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Index

Published online by Cambridge University Press:  21 May 2025

Margaret Sleeboom-Faulkner
Margaret Sleeboom-Faulkner
Affiliation:
University of Sussex

Information

Type
Chapter
Information
Regulatory Violence
The Global Dynamics of Regulatory Experimentation in Biomedicine and Health
 , pp. 315 - 346
Publisher: Cambridge University Press
Print publication year: 2025
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NC
This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC 4.0 https://creativecommons.org/cclicenses/

Index

Abe (Kyoto legal scholar), 165
Abe, Shinzo, 157, 159, 250
abortion, 102
Academia Japan, 168–169
Academia, Business and Clinical approach, 227
Academies of Military Medical Sciences (AMMS), 73, 76
Accelerated Approval Program, 114
acceleration. See regulatory acceleration
acceptable science, 27, 44, 52, 82, 147
access to treatment, 114–115, 238
acquisitive desire, 26, 213
caring solidarity and, 269–271
social contract and, 243
acquisitive imitation, 264
Act for the Promotion of Regenerative Medicine (Japan), 158
Act on the Safety of Regenerative Medicine (RM Act) (2013), 58, 158, 166, 169
fatalities and, 234
GMP and, 173
international brokerage and, 225
regulatory immunity and, 240
JSRM and, 222
Taiwan and, 236
active brokerage, 210–212, 216, 219, 221, 238–239
forms of, 217
Adams, Rachel, 270
imitative desire and, 264
adaptive licensing, 236
ADIPOA1, 119
Administrative Measures for Clinical Research for Stem Cells (Trial Implementation) (CFDA 2015), 68, 237–238, 282
Advanced Medical Treatment status (Japan), 159
Advanced Regenerative Medicine and Biopharmaceutical Safety and Support Act (2019), 233
Advanced Therapy Medicinal Products (ATMP), 50, 118–120
adverse trial effects, 106, 117, 179
advertising, 117
affordability, 104, 121
alternative regulation and, 252
political desire and, 105
R-CPX and, 136–137
agency, 23
lateral political pressures and, 215
regulatory capitalism and, 64
regulatory discrepancy and, 208
Agency for Medical Research Development (AMED), 158, 165, 178, 238
global brokerage and, 229–230
industrial investment and, 252
age-related macular degeneration (AMD), 163, 166, 170, 178
state investment and, 250
Agreement on Trade Related Investment Measures (TRIMS), 11
AIFA (Italian Medicine Agency), 120
Ali, Robin, 251
All Japan System (AJS), 30, 155–156, 159–162, 169–171, 174–177
approval-mechanisms and, 178–180
collaboration and, 163–165
funding and, 178–180
funding overhaul and, 159
iPSC research and, 165–169
misrecognition and, 177–178
politics and, 163
scientific constraints and, 163–174
vision of, 178
alleviation of suffering, 266
Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA), 60
Alliance for Regenerative Medicine (ARM), 230, 232
formulation of regulations and, 45
Japan and, 151
allogeneic stem cell therapy, 11
AJS and, 170–171
Australia and, 116
Category-3 drugs and, 70
CiRA and, 170
immune suppressants and, 176
Stempeutics and, 81–83, 85
transfusion and, 173
alternative medicine, 2, 63
Beike and, 111
health activism and, 204
alternative regulation
affordability and, 252–253
credible authority and, 97
Guangzhou Alliance and, 75
regulatory brokerage and, 64
regulatory immunity and, 106
Alzheimer’s Disease, 234
Amcell, 72
American Association of Blood Banks (AABB), 61, 109, 111
An Yihua, 73
Anspach, Mark, 96, 259–260
anything goes attitude, 65
Arendt, Hannah, 9
Asia
AJS and, 160, 164–165
fraudulent providers and, 41
global brokerage and, 230
HOs and, 186, 195
individual-rights discourses and, 202–203
IOMD and, 183
Japanese–Thai collaboration and, 132
patient populations and, 261
regulatory harmonisation and, 144
regulatory overhaul and, 42
stem cell tourism and, 182
unreliability and, 37
Asia Partnership Conference of Regenerative Medicine Associations, 230
Asian Cellular Therapy Organization (ACTO), 236
Asian financial crisis of 1987, 36
Asian Stem Cells, 57
Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, 230
assays (iPScs), 167–169, 175–176
Association of Southeast Asian Nations (ASEAN), 134, 141
regulatory capital and, 145
Thai Revised Drug Act and, 144
Astro Stem, 234
Athersys, 59
AusBiotech Regenerative Medicine Advisory Group (RMAG), 117
Australia, 116–118
caring solidarity and, 241
EU and, 120
regulatory reputation and, 121
Auto-Culture®, 129, 143
autologous stem cell therapy, 11–12
Australia and, 116–117
caring solidarity and, 241
Crohn’s and, 255
HICs and, 112
Parkinson’s Disease and, 170
pay-to-participate and, 115
regulatory immunisation and, 122
same surgical procedure exception and, 114
Takahashi pilot study and, 170
automation, 128–130, 143, 227. See also Japanese–Thai collaboration
AveXis, 249
Ayurveda, 192
Bayh-Dole Act (US), 159
BaYi Brain Hospital, 73
Beijing University, 109
Beike Biotechnology Company, 29, 56–57, 108–112
ICMS and, 61
patient ethics and, 111–112
stem cell tourism and, 102
universal regulation and, 122
Bell, Catherine, 25
regulatory redemption and, 153
Bharadwaj, Aditya, 103
Bianco, Paolo, 104
bilateral organisation, 217, 228
biliary cirrhosis, 70
bioethics, 16–18, 23
acceptable science and, 44, 94
Beike patients and, 111–112
caring solidarity and, 271
hegemony and, 69
local considerations and, 151
markets and, 96
practice of, 76
rational individualism and, 263
recklessness and, 102
regulatory immune-tolerance and, 95
scientific integrity and, 101
scientific uncertainty and, 99
socio-political positions and, 152
toeing the regulatory line and, 76
unethical binary with, 123
universal application of, 106
universal appraisals of, 105, 107
‘Bioethics Briefing Note’ (UK Nuffield Council), 17
biologics, 114
Australia and, 116–117
regulatory immunisation and, 121
South Korea and, 233
Biologics License Applications (BLAs), 51
biology, 43
conceptual uses of, 92
biomedical platform theory, 66
biomedical platforms, 78–79, 81–83
disjointedness of, 85
LMICs and, 88
Stempeutics and, 83, 87
technological rationale of, 89
biomedical products
clinical research and, 40
human rights–based discourse and, 204
BioNexus-status companies, 56
Biostar Research Institute, 234
Biosystems, 167
biotechnology, 185, 266–268
well regulated forms of, 113
Black, Julia, 4, 7, 215
bona fide science practices, 42, 63
bone marrow-derived mesenchymal stem cells (BM-MSC), 70
FDA and, 104
GvHD and, 74
thalassemia and, 136
boundary-making. See regulatory boundary-making
boundary-work. See regulatory boundary-work
bowel- and bladder-management, 187, 194
Braithwaite, John, 5, 35
Brazil, 42
Breakthrough Therapy Designation, 51, 114
Brexit, 238
Brian Salter, 258
bribery, 111
brokerage. See regulatory brokerage
Bufacchi, Vittorio, 8
bureaucracy, 9, 97
free individuals and, 205
Japan and, 156
Japanese–Thai collaboration and, 130
rogue science and, 111
Busch, Lawrence, 34
Bush, George W., 41, 152
California Institute for Regenerative Medicine (CIRM), 232
Calvert, M. J., 213
Cambodia, 131
Cambrosio, Alberto, 82
Canada, 81
capacity building. See regulatory capacity building
capital. See regulatory capital
capitalism. See regulatory capitalism
Caplan, Arnold, 104
caring solidarity, 19, 23, 26–27, 269–271
competition and, 246
competitive desire and, 31, 241
regulatory brokerage and, 212, 214
regulatory concepts and, 212
Cartistem, 58, 233
case studies, 18–19
Castells, Manuel, 35
catching-up policies, 66
category-3 drugs, 68, 70
caution, 267
Celgene, 249
Celixir, 238
cell and gene therapies (CGTs), 227
Cell and Gene Therapy Catapult, 226
cell banks, 249
biobank initiatives and, 60
HLA and, 12
standards for, 175See also umbilical cord blood banks (UCB)
cell ossification, 130
cell processing, 173
smart form of, 229
Cell Products & National Engineering Research Center, 71–72
cell reprogramming, 11–12, 156–157, 172
cell sourcing, 11, 171
politics of, 178
Cell Surgical Network (CSN), 115
cell therapy products (CTPs), 174–175
advertised as cell treatment, 53
Taiwan and, 236
CellSeed, 222
cell-sheet therapy, 221–222
Heartsheet and, 225
Cellular Biomedicine Group Inc. (CBMG), 62
Central Drugs Standard Control Organisation (CDSCO), 80
Central Military Commission (China), 72
central planning, 34
Centre for Biosystems Dynamics Research, 177
Centre for Cells and Tissue Engineering, 74
Centre for iPS Cell Research and Application (CiRA), 163–167, 169–170, 174–175, 178–179
AJS led by, 169, 171–172, 177
branding for, 168
changes to protocols and, 168
criticisms of, 176
Kyoto University and, 133
pilot study by, 172–173
pressure to work with, 173
Takahashi and, 171
Yamanaka and, 157, 160–162
charities, 188
HOs and, 203
Doctor Chaturvedi (pseudonym), 83
Chen, Y.-C., 236
China, 55, 111–112
2009 regulations and, 108–109, 112
2015 draft regulation and, 73, 75
2015 regulation and, 77
AJS and, 164
Beike Biotech and, 29, 108–112
CAMS and, 70–71
elite laboratories and, 88
entry into global science-competition and, 42
forms of authority in, 48
Guangzhou Alliance and, 74–75
Guangzhou use of local authority in, 49
hegemonic approaches and, 66, 69
HOs and, 205
industry collaboration and, 197–198
international networks and, 60–62
Japan and, 237–238
Japanese–Thai collaboration and, 138
knowledge activism and, 202–203
LMIC collaboration and, 57
lobbying in, 190
military research and, 72–73
MSC safety and, 104
needs of disabled and, 190–191
NGOs and, 188
off-label use in, 49
regulatory boundary-work and, 64
regulatory brokerage and, 215
regulatory capacity building and, 67–69
regulatory immunity and, 92, 240
regulatory orientation and, 69–71, 75–78
regulatory reputation and, 102
SCI and, 194–195, 200
semi-private enterprises and, 75–76
shared scientific cultures and, 52
stem cell trials in, 13
Tianjin stem cell cluster and, 71–72
UK and, 101
universal regulation and, 107, 122
US unauthorised clinics and, 115
China Bone Marrow bank, 72
China Disabled Persons Federation (CDPF), 189
China Food and Drug Administration (CFDA), 68
Administrative Measures of Clinical Research for Stem Cells (for Trial Implementation) (CFDA 2015), 68, 237–238, 282
Beike and, 109
BM-MSCs and, 70
Guangzhou Alliance and, 75
China SCI-Net, 61
China-bashing, 111
Chinese Academy of Medical Sciences (CAMS), 70–71
collaboration with, 76
military research and, 73
Peking Union Medical College and, 71
Chinese Academy of Sciences (CAS), 73
Chinese Medicine Registry and Management System, 69
chongsaem law (‘cutting-edge regenerative’ law), 233
Choose Wisely, 266
chronic and life-limiting illnesses, 254
Chulalongkorn University (CU), 29, 124–125, 139, 219–221
Cipla, 82–83
CITIC (China International Trust and Investment Corporation), 75
Class 1 treatments, 224
clinical firsts, 250
clinical research, 121
biomedical products and, 40
Japan and, 159
national vs. local permission for, 49
vindication of, 152
Clinical Research Organisations (CROs), 261
clinical research trials (CRTs), 2
AJS and, 154–155, 173
biotech industry and, 88
clinical, 14
clinical research and, 166
cost-benefit analysis of, 254–256
high expectations of participation in, 255
Indian bureaucracy and, 52
onus of risk and, 22
pathways for, 169–171
patient populations and, 260–263
PMDA and, 158
RCTs and, 53–55
regulatory challenges and, 16–18
regulatory threshold for, 157
research therapy tension and, 15
safety and efficacy studies of, 165
social contract and, 257–258
state investment and, 252
stem cell therapies and, 12
tension between therapy and, 14–15See also randomised control trials (RCTs)
ClinicalTrials.gov, 12, 109, 115
Coca-Cola, 197
collaboration, 1, 3, 18, 124–126
AJS and, 163–165, 168, 177–179
alternative therapeutic practices and, 63
anything goes attitude and, 65
case studies of, 19
China and, 76
CiRA and, 174
company competition and, 172
competition and, 29, 64, 123
competitive desire and, 213
Guangzhou Alliance and, 74–75
health organisations and, 189, 196–198
increase in regulatory competition and, 42
industry and, 175
Japanese universities and, 159
Japan–Thailand and, 131–133, 140–145
local authority and, 49
loose regulation and, 56
networks for, 44
niches for, 124
R-CPX and, 127–128
regenerative therapy and, 176–177
regulatory brokerage and, 64, 209
regulatory capital and, 145–147
regulatory discrepancies and, 130–131
regulatory immunity and, 239
regulatory knowledge and, 22
regulatory manipulation and, 35
regulatory orientation and, 77–78
regulatory patterns in, 244
regulatory redemption and, 150–151
scientific results of, 133–135
trust and, 137–139
commodification, 263
common good, 265–266
communal norms, 96
community, 187–188, 204, 263–265
common good and, 265
SCI and, 182
commutative justice, 268
compassionate treatment, 50, 223
competition, 2, 17
Australia and, 117
biological notions of, 213
clinical firsts and, 210
collaboration and, 29, 64, 123, 146
company affiliation as cause of, 172
destructive forms of, 216
international dynamics of, 62
Japan and, 233–234
mimetic rivalry and, 93–94
regulatory brokerage and, 209
regulatory capacity-building and, 88
regulatory capital and, 125
regulatory capture and, 40
regulatory reform and, 231
regulatory violence and, 3
structural spaces for, 100
UK and, 101
unreliability and, 37 See also competitive desire; regulatory capitalism; regulatory violence
competitive desire, 23–24, 26–27, 30
caring solidarity and, 31, 241, 269–271
collaboration and, 124–126
common good and, 265
Cossu and, 253
cost-benefit analysis and, 248
costs of, 253
foreseeable harm and, 238, 243
Girard and, 93
governance and, 250–251
Japan’s 2013 reforms and, 30
legal justice and, 269
mimesis and, 263–264
mimetic rivalry and, 97
regulatory brokerage and, 209, 211–214
regulatory reform and, 240
scapegoating and, 29
scientific value and, 252
social contract and, 246, 256, 258
state investment and, 45
virtue ethics and, 269
compliance, 5, 44, 55
Comprehensive Special Zones, 225–226
conditional approval, 230
AJS and, 180
India and, 235
REGROW Bill and, 241
Stempeucel and, 235
Taiwan and, 236
time-conditions and, 224, 229–230, 236
US and, 254
conflict avoidance, 146
conflict, collaborative contexts for, 126
contract development and manufacturing companies (CDMOs), 249
contract research organisations (CROs), 73
Control and Supervision of Drugs and Products from Stems Cells amendment (Thailand), 131
corneal cells, 218
cosmetic therapy, 53, 80, 84–85, 89
Japanese–Thai collaboration and, 131
reputational effects of, 21
Cossu, Giulio, 243, 253–254, 256–258
cost-benefits analysis, 254–256
community action and, 267
competitive desire and, 248–249
regulatory violence and, 248
virtue ethics and, 269
cost-effectiveness of treatment, 254
COVID-19, 214
creative desire, 27, 32
caring solidarity and, 212, 263–265, 270
generative principle of, 246
mimesis and, 212
regulatory concepts and, 211
creative mimesis, 263–264
Critical Limb Ischemia, 87
critical theory, 181
Crohn’s disease, 58, 254–255
Croley, Steven, 6
cryopreservation, 84
Cupistem, 58, 233
Custom Market Insight (CMI 2023), 249
Cyranoski, D., 179
cytokine production capacity, 84
Cytori Therapeutics, 59, 84
Dallas Buyer’s Club (film), 181
Dana and Christopher Reeves Act, 200
Deane-Drummond, Celia, 266–268, 270
Deinsberger, Julia, 12
Deloitte, 238
democratic decision-making, 94, 258
Demouchel, Paul, 126, 259
Department of Biotechnology (DBT) (India), 80, 86, 218
ISSCR criticism and, 235
Department of New Energy and Industrial Technology Development Organization (NEDO), 125, 132, 137, 219–220
regulatory capital and, 145
regulatory tolerance and, 147
deregulation, 4, 30, 113
as form of brokerage, 217
FTCM and, 183, 231
international brokerage and, 226
international health organisations and, 241
international patient movements and, 154
Japan and, 224–225, 229
neoliberalism and, 36
regulatory capital and, 146
desire, 243
forms of, 269–271
destructive desire, 243
developmental pathways, 81–83
length of, 227
regulatory orientation and, 78–79
therapy provision and, 80
dialectic of co-production, 150–151, 155, 163
dialectic of regulatory reproduction, 151
Diet (parliament of Japan), 222
difference. See regulatory difference
diplomatic immunity, 92
direct-to-consumer provision (DTCs), 107, 122
Australia and, 117
caring solidarity and, 241
Japanese–Thai collaboration and, 130
disability, 190–193
China classifications of, 189
self-perception of, 187
societal roots of, 184
discrepancy. See regulatory discrepancies
disease conditions, 254
distributive justice, 268
diversity, 206
donation vs. leasing, 132, 136, 138–139, 145
down-regulation, 162, 181, 184, 186, 223
misrecognition and, 153
patient movements and, 30
regulatory redemption and, 30, 154, 205
Drug Administration Law (China, 2001), 67
Drug Controller General (India), 80
Drugs and Cosmetics Act (1940), 235
Drugs and Cosmetics Act (DCA), 80
Drugs Controller General, 87
dual-track systems, 236–237
Duchenne muscular dystrophy (DMD), 50, 193
cost-effectiveness and, 254
personal decision-making and, 255
Dupuy, Jean-Paul, 271
Early Access to Medicine Scheme, 51
early-access programs, 238
‘The East or Scientific Feast’ (Anonymous, Economist Magazine), 41
Eastern Europe, 183
economic growth, 13, 26, 59, 64, 246
Australia and, 117
competitive desire and, 250
LMICs and, 121
regulatory brokerage and, 209
regulatory violence and, 248
targets for, 66, 88
economic metaphors, 92
elites, 25, 43–44, 67, 93
CAMS proactive orientation and, 71
funding and, 69
importing regulation by, 81
Japanese–Thai collaboration and, 147
network criticism by, 72
regulation and, 40
regulatory boundary-work and, 88
embodied conditions, 31
embodied ideals, 153
embodied identities, 103, 184, 203–204
embryo sourcing, 11
empathy, 27
enablement, 113, 123
endogenous stem cell therapy, 11
Entrepreneurial life-science networks, 44
entrepreneurial networking, 82
entrepreneurialism, 117, 183, 207, 210–212
innovation and, 52
prohibitive regulation and, 239
regulatory brokerage and, 216
regulatory gaps and, 206
science management and, 31
Tianjin cluster of, 71
unauthorised therapies and, 115
Esposito, Robert, 95
ethics, 16–18
acceptable science and, 44, 94
Beike patients and, 111–112
caring solidarity and, 271
ethics, 23
hegemony and, 69
local considerations and, 151
markets and, 96
practice of, 76
rational individualism and, 263
recklessness and, 102
regulatory immune-tolerance and, 95
scientific integrity and, 101
scientific uncertainty and, 99
socio-political positions and, 152
toeing the regulatory line and, 76
unethical binary with, 123
universal application of, 106
universal appraisals of, 105, 107
ethics of return, 56
ethnocentricism, 204
Europe, 227–228
Beike image in, 109
blood donation in, 173
compassionate treatment and, 223
FDA and, 151
international patient movements and, 154
knowledge activism and, 202
lay-expert input and, 197
modernity and, 113
patient movements and, 183
patient populations and, 261
private interest theories in, 6
registries in, 201
soft law and, 48
trust in state regulators in, 205
UK and, 251
unauthorised clinics in, 22
US and, 232
European Bank for iPSCs (EBiSC), 60
European human Pluripotent Stem Cell Register (hPSCreg), 60
European Medicines Agency (EMA), 48, 51, 100, 118–120
Biologics and, 116
direct-to-consumer and, 122
Orphan Drug Designation and, 51
regulatory capital and, 145
regulatory immunisation and, 121
WHO and, 123
European Union (EU), 118–120
2007 Regulation and, 100
accelerated approval and, 51
compassionate treatment and, 50
Hospital Exemption clause in, 116
influence of reform and, 231
Japanese reform and, 232
Japan–Thailand collaboration and, 128
market acceleration and, 51–52
patient protection in, 100
piecemeal regulation and, 59
RCTs and, 53–55
regulatory boundary-work and, 64
regulatory dynamics of, 63
regulatory exemptions and, 22
regulatory overhaul and, 42
regulatory tolerance and, 121
standards set by, 67
European Union Tissue and Cells Directive, 118
Eurostemcell (2022), 60
evidence-based medicine, 15
exemptions, 116
acceleration and, 205
Australia and, 117
HICs and, 121
US and, 115
expanded access, 114–115
related mechanisms for, 223
experimental practices, 16–18, 63
Australia and, 116–117
Beike and, 111
collaborative scientific results and, 133
HOs and, 205
political desire and, 105
protection of human subjects in, 14
regulatory exemptions for, 50–51
regulatory immunity and, 94
Wharton’s jelly cells as, 120
experimentation. See also innovation
exploitation, 93, 95
exploited regulatory brokerage, 26
family banking, 72
family care, 192
RCTs as alternative to, 106
FBRI (Foundation for Biomedical Research and Innovation), 164, 167, 176
FDA Safety Innovations Act (FDASIA), 51
French-Constant, Charles, 120
fieldwork, 19–20
Five-year Healthcare Innovation Strategy, 222
Five-year Medical Innovation Programme, 160
flexibility. See regulatory flexibility
Foong, Patrick, 117
Fordist production management, 35
foreignness, 24
clinical trials and, 205
experimental medicine and, 106
regulation and, 25, 28
scapegoating and, 96 See also rogue practices
foreseeable harm, 1–3
caring solidarity and, 269
competitive desire and, 243
definitions of violence and, 8–9
mimetic cultures and, 244
politics and, 29
regulatory brokerage and, 209–212, 215, 238
regulatory violence and, 247
table of concepts including, 211 See also regulatory violence; violence
foresight, 267
Forum for Innovative Regenerative Medicine (FIRM), 175, 221–222
companies within, 226
global brokerage and, 229–230
US influence and, 232
Foundation for Biomedical Research and Innovation (FBRI), 166
four-phased trials, 14, 16, 53–55
France, 251
soft law and, 48
fraudulent science, 42
Free to Choose Medicine (FTCM), 181, 206, 231–232
deregulation and, 154
EU and, 120
HOs and, 183–184
lobbying and, 190
freedom of choice, 200
fresh-cell therapy, 118
Friedman, Milton, 34, 36
Fukuoka Trinity Clinic, 234
funding, 156–159
AJS and, 175, 177
Bush moratorium on, 152
CiRA and, 174
developmental pathway length and, 227
elite laboratories and, 69
HOs and, 189
hybrid forms of, 71
Japan and, 223
redirection of, 256
virtue ethics and, 269
G-10 group, 36
GATT rules, 144
GEN website, 249
General Agreement on Trade in Services (GATS), 36
genetic testing, 187
genome analysis, 166
Germany, 118
Gieryn, Thomas, 37, 42
gift economies, 259–260
gift-giving, 263–264
Girard, Rene, 26, 31, 93, 213
imitative desire and, 264
mimetic rivalry and, 100
global hegemony approach, 66
Global North, 184
Global Regenerative Medicine Market Report – 2019 (GRMMR), 249
Global South, 184
globalisation, 29, 100
caring solidarity and, 270
collaboration and, 124
competition and, 28
hegemonic approaches to, 65–66
illegitimate regulatory brokerage and, 244
nation-states and, 246–248
neoliberalism and, 33–36
patient populations and, 261
pioneering industries and, 89
regulatory brokerage and, 228–231
regulatory discrepancies and, 242
regulatory gaps and, 239
social contract and, 259–260
variability and, 44 See also international regulation
Dr Gong, 110
Good Clinical Practice (GCP), 55, 237
Good Gene, Cell and Tissue Practice (GCTP), 169, 171
Good Laboratory Practice (GLP), 36, 49
India and, 235
Japan–Thailand collaboration and, 127–128
PMD pathway and, 169
scarcity of resources and, 39
Thailand and, 141–142
Good Manufacturing Practice (GMP), 36, 49, 55, 107
collaborative science and, 133
India and, 235
industrial standards and, 176
non-homologous use and, 113
PMD pathway and, 169
R-CPX and, 130, 135
RM Act and, 173
scarcity of resources and, 39
state investment and, 251
Thailand and, 141–142
good practice requirements, 55
governance, 208
AJS and, 159–163
competitive desire in, 250–251
HOs and, 186–190
knowledge activism and, 199–201, 203 See also politics
Graft versus Host Disease (GvHD), 50, 70, 74–75
controversial applications of, 105
R-CPX and, 137
Temcell and, 225
grass-root organisations, 188. See also patient organisations
grey experimental industries, 117
GTP (good tissue practice), 55
Guangzhou Alliance, 74–75
Guangzhou City Large S&T Expert Program, 74
Guangzhou Huanhuang, 75
Guangzhou Hygiene Department, 75
Guangzhou Institute for Biomedicine and Health (GIBH), 74
Guangzhou Province, 49, 61
Guangzhou Stem Cell and Regenerative Medicine Alliance, 61
Guidance for Research and Evaluation of Cellular Therapy Products (China), 237
Guidelines for Stem Cell Research and Therapy (India), 80–81
Haelios, 171
Han, Zhongchao, 71–72
Hanshi, 75
Hanshi (Beijing Health and Biotech Group), 72
Haraway, Donna, 92
hard law, 48, 52, 58
harmonisation. See regulatory harmonisation
Hashigawa (from FBRI), 176, 223
Hayek, Friedrich, 34
Headquarters of Healthcare Policy (Japan), 158
Healios, 166, 177
Health and Pharmaceutical Promotion Strategy, 155, 160, 164
health organisations (HOs), 185–186
cost-effectiveness and, 254
deregulation and, 241
diverse needs of disabled and, 190–193
down-regulation and, 254
health activism and, 203–204
industry and, 196–198, 253
internationalisation of, 181–184
knowledge activism, 199–203
locally situated demands and, 193–196
patient wishes and, 184
personal decision-making and, 255
political governance and, 186–190
political identity and, 204–206 See also networks; organisational levels; patient organisations
Healthcare Engineering Group, 129
healthcare insurance, 159, 224, 253
Beike and, 111
biotechnology ethics and, 267
cost-benefit analysis and, 255
globalisation and, 260
industry seeking payouts from, 197
national schemes for, 106
universal coverage and, 136–137
Hearticellgram, 58, 233
Heartland Institute, 183, 231
Heartsheet, 225
hegemony, 63
approaches to, 65–66
down-regulation and, 184
ethical conformity and, 69
health activism counter to, 204
LMICs and, 88
patient movements and, 182
regulatory capacity building and, 89
regulatory redemption and, 150
hematopoietic stem cells (HSCs), 10–11
Thailand and, 140
Zhao research on, 70
heterogeneous cell lines, 12
high-income countries (HICs), 3, 121–122
biotechnological solutions and, 185
biotechnology ethics and, 267
bureacracy and, 205
caring solidarity and, 264
collaboration and, 124
Cossu and, 253
cost and, 254
counter-hegemony and, 204
enablement and, 123
experimental practices and, 63
hegemony theories and, 66
HOs and, 186, 189
industry collaboration and, 196–198
knowledge activism and, 199–203
MD and, 195
MSCs and, 99
needs of disabled and, 191
political lobbying in, 190
regulatory brokerage and, 209
regulatory gaps and, 206
regulatory tolerance and, 112
SCI and, 193, 195
sustainability of healthcare in, 21
view of fraudulent science in, 42
‘Highway to the Realization of Regenerative Medicine’ (Japan), 157
HLA (human leukocyte antigen) matching, 11–12
holistic medicine, 53
home-keeping strategy (Japan), 230
homologous use, 113
Hong Kong University of Science and Technology, 109
horizontal pressure, 215
Hoshino, Toshihiko, 160, 162
Hospital Exemption (HE) (EU), 50, 116, 119–120, 223
Article 5(1), 50
non-routine use and, 53
House of Lords (UK), 238
debate in, 251–252
Huaxia Ganxibao Lianmeng (Beijing Health and Biotech Group), 72
human embryonic stem cell research (hESC), 175–176
Bush 2001 moratorium on, 41
hESC moratorium and, 41
investment in, 13
IPS cells and, 156
Japan and, 157
upscaling production of, 249
US funding cuts and, 101
human-rights discourse, 184
Hunan Guangxiu Biological Science Co., Ltd., 76
Hunan Guangxiu Hospital, 76
Hunan Provincial government, 76
Hwang Woo-Suk, 41, 194, 196, 198
Hybrid Assistive Limb (HAL®), 194
ideal regulation, 78
inequality and, 146
identity, 184
care and, 268
discursive messaging and, 96
normalcy and, 256
imitation, 26, 100
caring solidarity and, 270
Girard and, 213
imitative desire, 93, 97
objectification of others and, 264
immature therapies, 16
immune reactions, 12
immune suppressants, 176
immune tolerance. See regulatory immune tolerance
immunitarian force, 93–94
immunitary politics, 125
regulatory capital and, 148
immunitas, 93–97
immunological rejection, 170
in vitro generation, 13
India, 52, 55
2007 stem cell guidelines and, 86
2013 regulation and, 235
bureaucracy in, 52
elite laboratories and, 88
globally shared patient needs and, 204
Guidelines for Stem Cell Research and Therapy in, 80–81
hegemonic approaches and, 66
HO recognition in, 190
HO registries and, 201
HOs and, 205
human rights discourse and, 203
industry collaboration and, 197
international guidelines and, 67
Japan and, 234–236
Japanese–Thai collaboration and, 138
kosher/rogue binary in, 103
LMIC collaboration and, 56
needs of disabled and, 190–192
NGOs and, 188
off-label use in, 49
phase three trials and, 181
regulatory boundary-work and, 64
regulatory immunity and, 92, 240
responsible innovation in, 78–79
SCI and, 194, 200
stem cell tourism and, 195
Stempeutics and, 83–84
Stempeutics model and, 85–87
UK and, 101
ZCRM and, 218–219
Indian Council of Medical Research (ICMR), 52, 80–81, 86, 218
Indian Institute of Science (IISc), 82
indirect violence, 7–8
individual responsibility, 248
individual-rights discourses, 202–203
health activism and, 204
induced pluripotent stem cells (iPSCs), 10–12
AJS and, 155, 160–162, 174–179
AMD and, 163
assays for, 167–169
CiRA and, 163–166, 171–173
clinical trial pathways for, 169–171
collaborative science and, 133
competitive desire and, 250
creation of, 156–157
discovery of, 41
GMP conditions and, 173
investment in, 13
Japanese regulation of, 58
politics of, 156
publication and, 134
regenerative therapy and, 165
research success and, 158–159
state investment and, 249–250
Yamanaka Nobel Prize and, 136
industry, 171
AJS and, 175–176
Australia and, 117
HO collaborations with, 189
HOs and, 196–198, 253
individual-rights discourses and, 203
investment and, 88
Japanese investment and, 223–224
Japanese–Thai collaboration and, 142
regulatory gaps and, 206
responsible image of, 86
state investment and, 252–253
inequality, 146–147
political movements and, 154
infections, 176
infrastructure, 261, 269
effective creation of, 77
Japan and, 158
Initiatives under the Project for Japan Translational and Clinical Research Core Centers policies (Japan), 158
innovation, 4
contested science and, 105
exemptions for, 50
market acceleration and, 51–52
regulatory orientation and, 88
responsibility and, 78–79, 81, 86 See also experimentation
Institute for Biomedical Research and Innovation (IBRI), 167
Institute of Hematology (PUMC), 71–72
Institutional Committee for Stem Cell Research (IC-SCR), 80, 235
Institutional Ethics Committee (IEC) (India), 80
guidelines from, 219
institutional review boards (IRBs), 16, 49
Guangzhou Alliance and, 75
Thailand and, 140–141
Integrated Cell-Material Sciences (iCeMS), 164
intellectual property rights (IPR), 43–44
Beike and, 110
intentionality, 8
interest groups, 215
interest-group theory, 6
‘Interim Regulations on the Ethical Review of Biomedical Research Involving Human Subjects’ (MoH 2007), 67
internal mirroring, 92–93
International Alliance for Biological Standardization (IABS), 176
International Association of Neurorestoratology (IANR), 61, 97
International Cellular Medicine Society (ICMS), 60
credible authority and, 97
International Clinical Trials Registry Platform (ICTRP), 12
International Consortium of Stem Cell Networks (ICSCN), 60
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 229
International Monetary Fund (IMF), 36
International Organization for Muscular Dystrophy (IOMD), 182
International Organization for Spinal Cord Injury (IOSCI), 182
International Pharmaceutical Regulatory Harmonization Strategy, 230
international regulation, 5, 24
2008–2014 period for, 62
China’s adaptation of, 112
Chinese state laboratories and, 111
collaboration and, 124
competition and, 2, 34
credible authorities for, 97
global competition and, 27
global dynamics of, 18–19
guidelines and, 55
health organisation standards and, 205
hegemony and, 88
HOs and, 181–184
international, 47
knowledge of, 22
participation in, 45
patient movements and, 30
regulatory boundary-work and, 60–62
regulatory brokerage and, 239
regulatory capital and, 145–146
unauthorised clinics and, 108 See also globalisation
International Society for Cellular Therapy (ISCT), 60, 67
formulation of regulations and, 45
Japanese–Thai collaboration and, 134
social contract and, 260
International Society for Stem Cell Research (ISSCR), 60, 62, 67, 229
China and, 237
credible authority and, 80
formulation of regulations and, 45
India criticised by, 235
Japan and, 151
Japanese–Thai collaboration and, 134
regulatory capital and, 145
scarcity of resources and, 39
social contract and, 260
International Society of Plastic Surgeons, 85
International Stem Cell Bank Initiative (ISCBI), 60, 167
defining pluripotency and, 174
industrial standards and, 176
International Stem Cell Forum (ISCF), 60
International Stem Cell Initiative (ISCI), 43, 60
International Stem Cell Registry (ISCR), 60
inverse care law, 256
investigational new drugs (INDs), 49, 115
CiRA and, 173
Japan and, 223
US and, 115
investigational use, 80
FTCM and, 183
investment, 88, 171
caring solidarity and, 269–270
Japanese industry and, 223–224
political desirability and, 104
state support for, 249–250
virtue ethics and, 269
in-vitro fertilisation (IVF), 75–76
Invitrogen (ABI), 167
Invossa, 233
ischemic stroke trials, 73
Italy, 119, 197
AIFA medical agency and, 120
regulatory tolerance and, 121
Japan, 124–127
Australia and, 117
caring solidarity and, 241
China and, 237
competitive desire and, 250
competitive reform and, 233–234
conditional approval and, 231
fast-track pathways and, 57–60
forms of brokerage and, 217
FTCM and, 231
funding overhaul in, 156–159
global brokerage and, 229–231
HOs and, 194–195, 205
India and, 234–236
industry collaboration and, 198
informal brokerage and, 219
informal regulatory brokerage and, 218
international brokerage and, 224–228
knowledge activism and, 202
LMIC collaboration and, 56
market acceleration and, 51
national insurance and, 253
other country experiences similar to, 253
patient financial contributions in, 106
reform and, 30, 127
regulatory boundary-work and, 64
regulatory brokerage and, 239
regulatory capacity building and, 217
regulatory dynamics of, 63
regulatory immunity and, 240
regulatory overhaul and, 42
SCI and, 201
shared scientific cultures and, 53
social contract and, 258
soft law and, 48
South Korea and, 232
state investment and, 250, 252
state support brokerage and, 219–221
stem cell trials in, 13
Taiwan and, 236–237
tax on legacies in, 188
UK and, 238, 252 See also All Japan System (AJS)
Japan Medical Association, 165
Japan Muscular Dystrophy Association (JMDA), 195
Japan Revitalization Strategy, 219
Japan Science and Technology Agency (JST), 163–165
Japanese Society of Regenerative Medicine (JSRM), 221–222, 234
Japanese–Thai collaboration, 124–127, 131–133, 143–145
R-CPX and, 133–135
regulatory capital and, 145–147
regulatory discrepancies and, 130–131
state support brokerage and, 219–221
Jerne, Niels, 92
Jiao Hong, 215
Jordana, Jacint, 5, 35
judgement, 267. See also community
judicial systems, 94
June, 249
justice, 27, 32, 214, 265–266, 268–269
caring solidarity and, 212, 270
common good and, 265–266
creative desire and, 263
local notions of wisdom and, 246
patient protection and, 15
sacrificable victims and, 259 See also caring solidarity
Kanagawa Centre for Clinical Research and Strategy, 226
Kanishka (pseudonym), 82
Kawa (researcher at iCeMS), 163–164
Kawasaki (Japan), 226
Kawasaki Heavy Industry (KHI), 29, 124–129, 143–144
collaborative scientific results and, 133–135
Japanese–Thai collaboration and, 131–132
medical use and, 136–137
regulation and, 140–143
regulatory capital and, 145, 147
state support brokerage and, 219–221
trust and, 138–139
Keating, Peter, 82
Keihin Coastal Areas Comprehensive Special Zone for International Competitiveness, 225–226
Keio University, 160
KenCare, 57
Keynesianism, 34
Kishi (scientist), 172–173
knowledge activism, 190, 196, 199–203
knowledge assets, 14, 132, 134, 178
Kolon TissueGene, 233
Korean Food and Drug Administration (KFDA), 57, 232–233
Korean Ministry of Food and Drug Safety (MFDS), 58
kosher practices, 29, 103
discursive identification and, 97
foreign practices and, 24
grey areas and, 95
regulatory immunity and, 93
K-Stemcell, 57
Kuala Lumpur (Malaysia), 87
Kumar, M. (pseudonym), 82–85, 218
kusakariba ‘cutting from the hay-meadow commons’, 225
Kyoto University, 160
Centre for iPS Cell Research and Application (CiRA), 133
off the shelf cells and, 171
Kyoto University Hospital (KUH), 170
RM Act and, 173
Kyoto University Medical School, 164
Lancet Report (Cossu et al.), 243
Lanphier, Edward, 230
‘Large-scale cell production of stem cells for clinical application using the automated cell-processing machine’ (Kami et al. 2013), 133
last resort treatment, 75
Latin America, 182
Latour, Bruno, 113
law, 95
establishment of, 93–94
rule of, 15, 36
transcendental power and, 96
legal justice, 268
Levi-Faur, David, 5
regulatory state approach and, 5
liberalism, 34
Life Innovation Centre (LIC), 226
Life Technology, 167
Lifecell, 61
Lippmann, Walter, 34
lobbying, 35, 188, 190
active brokerage and, 239
FTCM and, 190
health funding priorities and, 45
localities, 44, 63
caring solidarity and, 270
collaboration and, 49
creative desire and, 264
dilemmas of, 66
disability and, 190–193
Guangzhou Alliance and, 75
hegemony and, 89
ideal regulation and, 78, 105–107
international networks and, 60–62
international regulation and, 67
jurisdictional differences and, 23
knowledge activism and, 201
LMICs and, 56, 122
local practices, 31
locally situated demands and, 193–196
organisational networks and, 216
patient populations and, 261–262
prudence and, 265
regulation in, 20, 63
regulatory boundary-work and, 46
regulatory brokerage and, 243
regulatory capacity building and, 77–78, 211
regulatory contagion and, 147
regulatory orientation and, 69, 77
regulatory redemption and, 149–154
rogue experimentation and, 103
self-help solutions and, 267
shared scientific culture and, 52
therapy provision and, 27
wisdom and, 246, 263, 268
workspaces and, 188
loopholes, 116
loose regulation, 56
loving desire, 263
lower and middle-income countries (LMICs), 1
Beike Biotech case and, 108, 111
biotechnology ethics and, 266–267
collaboration and, 124
Cossu and, 253
economic growth in, 121
hegemony and, 65–66, 89
HOs and, 186, 193–194, 204–206
industry collaboration and, 198
international guidelines and, 67
investment by, 14
knowledge activism and, 199–200, 202–203
local communities and, 263–265
MSCs and, 99
needs of disabled and, 192
neoliberalism and, 64
network complexity and, 70
patient financial contributions and, 106
patient movements and, 182
regulatory boundary-work and, 59, 88–89
regulatory dynamics of, 63
regulatory immunity and, 105
regulatory redemption and, 25
SCI and, 195
scientific ambitiousness and, 55
shared scientific cultures and, 52
small country investment and, 56–57
sustainability of healthcare in, 21
universal regulation and, 122
Western hegemony and, 41
Lu Daopei hospitals, 77
Lu Guangxiu, 75–76
Magellan Stem Cells, 116
Majone, Giandomenico, 5–6
major histocompatibility complex (MHC)–matched iPSCs, 170
Malaysia, 56–57, 64
Stempeutics branch in, 81–82, 85, 87
Malaysian Biotech Corporation, 56
malpractice, 80
Management Measures for the Clinical Use of Medical Technologies (MoH), 68
Management of Clinical Research and Transformation Applications for Somatic Cell Therapy (China), 237
‘Manifesto for Slow Science’ (Stengers), 214
Manipal Education and Medical Group (MEMG), 81–83
Manipal Hospital, 82
Manohar, B. N., 235
Professor Manote, 140–141
manufacturing, 250
facility construction in, 249
markets, 26, 31, 259–260
absence of regulation for, 131
automation and, 144
Depuy on, 271
distancing mechanism of, 248
ethics and, 96
innovative acceleration and, 51–52
Japanese–Thai collaboration and, 132, 144
national permission for, 49
neoliberalism and, 33–36
PMDA and, 158
product functionality and, 85
R-CPX and, 139
responsive-market tools and, 5
scientific applications and, 159
social contract and, 258
Stempeutics and, 87
time-limited authorisation and, 224
Martin, Emily, 92
Marxism, 34
Masayo, Takahashi, 165
Master, Z., 122
Medical Council of Thailand (MCT), 130, 140–142
medical device regulation, 62
Medical Practitioners Act (Japan), 223, 232
Medical Research Council (MRC) (UK), 238
medicinal signaling cells, 104
Medicines Adaptive Pathways to Patients (MAPPs), 51, 119
Medicines and Healthcare products Regulatory Agency (MHRA) (UK), 227
Early Access to Medicine Scheme and, 51
Melton, Doug, 215, 237
Memorandum of Understanding (MOU), 197–198
mesenchymal stem cells (MSCs), 10–11, 104–105
national income and, 99
patient funding and, 117
safety and, 104–105
Tianjin stem cell cluster and, 72
upscaling and, 130
mesenchymal stromal cells, 104
Mesoblast, 59
Metchnikoff, Elie, 92
methodology, 21–23
Michael J. Fox Foundation for Parkinson’s Research (MJFF), 254
military research, 70, 72–73
immunity metaphors and, 92
mimetic desire, 243
Others and, 211
mimetic principle, 31
mimetic rivalry
caring solidarity and, 270
competition and, 100
competitive desire and, 97
discursive messaging and, 96
regulatory immune-tolerance and, 95
regulatory immunity and, 93–98
scapegoating cultures and, 103
mimetic theory, 212–213
creative desire and, 265
creative mimesis and, 263–264
minimal manipulation, 53, 117–118, 235
Ministry of Economy, Trade and Industry (METI) (Japan), 157, 233
Ministry of Education (China), 74
Ministry of Education, Culture, Sports, Science and Technology (MEXT) (Japan), 157, 160, 164
Ministry of Health (MoH) (China), 67–68
hESR guidelines and, 102
January 2012 Notification by, 73
PLA and, 72
Tianjin UCB and, 71
Ministry of Health, Welfare and Labor (MoHWL) (Japan), 58, 142, 157–158, 195
competition and, 234
global brokerage and, 230
Parkinson’s Disease and, 170
PMD pathway and, 169
Takahashi and, 163
whole-genome sequencing costs and, 170
Ministry of Science and Technology (MoST), 70
minor histocompatibility antigen (MHA), 170
Mirowski, P., 159
misrecognition, 31
AJS and, 155, 163, 165, 177–178
international brokerage and, 228
life-saving medicine and, 211
politics of, 156
misrepresentation, 264
misrecognition and, 228
modernity, 112–113
monopoly, 3, 9, 34
morally binding action, 267–268
multi-centre clinical trials, 55
Multi-Stem, 50
muscular dystrophy (MD), 30, 185–188
diverse needs of disabled and, 190–192
embodied identities and, 204
industry collaboration and, 197–198
knowledge activism and, 200–202
locally situated demands and, 193, 195–196
patient movements and, 183
political governance and, 186–188, 190
muscular skeletal disorders, 175
mutations, 170
mutual surveillance, 118
mutuality, 26, 74
CRT participation and, 258
Depuy and, 271
good governance and, 257
market/gift exchanges and, 260
Dr Nakasone, 138
Nakauchi, Hiro, 160
Doctor Nantakam, 137, 140–141
National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT)(India), 52, 80, 219, 235
National Center for Child Health and Development (Tokyo), 133
National Centre for Human Stem Cell Research Engineering (NC-SCRE), 76
National Development and Reform Commission (China), 71, 76
National Ethics Committees, 57
National Guidelines for Stem Cell Research (2013) (India), 80–81, 219
National Guidelines for Stem Cell Research (2017) (India), 234–235
National Health and Family Planning Commission (NHFPC), 67–68
National Health Commission (NHC) (China), 237
National Health Service (NHS) (UK), 51, 101, 238
National Institute for Health and Care Excellence (NICE), 51
National Institute for Health and Care Research (NIHR) (UK), 101
National Institute of Advanced Industrial Science and Technology (NAIST), 133
National Institute of Health (NIH) (Japan), 225
National Institute of Health (NIH) (Korea), 232
National Institute of Health (NIH) (USA), 53, 109
Clinicaltrials.gov database, 115
funding by, 223
National Key Research and Development Program ‘Stem Cell and Transformation Research’ (China), 237
National Medical Products Administration (NMPA) (China), 237
National Organization for Rare Disorders (NORD), 254
National Stem Cell Engineering (NSCE) Industrialization Base, 71
nation-states, 38
cost-benefit analysis and, 248
globalisation and, 246–248
immunity metaphors and, 92–93
monopoly and, 3
policy formation and, 45–47
power and, 94
regulatory boundary-work and, 28, 44–45
regulatory gaps and, 206
regulatory governance and, 5
regulatory immune-tolerance and, 95
Self and, 29
social contract and, 257
state support brokerage, 217, 219–221
support for investment by, 249–250
transcendental authority and, 260
trust and, 205 See also regulatory governance
Nature Cell, 234
negotiation, 145
collaboration and, 127–128
levels of organisation and, 216
regulatory brokerage and, 239
regulatory capital and, 126
neoliberalism, 4
FTCM and, 181
outsourcing regulation and, 215
regulatory boundary-work and, 64
regulatory capitalism and, 33–36
Netherlands, 118, 183
networks, 18
alternative therapeutic practices and, 63
biomedical platforms and, 82
case-studies of, 19
complexity of, 70
entrepreneurism and, 82
funding through, 72
Guangzhou Alliance and, 74–75
regulatory boundary-work and, 60–62
regulatory orientation and, 77–78
Zhao access to, 71. See also health organisations; organisational levels; patient organisations
Neuralstem, 73
Neurogen, 50, 235
neurorestorative therapies, 61
New Drugs and Clinical Trial Rules (India), 235
Niscell, 56
non-disclosure agreements (NDA), 223
non-governmental organisations (NGOs), 188
non-homologous use, 113
non-political organisations (NPOs), 188
non-routine use, 53
Non-Self, 29
Norio, Nakatsuji, 175
normalcy, 204, 254
North America, 114
‘Notification on Self-Evaluation and Self-Correction Work regarding the Development of Clinical Stem Cell Research and Applications’ (MoH 2011), 68, 298
Novartis, 249
Novumcella, 235
objectification, 263–265
Office of Medical Innovation (Japan), 221
off-the-shelf therapies, 171
AJS and, 178
state investment and, 249
Okano, HIdeyuki, 160
Okano, Teruo, 221–222
oligopoly, 34
oocyte sourcing, 11, 176
opportunistic regulatory brokerage, 210–212, 216–217, 219, 224, 239
slow science and, 214
organ bioengineering, 101
Organisation for Economic Co-operation and Development (OECD), 4
organisational level. See also health organisations; networks; patient organisations.
organisational levels, 216
orientations. See regulatory orientation
Orphan Drug Designation (ODD), 50
Osaka Declaration, 222
Osiris, 74
osteoarthritis, 58, 125, 133, 135, 142–143
osteoporosis, 252
Other-ability movement, 184
normalcy and, 204
Othering, 264–265
Others, 26, 92, 211
immunity metaphors and, 92
snake-oil and, 42
pain management, 187, 192
Pal, Ratan (pseudonym), 81–82
parent organisations, 187
Parents of Patients with Muscular Dystrophy Organization (PPMDO), 187
Parkinson’s Disease, 105, 169–170, 178
small-scale studies and, 107
parliamentary discussion, 248
Patel, Lord Kamlesh, 251
Patent Act (Japan), 158
patient choice, 107, 111
patient confidentiality, 110
patient engagement, 257–258
patient financial contributions, 106
Australia and, 117
Beike and, 109, 111
ethicality of, 107
US and, 114–115
Patient For Stem Cells, 115
patient movements, 30
Deane-Drummond and, 266
deregulation and, 154
experimentation and, 205–206
HOs and, 181–184, 186, 189, 193–195
knowledge activism and, 199–200
regulatory brokerage and, 207
patient needs, 42
AJS and, 174, 178
AJS lack of priority for, 164
caring solidarity and, 214, 240
CGTs and, 227
disability and, 190–193
down-regulation and, 184
global sharing of, 204
local communities and, 268
misrecognition and, 31, 153, 228
political desirability of, 104
regulatory tolerance and, 121
regulatory violence and, 2, 185
patient organisations: See also health organisations; networks; organisational levels
patient rights, 202
patients, access to, 260–263
Pei Duanqing, 74
Peking Union Medical College (PUMC), 71
collaboration with, 76
Institute of Hematology of, 71–72
People’s Liberation Army (PLA), 73
307 Hospital patients at, 70
performance, 20, 23, 25, 150–151, 154, 207
All Japan System and, 30, 154
international dynamics of, 209
political movements and, 19, 31, 52
regulation as, 7
regulatory boundary-work and, 99
regulatory brokerage and, 217
regulatory change and, 18
regulatory discrepancies and, 245
regulatory flexibility and, 5
regulatory redemption and, 151
varying enactments of, 149
permissive regulation, 113
AJS and, 178–179
Australia and, 116–117
HOs and, 205
Japan and, 224
Japanese–Thai collaboration and, 144
prohibitive regulation and, 239
regulatory brokerage and, 210, 239
Pfizer, 176
Pharmaceutical Affairs Law (PAL), 58
Pharmaceutical and Medical Drugs Agency (PMDA) (Japan), 133
pharmaceuticals, 16–17, 101, 143, 205
Chinese classification as, 68
FTCM and, 181
HOs and, 198
industrial standards and, 176
lowering costs and, 183
monopoly of, 205
rogue practices and, 197
takeover targets and, 249
Pharmaceuticals and Medical Devices Agency (PMDA)(Japan), 58, 159, 169–170
global brokerage and, 229–230
GMP and, 173
INDs and, 173
internationalisation and, 177
Japanese–Thai collaboration and, 145
Kanagawa Centre and, 226
patient financial contributions in, 106
predatory firms and, 234
product approvals and, 180
Taiwan and, 236
time-conditioned approvals and, 241
Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act), 58
international brokerage and, 225
JSRM and, 222
Parkinson’s Disease and, 170
regulatory immunity and, 240
state investment and, 252
phase three trials, 181
phase two trials, 181
physical exercise, 195
placebos, 55, 107, 110
Plan for the Promotion of Medical Research and Development, 219
platelet prduction, 173
pluripotent stem cells (PSCs), 10
classifications of, 175–176
iPSCs and, 11–12
ISCBI and, 174
upscaling production and, 249
Poland, 120
Polanyi, Michael, 34
policy formation, 45–47
political desire, 121
experimentation and, 105
regulatory harmonisation and, 103
politics, 23–25, 29, 151, 186–190
AJS and, 156, 163, 174, 177–178
effectiveness in, 258
formation of political society and, 257
globalisation and, 246–248
HOs and, 204
identity and, 203, 206
misrecognition and, 152–153
regulatory boundary-work and, 52
regulatory immunity and, 245
regulatory redemption and, 149–155
social contract and, 258–259 See also regulatory boundary-work
polycentric regulation, 4
pop-up markets, 107
poverty, 203, 261
power, 157
AJS and, 168
nation-states and, 94
regulatory redemption and, 129, 150
transcendental forms of, 70
transfer of, 247
pragmatism, 203
trial design and, 262
pre-market authorisation, 114
prenatal genetic testing, 187
primary care, 268
primary prevention of medical conditions, 268
Priority Medicine (PRIME), 119
private interest theories, 6
privatisation, 35
product functionality, 85
production, 53, 101
dialectic of, 150–151, 155, 163
global expansion of, 35
profit, 107
caring solidarity and, 270
high-risk strategies and, 246
political desire and, 105
prohibitive regulation, 113
active brokerage and, 221
FTCM and, 183
Japan–Thailand collaboration and, 128
opportunistic brokerage and, 239
regulatory brokerage and, 210, 217
regulatory immunity and, 240
Promising Innovative Medicine (PIM) designation, 51
protectionism, 34
prudence, 27, 32, 214, 263
caring solidarity and, 212, 270
common good and, 265–266
local notions of wisdom and, 246
utilitarianism and, 269
wisdom and, 268 See also caring solidarity
Prudent Healthcare, 266
public choice theory, 6
public discussion, 22
public interest theories, 6
regulatory reputation and, 91
public needs, 45
publication of research, 134
pure vs. applied science, 159
Quality Control Standards for Clinical Drug Trials’ (CFDA), 67
race, 262
radical regulatory change, 42, 47, 58–60, 63
AJS and, 162
South Korea and, 64
randomised control trials (RCTs), 53–55
adverse effects and, 106
ethical appraisal of, 107–108
kosher/rogue binary and, 103
poor insurance conditions and, 202
universal regulation and, 105–106 See also clinical research trials (CRTs)
rare disease criteria, 50
rational individualism, 263
RBio, 234
reactive brokerage, 224, 231
forms of, 217
reconstructive procedures, 84–85
recruiter patients, 182
Red Cross, 138
red envelopes (bribes), 111
redemption. See regulatory redemption
reform. See regulatory reform
regenerative medicine, 10–13, 165, 176–177
experimental therapy, 16–18
foreseeable harm and, 1–2
global dynamics of, 18–19
investment in, 13–14 See under regulation
Regenerative Medicine (journal), 117
Regenerative Medicine Expert Group (House of Lords, UK), 238
Regenerative Medicine Industrialization Task Force (RMIT), 226
Regenerative Medicine Law (Japan), 238
Regenerative Medicine Markets Analysis and Forecast, 13
Regenerative Medicine Promotion Act (RMP Act), 222, 241, 258
Regenerative Sciences, 104
Regenexx, 104, 115
registries, 200–202
REGROW-Act (USA), 232, 235, 241
regulation, 3, 14
alternative forms of, 15
Black on, 215
change process and, 20
definitions of, 4
experimental practices and, 16–18
global dynamics of, 18–19
Japanese–Thai collaboration and, 140–143
multiple pressures on, 7
neoliberalism and, 4–5
rebellion against dominant modes of, 60
regulatee binary and, 7
regulatory violence and, 21
scientific rationale of, 28
theories of, 5–7
Regulation on the Review and Authorization of Biological Products (South Korea, 57
regulatory acceleration, 48
Australia and, 118
exemptions and, 205
fast-track approval and, 57
HOs and, 190
PMDA and, 180
R-CPX and, 142
regulatory brokerage and, 210
US and, 114–115
regulatory adjustment, 46, 118, 231, 240
regulatory agencies, 107
regulatory assets, 136
regulatory authority, 48
regulatory boundary-making, 29
caring solidarity and, 270
international brokerage and, 228
Japanese style of, 219
performance and, 149
scapegoating and, 97
regulatory boundary-work, 23, 25, 37–42, 62–64
authority and, 48–49
collaboration and, 124
ethical binaries and, 123
factors underpinning, 59
HICs and, 121
innovation and, 52
international networks and, 60–62
Japanese–Thai collaboration and, 144
LMICs and, 78, 88–89
local contexts for, 52
national conditions and, 45–47
nation-state politics and, 28
politics of reputation and, 91–92
RCTs and, 55
regulatory concepts and, 211
regulatory immunity and, 28, 99
regulatory orientation and, 89
regulatory reputation and, 102
scientific boundary-work and, 42–44
state governance and, 44–45
strategic practices of, 27
West and, 113
regulatory brokerage, 3, 23, 25, 27
AJS and, 162, 180
down-regulation and, 254
five forms of, 216–217
foreseeable harm and, 215
global brokerage and, 228–231
harmful consequences of, 243
illegitimate aims of, 246
illegitimate reasons for, 244
informal forms of, 217–219
international form of, 224–228
justice and, 269
marginal standards and, 35
neoliberalism and, 33
organisational levels of, 216
prohibitive regulation and, 239
reform and, 221, 224
regulatory boundary-work and, 46
regulatory capacity building and, 28
regulatory capitalism and, 64
regulatory difference and, 245
regulatory discrepancies and, 239
regulatory immunity and, 89
regulatory redemption and, 150, 153
regulatory violence and, 31, 209–212, 242–243
research therapy tension and, 15
state support and, 219–221
regulatory capacity building, 23, 25, 28, 30
China and, 67–69
competition and, 88
hegemony and, 89
India and, 80
Japanese–Thai collaboration and, 144
LMICs and, 66
prohibitive regulation and, 240
regulatory concepts and, 211
regulatory orientation and, 77–78
Stempeutics and, 83–84, 87 See also regulatory orientations
regulatory capital, 29
active brokerage and, 221
centrality of, 29
collaboration and, 125–126
commodification and, 239
international brokerage and, 225, 228
Japanese reform and, 224
Japanese–Thai collaboration and, 127–128, 133, 143–147
regulatory brokerage and, 209
regulatory concepts and, 211
regulatory difference and, 245
regulatory immunity and, 240
state support brokerage and, 219–221
regulatory capitalism, 2, 4–6, 15, 25–27
Beike and, 111
caring solidarity and, 31, 270–271
collateral sacrifice and, 248
commodification and, 263
competitive advantages under, 123
competitive strategies and, 246
conceptual terminology of, 23
creative desire and, 263
global brokerage and, 231
global dynamics of, 18–19, 204
globalisation and, 247
immunity metaphors and, 92
Japanese–Thai collaboration and, 147
large LMICs and, 108
LMICs and, 88
local communities and, 243
mutuality and, 257
neoliberalism and, 33–36
patient movements and, 30
patient populations and, 260, 262–263
political movements and, 154
regulatory boundary-work and, 39–40, 64
regulatory brokerage and, 213
regulatory immune-vacuum and, 93, 96–97
regulatory immunity and, 94
regulatory redemption and, 150
regulatory reputation and, 37–38
regulatory theories and, 216
social contract and, 243, 246, 256, 259–260
stem cell trials and, 13
theory of, 5
Regulatory Capitalism (Braithwaite), 35
regulatory capture theory, 6, 40, 215
regulatory cascades, 208, 212, 215–216, 231
regulatory competition, 2, 27
China and, 237
global dynamics of, 18
increase in collaboration and, 42
mimetic desire and, 31
regulatory compromise, 3
regulatory consciousness, 245
regulatory contagion, 147
regulatory convenience, 79
regulatory development, 85, 87
global dynamics of, 28, 89
LMICs and, 88
regulatory difference, 211, 266
Japan and, 234
local dilemmas and, 66
regulatory brokerage and, 245
regulatory capital and, 245
Stempeutics and, 87
regulatory discrepancies, 31, 40, 97, 152, 239, 242
agency and, 208
AJS and, 155
collaboration and, 216
competitive desire and, 213
Japanese–Thai collaboration and, 125–127, 130, 143, 145–146
parallel studies and, 228
performance and, 245
reactive brokerage and, 224
regulatory brokerage and, 217–218
regulatory capital and, 209
regulatory immunity and, 125
regulatory diversity, 63
regulatory facilitation, 153
affordability and, 253
misrecognition and, 153
regulatory flexibility, 145
COVID-19 and, 214
performance of, 5
Regulatory Framework for Biologics, 116–117
regulatory governance, 5–7
frictions in, 26
regulatory harmonisation, 91, 113, 174
Asian regulation and, 144
global brokerage and, 228, 230
Japan–UK and, 227
political desirables in, 103
Stempeutics and, 87
WHO and, 100
WTO and, 123
regulatory hegemony, 28
regulatory ideals, 101, 121
political desirability and, 104
RCTs and, 105, 107
regulatory immune tolerance, 28, 91, 93–96
regulatory concepts and, 211
scapegoating and, 96–97 See also regulatory immunity; regulatory tolerance
regulatory immune-vacuum, 93, 96–98
regulatory immunity, 24–25, 28
AJS and, 179
Beike and, 111–112
collaboration and, 126, 239
competitive desire and, 240
establishment of law and, 93–94
global brokerage and, 231
Japan and, 151, 155, 219
Japanese–Thai collaboration and, 147
politicisation and, 245
regulatory boundary-work and, 99
regulatory brokerage and, 197
regulatory concepts and, 211
regulatory discrepancies and, 125
regulatory immune-tolerance and, 91, 94–96
regulatory immune-vacuum and, 96–98
regulatory redemption and, 150
regulatory reputation and, 91–93
Self and, 101, 103
South Korea and, 233
time-conditionally-approved products and, 224
trust and, 234
universal regulation and, 106
US and, 114
weakness of, 240
regulatory immunisation, 113, 120–122
down-regulation and, 205
HOs and, 206
regulatory impasse, 47, 63, 112
regulatory inflation, 66
regulatory infrastructures, 261
regulatory knowledge, 245
regulatory loopholes, 114
regulatory manipulation, 21, 35
regulatory objectivity, 43
regulatory orientation, 69–70, 211
China and, 71, 75–78
India and, 88–89
Stempeutics and, 78–79, 81, 85 See also regulatory capacity building
regulatory pathways, 87
regulatory patterns, 244
regulatory permission, 48
regulatory politics, 62
regulatory redemption, 23, 25, 30, 149–151, 153–154
All Japan System and, 155–156, 159–160, 162–163
deregulation and, 184
down-regulation and, 181, 184, 205
FTCM and, 186
Japan’s 2013 reforms and, 30
misrecognition and, 153, 177
overhyped celebration of, 245
patient movements and, 30, 182
reform and, 224
regulatory concepts and, 211
Taiwan and, 236
transcendental force and, 151–152
regulatory reform, 127, 210, 231, 239
AJS and, 160, 163, 166, 168–169
cascades of, 216
China 2009 regulations and, 67
Comprehensive Special Zones and, 225
India and, 86
ISSCR and, 229
Japan and, 221–224, 234
Japanese–Thai collaboration and, 147
overhyping iPS and, 179
performance of, 154
regulatory capital and, 146
regulatory redemption and, 155–156, 159
scientific reality of, 177
South Korea and, 233
Taiwan and, 236
US influence on, 231–232
regulatory reproduction, dialectic of, 151
regulatory reputation, 28, 91
Australia and, 117
constrictive regulation and, 149
discursive messaging and, 96
EU and, 118
ICMS and, 61
India and, 78, 87
investment and, 57
Japan and, 155, 224
Japanese reforms and, 154
Japanese–Thai collaboration and, 128, 132, 134
manipulation of, 210–214
national income and, 99
public interest and, 81
R-CPX and, 143
regulatory immunity and, 91–93
regulatory redemption and, 150
risks to, 101–103, 170
soft law and, 221
Stempeutics and, 85
regulatory resistance, 79
regulatory ritualisation, 24–25
misrecognition and, 153–154
R-CPX and, 147
regulatory redemption and, 152
Regulatory Science Centre, 230
regulatory sovereignty, 246
regulatory space, 48
regulatory state approach (Levi-Faur), 5
regulatory tolerance, 28–29
Australia and, 116–117
Beike and, 108, 112
EU and, 120
HICs and, 112, 121
India and, 235
international brokerage and, 228
Japan–India collaboration and, 219
regulatory capital and, 147
regulatory immune-tolerance and, 94–96
regulatory redemption and, 150
risk differentiation and, 106
Self and, 101, 103
Therapeutic Goods regulation and, 122
universal regulation and, 99, 106
US and, 114–115, 240
regulatory uncertainty, 18
medical device regulatiom and, 62
regulatory violation, 8
regulatory violence, 2–4, 24, 26–27
caring solidarity and, 269–270
competitive desire and, 31
creative desire and, 263–264
definitions of violence and, 7–9
down-regulation and, 30
foreseeable harm and, 1–2
global dynamics of, 20
globalisation and, 246–248
immunity metaphors and, 92
local communities and, 266–268
patients movements and, 31
politics vs. capitalism and, 216
regulatory brokerage and, 31, 209–213, 242–243, 245–246
regulatory immunity and, 93
regulatory redemption and, 30
research therapy tension and, 15
sacrifice of patient interests and, 248
sustainability of healthcare and, 21
rehabilitation, 195
reimbursement eligibilty, 225
Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Act (REGROW), 254
Reliance, 56
REMEDI, 119
Remudy (MD-research collective), 195
Reproductive & Genetic Hospital CITIC-Xiangya, 75–76
reputation. See regulatory reputation
Research Institute of Economy, Trade and Industry (RIETI), 233
resistance, 44
responsible innovation, 78–79, 81, 86
responsive regulation, 215
retinal pigment epithelium (RPE), 165, 167, 170–171
‘return to society’ aims, 187
Revised Pharmaceutical Affairs Law, 158
right to try laws, 15, 154
RIKEN Centre for Developmental Biology (CDB), 160, 163, 166
closure of, 177
rising powers, 42, 88–89
risk-benefits analysis, 268–269
risk-management, 224, 247–248
differentiation of, 106
high-profit margins and, 246
industrial standards and, 176
RNL Bio, 234
RNL/Celltex, 53
Roadmap for Regenerative Medicine, 141
Robot Cultivate Cell Culture (R-CPX), 125–126, 128–130, 144–145
Japanese–Thai collaboration and, 132, 145
medical benefits of, 136–137
proving worth of, 144
regulation and, 140–143
regulatory capital and, 143, 146–147
scientific results of, 133–136
trust in collaboration and, 137–139
Robotic Stem Cell Incubation Laboratory, 137
rogue practices, 24–25, 29, 41, 63
Beike and, 111
discursive identification and, 97
grey areas and, 95
industry collaboration and, 197
RCTs and, 103
regulatory immunity and, 93
regulatory reputation and, 102
US and, 114–115
X-Cell and, 118
Roman law, 95
rule by nobody, 9
Russia, 42
sacrificeable victims, 259–260
same surgical procedure exception, 114
Sasai, Yoshiki, 160
Sawa, Yoshiki, 133, 135, 142, 222
scaffolding, 135, 175
Scandinavia, 183
scapegoating, 29, 93, 96–97, 264
caring solidarity and, 270
cultures of, 102
EU and, 120
HICs and, 121
Thailand and, 125
SCI USA, 61
science and technology studies (STS) approaches, 66, 78
biomedical platform debates and, 89
scientific atheism, 102
scientific boundary-work, 37, 42–44
scientific culture, 52
scientific rationales, 89
scientific results, 133–136
differing priorities within, 143
scientific uncertainty, 104
stimulus to research of, 105
SCI-Net, 67
secrecy, 172, 178
Seer, 75
Self and Non-Self, 29, 92
immunity metaphors and, 92–93
mimetic rivalry and, 93, 100
misrecognition and, 228
regulatory tolerance and, 101, 103
rogue competitors and, 97
self-assessment, 61
self-help, 74
self-regulation, 94, 100, 103
semi-private enterprises, 75–76
Sendai virus, 172
Sent, E. M., 159
Sharma, Alok, 235
Shenzhen (China), 109
Shirai (immunologist), 174
Shirakawa, 164
Siebers, Tobin, 184
Simons, Henry, 34
Singapore, 57
Japanese–Thai collaboration and, 138
Singh, Sanjay, 81–82, 85
SiriCell, 57
Sirindhorn, Crown Princess Maha Chakri, 138
small-scale studies, 107
Smith, Adam, 34
snake-oil science and treatments, 24
Beike and, 111
EU and, 120
HICs and, 42
regulatory violence and, 8
Thailand and, 125
Traditional Chinese Medicine and, 102
social care, 268
social knowledge, 262
social-contract, 246, 256–260, 271
investments too large to fail and, 256
Lancet Report and, 243
patient populations and, 262–263
sacrificeable victims, 259–260
socio-economic environment, 261–262
socio-political positions, 152
socio-scientific network structures, 83
soft law, 48
innovation and, 52
regulatory reputation and, 221
somatic call nuclear transfer (SCNT), 11
somatic stem cell therapy, 10–12
dual-track system and, 237
EU and, 118
promise of, 143
Dr Sombat, 134, 137–140, 142
South Korea, 232–233
Australia and, 117
fast-track pathways and, 57–60
HOs and, 196, 205
India and, 235
industry collaboration and, 198
influence of reform and, 231–232
Japan and, 233
Japanese–Thai collaboration and, 138
knowledge activism and, 201–202
LMIC collaboration and, 57
market acceleration and, 51
regulatory boundary-work and, 64
regulatory dynamics of, 63
regulatory immunity and, 240
SCI and, 194–195
shared scientific cultures and, 53
stem cell trials in, 13
Specials scheme (UK), 50
Spinal Cord Injury (SCI), 30, 105, 185–186
diverse needs of disabled and, 190–192
HICs and, 196
HOs and, 182
identity politics and, 204
industry collaboration and, 197–198
knowledge activism and, 200–203
locally situated demands and, 192–195
patient movements and, 183
personal decision-making and, 255
political governance and, 186–188, 190
problems of global activism and, 203
self-empowerment and, 189
Spinal Cord Injury Network (SCIN), 188, 194
spotted regulatory brokerage, 26
Sri Lanka, 188
Srinivasan, Professor (pseudonym), 86
stakeholders, 69, 150
Stamina Foundation, 119–121
standards, 43
deviant forms of, 52 See also regulatory boundary-work
Standards (Busch), 34
STAP-cells (Stimulus-triggered acquisition of pluripotency), 177
Stem Cell and Cell Based Products (SCCPs)designation, 80
Stem Cell and Regenerative Medicine Strategy Working Group, 160
Stem Cell Network (Canada), 60
Stem cell Network Asia Pacific (SNAP), 60
Stem Cell Research Society of Thailand, 140
stem cell science, 10–12
debating distinctions among, 103
limited expert knowledge in, 86 See also clinical research trials (CRTs); underregulation
stem cell tourism, 102
Beike and, 109
HOs and, 195
patient movements and, 182
R-CPX and, 136
Stemgenex, 115
Stempeucare, 83–85
Stempeucel, 83–84
2013 regulation and, 235
Stempeutics, 56, 59, 66, 81–83, 85–87
2013 regulation and, 235
allogeneic stem cells and, 81–83
formulating regulation and, 88
responsible innovation and, 78–79
three-fold plan by, 83–85
unauthorised clinics and, 81
Stempeutron, 83–85
Stengers, Isabelle, 214
strict regulation, 205
structural factors, 247, 269
structural violence, 8–9, 242
subsidiarity principle, 118
Sumitomo Dainippon Pharma Co, 170–171
Sun Yat-Sen University, 77
Sūpā Tokku (special disciplinary areas or networks), 158
sustainable health, 2, 32, 246, 263
caring solidarity and, 270
Japan and, 267
symbolism, 149
All Japan System and, 154, 168
R-CPX, 147
regulatory redemption and, 150–152
saving lives and, 153
Taiwan, 53, 236–237
Taiwan Association for Cellular Therapy, 236
Taiwan Department of Public Health, 236
Taiwan Food and Drugs Administration (Taiwan FDA), 236
Takahashi, Jun, 169–170
Takahashi, Kazutoshi, 11, 156–157
Takahashi, Masayo, 163, 166–168, 170–171
Healios and, 177
Takayama, Kazuo, 163
Tanabe, Koji, 169–170
Tanida (tissue engineer), 175
TEDA development zone, 71
Temcell, 225
Temple, Sally, 235
Terumo, 222, 225
Texas (US), 53
THAI [pseudonym]), 125, 128, 131
R-CPX and, 136, 145
regulation and, 141
regulatory capital and, 147
regulatory reputation and, 134
trust and, 139
Thai Food and Drug Administration (TFDA), 131, 138, 142–143, 145
Thai Physician Association (TPA), 140
Thai Revised Drug Act, 144
Thailand, 131, 138, 142–143, 145
2009 regulation and, 130
caring solidarity and, 241
collaboration with, 124–127
investment by, 56–57
patient populations and, 262
regulatory boundary-work and, 64
regulatory immunity and, 240
shared scientific cultures and, 53
state support brokerage and, 219–221
thallassemia, 124, 136–137
The Automation Partnership Biosystems (TAP Biosystems), 129
therapeutic goods, 116–117, 121
Therapeutic Goods Association (TGA), 117
therapy provision, 80–83, 85–86, 88
Beike and, 110
R-CPX and, 136–137
regulatory immunisation and, 121
risk and, 135
symbolic value of saving lives in, 139
tension between clinical research trials and, 14–15
TheraVitae, 57
Thomson, James, 11, 157
351 products, 114
361 products, 113
Tianjin Amcell Gene Engineering Co., Ltd., 72
Tianjin Huayuan Hi-tech Park, 71
Tianjin Municipality, 70–72
Tianjin Umbilical Cord Blood Bank, 71
Tianjin Xiehe hospital, 72
tiered payment systems, 198. See also healthcare insurance
tiered risk system, 224
TiGenix, 50
time-conditioned approval, 224, 229
RMP and, 241
Taiwan and, 236
tissue engineering, 175
tissue regeneration, 84
tissue-engineering centers (TECs), 74
Toda, Yuzo, 230
Tokyo University, 160
tolerance. See regulatory tolerance
Too Much Medicine, 266
Tooke, Sir John, 251
top-down approaches, 215
Trade Related Aspects of Intellectual Property Rights (TRIPS), 36
Traditional Chinese Medicine (TCM), 102, 192
transcendental authority, 96, 151–152
caring solidarity and, 269
social contract and, 260
translational research, 17, 39–40, 55
acceleration of, 51
AJS and, 179
bodily violence and, 247
competitive desire and, 251
credible authority and, 97
FDA and, 49
House of Lords and, 251
India and, 78, 82, 88
LMICs and, 56
medium-sized coutntries and, 57
regulatory brokerage and, 210
regulatory redemption and, 153
social contract and, 256
state investment and, 252
transparency, 72
trial design, 51
AJS and, 173–174
deficiencies in, 179
local conditions and, 262
triangular mimetic desire, 26–27, 31
trust, 137–139
HOs and, 194–195, 197–198
individual-rights discourses and, 203
Japan and, 234
Japanese–Thai collaboration and, 143
state regulators and, 205–206
Tsai, T.-H., 236
tumorigenicity, 12
21st Century Cures Act, 232
2001 moratorium on federal funding for human embryonic stem cell (hESC), 41
UK–JAPAN Life Innovation Symposium, 226–228
umbilical cord blood banks (UCB), 71–72, 76
Beike and, 110
umbilical cord mesenschymal stem cells (US-MSCs), 108–109
unauthorised practices, 16
Beike and, 111
closing clinics and, 103
formulating regulation and, 88
HOs and, 205
R-CPX and, 140
regulatory tolerance and, 107, 240
Stempeutics and, 87
US and, 114–115
unclear/developing regulation, 47
unethical practices, 22
collaboration on, 147
universal application and, 106
Union Stem Cell & Gene Engineering (USCGEN), 71–72
United Kingdom (UK), 197, 226–228
competition and, 101
Early Access to Medicine Scheme in, 51
HO resource competition in, 188
House of Lords debate in, 251–252
industry collaboration and, 198
Japan and, 238
Japanese investment and, 223
needs of disabled and, 191
SCI and, 193, 200
soft law and, 48
‘Specials scheme’ in, 50
United Kingdom Nuffield Council on Bioethics, 17
United Kingdom Research and Innovation (UKRI), 112
United Nations (UN), 267
US Congress, 51
US Court of Appeals, 114
US Federal Trade Commission (FTC), 122
US Food and Drug Administration (FDA), 113–115
accelerated approval and, 51
Biologics and, 116
compassionate treatment and, 50
conditional approval and, 254
direct-to-consumer and, 122
expanded access and, 115
forms of authority used by, 49
FTCM and, 181, 232
ICMS and, 61
IND programme and, 49
Japan and, 151
knowledge activism and, 200
minimal manipulation and, 53
Orphan Drug Designation and, 50
patient financial contributions in, 106
RCTs and, 55
Regenexx-C and, 104
right to try laws and, 15
same surgical procedure exception and, 114
scarcity of resources and, 39
unproven stem cell therapies and, 236
WHO and, 123
United States of America (US), 113–115, 121–123
allogeniec stem cells and, 81
Australia and, 116–117
competition with Japan and, 233
conditional approval and, 254
ethical funding halt in, 101
EU and, 120
FTCM and, 181
HOs and, 205
India and, 80, 235–236
INDs and, 223
industry collaboration and, 197
influence of reform in, 231–232
international patient movements and, 154
knowledge activism and, 200, 202
market acceleration and, 51–52
minimal manipulation and, 53
modernity and, 113
off-label use in, 49
opposition to cooperation with, 177
patient financial contributions in, 106
patient movements and, 183–184
piecemeal regulation and, 59
platelet donations in, 173
private interest theories in, 6
pure science and, 159
RCTs and, 53–55
REGROW Bill and, 241
regulatory boundary-work and, 42
regulatory dynamics of, 63
regulatory overhaul and, 42
SCI and, 194–195
soft law and, 48
standards set by, 67
state funding and, 223
state investment and, 251
Stempeutics and, 86
UK–Japan collaboration and, 227
unauthorised stem cell-provision and, 240
Yamanaka and, 168
universal prohibition, 111
universal regulation, 102–103, 105–107
China and, 122
pluritpotency and, 175
University for Pregnant Women, 71
University of Texas MD Cancer Anderson Centre, 56
University of Wisconsin, Madison, 157
university-linked alliances, 74
unproven stem cell therapies, 235
unrealistic hopes, 259
upscaling production, 130
cost-benefits of, 256
Japan and, 229
R-CPX and, 137
state support brokerage and, 221
US Stem Cell, 115
US Stemology, 114
utilitarian approaches, 269
Valley of Death, the, 17
venture capital, 223–224, 249
developmental pathway length and, 227
victims, 264
sacrificeability of, 259–260
Vietnam, 56–57, 64
Dr Vimal(pseudonym), 86
violence, 7–8
alternative methrods and, 63
caring solidarity and, 270
cycles of revenge and, 259
definitions of, 7–9
establishment of law and, 93–94
exteriorisation of, 96
psychological forms of, 8
regulation and, 21
social contract and, 256 See also regulatory violence
virtue ethics, 266, 268–269
Waseda University, 218
wealth, 62
community and, 264
political identity and, 204 See also high-income countries (HICs)
Weber, Max, 3
WeChat (weixin), 194
well regulated countries, 113
Wen Jiabao, 110
Western society, 15, 41, 112–113
down-regulation and, 184
HOs and, 186, 193, 205
knowledge activism and, 199
patient movements and, 182
political influence of, 188
SCI and, 186, 194
Western-hegemony theory and, 38, 40
Wharton’s jelly cells, 120
wheelchair access, 191, 195, 197
whole-genome sequencing, 170
Dr Wilipana, 135, 138–141, 221
Willis, George Philip, Lord of Knaresborough, 251
Windholz, Eric, 5–6
wisdom, 268, 270
local notions of, 246, 263
prudence as, 266
Wise Young, 61
women, expectation to care and, 192
workspaces, 188–190
cultural politics and, 196
health activism and, 204
World Health Organization (WHO), 100, 122–123
universal health coverage and, 267
World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (WMA 2018), 50
World Premier International Research Centre Initiative (WPI), 164
World Trade Organization (WTO), 36, 123
Wu Medical Centre, 57
Wu Zuke, 76
X-Cell, 118
Xi Jinping, 112
Xiang Hu, 112
Xiangya Reproductive Hospital, 75
Yamanaka assays, 169
Yamanaka methods, 178–179
Yamanaka, Shinya, 11, 134, 156–157
AJS and, 160
doubt spread by, 175
Nobel Prize for, 136
product standardisation and, 174
Sendai virus and, 172
state investment and, 250
Yamanaka assay and, 167–169
Yao-Chan Chen, 236
Yokohama Declaration, 222–223
Z Centre for Regenerative Medicine (ZCRM), 218–219
Zhao Chunhua, 70–71, 76
Zhejiang University, 70
Zhongyuan Union Stem Cell Bioengineering Corporation, 56, 112

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  • Index
  • Margaret Sleeboom-Faulkner, University of Sussex
  • Book: Regulatory Violence
  • Online publication: 21 May 2025
  • Chapter DOI: https://doi.org/10.1017/9781009461757.016
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  • Index
  • Margaret Sleeboom-Faulkner, University of Sussex
  • Book: Regulatory Violence
  • Online publication: 21 May 2025
  • Chapter DOI: https://doi.org/10.1017/9781009461757.016
Available formats
×

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  • Index
  • Margaret Sleeboom-Faulkner, University of Sussex
  • Book: Regulatory Violence
  • Online publication: 21 May 2025
  • Chapter DOI: https://doi.org/10.1017/9781009461757.016
Available formats
×