Regulating human embryonic stem cell in China : a comparative study on human embryonic stem cell's patentability and morality in US and EU / Li Jiang.
2016
KNQ3098.5 .J53 2016 (Map It)
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Details
Author
Title
Regulating human embryonic stem cell in China : a comparative study on human embryonic stem cell's patentability and morality in US and EU / Li Jiang.
Published
Singapore : Springer, [2016]
Copyright
©2016
Call Number
KNQ3098.5 .J53 2016
Former Call Number
Comp 270 J56 2016
ISBN
9789811021008
9811021007
9811021007
Description
xviii, 200 pages ; 25 cm
System Control No.
(OCoLC)952789083
Bibliography, etc. Note
Includes bibliographical references (pages 179-200).
Record Appears in
Gift
Purchased from the income of the Silver Fund
Gift
The Arthur W. Diamond Law Library
Purchased from the income of the Silver Fund
Table of Contents
1.
Stem Cell Tourism Phenomenon in China: An Introduction
1
1.1.
Reasons for Stem Cell Tourism Phenomenon
1
1.1.1.
Values of Human Embryonic Stem Cell (HESC) Research
1
1.1.2.
Inconsistency HESC Related Regulations Across Jurisdictions Leads to Stem Cell Tourism in China
3
1.1.3.
TRIPS Agreement Cannot Assure Symmetrical Coherence Between Moral Provision Within Patent Law and Moral Provision Outside Patent Law
6
1.1.4.
Inadequate Regulation of HESC Research in China
7
1.2.
Purpose and Focus of the Book
7
1.3.
Conceptual Framework
11
1.4.
Framework of the Book
17
2.
Legal Framework of Stem Cell Science and Medicine in China: An Overview
19
2.1.
HESC Research Environment in China
20
2.1.1.
HESC Research Funding in China
21
2.1.2.
HESC Industry in China
22
2.2.
Legal Framework of HESC Research in China
23
2.2.1.
Patent Law of China and Its Guideline for Patent Examination
24
2.2.2.
Ethical Guideline for HESC Research
25
2.3.
Case Studies
27
2.3.1.
Whether Article 5 of the Patent Law Excludes Inventions Related to HESC?
27
2.3.2.
Whether Adult Stem Cell Has the Practical Applicability Under Article 22 of Patent Law?
31
2.4.
Conclusion
33
3.
Moral Dilemma of Stem Cell Science and Medicine
35
3.1.
Overview of Moral Issues on HESC Research
36
3.1.1.
Human Dignity and the Rights of Human Embryo
38
3.1.2.
Create Embryos for Research
39
3.1.3.
Moral Issues in Embryo Donation
40
3.2.
Moral Status of Human Embryo
41
3.2.1.
Human Embryos Are Individual Human Beings
41
3.2.2.
Human Embryos Are Human Beings, but They Are not Human Persons
45
3.2.3.
Human Embryos Are not Human Beings
48
3.3.
What Is the Moral Source of Human Embryos: Use the Discard Human Embryos or Create Human Embryos for Research?
51
3.3.1.
Use the Spare Human Embryos from IVF
51
3.3.2.
Create Human Embryos for Research
54
3.4.
Will Therapeutic Cloning Use Lead to Reproductive Cloning Use?
56
3.4.1.
Will Therapeutic Cloning Use Turn to Commercial Use?
56
3.4.2.
Will the Distinction Between Therapeutic Cloning Use and Reproductive Cloning Use Be Impossible to Police?
58
3.5.
Whether Adult Stem Cell Could Be Fully Used as an Alternate to Embryonic Stem Cell?
59
3.5.1.
Adult Stem Cell Can Be Fully Used as an Alternate to Embryonic Stem Cell
60
3.5.2.
Adult Stem Cell Cannot Be Fully Used as Alternate Embryonic Stem Cell
60
3.6.
Conclusion
61
4.
Stem Cells, Patents and Regulation in China: Inadequacy
63
4.1.
Critical Issues of First Administration Measure on Clinical Stem Cell Research 2015
64
4.1.1.
Clarifying the Qualifications of Institution Conducting Clinical Stem Cell Research
65
4.1.2.
Establishing the Initial Review, Record Filing Mechanism, and the Research Project Reporting System
66
4.1.3.
Reporting the Unsafe Event in Clinical Stem Cell Research
66
4.2.
First Administrative Measure Cannot Effectively Control Stem Cell Therapy in China
67
4.2.1.
Lacking Liability Clause
67
4.2.2.
Lacking Traceability System
68
4.2.3.
Lacking Expert Responsible Authorities
69
4.2.4.
Non-applicable to Military Hospital
69
4.3.
Can Stem Cell Therapy Be Used in Patient Before Clinic Testing?
70
4.3.1.
From the Bench to Bedside: Stem Cell Therapy Should not Be Used in Patient Before Clinic Trials
70
4.3.2.
From the Bedside to the Bench: Stem Cell Therapy Should Be Used in Patient Before Clinic Trials
71
4.4.
Moral Exclusion In or Out Patent Law?
72
4.4.1.
Low Moral Status of Human Embryo in Practical Application
73
4.4.2.
High Moral Status of the Human Embryo in Patent Law
74
4.4.3.
Whether the Moral Exclusion Is Proper in China's Patent Law?
75
4.5.
Conclusion
76
5.
Stem Cells, Patents and Policy in the US: Inefficiency
77
5.1.
Political Background of HESC Regulation
77
5.2.
"First Patent, then Questioned"---The Approach of Patentability of Research Involving HESC Research Under Moral Concerns
79
5.2.1.
"Bayh-Dole Model" in HESC Research-Allow Universities to Patent on Research by Federal Funding
80
5.2.2.
Patent on Embryo: The Opening of "Human Embryo Farms"
82
5.2.3.
HESC Patents Challenges: From Technical Criterion to Moral Concerns
83
5.2.4.
Stem Cell Patent: Impediment or not?
86
5.2.5.
Public's "Right to Know" Right
87
5.3.
Political Interventions the Federal Funding Control of HESC Research Under Moral Concerns
88
5.3.1.
National Institutes of Health Revitalization Act: Allow Federal Funding of Research Related to Embryos at the Early Stage
90
5.3.2.
Dickey-Wicker Amendment: No Federal Funding on HESC Research Involving Destruction Embryo
91
5.3.3.
NIH Guideline 2000
93
5.3.4.
Bush Compromise: Accepted the Narrow Explanation of Dickey-Wicker Amendment but Exercised the Executive Power Instead of Legal Power to Allocate Funding
94
5.3.5.
Report from President Council on Bioethics Clarified that the Enforcement Law Was Dickey Amendment
95
5.3.6.
Executive Order by President Obama: Reverse the Bush Policy
96
5.3.7.
Result of Battle Over the Dickey-Wicker Amendment: The Funding Policy of HESC Research by Obama Administration Could Go Ahead
98
5.4.
Conflict Between Federal Law and State Law
99
5.4.1.
Proposition 71 in California: Success or Failure?
100
5.4.2.
Other States
106
5.4.3.
Interstate Alliance on Stem Cell Research (IASCR): A Venue for the States to Cooperate
106
5.4.4.
Conflicts Between the Federal and State Regulation
107
5.5.
Conclusion
108
6.
Stem Cells, Patents and Morality in the EU: Inconsistency
111
6.1.
Legal Framework of HESC Research in the EUROPE
113
6.1.1.
Moral Criterion of the European Patent Convention (EPC)
115
6.1.2.
Directive 98/44/EC Excludes "Uses Human Embryos for Industrial or Commercial Purpose" from Patenting
116
6.1.3.
European Group on Ethics in Science and New Technologies (EGE) Supply Authoritative Opinions to Legislation
118
6.2.
Cases Studies
120
6.2.1.
How to Assess the Morality?
120
6.2.2.
Whether HESC Should Be Included in "Human Embryo"? What Is the Scope of "Industrial or Commercial Use"?
125
6.3.
Regulatory Approaches of National Jurisdiction in HESC Research in EUROPE
133
6.3.1.
Permissive Policy: UK Approach
134
6.3.2.
Prohibition Policy: German Approach
139
6.3.3.
Intermediate Approach: Netherland Policy
144
6.4.
Lessons from EUROPE HESC Regulation Reconciliation
145
6.4.1.
Unitary Substantive Patent Law in the EUROPE: Considerable Freedom Still Given to National Legislations
146
6.4.2.
Biotechnology Directive---A Giant Step Towards Harmonising the European Patent Law on Biotechnology
150
6.4.3.
No Uniform Moral Definition and Legal Status of Human Embryo
155
6.4.4.
Uniform Concept of Human Embryo and Ban on Patenting Inventions that Involve the Destruction of Human Embryos
157
6.4.5.
Attempt of Infusing Moral Control with the Patent Regulation
159
6.4.6.
Space for Flexibility on the Basis of Minimum Standards: Let States Decide Moral Provisions Instead of a Universal Moral Standard Due to Culture Difference
161
6.5.
Conclusion
161
7.
Proposal for Controlling Stem Cell Science and Medicine in China: Internationalism
163
7.1.
Comparative Analysis of HESC Regulations in the US and the EUROPE
164
7.2.
Better Way to Control HESC Research in China: Regulate Research Itself in a International Regime
166
7.2.1.
Moral Exclusion Should not Be Regulated by the Patent Law
166
7.2.2.
China's Regulatory Approach on Stem Cell Research and Transfer: State Legislations is More Appropriate than Guideline
167
7.2.3.
International Reconciled Regime: Minimum Moral Standard for HESC Research
170
7.2.4.
United Nation (UN) is an Appropriate Platform for International HESC Regulation
172
7.2.5.
Established Framework of Human Rights is the Mainstay of a Reconciled International Policy
173
7.2.6.
Establish the Authority to Monitor the Reproductive Treatment and Research
174
7.3.
How Does International Agreement Push China to Regulate and Supervise Stem Cell Therapy?
175
7.3.1.
Controlling the Increased Demands
176
7.3.2.
Introducing New Rigorous Regulations
176
7.3.3.
Creating a Watch List
176
7.3.4.
Setting a Dispute Resolution Process
177
7.4.
Conclusion
177
Bibliography
179