File #2871: "2020_Book_MarketAccessOfTraditionalChine.pdf"
Testo
1|Preface|7
1|Acknowledgements|10
1|Contents|11
1|About the Author|15
1|Abbreviations|16
1|List of Figures|19
1|List of Tables|20
1|Chapter 1: Introduction|21
2|1.1 The Status of TCMP in the West|21
3|1.1.1 Traditional Medicine in Western Thought|22
3|1.1.2 Cases Raising Concern for Legislation|23
3|1.1.3 The EU Regulation for an Intention to Regulate and Develop CAM in the EU|25
2|1.2 State of Art of the Scientific Development of Traditional Medicine|26
3|1.2.1 Chances and Difficulties for Integration|26
3|1.2.2 Interdisciplinary Approaches to Study Traditional Medicine|30
2|1.3 The Inspiration for Writing This Book|33
3|1.3.1 The Author´s Concerns for Writing This Book|33
3|1.3.2 Problem, Hypothesis and Main Questions of the Study Developed in This Book|33
3|1.3.3 Designing the Study in This Book|34
3|1.3.4 The Use of Qualitative Study|36
2|References|39
1|Chapter 2: The Legal Theoretical Framework for Market Access of TCMP|42
2|2.1 Philosophical Theories That Influenced the Study|42
3|2.1.1 Dialectics and Contradiction Theory|43
3|2.1.2 Schools of Law|46
4|2.1.2.1 School of Natural Law: The Importance of the Relationship Between Law and Science and Technology|46
4|2.1.2.2 School of Legal Positivism: The Current Law Should be Obeyed, But a Developmental Perspective Is Also Significant|48
4|2.1.2.3 Sociological Jurisprudence: Disclosing the Relation Between Law and Society|50
4|2.1.2.4 Some Thoughts on Fundamental Law|52
2|2.2 Jural Relation Analysis|53
2|2.3 Legal Framework Surrounding Market Access|56
3|2.3.1 Market Access in Law|56
3|2.3.2 A General Overview of Different Legal Branches Relevant to Market Access of TCMP|57
4|2.3.2.1 The Branch of Administrative Law vs. the Branch of Economic Law|58
4|2.3.2.2 The Branch of International Trade Law vs. The Branch of Pharmaceutical Law|59
3|2.3.3 Specific Laws Relating to Market Access of TCMP|60
4|2.3.3.1 Principles in International Administrative Law: Economic Development Should Not Be the Primary Goal of the Legislation|60
4|2.3.3.2 An Analysis of the Legal Factors of Pharmaceutical Law and the Issue of Market Access of TCMP|62
5|2.3.3.2.1 The Purpose of Any Rules Concerning the Production and Distribution of Medicinal Products in the EU|63
6|Jural Relation in Pharmaceutical Law|63
6|What Is the Social Relation We Are Talking About?|64
6|Who Can Help Find the Balanced Interest Between Producers and Consumers?|64
6|Different Interests of Various Stakeholders Make the Issue Complicated|65
6|The Debate on Affiliating Market Access with Economic Law or Administrative Law|66
6|Rights/Power and Obligations/Duty|67
6|Legal Object|67
6|What Is the Role of TCMP in the Jural Relation?|68
6|Patient in the Jural Relation|68
6|How Do We Adjust the Jural Relation?|70
6|The Jural Relation Involving Patients|70
6|IPR Protection vs. Authorisation of Pharmaceutical Product|71
3|2.3.4 Legislative Techniques for Transferring the Concept of Public Health Into Law|71
2|2.4 Theories in WTO Law and Pharmaceutical Law|72
3|2.4.1 WTO Law Theories|72
3|2.4.2 Legal Theories Relevant to Pharmaceutical Law|73
4|2.4.2.1 The General Regulatory Goals on Public Health in the EC Treaty|73
4|2.4.2.2 Legal Theories in Western Medical Law|74
2|2.5 A Reflection on the Issue of Market Access from Economic and Political Angles|74
2|2.6 Chapter Summary|75
2|References|76
1|Chapter 3: The Conceptualisation of TCMP in Law|79
2|3.1 Understanding Traditional Chinese Medicine from a Semantic Perspective|79
3|3.1.1 Traditional Medicine vs. Western Conventional Medicine|80
3|3.1.2 Complementary and Alternative Medicine|81
3|3.1.3 Natural and Integrated Medicine|82
2|3.2 Forms of Existence of TCMP|83
3|3.2.1 Classifications of TCMP|83
3|3.2.2 Terms Used in Chinese Legislation|84
3|3.2.3 The Understanding of TCMP in Chinese TCM Practice|85
2|3.3 The Understanding TCMP in EU Pharmaceutical Law|87
3|3.3.1 Definition of Herbal Medicinal Product in EU Pharmaceutical Law|87
3|3.3.2 The Issue of Homology of Medicine and Food|88
3|3.3.3 TCMP vs. Food Supplements and Novel Food in the EU|91
3|3.3.4 Safety and Efficacy Concern|93
2|3.4 A Comparison on the Concept of TCMP in EU Law and Chinese Law|94
2|3.5 Chapter Summary|95
2|References|96
1|Chapter 4: Assessing the Issue of Market Access of TCMP in EU Pharmaceutical Law|99
2|4.1 Historical Review of the Development of TCMP Related Legislation in the EU|99
3|4.1.1 Overview of EU Law|100
4|4.1.1.1 EU Law|100
4|4.1.1.2 EU Soft Law Acts As Guidance for Administrative Practice|100
3|4.1.2 EU Directives Most Relevant to the Issue of the Market Access of TCMP|101
3|4.1.3 The Historical Development of TCM Legislation in the UK|102
4|4.1.3.1 Influence of Brexit on the EU|102
4|4.1.3.2 The Six Report|102
4|4.1.3.3 The Historical Development of TCM Legislation in the UK|104
2|4.2 Analysing the Legal Framework Through Application of Systematology Theory|106
3|4.2.1 Systematology|106
3|4.2.2 Validity and Incentive Analysis of Using Systematology in Social Science|108
3|4.2.3 Some Traits of Complex Systems|109
3|4.2.4 Overview of the Tool of Network Analysis|110
2|4.3 Comparison of the Legal Frameworks for Market Access of TCMP in the EU and China|112
3|4.3.1 Legislative Intent|112
3|4.3.2 Institutional System|114
4|4.3.2.1 EU´s Institutional System|114
4|4.3.2.2 China´s Institutional System|115
5|4.3.2.2.1 Understanding the General Legal Framework of TCMP in China|115
5|4.3.2.2.2 Evolution of the Administrative Institutions and Their Functions|116
5|4.3.2.2.3 The Coordination and Distribution of Responsibilities|118
4|4.3.2.3 Short Comparison of Institutional Systems|120
3|4.3.3 Information System|120
3|4.3.4 Statutory Regulations and Technical Standards for Medicinal Products|121
4|4.3.4.1 General Comparison of the Regulations Between the EU and China|122
4|4.3.4.2 An Overview of EU Legislation and Standards Regarding TCMP|123
5|4.3.4.2.1 The Development of EU Pharmaceutical Legislation|124
5|4.3.4.2.2 Standards Relevant to TCMP|125
4|4.3.4.3 An Overview of Chinese Administrative Legislation and Standards Relevant to TCMP|125
3|4.3.5 External Environment|128
2|4.4 The Functioning of EU Pharmaceutical Law Relating to Market Access of TCMP in the EU|128
3|4.4.1 Market Access of Registered TCMP in the EU|128
3|4.4.2 Market Access of Non-registered TCMP in the EU|129
4|4.4.2.1 Market Access Forms of Non-registered TCMP|130
4|4.4.2.2 Market Access Channels of Non-registered TCMP|131
5|4.4.2.2.1 General Regulative Status of EU Law on TCM Practitioners|131
5|4.4.2.2.2 Legal Conditions to Fulfil the Exceptional Situation of Non-registered TCMP for Importing|131
5|4.4.2.2.3 The Implementation of EU Pharmaceutical Law in EU Member States|132
5|4.4.2.2.4 Other Possibilities to Import Non-registered TCMP|133
2|4.5 Chapter Summary|134
2|References|135
1|Chapter 5: EU Pharmaceutical Law Relating to WTO Rules|140
2|5.1 Background of the Issue of Market Access of TCMP in International Law|141
3|5.1.1 Identifying the Legal Issues Relevant to Market Access of TCMP in WTO Law|141
3|5.1.2 International Trade Law Principles|142
4|5.1.2.1 Principles Relating to the Trade of Goods|142
4|5.1.2.2 Theories Relating to TCMP Related Services|143
3|5.1.3 WHO Official Documents Relating to Herbal Medicines|144
3|5.1.4 Definition of Medical Services by the United Nations Statistics Division|145
3|5.1.5 HS by World Customs Organisation|146
3|5.1.6 Highlighted International IPR Issues Regarding CAM|147
2|5.2 Export Channels and Status of TCMP in Practice Under the WTO Legal Framework|148
3|5.2.1 Export Channels|148
3|5.2.2 Export Status of China|151
2|5.3 The Most Relevant WTO Agreements|152
3|5.3.1 Tariffs Regarding Some TCMP|153
3|5.3.2 The WTO Rules Which May Inhibit the International Trade of TCMP|153
2|5.4 Discussion on the Rationality of EU Rules on Market Access of TCMP|155
3|5.4.1 National Treatment in SPS and TBT|156
3|5.4.2 Explanation of the Precautionary Principle|158
3|5.4.3 The Application of National Treatment and the Precautionary Principle in WTO Case Law|161
4|5.4.3.1 U.S. Shrimp Case|161
4|5.4.3.2 The Asbestos Case-Properly Defining the Likeness|164
5|5.4.3.2.1 Review of the Asbestos Case|164
5|5.4.3.2.2 Implications for Market Access of TCMP|166
4|5.4.3.3 The Hormones Case-Applying the Precautionary Principle|166
3|5.4.4 Argument on the Appropriateness|168
4|5.4.4.1 The `Likeness´ Between Traditional Chinese Herbal Medicinal Product and Western Traditional Use Herbal Medicinal Produ...|168
4|5.4.4.2 Criteria to Define `Likeness´|169
4|5.4.4.3 Argument from the Angle of the Precautionary Principle|170
2|5.5 Chapter Summary|170
3|5.5.1 Final Thoughts on Appropriateness of EU Pharmaceutical Law as Applied to TCMP|170
3|5.5.2 Impact on International Trade of TCMP Driven by the Prospect and Development Difficulties of TCM|171
2|References|173
1|Chapter 6: Ensuring Safety Efficacy and Quality Control on a Case-by-Case Basis|176
2|6.1 Recalling the Registration Procedure of Pharmaceutical Products in the EU|176
2|6.2 Risk Assessment and Management of EU Pharmaceutical Products|178
3|6.2.1 Risk Management Impact Factors for Market Access|181
3|6.2.2 Assessment of the Safety Efficacy and Quality Control of TCMP|181
4|6.2.2.1 Safety and Efficacy|182
4|6.2.2.2 Quality Control|186
2|6.3 The Precautionary Principle in EU Legislation|187
3|6.3.1 Purpose of the Precautionary Principle|187
3|6.3.2 Taking Measures or Not Taking Measures|188
2|6.4 Improving EU Pharmaceutical Law Regarding Market Access of TCMP|190
2|References|192
1|Chapter 7: TCMP in the EU: Enlightenment|195
2|7.1 Findings|195
2|7.2 The Relation Between Science, Economy, Politics and Law|197
2|7.3 Final Remark|199
2|Reference|199
1|Index|200
1|Acknowledgements|10
1|Contents|11
1|About the Author|15
1|Abbreviations|16
1|List of Figures|19
1|List of Tables|20
1|Chapter 1: Introduction|21
2|1.1 The Status of TCMP in the West|21
3|1.1.1 Traditional Medicine in Western Thought|22
3|1.1.2 Cases Raising Concern for Legislation|23
3|1.1.3 The EU Regulation for an Intention to Regulate and Develop CAM in the EU|25
2|1.2 State of Art of the Scientific Development of Traditional Medicine|26
3|1.2.1 Chances and Difficulties for Integration|26
3|1.2.2 Interdisciplinary Approaches to Study Traditional Medicine|30
2|1.3 The Inspiration for Writing This Book|33
3|1.3.1 The Author´s Concerns for Writing This Book|33
3|1.3.2 Problem, Hypothesis and Main Questions of the Study Developed in This Book|33
3|1.3.3 Designing the Study in This Book|34
3|1.3.4 The Use of Qualitative Study|36
2|References|39
1|Chapter 2: The Legal Theoretical Framework for Market Access of TCMP|42
2|2.1 Philosophical Theories That Influenced the Study|42
3|2.1.1 Dialectics and Contradiction Theory|43
3|2.1.2 Schools of Law|46
4|2.1.2.1 School of Natural Law: The Importance of the Relationship Between Law and Science and Technology|46
4|2.1.2.2 School of Legal Positivism: The Current Law Should be Obeyed, But a Developmental Perspective Is Also Significant|48
4|2.1.2.3 Sociological Jurisprudence: Disclosing the Relation Between Law and Society|50
4|2.1.2.4 Some Thoughts on Fundamental Law|52
2|2.2 Jural Relation Analysis|53
2|2.3 Legal Framework Surrounding Market Access|56
3|2.3.1 Market Access in Law|56
3|2.3.2 A General Overview of Different Legal Branches Relevant to Market Access of TCMP|57
4|2.3.2.1 The Branch of Administrative Law vs. the Branch of Economic Law|58
4|2.3.2.2 The Branch of International Trade Law vs. The Branch of Pharmaceutical Law|59
3|2.3.3 Specific Laws Relating to Market Access of TCMP|60
4|2.3.3.1 Principles in International Administrative Law: Economic Development Should Not Be the Primary Goal of the Legislation|60
4|2.3.3.2 An Analysis of the Legal Factors of Pharmaceutical Law and the Issue of Market Access of TCMP|62
5|2.3.3.2.1 The Purpose of Any Rules Concerning the Production and Distribution of Medicinal Products in the EU|63
6|Jural Relation in Pharmaceutical Law|63
6|What Is the Social Relation We Are Talking About?|64
6|Who Can Help Find the Balanced Interest Between Producers and Consumers?|64
6|Different Interests of Various Stakeholders Make the Issue Complicated|65
6|The Debate on Affiliating Market Access with Economic Law or Administrative Law|66
6|Rights/Power and Obligations/Duty|67
6|Legal Object|67
6|What Is the Role of TCMP in the Jural Relation?|68
6|Patient in the Jural Relation|68
6|How Do We Adjust the Jural Relation?|70
6|The Jural Relation Involving Patients|70
6|IPR Protection vs. Authorisation of Pharmaceutical Product|71
3|2.3.4 Legislative Techniques for Transferring the Concept of Public Health Into Law|71
2|2.4 Theories in WTO Law and Pharmaceutical Law|72
3|2.4.1 WTO Law Theories|72
3|2.4.2 Legal Theories Relevant to Pharmaceutical Law|73
4|2.4.2.1 The General Regulatory Goals on Public Health in the EC Treaty|73
4|2.4.2.2 Legal Theories in Western Medical Law|74
2|2.5 A Reflection on the Issue of Market Access from Economic and Political Angles|74
2|2.6 Chapter Summary|75
2|References|76
1|Chapter 3: The Conceptualisation of TCMP in Law|79
2|3.1 Understanding Traditional Chinese Medicine from a Semantic Perspective|79
3|3.1.1 Traditional Medicine vs. Western Conventional Medicine|80
3|3.1.2 Complementary and Alternative Medicine|81
3|3.1.3 Natural and Integrated Medicine|82
2|3.2 Forms of Existence of TCMP|83
3|3.2.1 Classifications of TCMP|83
3|3.2.2 Terms Used in Chinese Legislation|84
3|3.2.3 The Understanding of TCMP in Chinese TCM Practice|85
2|3.3 The Understanding TCMP in EU Pharmaceutical Law|87
3|3.3.1 Definition of Herbal Medicinal Product in EU Pharmaceutical Law|87
3|3.3.2 The Issue of Homology of Medicine and Food|88
3|3.3.3 TCMP vs. Food Supplements and Novel Food in the EU|91
3|3.3.4 Safety and Efficacy Concern|93
2|3.4 A Comparison on the Concept of TCMP in EU Law and Chinese Law|94
2|3.5 Chapter Summary|95
2|References|96
1|Chapter 4: Assessing the Issue of Market Access of TCMP in EU Pharmaceutical Law|99
2|4.1 Historical Review of the Development of TCMP Related Legislation in the EU|99
3|4.1.1 Overview of EU Law|100
4|4.1.1.1 EU Law|100
4|4.1.1.2 EU Soft Law Acts As Guidance for Administrative Practice|100
3|4.1.2 EU Directives Most Relevant to the Issue of the Market Access of TCMP|101
3|4.1.3 The Historical Development of TCM Legislation in the UK|102
4|4.1.3.1 Influence of Brexit on the EU|102
4|4.1.3.2 The Six Report|102
4|4.1.3.3 The Historical Development of TCM Legislation in the UK|104
2|4.2 Analysing the Legal Framework Through Application of Systematology Theory|106
3|4.2.1 Systematology|106
3|4.2.2 Validity and Incentive Analysis of Using Systematology in Social Science|108
3|4.2.3 Some Traits of Complex Systems|109
3|4.2.4 Overview of the Tool of Network Analysis|110
2|4.3 Comparison of the Legal Frameworks for Market Access of TCMP in the EU and China|112
3|4.3.1 Legislative Intent|112
3|4.3.2 Institutional System|114
4|4.3.2.1 EU´s Institutional System|114
4|4.3.2.2 China´s Institutional System|115
5|4.3.2.2.1 Understanding the General Legal Framework of TCMP in China|115
5|4.3.2.2.2 Evolution of the Administrative Institutions and Their Functions|116
5|4.3.2.2.3 The Coordination and Distribution of Responsibilities|118
4|4.3.2.3 Short Comparison of Institutional Systems|120
3|4.3.3 Information System|120
3|4.3.4 Statutory Regulations and Technical Standards for Medicinal Products|121
4|4.3.4.1 General Comparison of the Regulations Between the EU and China|122
4|4.3.4.2 An Overview of EU Legislation and Standards Regarding TCMP|123
5|4.3.4.2.1 The Development of EU Pharmaceutical Legislation|124
5|4.3.4.2.2 Standards Relevant to TCMP|125
4|4.3.4.3 An Overview of Chinese Administrative Legislation and Standards Relevant to TCMP|125
3|4.3.5 External Environment|128
2|4.4 The Functioning of EU Pharmaceutical Law Relating to Market Access of TCMP in the EU|128
3|4.4.1 Market Access of Registered TCMP in the EU|128
3|4.4.2 Market Access of Non-registered TCMP in the EU|129
4|4.4.2.1 Market Access Forms of Non-registered TCMP|130
4|4.4.2.2 Market Access Channels of Non-registered TCMP|131
5|4.4.2.2.1 General Regulative Status of EU Law on TCM Practitioners|131
5|4.4.2.2.2 Legal Conditions to Fulfil the Exceptional Situation of Non-registered TCMP for Importing|131
5|4.4.2.2.3 The Implementation of EU Pharmaceutical Law in EU Member States|132
5|4.4.2.2.4 Other Possibilities to Import Non-registered TCMP|133
2|4.5 Chapter Summary|134
2|References|135
1|Chapter 5: EU Pharmaceutical Law Relating to WTO Rules|140
2|5.1 Background of the Issue of Market Access of TCMP in International Law|141
3|5.1.1 Identifying the Legal Issues Relevant to Market Access of TCMP in WTO Law|141
3|5.1.2 International Trade Law Principles|142
4|5.1.2.1 Principles Relating to the Trade of Goods|142
4|5.1.2.2 Theories Relating to TCMP Related Services|143
3|5.1.3 WHO Official Documents Relating to Herbal Medicines|144
3|5.1.4 Definition of Medical Services by the United Nations Statistics Division|145
3|5.1.5 HS by World Customs Organisation|146
3|5.1.6 Highlighted International IPR Issues Regarding CAM|147
2|5.2 Export Channels and Status of TCMP in Practice Under the WTO Legal Framework|148
3|5.2.1 Export Channels|148
3|5.2.2 Export Status of China|151
2|5.3 The Most Relevant WTO Agreements|152
3|5.3.1 Tariffs Regarding Some TCMP|153
3|5.3.2 The WTO Rules Which May Inhibit the International Trade of TCMP|153
2|5.4 Discussion on the Rationality of EU Rules on Market Access of TCMP|155
3|5.4.1 National Treatment in SPS and TBT|156
3|5.4.2 Explanation of the Precautionary Principle|158
3|5.4.3 The Application of National Treatment and the Precautionary Principle in WTO Case Law|161
4|5.4.3.1 U.S. Shrimp Case|161
4|5.4.3.2 The Asbestos Case-Properly Defining the Likeness|164
5|5.4.3.2.1 Review of the Asbestos Case|164
5|5.4.3.2.2 Implications for Market Access of TCMP|166
4|5.4.3.3 The Hormones Case-Applying the Precautionary Principle|166
3|5.4.4 Argument on the Appropriateness|168
4|5.4.4.1 The `Likeness´ Between Traditional Chinese Herbal Medicinal Product and Western Traditional Use Herbal Medicinal Produ...|168
4|5.4.4.2 Criteria to Define `Likeness´|169
4|5.4.4.3 Argument from the Angle of the Precautionary Principle|170
2|5.5 Chapter Summary|170
3|5.5.1 Final Thoughts on Appropriateness of EU Pharmaceutical Law as Applied to TCMP|170
3|5.5.2 Impact on International Trade of TCMP Driven by the Prospect and Development Difficulties of TCM|171
2|References|173
1|Chapter 6: Ensuring Safety Efficacy and Quality Control on a Case-by-Case Basis|176
2|6.1 Recalling the Registration Procedure of Pharmaceutical Products in the EU|176
2|6.2 Risk Assessment and Management of EU Pharmaceutical Products|178
3|6.2.1 Risk Management Impact Factors for Market Access|181
3|6.2.2 Assessment of the Safety Efficacy and Quality Control of TCMP|181
4|6.2.2.1 Safety and Efficacy|182
4|6.2.2.2 Quality Control|186
2|6.3 The Precautionary Principle in EU Legislation|187
3|6.3.1 Purpose of the Precautionary Principle|187
3|6.3.2 Taking Measures or Not Taking Measures|188
2|6.4 Improving EU Pharmaceutical Law Regarding Market Access of TCMP|190
2|References|192
1|Chapter 7: TCMP in the EU: Enlightenment|195
2|7.1 Findings|195
2|7.2 The Relation Between Science, Economy, Politics and Law|197
2|7.3 Final Remark|199
2|Reference|199
1|Index|200