The pharmaceutical market in the people's Republic of China in transition: current situation and development trends
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| Format: | Abschlussarbeit Buch |
| Sprache: | English |
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| Beschreibung: | XI, 289 S. graph. Darst. 21 cm |
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| 245 | 1 | 0 | |a The pharmaceutical market in the people's Republic of China in transition |b current situation and development trends |c von Yu-Wen Chou |
| 264 | 1 | |c 2008 | |
| 300 | |a XI, 289 S. |b graph. Darst. |c 21 cm | ||
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| 502 | |a Köln, Univ., Diss., 2008 | ||
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| 650 | 7 | |a Arzneimittelrecht |2 stw | |
| 650 | 7 | |a China |2 stw | |
| 650 | 7 | |a Gesundheitspolitik |2 stw | |
| 650 | 7 | |a Nachfrage |2 stw | |
| 650 | 7 | |a Patent |2 stw | |
| 650 | 7 | |a Pharmazeutische Industrie |2 stw | |
| 650 | 7 | |a Pharmazeutisches Produkt |2 stw | |
| 650 | 7 | |a Regulierung |2 stw | |
| 650 | 7 | |a TRIPS |2 stw | |
| 650 | 7 | |a WTO-Beitritt |2 stw | |
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Datensatz im Suchindex
| _version_ | 1804138053582716928 |
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| adam_text | TABLE OF CONTENTS
Page
TABLE OF CONTENTS I
LIST OF FIGURES VII
LIST OF TABLES VIII
LIST OF ABBREVIATIONS IX
1. Introduction 1
1.1. The Current Situation of the Pharmaceutical Market in China 1
1.1.1. History of the Pharmaceutical Industry 1
1.1.2. Analysis of Market Volume and Potential 2
1.1.3. Macro-Environment of the Pharmaceutical Industry 3
1.1.3.1. Population and Medical Care 3
1.1.3.2. Production and Distribution 4
1.1.3.3. Health Institutions 6
1.1.3.4. Impact of Regulations and Industry Outlook 7
1.2. Characteristics of the Chinese Pharmaceutical Market 9
1.3. The Objective of the Study 12
1.4. The Structure of the Dissertation 13
2. Theoretical Framework 15
2.1. Regulation Theory in the Pharmaceutical Market 17
2.2. New Institutional Economics 24
2.2.1. Homo Oeconomicus as a Behavioural Hypothesis 26
2.2 2. The Role of Information for Economic Decisions 28
2.2.3. Economic Foundations of Bilateral Relationships 28
2.2.3.1. Property Rights Theory 29
2.2.3.2. Transaction Cost Theory 31
2.2.3.3. Principal-Agent Theory 33
2.3. Discussion 34
3. The Healthcare System 35
3.1. Insurance and Moral Hazard 3 S
3.2. Evaluation of Public Health Insurance 36
I
3.3. Healthcare Insurance in China 37
3.3.1. Evolution of Health Insurance in China pre-1978 38
3.3.2. 1978-1998 40
3.3.3. Since 1998 42
3.3.3.1. Basic Medical Insurance System for Urban and Township
Employees 43
3.3.3.2. Rural Cooperative Medical System 46
3.3.3.3. Problems and Challenges of the Reforms 47
3.3.3.4. Reimbursement List for Basic Medical Insurance 49
3.4. Conclusion: Health and Wealth 51
4. Composition of Drug Demand SS
4.1. Patients 55
4.1.1. Demography 5 5
4.1.1.1. The Population and its Composition 56
4.1.1.2. Distribution and Urbanization 58
4.1.1.3. Migration and the Floating Population 59
4.1.1.4. Ageing Population 60
4.1.1.5. The One-Child Policy 61
4.1.2. Healthcare Financing and Expenditure 62
4.1.3. Policies for Influencing Patient Demand 65
4.2. Physicians 67
4.2.1. Physicians Status in China 67
4.2.2. Prescribing Influences 71
4.2.2.1. State Regulation 72
4.2.2.2. Market Rule 73
4.2.2.2.1. Pharmaceutical Advertising 73
4.2.2.2.2. Medical Representative 73
4.2.2.2.3. Clinical Professional Standards 76
4.2.2.3. Discussion 76
4.2.3. Separation of Drug Prescription and Dispensing 78
4.3. Conclusion 79
5. Pharmaceutical Manufacturers 81
5.1. Reform since 1979 82
5.2. Ownership Structure and Situation 84
5.3. GMP 85
5.4. Characteristics 88
5.4.1. Concentration 88
5.4.2. Research and Development 89
5.4.3. Provincial Rivalry 92
5.5. Discussion 94
6. Pharmaceutical Distribution and Logistics 97
6.1. Porter s Value Chain 99
6.2 Drug Distribution in China 101
6.2.1. Development History 103
6.2.1.1. Planned Economy Stage (1950-1979) 104
6.2.1.2. Reform and Open Stage (1980-1989) 105
6.2.1.3. Market-Oriented Stage (1990-Present) 109
6.2.2. Current Distribution and Logistics in China 110
6.2.2.1. China seeks Distribution Reform 110
6.2.2.2. Pharmaceutical Logistics in China 112
6.2.2.3. Foreign-invested Distribution in China . 114
6.3. Discussion 116
7. Hospitals 118
7.1. Hospital Price Regulation 121
7.1.1. Pricing Structure and Incentives 123
7.1.1.1. High-tech Equipment 123
7.1.1.2. Prescription of Drugs 124
7.1.2. Organizational and Management Issues 125
7.2. The Impact of Economic Reforms on Rural Township
Hospitals (RTHs) 126
7.2.1. Decrease in Demand for RTHs Services 127
7.2.2. Increase in Input Prices 128
7.2.3. Decrease in Government Subsidy 128
III
7.2.4. Financial Crisis and its Consequences 129
7.2.5. Discussion 130
7.3. Teaching Hospital Sector 130
7.3.1. Increasing Reliance on user charges 130
7.3.2. Increase in Acquisition of High Technology Equipment 131
7.3.3. Bonus System 132
7.4. Hospital Bidding in Drug Purchasing 132
7.4.1. Effects and Problems 133
7.4.2. New Regulation in 2004 136
7.4.3. Discussion 139
7.5. Private Hospitals 140
7.5.1. Market-based Policies 140
7.5.2. The Emerging Hospital Industry 142
7.6. Conclusion 142
8. Pharmacy 146
8.1. The Over-the-counter Market 147
8.2. The Retail Sector 15 0
9. Patents and TRIPS 154
9.1. The Origin and Nature of Patent Protection 15 7
9.2. The Globalization of Patent Protection 160
9.2.1. Paris Convention and WIPO 160
9.2.2. From GATT to WTO 161
9 2.3. A Trip through TRIPS 163
9.2.3.1. TRIPS Obligations 163
9.2.3.2. Compulsory Licensing 165
9.2.3.3. Patent Exhaustion 166
9.3. Protection of Pharmaceuticals in China 168
9.3.1. IP Protection Measures 169
93.1.1. Patent 170
9.3.1.2. Administrative Protection 172
9.3.1.3. Trademark 174
9.3.1.4. Unfair competition 174
IV
9.3.2. Enforcement 175
9.3.2. [.Counterfeiting 175
9.3.2.2. Barriers to Effective Enforcement 178
9.3.2.2.1. Local Protectionism 178
9.3.2.2.2. Lack of Adequate Sanctions 182
9.4. Conclusion 183
10. Effects of WTO Accession on the Pharmaceutical Industry 186
10.1. Effects of China s Entry into the WTO 186
10.2. Concerns of the Pharmaceutical Market 189
10.2.1. Impact on Domestic Pharmaceutical Companies 191
10.2.1.1. Enterprise Reform and WTO Accession 191
10.2.1.2. R D Expenditure 195
10.2.2. Impact on Foreign Pharmaceutical Companies 196
10.2.2.1. Opportunities 196
10.2.2.2. Concerns 197
10.3. China s Legal System and the WTO 200
10.3.1. The WTO Requirement on the Legal System 200
10.3.2. China s Ability to Comply with WTO
Commitments and Procedures 202
10.3.3. Prospects for Assistance in Compliance and Capacity-Building 206
10.4. Conclusion 207
11. The State in Drug Regulatory Affairs 210
11.1. Development Stages ofChina s Drug Regulatory System 212
11.2. Regulatory Issues 216
11.2.1. New Drug Regulation 216
11.2.2. Summary of Major Differences in New Regulations 218
11.2.3. Import Drugs 220
11.2.4. Clinical Study and Contact Research Organisations 222
11.3. Perspectives since joining the WTO 225
11.4. Conclusions 226
12. Decentralization 228
12.1. Economic Effects of Decentralization 229
12.2. The Decentralized Nature of the Chinese Economy 231
12.3. Fiscal Decentralization 235
12.4. Discussion 238
12.4.1. Local Protectionism 238
12.4.2. New Institutional Economics and Corruption 240
13. Conclusion 245
REFERENCES 253
CURRICULUM VITAE 288
VI
LIST OF FIGURES
Page
Figure 1: Regulation Theory in the Pharmaceutical Market 21
Figure 2: The 1988 basic insurance model 44
Figure 3: Payment System of the 1998 Basic Insurance Model 45
Figure 4: Development of age distribution from 2000 to 2030 in China 57
Figure 5: Mode of Porter s Value Chain 100
Figure 6: China s Health Care Structure 103
Figure 7: Major Stages of Regulatory Control 210
Figure 8: Functional Bodies in the SFDA 215
Figure 9: Application and approval procedure for imported drugs (1) 221
Figure 10: Application and approval procedure for imported drugs (2) 222
Figure 11: Application and approval procedure for clinical trials 225
VII
LIST OF TABLES
Page
Table 1: GDP and growth of the pharmaceutical market
between 1995 and 2005 2
Table 2: Estimated market turnovers between 2005-2010 3
Table 3: Comparison by major parameters between the
Chinese and US markets in 2003 3
Table 4: Composition of total medical expenditure 4
Table 5: Number of Medical Institutions in 2004 7
Table 6: Allocation of consumption of Pharmaceuticals in China 11
Table 7: Comparison of sales channels in China and the USA 11
Table 8: Health Expenditure from 1980 to 2005 63
Table 9: Trends in Average Medical Drug Expenditure 2004-2006 64
Table 10: Average Drug Expenditure as % of Total
Medical Expenditure 2004-2006 64
Table 11: Percentage of Doctors By Age and Educational Level in 2005 68
Table 12: Number of Medical Institutions in 2006 120
Table 13: Number of Hospitals by Grade in 2006 121
Table 14: Major Governmental Institutions in Drug Regulatory Affairs 213
Table 15: Summary of major differences in new regulation 219
VIII
|
| adam_txt |
TABLE OF CONTENTS
Page
TABLE OF CONTENTS I
LIST OF FIGURES VII
LIST OF TABLES VIII
LIST OF ABBREVIATIONS IX
1. Introduction 1
1.1. The Current Situation of the Pharmaceutical Market in China 1
1.1.1. History of the Pharmaceutical Industry 1
1.1.2. Analysis of Market Volume and Potential 2
1.1.3. Macro-Environment of the Pharmaceutical Industry 3
1.1.3.1. Population and Medical Care 3
1.1.3.2. Production and Distribution 4
1.1.3.3. Health Institutions 6
1.1.3.4. Impact of Regulations and Industry Outlook 7
1.2. Characteristics of the Chinese Pharmaceutical Market 9
1.3. The Objective of the Study 12
1.4. The Structure of the Dissertation 13
2. Theoretical Framework 15
2.1. Regulation Theory in the Pharmaceutical Market 17
2.2. New Institutional Economics 24
2.2.1. Homo Oeconomicus as a Behavioural Hypothesis 26
2.2 2. The Role of Information for Economic Decisions 28
2.2.3. Economic Foundations of Bilateral Relationships 28
2.2.3.1. Property Rights Theory 29
2.2.3.2. Transaction Cost Theory 31
2.2.3.3. Principal-Agent Theory 33
2.3. Discussion 34
3. The Healthcare System 35
3.1. Insurance and Moral Hazard 3 S
3.2. Evaluation of Public Health Insurance 36
I
3.3. Healthcare Insurance in China 37
3.3.1. Evolution of Health Insurance in China pre-1978 38
3.3.2. 1978-1998 40
3.3.3. Since 1998 42
3.3.3.1. Basic Medical Insurance System for Urban and Township
Employees 43
3.3.3.2. Rural Cooperative Medical System 46
3.3.3.3. Problems and Challenges of the Reforms 47
3.3.3.4. Reimbursement List for Basic Medical Insurance 49
3.4. Conclusion: Health and Wealth 51
4. Composition of Drug Demand SS
4.1. Patients 55
4.1.1. Demography 5 5
4.1.1.1. The Population and its Composition 56
4.1.1.2. Distribution and Urbanization 58
4.1.1.3. Migration and the Floating Population 59
4.1.1.4. Ageing Population 60
4.1.1.5. The One-Child Policy 61
4.1.2. Healthcare Financing and Expenditure 62
4.1.3. Policies for Influencing Patient Demand 65
4.2. Physicians 67
4.2.1. Physicians' Status in China 67
4.2.2. Prescribing Influences 71
4.2.2.1. State Regulation 72
4.2.2.2. Market Rule 73
4.2.2.2.1. Pharmaceutical Advertising 73
4.2.2.2.2. Medical Representative 73
4.2.2.2.3. Clinical Professional Standards 76
4.2.2.3. Discussion 76
4.2.3. Separation of Drug Prescription and Dispensing 78
4.3. Conclusion 79
5. Pharmaceutical Manufacturers 81
5.1. Reform since 1979 82
5.2. Ownership Structure and Situation 84
5.3. GMP 85
5.4. Characteristics 88
5.4.1. Concentration 88
5.4.2. Research and Development 89
5.4.3. Provincial Rivalry 92
5.5. Discussion 94
6. Pharmaceutical Distribution and Logistics 97
6.1. Porter's Value Chain 99
6.2 Drug Distribution in China 101
6.2.1. Development History 103
6.2.1.1. Planned Economy Stage (1950-1979) 104
6.2.1.2. Reform and Open Stage (1980-1989) 105
6.2.1.3. Market-Oriented Stage (1990-Present) 109
6.2.2. Current Distribution and Logistics in China 110
6.2.2.1. China seeks Distribution Reform 110
6.2.2.2. Pharmaceutical Logistics in China 112
6.2.2.3. Foreign-invested Distribution in China . 114
6.3. Discussion 116
7. Hospitals 118
7.1. Hospital Price Regulation 121
7.1.1. Pricing Structure and Incentives 123
7.1.1.1. High-tech Equipment 123
7.1.1.2. Prescription of Drugs 124
7.1.2. Organizational and Management Issues 125
7.2. The Impact of Economic Reforms on Rural Township
Hospitals (RTHs) 126
7.2.1. Decrease in Demand for RTHs' Services 127
7.2.2. Increase in Input Prices 128
7.2.3. Decrease in Government Subsidy 128
III
7.2.4. Financial Crisis and its Consequences 129
7.2.5. Discussion 130
7.3. Teaching Hospital Sector 130
7.3.1. Increasing Reliance on user charges 130
7.3.2. Increase in Acquisition of High Technology Equipment 131
7.3.3. Bonus System 132
7.4. Hospital Bidding in Drug Purchasing 132
7.4.1. Effects and Problems 133
7.4.2. New Regulation in 2004 136
7.4.3. Discussion 139
7.5. Private Hospitals 140
7.5.1. Market-based Policies 140
7.5.2. The Emerging Hospital Industry 142
7.6. Conclusion 142
8. Pharmacy 146
8.1. The Over-the-counter Market 147
8.2. The Retail Sector 15 0
9. Patents and TRIPS 154
9.1. The Origin and Nature of Patent Protection 15 7
9.2. The Globalization of Patent Protection 160
9.2.1. Paris Convention and WIPO 160
9.2.2. From GATT to WTO 161
9 2.3. A Trip through TRIPS 163
9.2.3.1. TRIPS Obligations 163
9.2.3.2. Compulsory Licensing 165
9.2.3.3. Patent Exhaustion 166
9.3. Protection of Pharmaceuticals in China 168
9.3.1. IP Protection Measures 169
93.1.1. Patent 170
9.3.1.2. Administrative Protection 172
9.3.1.3. Trademark 174
9.3.1.4. Unfair competition 174
IV
9.3.2. Enforcement 175
9.3.2. [.Counterfeiting 175
9.3.2.2. Barriers to Effective Enforcement 178
9.3.2.2.1. Local Protectionism 178
9.3.2.2.2. Lack of Adequate Sanctions 182
9.4. Conclusion 183
10. Effects of WTO Accession on the Pharmaceutical Industry 186
10.1. Effects of China's Entry into the WTO 186
10.2. Concerns of the Pharmaceutical Market 189
10.2.1. Impact on Domestic Pharmaceutical Companies 191
10.2.1.1. Enterprise Reform and WTO Accession 191
10.2.1.2. R D Expenditure 195
10.2.2. Impact on Foreign Pharmaceutical Companies 196
10.2.2.1. Opportunities 196
10.2.2.2. Concerns 197
10.3. China's Legal System and the WTO 200
10.3.1. The WTO Requirement on the Legal System 200
10.3.2. China's Ability to Comply with WTO
Commitments and Procedures 202
10.3.3. Prospects for Assistance in Compliance and Capacity-Building 206
10.4. Conclusion 207
11. The State in Drug Regulatory Affairs 210
11.1. Development Stages ofChina's Drug Regulatory System 212
11.2. Regulatory Issues 216
11.2.1. New Drug Regulation 216
11.2.2. Summary of Major Differences in New Regulations 218
11.2.3. Import Drugs 220
11.2.4. Clinical Study and Contact Research Organisations 222
11.3. Perspectives since joining the WTO 225
11.4. Conclusions 226
12. Decentralization 228
12.1. Economic Effects of Decentralization 229
12.2. The Decentralized Nature of the Chinese Economy 231
12.3. Fiscal Decentralization 235
12.4. Discussion 238
12.4.1. Local Protectionism 238
12.4.2. New Institutional Economics and Corruption 240
13. Conclusion 245
REFERENCES 253
CURRICULUM VITAE 288
VI
LIST OF FIGURES
Page
Figure 1: Regulation Theory in the Pharmaceutical Market 21
Figure 2: The 1988 basic insurance model 44
Figure 3: Payment System of the 1998 Basic Insurance Model 45
Figure 4: Development of age distribution from 2000 to 2030 in China 57
Figure 5: Mode of Porter's Value Chain 100
Figure 6: China's Health Care Structure 103
Figure 7: Major Stages of Regulatory Control 210
Figure 8: Functional Bodies in the SFDA 215
Figure 9: Application and approval procedure for imported drugs (1) 221
Figure 10: Application and approval procedure for imported drugs (2) 222
Figure 11: Application and approval procedure for clinical trials 225
VII
LIST OF TABLES
Page
Table 1: GDP and growth of the pharmaceutical market
between 1995 and 2005 2
Table 2: Estimated market turnovers between 2005-2010 3
Table 3: Comparison by major parameters between the
Chinese and US markets in 2003 3
Table 4: Composition of total medical expenditure 4
Table 5: Number of Medical Institutions in 2004 7
Table 6: Allocation of consumption of Pharmaceuticals in China 11
Table 7: Comparison of sales channels in China and the USA 11
Table 8: Health Expenditure from 1980 to 2005 63
Table 9: Trends in Average Medical Drug Expenditure 2004-2006 64
Table 10: Average Drug Expenditure as % of Total
Medical Expenditure 2004-2006 64
Table 11: Percentage of Doctors By Age and Educational Level in 2005 68
Table 12: Number of Medical Institutions in 2006 120
Table 13: Number of Hospitals by Grade in 2006 121
Table 14: Major Governmental Institutions in Drug Regulatory Affairs 213
Table 15: Summary of major differences in new regulation 219
VIII |
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| author | Chou, Yu-Wen 1973- |
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| author_facet | Chou, Yu-Wen 1973- |
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| bvnumber | BV035094764 |
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| genre | (DE-588)4113937-9 Hochschulschrift gnd-content |
| genre_facet | Hochschulschrift |
| geographic | China (DE-588)4009937-4 gnd |
| geographic_facet | China |
| id | DE-604.BV035094764 |
| illustrated | Illustrated |
| index_date | 2024-07-02T22:11:49Z |
| indexdate | 2024-07-09T21:22:04Z |
| institution | BVB |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016762826 |
| oclc_num | 269514804 |
| open_access_boolean | |
| owner | DE-N2 DE-355 DE-BY-UBR DE-384 DE-19 DE-BY-UBM DE-188 |
| owner_facet | DE-N2 DE-355 DE-BY-UBR DE-384 DE-19 DE-BY-UBM DE-188 |
| physical | XI, 289 S. graph. Darst. 21 cm |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| record_format | marc |
| spelling | Chou, Yu-Wen 1973- Verfasser (DE-588)136236073 aut The pharmaceutical market in the people's Republic of China in transition current situation and development trends von Yu-Wen Chou 2008 XI, 289 S. graph. Darst. 21 cm txt rdacontent n rdamedia nc rdacarrier Köln, Univ., Diss., 2008 Arzneimittelmarkt stw Arzneimittelrecht stw China stw Gesundheitspolitik stw Nachfrage stw Patent stw Pharmazeutische Industrie stw Pharmazeutisches Produkt stw Regulierung stw TRIPS stw WTO-Beitritt stw Übergangswirtschaft stw Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf China (DE-588)4009937-4 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content China (DE-588)4009937-4 g Pharmazeutische Industrie (DE-588)4045696-1 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016762826&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Chou, Yu-Wen 1973- The pharmaceutical market in the people's Republic of China in transition current situation and development trends Arzneimittelmarkt stw Arzneimittelrecht stw China stw Gesundheitspolitik stw Nachfrage stw Patent stw Pharmazeutische Industrie stw Pharmazeutisches Produkt stw Regulierung stw TRIPS stw WTO-Beitritt stw Übergangswirtschaft stw Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| subject_GND | (DE-588)4045696-1 (DE-588)4009937-4 (DE-588)4113937-9 |
| title | The pharmaceutical market in the people's Republic of China in transition current situation and development trends |
| title_auth | The pharmaceutical market in the people's Republic of China in transition current situation and development trends |
| title_exact_search | The pharmaceutical market in the people's Republic of China in transition current situation and development trends |
| title_exact_search_txtP | The pharmaceutical market in the people's Republic of China in transition current situation and development trends |
| title_full | The pharmaceutical market in the people's Republic of China in transition current situation and development trends von Yu-Wen Chou |
| title_fullStr | The pharmaceutical market in the people's Republic of China in transition current situation and development trends von Yu-Wen Chou |
| title_full_unstemmed | The pharmaceutical market in the people's Republic of China in transition current situation and development trends von Yu-Wen Chou |
| title_short | The pharmaceutical market in the people's Republic of China in transition |
| title_sort | the pharmaceutical market in the people s republic of china in transition current situation and development trends |
| title_sub | current situation and development trends |
| topic | Arzneimittelmarkt stw Arzneimittelrecht stw China stw Gesundheitspolitik stw Nachfrage stw Patent stw Pharmazeutische Industrie stw Pharmazeutisches Produkt stw Regulierung stw TRIPS stw WTO-Beitritt stw Übergangswirtschaft stw Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| topic_facet | Arzneimittelmarkt Arzneimittelrecht China Gesundheitspolitik Nachfrage Patent Pharmazeutische Industrie Pharmazeutisches Produkt Regulierung TRIPS WTO-Beitritt Übergangswirtschaft Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016762826&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT chouyuwen thepharmaceuticalmarketinthepeoplesrepublicofchinaintransitioncurrentsituationanddevelopmenttrends |