105–123.

See also Correa C. M. , “Pro-competitive Measures Under TRIPS to Promote Technology Diffusion in Developing Countries,” in Drahos P. Mayne R. , eds., supra note 48, at 40–42; Global Economic Prospects 2002, supra note 89, at 139–144; Sachs J. D. , The End of Poverty (New York: Penguin Books, 2006): At 62 (“The innovation gap is one of the most fundamental reasons why the richest and the poorest countries have diverged, and why the poorest have not managed to get a foothold on growth.”).

See Global Economic Prospects 2005, supra note 126, at 111; Global Economic Prospects 2002, supra note 89, at 147–148; Fink Maskus , supra note 124, at 13; Report of the Commission on Intellectual Property Rights, Innovation and Public Health, supra note 11, at 126.