Cambridge University Press Medicines Edited by Thomas ...assets.cambridge.org/97805211/16565/index/9780521116565_index.pdf · Banda, Chikosa, 128 n. 111, 160 Bangladesh, right to

INDEX

Abbott, Frederick, 14–15, 412 n. 24Abbott Laboratories, 13, 126, 355, 402,

406, 409, 423Abramowicz, Michael, 195, 196access to essential medicines

causes of problem, 4–6, 136–43non-patent related obstacles, 112

Clinton presidency and, 336–7compulsory licensing. See

compulsory licensingDoha Declaration, 113–14Gates Foundation and, 326, 330non-state actors and. See NGOsoff-patent pharmaceutical drugs,

115–16, 148patent issues, 113–14, 139–43, 265–9

poverty, 135, 155patented pharmaceutical drugs

competition from generics, 117compulsory licensing, 119–25limiting patentability, 127neglected diseases, 128–30parallel imports, 117, 118–19reform, 116–27, 143–8

prizes. See prize systemreform

See also specific optionsHIF. See Health Impact Fundinitiatives, 111–27, 156, 257 n. 117options, 177–9, 313

responses to health crisis, 138–9right to health and. See right to

healthTRIPS effect, 113–14, 139–43

counterfeiting, 141, 152excessive marketing, 141, 152–3,

185–6

high prices, 139–40, 151–2,169–70

last-mile problem, 141–2, 153maintenance drugs bias, 140, 152neglected diseases, 139, 152Thai dispute, 413–21wastefulness, 140–1, 152, 185–6

voluntary licensing, See voluntarylicensing

access to genetic resources,284–311 n. 179

access to knowledge (A2K), 15, 17,102, 109, 110, 157, 274, 278,344 n. 5, 356

Access to Medicine Foundation, 316Access to Medicine Index, 316, 328accountability 38, 55, 88, 98, 99, 131,

229, 305, 320, 323, 330, 331,337, 338, 343 n. 3, 354, 355, 385

Achmat, Zackie, 30, 354, 370ACT UP, 337, 343, 354, 355administrative law, xvii, 55, 64, 95,

98, 106, 106 n. 17, 112, 156,199, 201, 260, 292, 293,296, 408

global, xvii, 55, 106 n. 17, 156, 292,293, 296, 408

advance market commitments, 129,147, 149, 178, 205, 283, 330

advance purchase schemes, 239,283, 330

African Group, 109agriculture 53, 248, 287, 304AIDS. See HIV/AIDSAIDS Law Project, 355 n. 44AIM, 320Ali, Muhammed, 321

486

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Allarakhia, Mina, 272Alliance for Cell Signaling, 274Alternative Law Forum, 391Aluvia, 402American Express, 320amicus curiae, 30, 365, 366, 379Amprenavir, 402Amyris Biotechnologies Inc., 279anthrax, 350antiretrovirals. See HIV/AIDSAPEC, 54Apotex, 351Appellate Body, 36, 46Apple Inc., 317, 320Aranha, Graça, 17Argentina, 16–17, 98, 108, 108 n. 19,

110 n. 28, 395Asongu, J. J., 319Aspen PharmaCare, 335AstraZeneca, 126, 402Australia

AIDS demonstrations, 370NGOs, 352Pharmaceutical Benefits Scheme,

223–5, 227springboarding exemption, 10 n. 35TRIPS Waiver and, 12WTO disputes, 213

Australia–United States Free TradeAgreement (AUSFTA), 81, 88,223–5

Australian Research Council, 154avian influenza virus

genetic resource, 286–8patents, 13sharing, 284–5TRIPS regime, 298WHO and, 300–8

assessment, 308–12compromise agreement, 305–8

AZT, 3 n. 12, 398, 399, 401 n. 60

Bahrain–United States Free TradeAgreement, 82, 88

Baker, Brook, 27Baker & McKenzie, 409, 412Bamako Initiative, 373 n. 47Banda, Chikosa, 128 n. 111, 160

Bangladesh, right to health, 383Barré-Sinoussi, Françoise, 1–3Basheer, Shammad, 389 n. 26bazaar governance, 265, 279Bedingfield, Natasha, 322Belgium, 398benefit sharing, 284–311 n. 179Benkler, Yochai, 45Berkeley, Seth, 334, 337Beyer, Peter, 247bilateral agreements. See free trade

agreementsbiochemicals, 287bioequivalence testing, 43–4,

215, 218bioinformatics 37Bio-Markers Consortium, 283biopiracy, 310BIOS, 264Biotechnology industry, 125, 140,

152, 154, 221, 238, 264, 265,291, 292, 293, 387, 409

bioterrorism, 10bird flu. See avian flu virusBIRPI, 49BMS, 355 n. 45Bolivia, 22, 110 n. 28Bonn Guidelines, 294–5Bono, 315, 317, 319, 321, 339,

344, 354Boulding, Kenneth, 232Bourdieu, Pierre, 315Bowrey, Kathy, 325Boyle, James, 16Brazil

AIDS demonstrations, 370compulsory licensing, 13, 119, 422Doha Declaration and, 11drug patents disputes, 10Friends of Development,

110 n. 28Glivec International Patient

Assistance Program, 395IPRs and, 37, 51public health v. IPRs 384right to health, 358trade negotiations, 98TRIPS Waiver and, 350

index 487






Brazil (cont.)universal health programme, 415WHO debate, 22WIPO and, 16–17, 108, 108 n. 19

BRICS Alliance, IPR agenda, 13Buffett, Warren, 326, 327, 331BUPA Foundation, 154burden of disease, xix, 5, 126, 135,

196, 193 n. 32, 199, 204, 230,266, 281

Burkina Faso, HIV treatmentprogramme, 399

Burton-MacLeod, Jonathan, 31Bush, George W., 100Buy(Less), 322

Caenorhabditis elegans, 273, 274Caenorhabditis Genetics Center, 273Cambodia, HIV treatment

programme, 399Canada

AZT patent dispute, 3 n. 12Canada – Pharmaceuticals, 10,

43–4, 46compulsory licensing of drugs

Access to Medicine regime, 350–1royalty guidelines, 122TRIPS disputes, 10, 43–4, 46TRIPS Waiver, 12, 69, 121

export licence procedures, 355HIV/AIDS Legal Network, 351, 354Jean Chrétien Pledge to Africa Act

(2004), 419NGOs, 352WHO debate, 22

cancer 1, 120, 128 n. 109, 155, 382, 386,390, 391, 395, 396, 402, 423

Cancer Patients Aid Association,390–1, 395, 396

cardiovascular diseases (heart diseases)18, 31, 120, 128 n. 109, 139 n. 5,155, 331, 417

Carnegie, Andrew, 324CBD. See Convention on Biological

Diversitycelebrities, 315, 320–2, 344Celexa, 184 n. 8Central African Republic, 399

Central American–DominicanRepublic Free Trade Agreement(CAFTA), 79, 81

Chagas, 128 n. 109, 331Chan, Margaret, 19, 129, 210Chandra, Rajshree, 30–1charity 7, 28, 114, 123, 124, 131,

139, 177, 314–39 n. 167, 343 n. 3Chayes, Abram and Antonia, 96chemical industry 80, 105 n. 13, 166,

216, 268 n. 22, 276, 287, 346–7,387, 388 n. 24, 391

Childs, Michelle, 31–2Chile

Chile–United States TradePromotion Agreement, 81, 88

TRIPS and, 54WHO debate, 22WIPO Development Agenda and, 109

China, 22, 47, 51, 98, 281Chirac, Jacques, 2chronic diseases, 417Cipla, 335, 389, 390, 398, 400circuit layout designs, 221clean technologies, 277 n. 45clearing house mechanisms, 236 n. 6, 240climate change, 190 n. 24, 332clinical trials

cost-effectiveness, 228costs, 136, 150, 239funding, 280–1limits, 170open sourcing and, 270, 279protection of data, 172, 280

clinics 6, 361, 363, 372, 375, 414Clinton, Bill, 138, 315, 332–8, 339, 353,

354, 369, 378Clinton Foundation, 28, 29, 267, 315,

316, 332–8, 355, 398Clinton Global Initiative, 335, 338Clinton, Hilary, 337Coalition for Intellectual Property

Rights (CIPR), 103, 107–8,111–12, 120

Codex Alimentarius Commission,51, 53

Cohen, Jon, 326CollabRx, 283

488 index






collusion, 237, 256Colombia

Colombia–US Free TradeAgreement, 82, 89

human rights record, 89right to health, 358WHO debate, 22, 352WIPO and, 109

Combivir, 401 n. 60competition law and policy

cartels 217drug prices and, 354–5Gates Foundation and, 330Patents and, 136–8, 182–3, 214–19,

236, 237patent pools and, 237, 245, 254–9remedies for anti-competitive

conduct 9, 80, 120compulsory licensing

access to essential medicines and,119–25

Canada. See Canadacapacity, 61, 62–4, 121–2circumstances of extreme urgency

60, 62–4, 63, 63 n. 26, 66, 371 n.38, 411, 413

controversy, 119counter-productive effects, 142–3essential medicines, 407–8

chronic diseases, 417defining, 416–17

Health Impact Fund and, 175–6increasing use, 178national emergency 60, 62–4, 63, 63

n. 26, 66, 67, 84 n. 12, 226, 370,371 n. 38, 411, 413, 414, 415,415 n. 35, 416, 417, 418, 419,420, 421

neglected diseases and, 143new normative boundaries, 413–21notification 69, 71, 351, 411, 416Nuffield Council Report, 124–5Paris Convention, 35 n. 3politics of disputes, 422–4public interest, 120public non-commercial use, 9, 60,

66, 411, 412, 414, 414 n. 30, 415,415 n. 34, 417, 420, 421

remuneration (reasonablecommercial terms), 60, 64, 66,84 n. 12, 122, 411

South Africa. See South AfricaThailand. See ThailandTRIPS regime, 9, 13, 40

conditions, 60–1, 120–1, 401–3,410–13

definition of essential medicines,416–17

domestic use, 61, 66–7, 419due process, 410, 411, 415–16government authorization,

60, 143new normative boundaries,

413–21Protocol, 67, 72, 121public non-commercial use,

413–15remuneration, 60, 64state practice and subsequent

interpretation, 418Thai dispute, 413–21

TRIPS Waiver, 176 n. 49, 299capacity, 62–4, 121–2, 407–8Doha Declaration, 11, 62,

176 n. 49LDCs and, 407–8legal status, 64–5Paragraph 6 exception, 62–4,

226–7, 408permanent amendment

alternative, 67practice, 69–72vaccines, 299

US and anthrax, 350WTO General Council Decision of

the 30 August 2003, 63–4avoidance of trade diversion,

64, 71Chairman’s statement and article

31(b), 65–7legal status, 64–5NGO role, 350–1notification condition,

63, 71remuneration, 64specifications, 64

index 489






consensual licensing, 125–7Constitutional Court of South Africa,

364, 364 n. 21, 366 n. 28,368 n. 33

constitutional law, xvii, 10, 13, 19, 29,30, 38 n. 18, 194, 357, 358, 358n. 3, 359 n. 7, 360, 362, 364, 364n. 21, 365–6, 365 n. 25, 366, 366n. 29, 367, 368, 368 n. 33, 369,372, 372 n. 44, 373 n. 45, 376,378–80, 381–99 n. 54

Bangladesh, 383Brazil, 358, 358 n. 6Columbia, 358, 358 n. 6Ecuador, 383Ghana, 358, 360, 372, 372 n. 44, 376,

378–80India, 13, 30, 38 n. 18, 358, 358 n. 6,

359 n. 7, 373 n. 45, 381–99 n. 54South Africa, 30, 358, 360, 364, 364

n. 21, 365–6, 365 n. 25, 366, 366n. 29, 367, 368, 368 n. 33, 369,372, 379, 383, 386

United States, 194, 344 n. 5Venezuela, 383

constitutionalism of WTO regime,77, 164

Consumer Project on Technology(CPTech), 242 n. 30, 350

consumers, 113, 117, 132, 137, 141, 141n. 8, 158 n. 9, 160, 168, 170, 177,178, 182, 188, 218, 219, 230,245, 246, 254, 314, 315, 316,317, 318, 321, 322, 323, 324,328, 329, 338, 339, 355, 376,389, 389 n. 26

contract research organizations,270, 271

Convention on Biological Diversity(CBD)

access and benefit sharingBonn Guidelines, 294–5framework, 292–5

avian flu virus andgenetic resource, 286–8TRIPS/CBD context, 289–92

definition of genetic resources,286–8

negotiations, 289–90objective, 286technology transfer, 289–90, 293–4traditional knowledge, 294

Converse, 317, 320Cook-Deegan, Robert, 271Coombe, Rosemary, 315copyright law, 43, 54, 169corporate governance, 323corporate social responsibility, 29,

125–7, 217, 316, 322–3, 327,329, 397

COSATU, 370cosmopolitanism, 230cost-effectiveness

Australian Pharmaceutical BenefitsScheme, 223–5

bilateral agreements and drugs, 222–5health technology, 211–12

trade agreements, 225–7HTSCEE Agreement, 227–30market fundamentalism and drug

patents, 219–22US drug regulation and, 218–19

Costa Rica, WHO and, 22Costello, Elvis, 321counterfeiting, 141, 152, 210Court of Appeals for the District of

Columbia Circuit, 344 n. 5Court of Appeals for the Federal

Circuit (CAFC), 216, 217CPTech, 242creative capitalism

accountability, 330–1critique, 329–32effect on R&D priorities, 331health outcomes, 330historical debate, 324ideology, 327–9IPRs and, 339–40meaning, 316, 317symbolic capital, 324, 327

Creative Commons, 329cross licensing, 236 n. 6, 240Cruz, Penelope, 315Cuba, 22, 110 n. 28Curtiss, Glenn, 245customs unions, 73

490 index






d4t, 355 n. 45D’Adesky, Anne-Christine, 335, 337DALYs, 193–208, 193 n. 32, 266data protection, 45, 80, 87, 179, 280ddI, 401 n. 60Death Cab for Cutie, 321Dell, 320democracy

decision-making, 97, 206, 354, 360deficit, xix, 78, 86, 89, 94, 95, 96,

100, 229treaty-making, 88, 89TRIPS-Plus agreements and, 86–9,

96–7WTO 38

dengue fever, 193Denmark, 370deregulation, 219designs law, 328 n. 98detention, arbitrary detention, 375–6developed countries, 20, 21, 36, 37, 42

n. 38, 45, 46, 47, 51, 58, 70, 98,103, 104, 105, 106, 106 n. 15,107, 111, 112, 113, 119 n. 66,121, 123, 125, 181, 184, 186,191, 192, 206, 221, 289 n. 30,325, 339, 345 n. 9, 346, 346n. 11, 353, 400, 401 n. 61

diseases affecting, 113, 191economies, 36–7, 45health infrastructure, 103, 112, 325industrialization, 106markets, 126, 346, 400negotiating power, 98, 103, 104,

346 n. 11patent regimes, 42 n. 38, 44, 45, 105,

106 n. 15, 339pharmaceutical industry, 102, 184politics, 206research and development, 20, 37,

121, 123, 181, 192, 206technology transfer, 21trade disputes, 46, 47and TRIPS, 58, 70, 103, 104, 106,

121, 345 n. 9WTO General Council Decision of

30 August 2003, 401 n. 61waiver, 121

developing countries, 7, 8, 11, 15, 16, 18,19, 20, 21, 22, 24, 31, 32, 36, 44,47, 50, 50 n. 68, 50, 51, 55, 56, 57,58, 59, 61, 68, 69, 70, 72, 73, 75,77, 78, 84, 86, 87, 88, 93, 94, 98,100, 103, 104, 104 n. 11, 105n. 11, 106, 107, 108, 109, 110,111, 112, 113–14, 114 n. 44, 115,116, 117, 118, 119, 119 n. 66, 120,121, 123, 124 n. 88, 125, 126, 127,128 n. 109, 128 n. 111, 129, 136,156, 160, 177 n. 53, 181, 182, 183,184, 190, 191, 192, 199, 200, 201,204, 206, 207, 222, 243, 246,248 n. 58, 249, 257, 264, 264 n. 7,267, 268 n. 22, 270, 270 n. 33,271, 272, 279, 293, 298, 300,305, 306, 307, 311, 316, 325, 326,332, 333, 335, 339, 343, 343 n. 3,344 n. 5, 345, 345 n. 9, 346, 346n. 11, 347, 349, 350–1, 352, 353,355, 356, 364, 384, 387, 390, 394,396, 397, 398, 399, 401 n. 61, 407,411, 417, 419

access to essential medicines. Seeaccess to essential medicines

diseases afflicting. See diseases orspecific diseases

identification, 345 n. 9LDCs. See least-developed countriesR&D capacity, 270reasons for agreeing to TRIPS, 6, 104

development,Clinton Foundation and, 335Friends of Development, 109, 110Millennium Development

Goals, 109WIPO Development Agenda. See

WIPOdiabetes, 18, 104 n. 10, 128 n. 109, 155diagnostic testing, 1, 2 n. 4, 6, 22, 40 n.

28, 53, 112, 127, 158, 167, 198,239, 248 n. 58, 280, 296, 297,301, 316, 333

diarrhoea, 5, 154, 217, 219–20differential pricing, 124 n. 88, 177,

177 n. 53, 177 n. 54DiMasi, Joseph, 188, 189, 205

index 491






Dinwoodie, Graeme, 42direct purchasing schemes, 178diseases, 1, 2, 3, 4, 6, 7, 8, 19, 20, 21, 22,

25, 32, 38, 41, 42, 45, 50, 55, 72,85, 100, 112, 113, 116, 117, 123,126, 127, 128 n. 111, 128, 128n. 112, 129, 129 n. 114, 131, 135,136, 137 n. 2, 138, 139, 140, 141,142, 143, 145, 146, 147, 148,150, 152, 153, 154, 155, 158,160, 161, 165, 165 n. 24, 170,170 n. 36, 181, 182, 183, 184,185, 191, 192, 193, 193 n. 32,196, 198, 199, 200, 201, 202,203, 204, 205, 206, 208, 210,212, 217, 219, 230, 231, 235,243, 249, 250, 260, 264, 264 n. 7,266, 267, 268, 268 n. 22, 271,278, 280, 281, 282, 300, 313,314, 316, 317, 321, 325, 326,327, 330, 335, 336, 349, 355, 358n. 2, 382, 384, 390, 396, 416,417, 419

See also specific diseases, such asavian influenza, cancer,cardiovascular diseases,Chagas, dengue fever, diabetes,hepatitis, HIV/AIDS, influenza,influenza A, malaria, measles,neglected diseases,onchocerciasis, SARS, swine flu,trypanosomiasis, tuberculosis,yaws

of developing countries, 7, 8, 22, 23,25, 100, 112, 113, 128, 128 n. 111,128 n. 112, 129, 129 n. 114, 131,136, 139, 145, 152, 184, 201, 243,268, 325, 326, 349, 355

infectious diseases, 1, 2, 3, 72, 113 n.39, 135, 149 n. 15, 170 n. 36,181, 182, 200, 201, 209, 243,250, 314, 316, 382

mortality statistics, 181pandemics, 17, 28, 29, 31, 85,

106, 119 n. 66, 209, 239 n. 18,250, 251, 284, 285, 300, 302,303, 307, 308, 311, 317,323, 372

rare diseases, 200, 202Type I, 4, 18, 20, 28, 128 n. 109Type II, 18, 20, 28, 128 n. 109Type III, 18, 20, 28, 128 n. 109WHO classification, 18

dispute resolutionHealth Impact Fund, 173–4HTSCEE Agreement, 229–30SPS Agreement, 213–14TRIPS, 39WTO system, 46, 213, 229

Dispute Settlement Understanding(DSU), 36

Doctors, 6, 7, 141, 153, 154, 185, 220,317, 343, 370, 375

Doha Declaration on TRIPS and PublicHealth

See also TRIPS Waiveraccess to essential medicines, 113–14compulsory licensing, 411contents, 61–2effect, 13implementing decision (2003),

11–13, 63–4Chairman, statement and article

31(b), 65–7legal status, 64–5NGO role, 350–1scope, 419

interpretation of TRIPS, 299LDCs, 61, 62, 407–8legal status, 64–5milestone, 16, 37NGO role, 350, 370–1overview, 10–11Paragraph 6 exception, 62–4,

226–7, 408US public policy and, 86, 87, 89, 350

Doha Round, failure, 47domestic law, 3, 12, 12 n. 49, 15, 24, 25,

31, 35, 40, 43, 80, 84, 89, 95, 96,99, 100, 104, 120, 130, 172, 220,227, 228, 230, 303, 339, 345,346, 353, 354, 355, 370, 371,373, 378, 385, 401, 411,416 n. 39

Dominican Republic, 110 n. 28Dr Reddy’s, 389

492 index






Dreyfuss, Rochelle C., 23–24, 322due process, 173, 344 n. 5, 409, 410,

411, 415–16, 416 n. 39, 420DVD technology, 246Dylan, Bob, 321

Easterbrook, Frank, 176–7ECOWAS, 74Ecuador, 110 n. 28, 383Edwards, Aled, 271Efavirenz, 401 n. 60, 402, 406, 422Egypt, 110 n. 28, 213Eli Lilly, 402Emcure, 139 n. 5emergencies, 60, 62, 66–7, 69, 411, 413,

414, 416–17, 420eminent domain, 194Emporio Armani, 317, 320environmental hazards, 135, 358 n. 2environmental laws, 212, 213, 361Essential Inventions, Inc., 248European Patent Convention (1973),

165, 166European Patent Office (EPO), 165European Union

Database Directive, 158 n. 8experimental use defence, 9 n. 34geographical indications, 43Health Impact Fund and, 154legitimacy, 95parallel trade regulation, 119 n. 66patent pools and, 240, 256Thai compulsory licensing and, 226,

415, 423–4trade sanctions, 98TRIPS-Plus agreements, 412TRIPS Protocol, 68TRIPS Waiver and, 12WHO and, 23WTO disputes

asbestos, 213beef hormones, 213, 214biotech, 214pine wood nematodes, 213

evergreening, 41–2, 218exhaustion of IPRs, 9, 118experimental use defence, 9,

9 n. 34, 45

Fair trade, 315Faunce, Thomas, 26, 53Feachem, Richard, 317–18Federal Office of Research Integrity, 2Feinstein, Diane, 86financial crisis, 209, 228first sale doctrine, 118 n. 64Fischbaum, Marvin, 194, 195Fisher, William, 26Fleishman, Joel, 330Food and Agriculture Organization

(FAO), 53, 287foreign direct investment, IPR

protection and, 104–5 n. 11foundations, 266

See also specific foundationsFrance, 2, 370Francisco, Andrés de, 266Franck, Thomas, 95–6Frazier, Mya, 323Free Software Foundation, 328free trade agreements

definition, 73drug cost-effectiveness and, 222–5IPR/public health balance and, 131market fundamentalism, 220TRIPS-Plus agreements, 94,

401 n. 61restriction of TRIPS flexibilities,

46 n. 48, 77, 267Thai dispute, 412United States, 12, 46 n. 48, 78–86

TRIPS Waiver and, 72–5Free Trade Area of the Americas

(FTAA), 97freedom to operate (FTO)clearing, 239meaning, 237patent mapping, 251patent pools

assembly, 241horizontal platforms, 239

transaction costs, 237, 251Friends of Development, 109, 110

Gaia hypothesis, 230Gallo, Robert, 1–3GAP, 317, 320, 321

index 493






Gates, Bill, 28, 315, 316, 317, 325–6,327–9, 331–2, 335–6, 339

Gates Foundationaccountability, 330–1AIDS activities, 343Clinton on, 337creative capitalism, 324–32critique, 329–32health outcomes, 330ideology, 327–9motivations, 331–2neglected diseases and, 267personality cult, 315priorities, 331private–public partnerships, 129,

132 n. 123Product Development

Partnership, 279public relations and, 329research funding, 314symbolic capital, 315

Gathii, James, 411GATT, Enabling Clause, 73Gay Mens Health Crisis, 354generic drugs

See also compulsory licensingaccess to, 148Clinton Foundation agreements, 332competition with patented drugs, 117destroying innovation, 144Indian production, 397–400judicial challenges, 140markets, 115–16prices, 399–400springboarding, 218transitional access to, 58–9US TRIPS-Plus agreements and, 87

genetic resourcesaccess and benefit sharing

Bonn Guidelines, 294–5Convention on Biological

Diversity framework, 292–5Standard Materials Transfer

Agreement, 307TRIPS framework, 295–300

bio-piracy, 310Convention on Biological Diversity,

definition, 286–8

influenza virus as genetic resource,286–8

sharing, 285state sovereignty over

CBD, 286, 292, 304WHO, 288, 304, 307

transfer of technology,289–90

value, 308Geneva Declaration on the Future of

WIPO (2004), 15–16, 108geographical indications, 43Germany, 370Gerson, Michael, 354Ghana

compulsory licensing and, 351constitutional right to health,

358, 372user fees, 360, 372–8

legal system, 372manufacturing capacity, 75structural adjustment

programmes, 372World Bank and IMF

policies, 373Gilead Sciences, 402giving philosophy

Clinton Foundation, 332–8critique, 336–8

GlaxoSmithKline, 27, 126, 191,354–5

Glivec, 386, 390–7, 403Glivec International Patient Assistance

Program, 394–7global financial crisis, 209, 228Global Fund for AIDS, Tuberculosis,

and Malaria, 248, 314, 317–18,323, 343, 398

Global Influenza Surveillance Network,285, 298, 309–10

Golden Rice, 246–8Google Inc., 328 n. 98Gore, Al, 337Grabowski, Henry, 191–2, 194Grover, Anand, 402Guell, Robert, 194, 195Guggenheim, David, 324Gurry, Francis, 17, 110

494 index






habeas corpus, 30, 376, 377, 378Haiti, 347Hallmark 291Hamied, Yusuf, 398HapMap, 264, 275Harris, Emmylou, 321Health Action International,

344 n. 4, 350Health Gap, 344 n. 4, 354, 355Health Impact Fund (HIF)

alternative to patent pools, 261better alternative, 176–9compliance issues, 172–6

compulsory licensing response,175–6

dispute resolution, 173–4reduced litigiousness,

174–5contributions, 151, 161description, 148–53, 157–9distributions, 150–1effect

counterfeiting, 152excessive marketing, 152–3last-mile problem, 153maintenance drugs bias, 152neglected diseases, 152prices, 151–2wastefulness, 152

efficiency gains, 149eligibility rules

alternative threshold, 167–8critique, 162–8market authorization alternative,

167–8national patent criteria, 162–5patent prerequisite, 165–7

IPR critique, 156–7compliance, 172–6costs, 161–2eligibility rules, 162–8empirical evidence, 180incentives, 159–61patent system and, 179scope of privilege, 168–72

new IPR, 158Open Source drug discovery

and, 282

option, 130, 353pharmaceutical industry and,

179–80problem, 136–43

counterfeiting, 141, 210excessive marketing, 141high prices, 139–40last-mile problem, 141–2maintenance drugs bias, 140neglected diseases, 139wastefulness, 140–1

reasoning, 143–8scope of privilege, 168–72

duration, 168–9health impact calculation, 170–1price calculation, 169–70residual rights, 171–2

health technologycost-effectiveness

issues, 211–12trade agreements, 225–7

importance, 209WTO–WHO HTSCEE Agreement,

228–32healthcare

efficiency 231equity and inequity, 4, 23, 29, 111,

123, 161, 209, 211, 225, 228,231, 284–311 n. 179, 316, 325,326, 339, 373, 379, 395

public health. See public healthright. See right to healthsafety 25, 26, 114, 125, 166, 172,

181, 193, 198, 199, 204,209–32 n. 68,344 n. 5, 405

Heller, Michael, 334Helms, Jesse, 354Henderson Global Investors,

126 n. 95hepatitis, 18, 402Hetero drugs, 335, 390, 400High Court of Australia, 3High Court of Madras (Chennai), 13,

31, 392, 393, 394, 396, 422High Court of South Africa, 364, 365,

369, 370, 379Hirst, Damien, 321

index 495






HIV/AIDS13th International Conference

(2000), 369–70access to essential medicines, 112

See also specific drugscompulsory licensing, 119,

406–7differential pricing, 124 n. 88IPR issues, 267patent pools, 238, 248–9

Clinton Foundation and,332–7, 343

generic drugs, 116Indian production, 402

Global Fund, 314, 317–18Lazarus Effect, 313, 317national emergencies, 62neglected disease, 18NGOs and, 344, 347–8, 349–52off-patent drugs, 115patent pools, 245(RED) Campaign and, 319, 322,

326 n. 81right to health and, 371South African crisis, 225, 349TAC campaign, 366TriAvir, 69trigger for public health

debate, 106vaccine, 337virus, patent competition, 1–3

Hocking, Barbara, 28Hollis, Aidan, 156, 159–60, 162, 163,

164, 171, 177–8, 197–8, 198–9Holocaust, 206 n. 60Horwitz, Will, 322hospitals, 6, 30, 361, 363, 375, 376, 376

n. 56, 377, 379, 383 n. 7HTSCEE Agreement

dispute settlement, 229–30roadmap, 227–30

Hubbard, Tim, 200–1, 202–3, 204, 207Hughes, Bethan, 283human genome, 271–2human rights

arbitrary detention and, 375–6basic rights, 381discourse, 357–60, 383

enforcement mechanisms, 361health. See right to healthwrongful imprisonment, 377

I-MAK, 402IBM, 276ICESCR, right to health, 90, 99,

358, 373IMF, 220, 372, 373, 378incentives, 3, 7, 8, 19, 20, 21, 23, 28, 36,

38, 41, 55, 70, 102, 124 n. 89,128, 128 n. 111–112, 129, 129n. 114, 130, 132 n. 123, 136, 137,138, 140, 141, 142, 146, 147,148, 149, 150, 152, 153, 156,158, 159, 160, 161, 166, 171,176, 177 n. 54, 179, 181, 182,186, 187, 189, 190, 192, 194,195, 196, 197, 198, 199, 200,202, 204, 214, 215, 227, 231,235, 236 n. 4, 243, 247, 248,253, 261, 262, 265, 273, 276,279, 280, 281, 282, 290, 292,294, 297, 306, 307, 308, 327,328, 343, 346, 353, 367, 397

See also advance marketcommitments, advancepurchase schemes, creativecapitalism, direct purchasingschemes, Health Impact Fund,Open Source drug discovery,patent law, patent pool, PriorityReview, private–publicpartnerships, prize system

economic v. non-economic, 160,179, 247

for collusion, 195for commercialization, 41, 70for conservation and sustainable

use of biological diversity, 292,297, 308

for co-operation, 279for innovation, 28, 138, 177 n. 54,

187, 204, 214, 235, 236 n. 4, 328,343, 367

for investment, 129, 136, 137, 146,158, 160, 189, 328

for litigation, 140, 141, 152

496 index






for management, 70, 253, 262for marketing, 141, 152, 171, 186,

327, 397for Open Source production, 265for research and development, 3, 7, 8,

19, 21, 23, 36, 128, 129, 130, 132 n.123, 146, 150, 156, 160, 161, 166,190, 192, 194, 231, 280, 282, 306

for public health, 19, 38, 142, 147,149, 153, 202, 227, 290

patent rights, 20, 55, 102, 124 n. 89,148, 171, 176, 182, 187, 215,304, 346, 353

Indiaclinical trials, 281compulsory licensing, 120constitutional rights, 372

equality, 391patent law and, 393, 394right to life, 391

Council for Scientific and IndustrialResearch, 281

Doha Declaration and, 11Glivec International Patient

Assistance Program, 396HIV treatment programme, 399IPRs and, 37, 51, 384Network for People Living With

HIV/AIDS, 402patent law, 38, 387–9

2005 Act, 354, 387–9constitutionality, 393, 394effect of change, 145Novartis/Glivec case, 13, 42, 386,

390–7, 403, 422pre-grant oppositions, 355, 392,

402section 3(d), 387–9, 392,

404–5TRIPS compliance, 393use of TRIPS exemptions,

40–2patent office, 30, 390, 392,

393, 402pharmaceutical industry, 7 n. 26, 41

generic drugs, 389, 390,397–400

right to health, 358

case law, 383non-justiciability, 386

trade negotiations, 98TRIPS and

accession, 6, 404disputes, 47TRIPS Waiver, 350

tuberculosis project, 281–2WHO debate, 22WIPO and, 50.

Indonesiaavian influenza virus, 13

discussion, 308–11sharing, 284–5state sovereignty over,

288, 304TRIPS regime, 298WHO compromise agreement,

305–8compulsory licensing, 401 n. 60

industrialization 106infectious diseases

mortality statistics, 181pandemics, 31–2, 209, 250–1, 285WHO classification, 18

influenzaSee also avian influenza virusGlobal Influenza Surveillance

Network, 285, 298, 309–10influenza A, H1N1, (swine flu), 31–2vaccines, 250–1, 301

information technology industry, 110,221, 246, 321, 328

informed consent, 284–311 n. 179infrastructure, 6, 141, 142innovation

See also innovation cycle, researchand development cycle

developing countries and, 38–9IPR balance, 101–2, 236patents system and, 102, 111, 136–8

patent strength relation, 221innovation cycle

Health Impact Fund, discoverystage, 261

patent pools, 238–40delivery stage, 239–40, 245–6,

246–9, 262

index 497






innovation cycle (cont.)development stage, 239discovery stage, 238–9,

249–50, 261public health, 235

Innovation Partnership, The (TIP),248–9, 258

insurance, 112, 123, 141, 141 n. 8, 183,361, 363, 377, 396, 414

Institute for One World Health, 279Intellectual Property Rights. See circuit

layout designs, copyright law,data protection, geographicalindications, patent law, trade-mark law and trade secrets(confidential information)

International Court of Justice, 418International Covenant on Economic,

Social and Cultural Rights(1966) (ICESCR), 90, 99,358, 373

International Criminal Court, 352 n. 34International Dispensary Association,

397, 398International Federation of

Pharmaceutical ManufacturersAssociations (IFPMA), 126

international law, 4, 7, 8, 10, 23, 29, 32,55, 58 n. 5, 77, 78, 85, 86, 89, 90,94, 95, 96, 97, 99, 100, 211, 212,229, 289, 293, 346 n. 11, 360, 361,365, 408, 418, 421 n. 55, 424

fragmentation, 90legitimacy, 94, 95–6public law connection, 3–8

International Law Commission,Koskenniemi Report (2006), 90

international organizations, 8–23See also specific organizations

International Standards Organization, 51Iran, 110 n. 28ISIS Asset Management, 126 n. 95Israel–United States Free Trade

Agreement, 80Italy, 370

Japan, 12, 22, 122, 213Japan Patent Office, 122

Johansson, Scarlett, 315, 322John, Elton, 321Jordan–US Free Trade Agreement, 80

Kaletra, 355, 401 n. 60, 402, 406Kapczynski, Amy, 346–7Katz, Stanley, 324Kefauver Report, 215Kench, Brian, 269, 274–6Kennedy, Edward, 86Kenya, 110 n. 28, 111 n. 33, 370King, Martin Luther, 324Kirby, Michael, 3Klug, Heinz, 29Knowledge Ecology International, 242,

244, 245, 343, 350, 352Knowledge Economy, 37Koch, Ararata, 331Koskenniemi Report (2006), 90–1Krattiger, Anatole, 250Kremer, Michael, 195, 196, 205–6Kyrgyzstan, 399

Lamivudine, 401 n. 60Lamy, Pascal, 13–14Lanjouw, Jenny, 45last-mile problem, 141–2, 148, 153Lawson, Charles, 28lawyers,

cause, 353, 358 n. 3, 359, 363, 374,376, 377, 379 n. 61, 390, 402

company, 415 n. 34, 416intellectual property, 174, 186international, 3, 4, 32, 346 n. 11public, 3, 4, 29trade, 220, 229, 346 n. 11

Lawyers’ Collective, 353, 391, 402Lazarus Effect, 313, 317least-developed countries (LDC), 4,

6, 7 n. 26, 11, 24, 27, 37, 38, 40n. 32, 45, 56, 59, 61, 61 n. 16, 62,63, 69, 72, 73, 74, 75, 105, 106,111, 112, 118, 121, 126 n. 101,138, 143, 145, 267, 293,298, 339, 345 n. 10, 351,371 n. 38, 407, 408

capacities, 61, 62–4, 106, 407–8coalitions, 37

498 index






and Doha Declaration, 11, 56, 61, 62,63, 407

extension of transition period, 62health systems, 6, 126 n. 101markets, 118, 267patent pools 27and regional free trade agreements,

73, 74, 75transition periods, 45, 58TRIPS, 7 n. 26, 24, 39 n. 23, 45,

56, 59, 61, 61 n. 16, 62, 63,69, 72, 75, 105, 293,345 n. 10, 407

Waiver, 72, 121and WTO General Council

Decision of 30 August 2003,63, 69, 72, 339, 351,371 n. 38, 407

Legal Resources Centre, 374–8legitimacy

global IPR system, 112international law, 95–6US TRIPS-Plus agreements, 94–9

input legitimacy, 96–8output legitimacy, 98

leishmaniasis, 193Lerner, Josh, 221Lesotho, 398leukaemia, 390, 395Lewis, Stephen, 334, 354Liddell, Kathleen, 25–6life expectancy, inequalities, 4Lim, Esther, 322Linux, 276Locke, John, 144longitude, 187Love, James, 200–1, 202–3, 204, 207,

245, 330, 354lymphadenopathy (LAV), 1–3

Macpherson, Elle, 315, 322Magaziner, Ira, 335, 355maintenance drugs, 140, 152Make Poverty History, 315Malaria, 5, 11, 38, 62, 72, 112, 113, 116,

128 n. 109, 184 n. 7, 191, 199 n.46, 203, 204, 205, 217, 248 n. 58,250, 251, 266, 278, 279, 298,

322, 323, 326 n. 81, 328, 331,332, 333, 343, 371, 371 n. 38,372, 382, 413

access to essential medicines, 112effect of Gates Foundation on

research, 331generic drugs, 116Global Fund, 314national emergencies, 62neglected disease, 5, 217vaccines, patent pools, 250–1

MalariaGEN, 278Malawi, 399Malaysia, 22, 115 n. 48, 401 n. 60Mandela, Nelson, 226, 415, 424Mandelson, Peter, 409Mann, Jonathan, 191marine resources, 287market fundamentalism, drug patents

and, 219–22marketing, 141, 152–3, 185–6, 318–22Marley, Ziggy, 322Martin, Amy Elizabeth, 320–1, 323–4Maskus, Keith, 119 n. 67Matlin, Stephen, 266Matrix, 335Maurer, Stephen, 281, 330Max Planck Institute, 54May, Christopher, 14‘me-too’ drugs, 141, 185, 193Médecins Sans Frontières. See MSFmedia, 321–2Merck, 402, 406, 422methods of human treatment, 15, 40

n. 28, 127, 169 n. 31, 296, 387Mexico, 109, 213Microsoft Corporation, 320, 325, 328Millennium Development Goals,

50, 109Miller, David, 385Mitchell, Andrew, 24Moe, Jeffrey, 191–2, 194Moerman, Don, 273monetarism, 219–20Mongolia, 399Montagnier, Luc, 1Morgan, Maxwell, 177, 177 n. 53Morley Fund Management, 126 n. 95

index 499






Morocco, 22, 81, 88Motorola, 317, 320, 321MPEG technology, 246MSF, 199, 248, 343, 350–1, 370, 397–8Multilateral Agreement on

Investment, 220MySpace, 320

Na Songkhla, Mongkol, 410, 414Nasu, Hitoshi, 24Natco, 390, 396Nathan, Carl, 273neglected diseases, 4, 5, 18, 19, 20, 23,

25, 27, 38, 41, 42, 44, 45, 50, 55,127–9, 139, 140, 143, 146, 147,148, 152, 158, 160, 161, 165,170, 184, 191, 192, 193, 194,196, 198, 199, 200, 201, 205,206, 208, 210, 231, 243, 264, 264n. 7, 266, 267, 268, 268 n. 22,271, 271 n. 35, 275 n. 43, 278,280, 281, 282, 313, 314, 316,327, 330, 349, 382

See also specific diseasescompulsory licensing and, 143Health Impact Fund and, 152IPR issues, 266–8last-mile problem, 148prize system and, 184–5

design options, 190–208research and development, 20, 38

incentives, 128–30issues, 266–8motivation, 160TRIPS regime, 45

TRIPS effect, 45, 139tropical diseases, 5Type I diseases, 128 n. 109Type II diseases, 128 n. 109Type III diseases, 128 n. 109

neo-liberalism, 219–22Network of Positive People, 402Nevirapine, 401 n. 60Ng, Elizabeth, Siew-Kuan, 24NGOs

See also specific organizationsadvocacy through proxies, 348–52AIDs and, 344, 347–8

alternative role, 352–6Doha Declaration and, 350,

370–1outsiders, 345–8TRIPS Council and, 49

Nicaragua, 22Nicol, Dianne, 27Nielsen, Jane, 27Nigeria, 4Niman, Neil, 269, 274–6Nobel Prize, 2–3non-state actors. See NGOsNordhaus, William, 214, 215North American Free Trade

Agreement (NAFTA), 80,97, 337

Novartis, 13, 30–1, 42, 126, 366 n. 26,386, 390–7, 403

Novogrodsky, Noah, 29Nuffield Council on Bioethics, 124–5nurses, 6, 7, 153, 375nutrition, 4, 9, 16, 57, 135, 153,

154, 298, 333, 372,373 n. 45

Obama, Barack, 321Odell, John, 10OECD, 124, 220, 254off-patent drugs, 115–16, 148Oman, US FTA, 82, 88onchocerciasis (river blindness), 90Opderbeck, David, 45open access communities, 328Open Science, 265Open Society Institute, 54Open Source

drug discovery. See Open Sourcedrug discovery

Gates opposition to, 328meaning, 264–5software, 263, 264, 276

Open Source Development Laboratory,275–6

Open Source drug discovery, 22, 23, 28,28 n. 136, 236 n. 6, 263–83 n. 55,314 n. 5, 356

growth, 269–71hybrid models, 264

500 index






initiatives, 263model, 274–6option, 130, 236 n. 6organizing, 271–82synergies, 282–3

Open Source Movement, 329orphan drug scheme, 158Overwalle, Geertrui van, 45

Panama–United States TradePromotion Agreement, 82

pandemics, 31–2, 209, 250–1, 285Paquette, Cherie, 188, 189Paraguay, 22Paris Convention, 35Partners in Health, 347Pasteur Institute, 1–2patent law

buy-outs, 130, 177, 178claims, 162, 175, 250, 252 n. 78, 297,

298 n. 90, 302, 305, 310, 387,389, 392, 405

clearing houses, 124, 236 n. 6,240, 241

compulsory licensing. Seecompulsory licensing

Crown use/state use, 15development and, WIPO

rebalancing, 107–11disclosure, 164, 168, 297, 387drugs. See drug patentsduration, 39, 41, 80, 84, 86, 87, 87

n. 28, 93, 155, 156, 168, 177,178, 192, 215, 218, 345,346, 388, 389, 391 n. 32, 394,394 n. 36

evergreening, 41, 218, 346, 388,389, 394

exclusions, 9, 15, 127, 296exclusive rights, 136, 182, 214,

235, 237power, 237social welfare losses, 182

exhaustion doctrine (first saledoctrine), 9, 15, 84 n. 14, 118,118 n. 63–64, 119

experimental use, 3, 9, 9 n. 34, 45,236 n. 5, 339, 351, 355

extensions, 80, 84, 86, 87, 87 n. 28,93, 156, 177, 178, 192, 345,391 n. 32, 394 n. 36

infringement, 10 n. 35, 140, 174, 175,245, 255, 277, 339

innovation and, 102, 111, 136–8patent strength relation, 221

invention, 1, 9 n. 31–4, 24, 35, 39, 40,40 n. 28, 41, 44, 44 n. 43, 78, 117,119, 120, 124, 127, 130, 143, 144,148, 155, 156, 156 n. 2, 158, 159,163, 164, 164 n. 21, 165, 166, 171,194, 196, 198, 202, 203, 204, 215,216, 238, 251, 252, 253, 277, 290,295, 296, 297, 387, 388, 393, 404,414 n. 30

inventive step (non-obviousness),39, 40, 44–5, 78, 127, 164, 165,166, 168, 182, 295, 296, 297,387, 388, 391, 405 n. 71

justifications, 102–3, 111covering innovation costs, 102,

136–8, 181–2information function, 102, 157natural law, 155 n. 2utilitarianism, 155–6, 155 n. 2, 207

landscape, 215, 235, 237, 238, 239,241, 249, 251, 252 n. 78, 256,260, 261, 262, 270

licensing terms, patent pools, 257–8mapping, 251national criteria, 162–5novelty (anticipation), 39, 164 n. 21,

165–6, 182, 297, 387, 388, 388 n.24, 389, 391, 404, 404 n. 71

parallel importation, 80, 84, 84 n. 14,88, 114, 117, 118–19, 118 n. 61,118 n. 63–64, 119, 119 n. 66,121, 123 n. 86, 131, 226, 337,346, 349–52, 365, 365 n. 23

patent races, 188, 189patentable subject matter (manner of

manufacture), 15, 40, 44 n. 43,101, 127, 163, 164, 253, 387,388, 392, 393

person skilled in the art, 164, 166pools. See patent poolsprior art, 165, 166, 175

index 501






patent law (cont.)remedies (including damages and

injunctions), 217, 218,339, 360

safe harbour (the ‘Bolar’ exemption),9, 9 n. 35, 15, 217

selection patents, 388specifications, 164springboarding, 218technology neutrality,

avoiding, 107TRIPS regime, 35, 41

technology transfer, 17, 22, 24,45, 104 n. 11, 110, 217, 249 n.65, 260, 291, 292, 293, 302

thickets, 238, 239, 334TRIPS regime. See TRIPSutility (capable of industrial

application), 387voluntary licensing. See voluntary

licensingwritten description, 165, 297

patent offices, 1, 30, 109, 122, 165, 175,318, 333, 390, 391 n. 32, 392,393, 402

patent poolsadministrative burden, 260assembly, 241assessment, 260–2balancing risks and benefits, 259basic features, 240–2benefits, 251–2complementarity, 242definition, 237, 240dominant patents and, 238, 249effect, 237Essential Medical Inventions

Licensing Agency (EMILA),244, 260

HIF alternative, 261humanitarian pooling, 242

delivery phase, 246–9discovery stage, 249–50discovery to delivery, 250–1Golden Rice, 246–8HIV/AIDS, 245, 248–9pandemics, 250–1practice, 246–51

SARS, 249–50, 261social benefits, 252WHO proposals, 242–4

incentives, 262innovation cycle, 238–40

delivery stage, 239–40, 245–6,246–9, 262

development stage, 239discovery stage, 238–9, 249–50, 261

licensing termscompetition, 257–8grant-back provisions, 255 n. 96model licensing, 244

mandated, 240–1, 244–5non-patent IPRs and, 252option, 130, 156, 353practice, 244–51

delivery phase, 245–6humanitarian pools, 246–51standardization purposes, 246,

254risks, 252–9

balancing benefits and, 259competition issues, 237, 245,

254–9freeriding, 254invalid patents, 257non-aligned interests, 253–4return on investment, 253–4

royalty-sharing, 241uncertainty, 242

Paxil, 184 n. 8Pecoul, Bernard, 18Pegasys, 402Pérez del Castillo, Carlos, 65–7Persuaders LLC, 319Peru, 4, 110 n. 28, 399Peru–United States Trade Promotion

Agreement, 83, 84, 100Pfizer, 221, 347, 402pharmaceutical drug patents

See also patent lawaccess to essential medicines and

competition from generics, 117compulsory licensing, 119–25consensual licensing, 125–7exacerbation, 155–6globalized regime, 5, 139–43

502 index






initiatives, 156limiting patentability, 127parallel imports, 117, 118–19reform, 116–27, 143–8


enhanced protection, prize system,190–4

evergreening, 41–2, 218Health Impact Fund and, 165–7, 179market fundamentalism, 219–22monopolies or private rights,

214–19patent pools. See patent poolsprize alternative. See prize systemschools of thought, 3thickets, 238TRIPS and

See also Doha Declarationconflicts, 10–11flexibilities, 401–3future, 13–14global effects, 5, 139–43overview, 7 n. 26Protocol, 67, 72, 121transition periods, 58–9, 62TRIPS Waiver. See TRIPS Waiver

US TRIPS-Plus agreements, 78–86democratic deficit, 86–9legitimacy, 94–9normative fragmentation, 89–92regulatory failure, 92–4

pharmaceutical drug pricesAIDS drugs, 111 n. 33CIPR and, 111–12competition and, 354–5developing world and, 5differential pricing, 124 n. 88, 177,

177 n. 53–54generic v. branded drugs,

399–400Health Impact Fund and, 151–2,

169–70off-patent drugs, 115–16patent system and, 136patented drugs, 116–27price-fixing, 256TRIPS effect, 139–40

value-based, 178WHO strategy, 21

pharmaceutical drugsaccess. See access to essential

medicinescategories, 140counterfeiting, 141, 152, 210drug resistance, 6, 141exports, TRIPS Waiver, 11–13innovation cycle, 235maintenance drugs bias, 140, 152marketing, 141‘me-too’ drugs, 141, 185, 193patents. See pharmaceutical drug

patentsprices. See pharmaceutical drug

pricespharmaceutical industry

access to essential medicinesand, 112

compulsory licensing and, 142–3corporate social responsibility,

125–7, 316, 322–3, 397declining productivity, 268–9dependence on patent systems, 102donations, 178ethos, 161gifts to physicians, 220Health Impact Fund and,

179–80last-mile problem, 141–2maintenance drugs bias, 140, 152marketing excesses, 141, 152–3,

185–6‘me-too’ drugs, 141, 185, 193neglect of diseases of the poor, 4–5open access companies, 273–4parallel exports and, 118political power, 179South African challenge, 349TRIPS negotiations, 346–7wastefulness, 185–6

Pharmaceutical Manufacturers’Association of South Africa,364–71

Pharmaceutical Research andManufacturers of America(PhRMA), 226, 354

index 503






philanthropy, 28, 29, 266, 271 n. 35, 280,314–39 n. 167, 343, 396, 397

Philippines, 22, 66, 115 n. 48, 120, 370,404 n. 71

philosophy, 3, 8, 9 n. 34, 96, 144, 329,331, 332, 336, 359, 359 n. 9

physicians, gifts from drugindustry, 220

Piot, Peter, 330Plavix, 406, 417pneumonia, 5, 217Pogge, Thomas, 25, 45, 130, 156,

159–60, 162, 163, 164, 171,177–8, 198–9, 261, 282, 384

Posner, Richard, 329Potrykus, Ingo, 247poverty, global poverty, 135, 155Pratt, Edmund, 347precautionary principle, 212–13, 214Priority Review, 185, 191, 192, 193,

194, 314, 328private–public partnerships,

129, 239, 270, 271, 272,278, 283

privatizations, 219prize system

benefitsbetter information, 183–5competition gains, 183neglected diseases, 184–5overview, 182–6reduced wastefulness, 185–6

design, 190–208enhanced patent protection,

190–4fixed-pot social valuation,

196–203patent-related prizes, 194–6relative social valuation, 203–8

disadvantages, 147–8, 178distrust of government, 187duplication of research, 187–90increased taxation, 186overview, 186–90rent-seeking, 186–7, 201sequential innovation issue, 187

mechanism, 182option, 129, 239, 353

Product Development Partnership,279–80

property rights, Locke, 144Prozac, 184 n. 8Prusoff, William, 355 n. 45pseudo-diseases, 141public domain, 17, 41, 103, 108, 109,

115, 194, 195, 231, 272, 273,275, 280, 282

public fundinginformation issues, 183push and pull, 146, 147research and development,

146–8public goods, 93, 149, 216, 219, 231,

232, 280public health

access to essential medicines and,111–27, 257 n. 117

crisis. See public health crisisGates Foundation and, 326, 330innovation cycle, 235TRIPS and

Doha Declaration. See DohaDeclaration

need for reform, 57–8objectives and principles, 57obstacle, 56

US TRIPS-Plus agreements and, 86side letters, 91

public health crisiscauses, 136holocaust, 206 n. 60public opinion and, 206–7responses, 138–9TRIPS and, 298–300

public interest, compulsory licensingand, 120

public law, xvii, xviii, xix, 4, 7, 23, 24,29, 77–8, 94, 100

public law, international lawconnection, 3–8

public order exceptions,TRIPS, 296

public policy, TRIPS and, 57public–private partnerships, 129,

239, 270, 271, 272,278, 283

504 index






QALYs, 150 n. 18, 167, 173, 208Qatar, WHO debate, 22Queen Mary Institute, 54

Rai, Arti, 271Ranbaxy, 335, 389, 390, 400rational drug design, 269Reagan, Ronald, 2, 220(RED) Campaign

accountability, 323–4celebrity cult, 315, 320–2, 344corporate social responsibility

model, 322–3critique, 322–4effectiveness, 322, 326 n. 81exploitation of trademarks, 315,

318–20Lazarus Effect, 313marketing, 318–22media use, 321–2objective, 314overview, 317–24

Relenza, 13Remnick, David, 336research and development

See also clinical trials, innovationcosts, 136

inclusion of poor, 143–4patent system and, 136–8, 181–2

cycle. See innovation cycledeclining productivity, 268–9developing countries, 270effect of Gates Foundation on, 331incentives, 128–30

HIF. See Health Impact Fundprizes. See prize system

neglected diseases, 20, 38incentives, 128–30issues, 266–8motivation, 160TRIPS regime and, 45

public funding, 146–8South African case and, 367treaties, 238, 239, 283WHO strategy, 20, 21

opposition to, 23Rice, Condoleezza, 321Ridley, David, 191–2, 194

right to healthbasic right, 19, 381–2institutionalizing, 383–4legal instruments, 90, 99, 357–9practice, 360–78

Ghanaian user fees, 372–8Indian Novartis/Glivec case, 386lessons, 378–80South African PMA litigation,

364–71Thailand, 407

public good, 232Rimmer, Matthew, 28–9, 72river blindness (onchocerciasis), 18Roche, 402Roche, Sheila, 318Rock, Chris, 321Rockefeller, John D., 324Rockefeller Foundation, 330Rosemann, Mark, 322–3Royal Society, 120 n. 74Rubenstein, Kim, 1–32Rubin, Robert, 319Rwanda, TRIPS Waiver and, 12, 69,

121, 351

Sachs, Jeffrey, 344, 354SADC, 74–5Sage, 283Sanders, Bernie, 200Sanofi-Aventis, 139 n. 5SARS, 116, 249–50, 261Schapf, Fritz, 95Scherer, Frederick, 188Schoen-Angerer, Tido von, 22Schroder Investment Management,

126 n. 95Schumacher, E. F., 232Schwab, Susan, 412secret information

clinical trial data, 172, 280TRIPS patent regime, 39US TRIPS-Plus agreements, 84

Sell, Susan, 10Sen, Amartya, 232sewing machine industry, 245, 247Shavell, Steven, 204Shriver, Bobby, 317, 318

index 505






Shue, Henry, 381Sierra Leone, Friends of Development,

110 n. 28Signal Rock Communications, 319Singapore, 115 n. 48Singapore–United States Free Trade

Agreement, 81, 88Singer, Peter, 331–2sleeping sickness (trypanosomiasis), 18Smith, Adam, 219Smith, Mogha Kamal, 401 n. 61Smith, Tamsin, 318Smith Ellis, Susan, 318SNP Consortium, 247 n. 56, 261, 264,

270, 271software, open sourcing, 263, 264, 329solidarity, 230South Africa

13th International AIDS Conference(2000), 369–70

AIDS crisis, 398compulsory licensing and AIDS

crisis, 225–6constitutional right to health, 358

case law, 383practice, 360, 364–71

democratic process, 354Friends of Development, 110 n. 28inequalities, 368IPRs and, 37, 51manufacturing capacity, 75Medicines Amendment Act (1997),

364, 365–6US response, 226, 369

PMA litigation, 336–7, 364–71AIDS crisis, 349lessons, 378–80overview, 10TRIPS compliance issue, 366

Tau v. GlaxoSmithKline, 354–5South Korea, 395South Korea–United States Free Trade

Agreement, 83, 227sovereignty. See state sovereigntySpethmann, Betsy, 320SPS Agreement, 209

contents, 212disputes, 213–14

precautionary principle and,212–13, 214

scientific assessment of evidence,212–14

Sridhar, Devi, 11Srinivas, Krishna Ravi, 27, 28standardization, patent pools and,

246, 254stare decisis, 46state practice, 418state sovereignty and genetic resources

Biodiversity Convention, 286, 292, 304WHO recognition, 301, 307, 346

stem cell research, 238, 331Stone, Joss, 322Structural Genomics Consortium, 271subsidies 117, 123, 138, 154, 197, 198,

221, 228, 271 n. 35, 280, 374Supreme Court of Bangladesh 383 n. 9Supreme Court of Canada 3 n. 12Supreme Court of India 383 n. 7, 386Supreme Court of the United States

216, 217, 319 n. 35sustainability, 230, 232Swaziland, 399swine flu (influenza A, H1N1), 31–2Switzerland, 12Syed, Talha, 26Sykes, Richard, 104 n. 7, 112symbolic capital, 324, 327synthetic biology, 37

’t Hoen, Ellen, 11, 424Taiwan, 115 n. 48, 401 n. 60Tamiflu, 13, 401 n. 60, 402Tanzania, 110 n. 28tariffs, 73, 84, 92, 117, 211, 217, 218,

228, 366 n. 30Taubman, Anthony, 13taxation, 36, 112, 117, 148, 149, 151, 151

n. 19, 177, 181, 182, 186, 202,228, 276, 281, 366 n. 30, 368, 369

prize system and, 186TBT Agreement, 52technology

health. See health technologystandardization, 246technology transfer, 45, 289–90, 293–4

506 index






Tenofovir, 402Thailand

AIDS demonstrations, 370compulsory licensing, 267

Abbott response, 13AIDS drugs, 120, 401 n. 60dispute, 406–7, 409–13drug prices, 123 n. 85EU response, 226, 415,

423–4new normative boundaries,

413–21politics of dispute, 422–4TRIPS conditions, 410–13US response, 406, 409, 412,

416, 423Doha Declaration and, 11drug prices, 123 n. 85, 139 n. 5Patent Act 1979, 404 n. 71public health v. IPRs, 384right to health, 359TRIPS Waiver and, 350universal health programme, 415

Thatcher, Margaret, 220trade diversion, 64, 71trade law, 7, 10, 23, 31, 35–55 n. 91, 220,

229, 346 n. 11, 347See also TRIPS, and WTO

trade liberalization, 220trade secrets (confidential

information), 172, 179, 221,252, 328, 328 n. 98

trademark lawdistinctiveness 319geographical indications, 43philanthropic use, 314–15(RED) Campaign and, 318trademarks 28, 217, 314, 315, 316,

318–19, 319 n. 35, 326, 333,334, 334 n. 136, 338

traditional knowledge, 50 n. 68,294

tragedy of the anti-commons, 334transaction costs, 237transparency, 29, 38, 52, 55, 71,

97, 99, 229, 305, 320, 323–4,330–1, 337, 338, 339,409, 416

treatiesunilateral modification, 91validity, coercion, 84–6

Treatment Action Campaign (TAC),30, 343, 354, 365, 366–9,374, 379

TriAvir, 69TRIPS Agreement (TRIPS)

access to genetic resources, 295–300avian influenza virus and, 289–92


copyright, reforming, 54developing countries, reasons for

joining, 6, 104dispute resolution, 39distributive consequences, 36domestic implementation,

methods, 92enforcement, 36exhaustion of IPRs, 9, 118flexibilities

adjudicative limitation, 42–6AIDS drugs and, 407developing countries, 15, 23–4,

42–6enhancing, 107impact on drugs, 401–3misuse, 420new normative boundaries,

413–21restriction by Free Trade

Agreements, 46 n. 48, 77, 267territorial scope, 420

global effects on drugs, 139–43, 267counterfeiting, 141, 152excessive marketing, 141, 152–3,

185–6high prices, 139–40, 151–2last-mile problem, 141–2, 153maintenance drugs bias,

140, 152neglected diseases, 139, 152wastefulness, 140–1, 152, 185–6

harmonizing effect, 164, 267,345–6

legitimacy, 112market fundamentalism, 221–2

index 507






TRIPS Agreement (TRIPS) (cont.)minimum standards regime, 36, 39,

295, 413–21negotiations, 97–9, 290–2, 345–7NGOs and

advocacy through proxies, 348–51negotiations, 345–7

obligations of WTO members,35–6, 39

patent regime, 39–46access to essential medicines and,

113–14compulsory licensing. See

compulsory licensingduration, 39exceptions, 40–2, 59–61, 222,

236 n. 5, 296genetic resources, 295–300limiting patentability, 127need for reform, 57–8normative claim, 367Protocol, 67, 72, 121public interest exceptions, 222reconceptualizing, 46–55secret information, 39technology neutrality, 36–8, 42–6technology transfer, 45tilt towards developed countries,

103–5, 107trade-bias interpretation, 42–6transition periods, 45, 59, 62

pharmaceutical drug patents andSee also compulsory licensingbioequivalence testing, 43–4conflicts, 10–11Doha Declaration. See Doha

Declarationflexibilities, 401–3, 407future, 13–14global effects, 139–43neglected diseases, 45overview, 8–14Protocol, 67, 72, 121transitional access to generic

drugs, 58–9TRIPS Waiver. See TRIPS Waiver

Principles and Objectives, 37, 43, 57public health crisis and, 56, 298–300

public law use for privategoods, 92–3

reconceptualizing, 46–55inadequacy of TRIPS Council, 48–9WHO role, 53WIPO role, 49–53

South African compliance, 366tilt towards developed countries,

103–5, 107US origins, 138, 221

TRIPS Councilfunction, 348inadequacy, 48–9

TRIPS Waivercompulsory licensing. See

compulsory licensingcritique, 70–1Doha Declaration, 61–4, 226–7, 408Free Trade Agreements and, 72–5implementing WTO General

Council decision of 30 August2003, 11–13, 63–4

avoidance of trade diversion,64, 71

Chairman’s statement and article31(b), 65–7

legal status, 64–5notification conditions, 63, 71remuneration, 64specifications, 64

legal status, 64–5manufacturing capacities and, 62–4,

121–2meaning, 11–13NGOs and, 350–1permanent amendment option,

67, 121transition periods, 62transitional solution, 61–9

Tropical Diseases Initiative, 271tropical diseases, research

neglect, 5trust, distrust of government, 187trypanosomiasis (sleeping

sickness), 172tuberculosis

access to essential medicines, 112Directly Observed Therapy, 199

508 index






drug resistance, 141generic drugs, 116Global Fund, 314Indian project, 281–2national emergencies, 62neglected disease, 5, 18, 217

Turkey, WTO dispute, 213Turlington, Christy, 315

Ukraine, 399UNAIDS, 248, 330UNCITRAL, 173UNDP, Human Development Report

2001, 122UNEP, 290UNICEF, 398–400UNITAID, 248, 257, 258United Kingdom, 187, 370United Nations, CESCR, 53United States

access to essential medicinesClinton presidency, 336–7consumer access, 88

AIDS blood test patent, 1–2French agreement, 2

AIDS demonstrations, 370Bolar exemption, 9, 9 n. 35,

15, 217Doha Declaration and, 86, 87,

89, 350Food and Drug Administration

(FDA) 185, 215, 384 n. 12, 398free trade agreements

Australia–United States FreeTrade Agreement (AUSFTA),81, 88, 223–5

Bahrain–United States Free TradeAgreement, 82, 88

Central America–DominicanRepublic Free Trade Agreement(AFTA), 81

Chile–United States TradePromotion Agreement,81, 88

Colombia–United States FreeTrade Agreement, 82, 89

Israel–United States Free TradeAgreement, 80

Jordan–United States Free TradeArea Agreement, 80

Korea–United States Free TradeAgreement, 83, 227

Morocco–United States FreeTrade Agreement, 81, 88

North American Free TradeAgreement (NAFTA), 80, 97, 337

Oman–United States Free TradeAgreement, 82, 88

Panama–United States TradePromotion Agreement, 82

Peru–United States TradePromotion Agreement, 83,84, 100

Singapore–United States FreeTrade Agreement, 81, 88

TRIPS-Plus agreements, 12,78–86, 401 n. 61, 412

generic drugs, 87Hatch-Waxman Act (1984), 87, 88,

98, 192, 217IPRs and

CBD proviso, 291development, 15

Manufacturers AircraftAssociation, 245

‘me-too’ drugs, 185Medical Innovation Prize Fund Act,

200–1, 203NGOs, 352Oregon state health plan, 208patent pools

aircraft manufacturing,244–5, 247

anti-trust issues, 254–5patents

duration, 214extension of term, 215–16incremental innovation, 216judicial approaches, 216–18priority reviews, 191–2, 327

PEPFAR, 347, 398, 400pharmaceutical drug patents

abuse, 215bilateral agreements, 77–8cost-effectiveness, 218–19, 227–8duration, 217

index 509






United States (cont.)evergreening, 218experimental use defence, 9 n. 34Kefauver Report, 215legislation, 217, 222priority reviews, 191–2, 328private rights, 214–19public sector discoveries, 216South African dispute, 226TRIPS Waiver and, 12

presidential elections 2008, 206South African drug law and, 226, 369trade sanctions, 97TRIPS and

industrial alliance, 138, 221national emergencies, 416Protocol, 70

TRIPS-Plus agreements, 12bypassing TRIPS flexibilities, 46 n.

48, 77coercion, 84–6compulsory licensing, 84democratic deficit, 86–9, 96–7drug cost-effectiveness and, 222–3extension of patent term, 84, 87fast-track rules, 86, 88generic drugs, 87input legitimacy, 96–8national law comparisons,

80–3, 87non-transparent negotiations, 97normative fragmentation, 89–92output legitimacy, 98overview, 78–86parallel imports, 84pharmaceutical drug

patents, 77–78public health side-letters, 91public law perspective, 94–9regulatory failure, 92–4secret information, 84strategic value, 99–100third party marketing, 84threat to public health, 86

user fees and, 378United States Patent and Trademark

Office (USPTO) 1, 318, 333,391 n. 32

USTR Watch List, 46 n. 48South Africa, 369Thailand, 406, 409, 412, 416, 423

vaccine production, 185Washington Consensus, 220WHO and, 21, 22, 23

Universal Declaration of HumanRights (1948), 357

Universities Allied for EssentialMedicine (UAEM), 355

Uruguay, 110 n. 28use of force, meaning, 85user fees, 372–8Uzbekistan, 22

vaccinesAIDS, 337avian influenza, WHO strategy, 301compulsory licensing, TRIPS

Waiver, 299dengue fever, 193economics, 140influenza, 250–1, 301leishmaniasis, 193pandemics, 285patent pools, 250–1production deficit, 185SARS, 250

Valenti, Jack, 323Van Ypersele, Tanguy, 204Vanity Fair, 321Varmus, Harold, 326Veenat, 396Venezuela, 110 n. 28, 383Vienna Convention on the Law of

Treaties, 58, 85, 91, 418Virtual Pharma, 271voluntary licensing, 60, 66, 71, 84 n. 12,

114, 125, 156, 175, 176, 177,240, 241, 244, 248, 259, 262,355 n. 44, 356

Voon, Tania, 24

Wadman, Meredith, 330–1Washington Consensus, 220wastefulness, 140–1, 152, 185–6water, clean, 4, 135, 153, 154, 158, 332,

372, 381 n. 2

510 index






Webb, Douglas, 347Weber, Steve, 265Wei, Marlynn, 201, 203Wensley, Anthony, 272West, Kanye, 315WHO

avian influenza and, 300–8assessment, 308–12CBD application, 288compromise agreement, 305–8virus sharing, 284–5

Commission on IntellectualProperty Rights, 18, 94, 243,306–7

criticisms, 18, 22disease burden data, 196drug prices and, 21Global Influenza Surveillance

Network, 285, 298, 309–10global IPR strategy, 19–22, 210,

306–7equitable regulation, 228human rights, 19IPRs and public health, 236neglected diseases, 129

Global Pandemic Influenza ActionPlan, 301

on health initiatives, 7human rights and, 19International Health Regulations

(2005), 300mandate, 17NGOs and, 352overview, 17–23patent pools, 236, 239

proposals, 242–4SARS, 249

prize competitions and, 129R&D promotion, 20, 21Standard Materials Transfer

Agreement, 307state parties, 346TRIPS and, 53, 70US TRIPS-Plus agreements and,

89–90WTO collaboration, 210–11WTO–WHO HTSCEE Agreement,

228–32

Winfrey, Oprah, 315, 320–1WIPO

creation, 49criticisms, 14–15Development Agenda, 102

AIDS crisis, 106NGOs and, 356objectives, 50overview, 108–11rebalancing the system, 107–11

Director-General, 17Doha Declaration and, 16function, 50Geneva Declaration (2004), 15–16, 108overview, 14–17TRIPS role, 49–53voting procedure, 49

Witty, Andrew, 27World Aids Foundation, 2World Bank

on compulsory licensing, 414market fundamentalism, 220structural adjustment programmes,

372on TRIPS and developing

countries, 104user fee policies, 373, 378Washington Consensus, 220

World Business Council for SustainableDevelopment, 125 n. 92

World Health Organization. See WHOWorld Intellectual Property

Organization. See WIPOWright brothers, 245wrongful imprisonment, 377WTO

accountability, 38Appellate Body, 36, 46constitutionalization, 77, 164dispute settlement system, 213, 229enforcement mechanisms, 361FTAs and, 73market fundamentalism, 220SPS Agreement, 209, 212–14TBT Agreement, 52TRIPS. See TRIPSWashington Consensus, 220WHO collaboration, 210–11

index 511






WTO General Council Decisionof 30 August 2003, 11,12, 62, 63, 63 n. 24–25,64, 65, 66, 67, 69, 70, 72,73 n. 70, 76, 78 n. 7,121 n. 78

Canada, 12, 69, 121practice, 69–72Rwanda, 12, 69, 121

WTO–WHO Health TechnologySafety and Cost-Effectiveness

Evaluation ProposedAgreement, 209–32 n. 68

yaws 193Young, Katharine, 29–30, 383YouTube, 321Yu, Peter, 13

Zakari, Mohammed, 375–8Zimbabwe, 397Zoloft, 184 n. 8

512 index






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