An international law perspective on the protection of human rights in the TRIPS agreement : an interpretation of the TRIPS agreement in relation to the right to health / by Ping Xiong.
2012
K3943 .X56 2012 (Map It)
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Author
Title
An international law perspective on the protection of human rights in the TRIPS agreement : an interpretation of the TRIPS agreement in relation to the right to health / by Ping Xiong.
Published
Leiden ; Boston : Martinus Nijhoff Publishers, 2012.
Call Number
K3943 .X56 2012
ISBN
9789004211971 (hardback : alk. paper)
9004211977 (hardback : alk. paper)
9004211977 (hardback : alk. paper)
Description
xx, 368 pages ; 25 cm.
System Control No.
(OCoLC)771065401
Bibliography, etc. Note
Includes bibliographical references and index.
Record Appears in
Table of Contents
Abstract
xiii
Preface
xv
Acknowledgement
xxi
1.
Introduction
1
I.
The Issue
1
II.
Approach to the Argument of this Book
9
III.
Focus of this Book
10
IV.
Scheme of this Book
10
pt. ONE
PRELIMINARY
2.
The International Human Rights Context
15
I.
The Right to Health in International Law
15
A.
Wide Recognition
15
1.
International Recognition
16
2.
National Recognition
18
3.
Significance of the Recognition
23
B.
Scope and Content of the Right to Health
23
1.
Scope
24
2.
Elements in Content
25
(a).
Curative and Preventive Elements
25
(b).
Underlying Preconditions
26
(c).
Essential Elements
27
3.
Obligations of States
29
(a).
Legal Obligations
30
(i).
To Respect
30
(ii).
To Protect
31
(iii).
To Fulfil
32
(b).
International Obligations
34
(c).
Core Obligations
34
4.
Summary
35
C.
Public Health under the Right to Health
36
1.
The Right to Health Originates from Public Health
36
2.
The Right to Health Realises Public Health
37
3.
The Right to Health Depends on Public Health
40
4.
The Right to Health Limits other Rights under Public Health
41
II.
The Right to Life in International Law - Refusal of Access to Life-Saving Facilities
41
A.
The Right to Life
42
1.
Scope of the Right to Life
42
2.
Content of the Right to Life
44
B.
Relationship between the Right to Life and the Right to Health
46
C.
Summary
50
III.
The Right to Property and the Right to Fruits of Creation
50
A.
The Rights
51
1.
The Right to Property and Intellectual Property Rights
51
(a).
The Right to Property
51
(b).
Scope
52
(c).
Content
55
(i).
Peaceful Enjoyment
55
(ii).
Interference with Property
55
(iii).
Legality of Interference
56
(d).
The Implication
57
(i).
Compulsory Licensing Interference
57
(ii).
Status of the Norm
58
2.
The Right to Fruits of Creation and Patent Rights
59
(a).
UDHR and ICESCR
59
(b).
Scope and Content
60
(c).
Summary
63
B.
Human Rights Approach to Patents
64
1.
History and Justification of Patent Protection
64
(a).
The Development of Patent Protection
64
(b).
Justifications
66
2.
Connections between Human Rights and Patent
70
(a).
Views
70
(b).
Relationships between the Two Regimes
71
(i).
Right to the Benefits of Scientific Progress and Patent
71
(ii).
Balance with Other Human Rights
73
3.
Conflict or Coexistence between Human Rights Norms and TRIPS
75
I.
TRIPS and the Right to Health
75
A.
The History of TRIPS
76
B.
Patent Protection in TRIPS and the Right to Health
78
1.
Intellectual Property Protection in TRIPS
78
2.
Pharmaceutical Patent Protection and the Right to Health
79
(a).
Article 27 (1) - Non-discrimination
79
(b).
Article 27(2) - The Exclusion and Its Proviso
80
(c).
Article 8(1) - The Principles and The "Limitation"
80
II.
Limitation and Derogation in the Regimes - an Internal Mechanism
81
A.
Limitation and Derogation in Human Rights
81
1.
Limitation
82
(a).
Clauses
82
(b).
Elements
84
(i).
Principle of Legality
84
(ii).
General Welfare in Democratic Society
86
(c).
Grounds
87
(i).
Public Order and Ordre Public
87
(ii).
Morality and Public Morals
88
(iii).
Public Health
88
2.
Derogation - Public Emergency
90
3.
Application
90
B.
Use of Limitation and Derogation Language in TRIPS
92
1.
Terms used in TRIPS and in WTO Jurisprudence
92
(a).
Terms used in TRIPS
92
(b).
WTO Jurisprudence
95
2.
Two-tiered Test under GATT Article XX
97
(a).
The Test
97
(b).
TRIPS and the Article XX Two-tiered Test
100
C.
Relationship of the Concepts in the Two Regimes
101
III.
Human Rights in TRIPS - Is an External Mechanism Needed
101
A.
Integration or Fragmentation
104
B.
Resolution of the Conflict
107
pt. TWO
INTERPRETATION OF TRIPS
4.
Rules of Interpretation of Public International Law
115
I.
Application of VCLT by the WTO
115
A.
Article 31(1) of VCLT and Its Application
116
1.
Ordinary Meaning - Article 31(1)
116
2.
Application
118
B.
Contextual Material - Article 31(2) of VCLT
120
C.
Article 31(3) of VCLT and Its Application
121
1.
Non-contextual Materials - Article 31(3)
121
(a).
Subsequent Agreement - Article 31(3)(a)
122
(b).
Subsequent Practice - Article 31(3)(b)
122
(c).
Relevant Rules of International Law - Article 31(3)(c)
125
(i).
Scope
125
(ii).
Parties
127
(iii).
Inter-temporality
128
(d).
Application Relationship
130
2.
Application of Article 31(3)(c) in WTO
130
D.
Supplementary Means - Article 32 and Its Application
132
1.
Article 32
132
2.
Application
133
E.
Summary
134
II.
Consistent Interpretation of TRIPS and WTO Laws
134
A.
TRIPS and Other Covered Agreements
134
1.
Historical Link
135
2.
Textual Link
136
B.
TRIPS and Incorporated Conventions
138
III.
Evolutionary Interpretation
139
5.
Examination of TRIPS in Light of the Interpretive Analyses
143
I.
Coverage and Flexibilities Offered by TRIPS
143
II.
Object and Purpose of TRIPS
146
A.
Ordinary Language Used in TRIPS
146
1.
Preamble
147
2.
Articles 7 and 8
150
3.
Summary
154
B.
Subsequent Agreement and Practice
154
1.
Doha Declaration
154
2.
The 2003 Decision
157
3.
2005 Decision - Proposed Amendment of Article 31bis
158
III.
Interpreting Specific Provisions
160
A.
Article 27 - Non-discrimination and Exclusion of Protection
160
1.
Patentability
160
(a).
Three Criteria
161
(b).
Interpretation
162
2.
Non-discrimination
163
(a).
Place, Product and Process, and Field of Technology
163
(b).
Canada - Pharmaceutical Patents
164
(c).
Open-endedness
165
3.
Interpreting Open-ended Language
165
4.
Second Use Patent
167
(a).
Ordinary Meaning
167
(b).
Contextual Interpretation
169
5.
Exclusion of Patentability
169
(a).
Ordre Public or Morality
170
(i).
Contextual Interpretation
170
(ii).
Relationship with GATT Article XX(b)
174
(iii).
Summary
176
(b).
Diagnostic, Therapeutic and Surgical Methods
177
(c).
Plants and Animals
177
B.
Article 28 - Rights Conferred
178
1.
Product and Process Patents
179
(a).
Product Patents
179
(b).
Process Patents
180
2.
Exhaustion in Article 6
181
C.
Article 6 - Exhaustion of Rights
182
1.
The Article
182
(a).
Parallel Import and Exhaustion
182
(i).
Exhaustion of Rights
182
(ii).
Parallel Import
184
(b).
Open Interpretation
185
2.
Relationship with GATT and Incorporated Conventions
186
(a).
Relationship with Paris Convention
186
(b).
Relationship with GATT
187
(i).
Relationship
187
(ii).
Interpretation of Relationship
188
D.
Article 31 - Compulsory Licensing
191
1.
The Title and Chapeau
193
2.
Individual Merits
194
3.
Circumstances
194
(a).
Prior Negotiation
195
(b).
National Emergency and Extreme Urgency
196
(c).
Public Non-commercial Use
198
4.
Scope and Duration
202
(a).
Duration - Temporary
203
(b).
Scope - Proportional
204
5.
Domestic Supply and the Paragraph 6 Problem
204
(a).
The Problem
204
(i).
Legal Issues
206
(ii).
Economic Scale Concern
207
(iii).
Practical Issues
207
(b).
Subsequent Agreement
210
(i).
Legal Value and Objective of the 2003 Decision and 2005 Decision
211
(ii).
Clarification of Practical Issues
214
(c).
Subsequent Practice
217
(d).
Interpretation
218
(i).
Contextual Interpretation
218
(ii).
Article 6 in the Interpretation
220
(iii).
WTO Covered Agreement
220
6.
Adequate Remuneration
221
E.
Article 30 - Limited Exceptions
222
1.
Relationship with Articles 27.1, 28 and 31
222
2.
Article 30 - Exceptions to Rights Conferred
223
(a).
Exceptions to be Limited
224
(b).
Unreasonable Conflict with Normal Exploitation of Patent
227
(c).
Unreasonable Prejudice to Legitimate Interests
227
3.
Interpretation
229
(a).
Health Related Exceptions
229
(b).
Ordinary Meaning
231
(c).
Contextual Interpretation
233
(d).
Supplementary Means
234
F.
Article 73 - Security Exception
235
1.
Coverage of the Exception
236
2.
Limit of the Exception
237
6.
Application of Human Rights Norms
239
I.
TRIPS and Human Rights Norms
239
A.
TRIPS is Not Self-contained
239
1.
WTO is Not a "Closed Legal Circuit"
239
(a).
WTO Law is Broader than GATT
240
(b).
The Text of WTO DSU
241
(c).
Evolutionary Manner of Interpretation of WTO Laws
242
(d).
Extraneous Sources in WTO Jurisprudence
244
2.
TRIPS should not be Isolated from Human Rights Norms
244
B.
TRIPS Invites the Use of Human Rights Norms
245
1.
The Aim of TRIPS
245
2.
Article 31(3)(c) of VCLT
247
3.
The Language Used in TRIPS
248
4.
The Regime Shift in Intellectual Property Protection
250
II.
Rights to Health, Property and Fruits of Creation in TRIPS
251
A.
Application
251
1.
Hierarchical Status of Various Human Rights Norms
251
(a).
Human Rights Sources and UN Human Rights Bodies
251
(b).
The Status of the Human Rights Norms
252
(i).
Customary International Law
253
(ii).
Treaty Law
254
(iii).
Soft Law
256
(iv).
Vital Interest Protection
260
2.
The Impact of Reference to Human Rights
261
(a).
Human Rights Limit Patent Protection
262
(b).
Human Rights Reinforce Patent Protection
266
(c).
Human Rights Realisation through Interpretation of TRIPS
267
B.
Applying GATT Interpretation Methods to TRIPS
272
1.
Links Between Human Rights and GATT
272
2.
Application of GATT Interpretation Method
274
III.
The Right to Health in TRIPS
275
A.
Object and Purpose
275
B.
Specific Provisions
279
1.
Article 27
279
2.
Article 28
281
3.
Article 31
282
(a).
Grounds
282
(b).
Duration
284
(c).
Scope
286
(d).
Supply and Parallel Importation
287
(e).
Remuneration
288
(f).
Summary
289
4.
Article 30
290
5.
Article 73
291
pt. THREE
IMPACTS OF INTERPRETATION
7.
Impacts on TRIPS-Plus in FTAs
297
I.
Interpretive Relationship Between TRIPS and FTAs
297
A.
Relationship in the Interpretation
297
1.
Choice of Forum and Interpretation Rules in FTAs
297
2.
Impacts on Interpretation
300
B.
Relationship with TRIPS
302
II.
Heightened Patent Protection in FTAs
304
A.
Heightened Patent Protection in FTAs
304
B.
Justification for Heightened Patent Protection in FTAs
309
C.
Implication of the Justification
311
III.
Interpretation and Human Rights
314
A.
Flexibility in FTAs
314
B.
Interpretation
317
1.
Compulsory Licensing
317
2.
Side Letters
320
3.
Non-derogation Provisions
321
C.
Human Rights
323
1.
TRIPS Language
323
2.
Non-derogation Provisions
323
3.
Reference to TRIPS
324
4.
Counter-regime of Human Rights
324
IV.
Summary
325
8.
Conclusion
327
Bibliography
333
Index
353