Basic Survival Needs and Access to Medicines - Coming to Grips with TRIPS: Conversion + Calculation

Journal of Law, Medicine and Ethics

Volumn 38, Issue 3, 2010, Pages 520-549

  Van Puymbroeck, Rudolf V ^a  

^a GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ESSENTIAL DRUG;

ARTICLE; BRAZIL; COMMERCIAL PHENOMENA; DEVELOPING COUNTRY; DRUG INDUSTRY; ECONOMICS; HEALTH CARE DELIVERY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; LEGAL ASPECT; PATENT; PHILIPPINES; THAILAND; WORLD HEALTH ORGANIZATION;

ANTI-HIV AGENTS; BRAZIL; COMMERCE; DEVELOPING COUNTRIES; DRUG INDUSTRY; DRUGS, ESSENTIAL; HEALTH SERVICES ACCESSIBILITY; HIV INFECTIONS; HUMANS; INTERNATIONAL COOPERATION; PATENTS AS TOPIC; PHILIPPINES; THAILAND; WORLD HEALTH ORGANIZATION;

EID: 77957239460     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00510.x     Document Type: Article

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127. 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.
128. Arunmas Phusadee. Pharma Amps Up Pressure on Thailand, Bangkok Post. January 31, 2008, ip-health@lists.essential.org, posted by Robert Weiss-man, Essential Medicines, to <> on January 31, 2008
129. ip-health@lists.essential.org, 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 <> on February 15, 2008
130. Silverman E. Thailand Minister to Review Compulsory Licensing. http://www.pharmalot.org/2008, Pharmalot,, last visited on November 19, 2009
131. Business Groups Seek to Engage New Thai Ministry on Compulsory Licensing. ip-health@lists.essential.org, BNA WTO Reporter, February 20, 2008, at A-11, posted by Sarah Rimmington, Essential Action, to <> on February 20, 2008
132. http://www.keionline.org,ip-health@lists.essential.org, The mission produced a report " Improving Access to Medicines in Thailand: The Use of TRIPS Flexibilities" (, 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 Sara Rimmington, to <> on February 20, 2008) but the former Minister of Public Health was not so sanguine (M. Na Songkla, " Health Before Profits? Learning from Thailand's Experience," 373, no. 373 (February 7, 2009): at 441-442
133. 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. ip-health@lists.essential.org, Bangkok), February 21, 2008, posted by Sarah Rimmington, to <> on February 20, 2008
134. Heart Pills Supply Cut, Indian company Stops Exports over Confusion with Govt Policy," ip-health@lists.essential.org, (Thailand), February 22, 2008, posted by Robert Weissman, to <> on February 22, 2008
135. Thai Chief Drug Price Negotiator Removed from Post,": Reuters. February 26, 2008, ip-health@lists.essential.org, posted by Sarah Rimmington, to <> on February 26, 2008
136. Head of Thailand's FDA Resigns After One Week,": Associated Press. March 3, 2008, ip-health@lists.essential.org, posted by Judit Rius Sanjuan, to <> on March 3, 2008
137. Treerutkuarkul A. Health Ministry to Push for Discounts,": Bangkok Post. March 8, 2008
138. Sarnsamak P. Health Minister Does a Licensing About-Turn As Pressure Mounts,": The Nation (Bangkok). March 12, 2008, ip-health@lists.essential.org, P. Sarnsamak, " Soliciting of Signatures to Remove Health Minister Continues," (Bangkok), March 12, 2008, posted by Sarah Rimmington, to <> on March 13, 2008
139. Ashayagachat A. USTR: No CL Complaint," Bangkok Post. March 8, 2008, ip-health@lists.essential.org, posted to <>, March 7, 2008
140. Cancer Patients' Lifeline, Chaiya Backs Down on Licensing,": The Nation. March 11, 2008, ip-health@lists.essential.org, posted by Robert Weissman, to <> on March 10, 2008
141. Thailand Says Will Keep Generic Drugs for Cancer Treatment,": AFP (Bangkok). March 11, 2008, ip-health@lists.essential.org, posted by Sarah Rimmington, Essential Action, to <> on March 13, 2008
142. 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, note 220
143. Thai Health Minister to Maintain Compulsory Licenses Issued by Country," http://www.kaisernetwork.org, March 12, 2008, Kaiser Network,, last visited June 25, 2010
144. Gauri V, Beyrer C, Vaillancourt D. From Human Rights Principles to Public Health Practice: HIV/AIDS Policy in Brazil," Public Health and Human Rights: Evidence-Based Approaches 2007, 289. Beyrer C, Pizer H F, in, Baltimore, Johns Hopkins University Press, at
145. Le Loup G, Pereira de Assis A, Costa-Couto M H, Thoenig J-C, Fleury S, Rochel de Camargo K, Larouzé B. The Brazilian Experience of 'Scaling-up': A Public Policy Approach," The Political Economy of HIV/AIDS in Developing Countries: TRIPS, Public Health Systems and Free Access 2008, 114. Coriat Benjamin, in, Cheltenham, Edward Elgar, at
146. ; Between 1996 and 2002, mortality dropped by 70 percent and morbidity by 80 percent, with a 70 percent decrease in hospitalizations. C. de Albuquerque Possas, " Compulsory Licensing in the Real World: The Case of ARV Drugs in Brazil," in Coriat, note 228, at 152
147. Biehl J. Pharmaceutical Governance," Global Pharmaceuticals: Ethics, Markets, Practices 2006, 210. Petryna ALakoff AKleinman A. in, Durham, and, London, Duke University Press, at
148. Cardoso F Henrique. The Accidental President of Brazil: A Memoir 2006, 214. New York, Public Affairs, at
149. 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 January 2009, 99(no. 1). at 30; see Le Loup et al., note 228, at 108
150. Constitutions of the Countries of the World, Vol. III, The Federative Republic of Brazil 2008, Art. 196, Oceana, Oxford University Press, hereinafter Constitution of the Federative Republic of Brazil
151. , 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, note 165, at 45
152. Condon, Sinha. See, note 189, at 38-39; M. Auxiliadora Oliveira and A. Esher, " Acesso Universal ao Tratamento para as Pessoas Vivendo com HIV e AIDS no Brasil," in J. A. Z. Bermudez, M. Auxiliadora Oliveira, and A. Esher, [Access to Medicines: Fundamental Right, Role of the State] (Brazil: ENSP/OPS/OMS-Fiocruz, Ministerio de Salud 2004): at 233-250
153. Condon, Sinha. See, note 189, at 39; Possas, note 229, at 152; Biehl, note 231, at 214-216; Le Loup et al., note 228, at 114
154. " 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, note 231, at 219
155. See Possas, 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. P. Drahos, " Negotiating Intellectual Property Rights: Between Coercion and Dialogue," in Drahos and Mayne, note 48, at 171
156. Oliveira Auxiliadora, Chaves Costa, Epsztejn. See, note 50, at 153
157. , 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, note 229, at 155
158. 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. ., at 228
159. Cassier M, Correa M. Scaling-Up and Reverse Engineering: Acquisition of Industrial Knowledge by Copying Drugs in Brazil," in Coriat, note 228, at 132-135
160. Brazil - Measures Affecting Patent Protection. http://www.wto.org, WTO, WT/DS199/1, dated June 8, 2000,, last visited June 25, 2010
161. But Brazil had to commit that in the future it would hold talks with the U.S. government prior to granting compulsory licenses: Brazil - Measures Affecting Patent Protection: Notification of Mutually Agreed Solution. http://www.wto.org, WTO, WT/DS/199/4, dated July 19, 2001, last visited June 25, 2010
162. Ford N, Wilson D, Chaves G Costa, Lotrowska M, Kijtiwatchakul K. Sustaining Access to Antiretroviral Therapy in the Less-Developed World: Lessons from Brazil and Thailand," AIDS 2007, 21(suppl. 4):521-529.
163. Oliveira. http://docsonline.wto.org, See, 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 , WT/DS 114/R, March 17, 2000,, last visited June 25, 2010
164. Possas. See, note 229, at 156. The four drugs were: efavirenz (Merck), nelfinavir (Roche), lopinavir/ritonavir (Abbott), and tenofovir (Gilead)
165. Ford. See, note 271, at S26. More than one-third of all Brazilian patients on antiretroviral treatment use efavirenz in their treatment regime. Open Society Institute, (July 2008): at 19
166. 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 2007, 4(no. 11):1804-1816. at 1804
167. Playing by the Rules: Using Intellectual Property Law and Policy to Improve Access to Essential Medicines. 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, supra note 278
168. PITC asks IPO to Cancel Pfizer's Patent on Drug,": Manila Bulletin. May 9, 2007, http://www.pitc.gov.ph/archives/ipo_cancel.html, Another source reported the importation of only 80 samples. B. Cahile-Magkilat, last visited June 25, 2010
169. U.S. Court of Appeals for the Federal Circuit, Case 2006-1261. Pfizer, Inc. v. Apotex, Inc., decided March 22, 2007, (last visited March 1, 2009). The Court invalidated the patent on grounds of obviousness (lack of inventive step in TRIPS terminology, TRIPS Agreement, note 43, at Art. 27.1, footnote 5
170. Acosta R, de Leon M. http://www.pitc.gov.ph/archives/1st_salvo.html, Government Fires First Salvo in Big IP Case vs. Pfizer, May 9, 2007,, last visited June 25, 2010
171. http://www.senate.gov.ph/republic_acts/, 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,, last visited March 1, 2009
172. http://www.senate.gov.ph/lis/bill_res.aspx?congress=14&q=SBN-1658, State of the Phillippines, 14th Congress, Senate Bill No. 1458,, last visited June 25, 2010
173. 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)
174. On the average, essential medicines are available in less than 35 percent of public sector outlets. See text " The Facts on the Ground."
175. 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."
176. Figures are for 2007. See text " The Facts on the Ground."
177. Closing the Gap in a Generation: Health Equity Through Action on the Social Determinants of Health. 2008, WHO, Commission on Social Determinants of Health, at 102 [hereinafter
178. See, Constitution of the Federative Republic of Brazil, note 238, at Arts. 196 and 198
179. To critics of globalization, the fight over intellectual property is a fight over values." See Stiglitz, note 117, at 105
180. WHO Medicines Strategy 2008-2013. http://www.who.int, See, Draft 8, June 13 2008, at 5,, last visited June 25, 2010
181. 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); , OHCHR and WHO, Fact Sheet No. 31 (June 2008); H. V. Hoherzeil, M. Samson, and J. Vidal Casanova, WHO, 2004; H. V. Hoherzeil, M. Samson, and J. Vidal Casanova, WHO EDM Series No. 14 (2003); and H. Nygren-Krug, WHO, Health & Human Rights Publication Series Issue No. 1 (July 2002)
182. http://www2.essex.ac.uk/human_rights_centre/rth/,http://www.ohchr.org, 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,, and, both last visited June 25, 2010
183. http://www.who.int, WHA61.21 dated 24 May 2008 and Annex,, last visited June 25, 2010
184. 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, note 11, at 13
185. Correa C M. Pro-competitive Measures Under TRIPS to Promote Technology Diffusion in Developing Countries," See also, in, P. Drahos and R. Mayne, eds., note 48, at 40-42; Global Economic Prospects 2002, note 89, at 139-144; J. D. Sachs, (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." )
186. Global Economic Prospects 2005. See, supra note 126, at 111; note 89, at 147-148; Fink and Maskus, note 124, at 13; Report of the Commission on Intellectual Property Rights, Innovation and Public Health, note 11, at 126