Cover image for Human rights and the WTO : the case of patents and access to medicines
Title:
Human rights and the WTO : the case of patents and access to medicines
Personal Author:
Publication Information:
New York, NY : OUP Oxford, 2008
Physical Description:
xxxvi, 369 p. ; 24 cm.
ISBN:
9780199552177

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30000010201219 K3240 H47 2008 Open Access Book Book
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Summary

Summary

The international trading system has come under increasing attack by activists as being in conflict with human rights law. Others have defended the system as contributing more to the fulfillment of human rights than many other areas of international law. This study examines the alleged conflict of WTO law with international human rights law, using one of the most prominent examples of such a conflict: that between international patent law, ie the TRIPS Agreement, and access to medication as guaranteed eg by the International Covenant on Economic, Social and Cultural Rights. This highly controversial political issue of the appropriate use of international patent law on life saving medicines gained the world's attention during the discussion about the price of AIDS medication, but recent instances also include the availability of the patented medication for bird flu and for anthrax.

The book discusses both the patent law and the international human rights law involved in great depth, distinguishing between obligations under different human rights instruments and including a highly readable introduction into both areas of law. It then explains the concept of conflict between legal regimes and why patent law and human rights law are in conflict. The current state of international law on the conflict between legal regimes and the origin of such conflicts is analyzed, covering such issues as hierarchy in international law and introducing the concept of 'factual hierarchy'. The book then turns to the role of human rights law in the WTO system, concluding that such law currently is limited to aiding the interpreting of the WTO agreements. It shows how a further integration of human rights law could be achieved and describes the progress made towards accommodating human rights concerns within the TRIPS Agreement, culminating in the first ever decision to amend a core WTO Agreement in December 2005.


Author Notes

Dr Holger Hestermeyer is a Senior Research Fellow at the Max Planck Institute for Comparative Public Law and International Law, Heidelberg, Germany


Table of Contents

Table of Cases (Selection)p. xvii
Table of Laws and Treaties (Selection)p. xxii
List of Abbreviationsp. xxvii
Introductionp. xxxiii
1 Background of the Debatep. 1
I Finding a Cure for a New Diseasep. 2
II BW's Decision on AZT Pricing Causes Outragep. 5
III The HIV/AIDS Pandemic Todayp. 6
IV The TRIPS Agreement and Access to Medicine: The South African Medicines Actp. 11
V Beyond AIDS Drugs: Anthrax and Ciprop. 15
2 Patent Lawp. 18
I A Short Primer on Patentsp. 19
II The History of Patent Lawp. 20
1 Patent Privilegesp. 21
2 The First Patent Actsp. 22
3 The 19th Centuryp. 27
4 The Patentability of Pharmaceutical Productsp. 28
III Rationales of Patent Lawp. 29
1 Natural Law Rationalep. 29
2 Contract Rationalep. 30
3 Reward Rationalep. 31
4 Incentive Rationalep. 31
5 Prospect Theoryp. 32
IV International Patent Lawp. 33
1 International Patent Law before the TRIPS Agreementp. 34
2 Shortcomings of the Traditional Systemp. 36
3 The North-South Divide: Arguments for and against Stronger Patent Protectionp. 37
4 Unilateral Pressure on Developing Countriesp. 39
5 The WTO/GATT settingp. 41
A Background: The GATTp. 41
B Intellectual Property in the GATTp. 43
C The Uruguay Roundp. 44
D Validity of the TRIPS Agreementp. 48
V Trips Agreement Patent Standardsp. 49
1 Interpretation in Light of the Object and Purpose of the TRIPS Agreementp. 50
2 Basic Principles of the TRIPS Agreementp. 51
3 Conditions of Patentabilityp. 53
A Patentable Subject Matterp. 53
a Inventionsp. 54
b All Fields of Technology, Exceptions, Non-Discriminationp. 55
aa All Fields of Technologyp. 55
bb Exceptions for Pharmaceuticals?p. 56
cc Non-Discriminationp. 59
dd The Drug Approval Process: Patent Law Implicationsp. 60
c Product and Process Patentsp. 64
B Noveltyp. 65
C Inventive Stepp. 66
D Capability of Industrial Applicationp. 66
E Disclosurep. 67
4 Rights Conferredp. 67
5 Transitional Arrangementsp. 70
6 Conclusion on Patent Lawp. 75
3 Access to Medicine as a Human Rightp. 76
I Backgroundp. 79
1 International Human Rightsp. 79
2 Health and Human Rightsp. 83
3 Intellectual Property and Human Rightsp. 84
II The Interpretation of Human Rights Conventionsp. 85
III Justiciabilityp. 86
1 Terminologyp. 87
2 Economic, Social, and Cultural Rights as Justiciable Rightsp. 89
IV Who is Bound by International Human Rights Law?p. 94
1 Human Rights Obligations of Corporationsp. 94
2 Human Rights Obligations of International Organizationsp. 99
V Conventionsp. 102
1 Icescrp. 102
A Access to Medicine as Part of the Right to Healthp. 102
a Content of the Rightp. 103
b Duties imposed on States Partiesp. 107
aa Obligation to Respectp. 107
bb Obligation to Protectp. 109
cc Obligation to Fulfilp. 110
dd Justifying Non-Compliance with Lack of Financial Meansp. 110
B Enjoyment of the Benefits of Scientific Progressp. 112
2 The WHOp. 112
3 ICCPRp. 115
A Content of the Rightp. 115
B Duties Imposed on States Partiesp. 118
4 Universal Declaration of Human Rightsp. 119
5 Other Agreementsp. 121
VI General International Lawp. 121
1 Customary International Lawp. 122
A Treaties and Customary International Lawp. 122
B State Practicep. 123
C Opinio jurisp. 133
2 General Principlesp. 134
VII Conclusion on Human Rightsp. 136
4 Conflict between Patents and Access to Medicinep. 137
I Interference of Patents with Access to Medicine due to Price Effectsp. 138
1 Microeconomic Theoryp. 138
A Competitive Marketp. 138
B Monopoly Pricingp. 142
C Patents as Monopolies-other Pricing Factorsp. 144
D Pricing in Developing Countriesp. 146
2 Empirical Studies and Extrapolationsp. 148
3 Severity of the Access Impactp. 150
II Justification of the Interferencep. 152
1 Protection of the Inventor's Material Interestsp. 153
A Author-Scope ratione personaep. 154
B Interests of Inventors-Scope ratione materiaep. 155
C Moral and Material Interestsp. 157
D The Right in the Conflict with Access to Medicinep. 157
2 Justification as an Incentive for Future Researchp. 158
III Effects on Third Parties: Duty to Cooperatep. 166
IV A Conflict between the Patent and the Human Rights Regime?p. 169
1 Conflict of International Legal Regimes: Terminologyp. 170
A Fragmentation of International Lawp. 170
B International Legal Regimesp. 172
C Conflictp. 173
a Definition of Conflictp. 174
b Typologies of Conflictsp. 179
2 Conflict of International Legal Regimes: Towards Hierarchy?p. 182
A Law of Coexistence and Reciprocity-A Law without Hierarchyp. 182
B Law of Cooperation and Community Interests-Hierarchy in International Lawp. 185
a Erga Omnes Obligations-Integral Treatiesp. 187
b Jus cogensp. 190
c Non-consenting States and Community Interestsp. 192
C Institutionalization, Factual Hierarchyp. 193
D 'Soft-enforced' Human Rights Meet 'Hard-enforced' WTOp. 197
a The WTO Regimep. 197
aa Normative Hierarchy: An Instrumental Order of the Bilateral or Integral Type?p. 197
bb The WTO in the Factual Hierarchy of Regimes: A Powerhousep. 199
cc The WTO and Regime Conflictp. 200
b The Human Rights Regimep. 203
aa Normative Hierarchy: Law of Valuesp. 203
bb Factual Hierarchy: Soft Enforcementp. 205
cc Human Rights and Regime Conflictp. 205
c Perplexityp. 206
5 Access to Medicine as a Human Right in the WTO Orderp. 207
I Access to Medicine as a Human Right within WTO Dispute Settlementp. 208
1 Five Models for the Use of Non-WTO Law in WTO Dispute Settlementp. 209
2 The WTO: A Self-contained Regime?p. 210
3 Jurisdictionp. 212
A Violation Complaintsp. 213
B Non-Violation Complaintsp. 213
C De Lege Ferendap. 214
4 Applicable Lawp. 215
A Examples of Provisionsp. 215
B Article 7 of the DSUp. 216
C Article 11 of the DSUp. 218
D Article 3.2 of the DSUp. 218
a The Function of Article 3.2 of the DSUp. 218
b The Approach Prescribed by the DSU: Use of International Law for Interpretationp. 219
c Interpretation in Light of the Object and Purposep. 222
5 Jurisprudence on Non-WTO Law in WTO Dispute Settlementp. 223
A Treatiesp. 223
B General International Lawp. 226
6 Access to Medicine as jus cogens within WTO Dispute Settlement?p. 229
II TRIPS Agreement Flexibilities in the Light of Human Rightsp. 229
1 Parallel Importsp. 230
A No International Exhaustionp. 232
B Mandatory International Exhaustionp. 232
C The Choice is Left to Membersp. 233
2 Limited Exceptionsp. 234
A Limitedp. 235
B Conflict with Normal Exploitationp. 236
C Prejudice Legitimate Interestsp. 236
D Article 27 of the TRIPS Agreement and Its Scopep. 237
E Examples of Measures under Article 30 of the TRIPS Agreementp. 238
3 Compulsory Licencesp. 239
A Grounds for Granting Compulsory Licencesp. 241
a Local Working Requirements and Article 27 of the TRIPS Agreementp. 242
b Commonly Suggested Groundsp. 244
B Procedure of the Grantp. 245
a Authorization on Individual Meritsp. 245
b Prior Negotiationsp. 245
aa The Requirement of Prior Negotiationsp. 246
bb Waiver of the Requirementp. 246
c Adequate Remunerationp. 247
d Review of the Decisionsp. 249
C Scope of the Rights under Compulsory Licencesp. 249
a Limited by the Purposep. 250
b Non-exclusive, Non-assignablep. 250
c Territorialityp. 250
aa Interpretation of the Provisionp. 251
bb Options for Members Lacking Pharmaceutical Manufacturing Capacityp. 251
D Conclusion as to Compulsory Licencesp. 253
4 Revocation of Patentsp. 253
5 Conclusionp. 255
III WTO Decisions to Remedy Insufficienciesp. 255
1 The Doha Declarationp. 256
A Negotiating Historyp. 256
B Content of the Decisionp. 257
C Evaluationp. 261
2 The Decision of 30 August 2003p. 261
A Negotiating Historyp. 262
B Content of the Decisionp. 264
a Product Scope of the Decisionp. 265
b Country Scopep. 265
c Waiver of Article 31(f) of the TRIPS Agreementp. 266
aa Notification by Importing Memberp. 267
bb Conditions of Compulsory Licence Granted by Exporting Memberp. 267
cc Notification by Exporting Memberp. 268
d Waiver of Article 31(f) of the TRIPS Agreement within Regional Trade Agreementsp. 268
e Waiver of Article 31(h) of the TRIPS Agreementp. 269
f Further Safeguards against Trade Diversionp. 269
g Technicalitiesp. 270
C Implementationp. 270
D Evaluationp. 271
3 Amendment of the TRIPS Agreementp. 272
A Negotiating Historyp. 272
B Content of the Decisionp. 274
C Evaluationp. 275
4 The Legal Status of the Decisions: Flexibility in Decision-Makingp. 276
A Background: Decision-Making in the WTOp. 276
B The Doha Declarationp. 279
C The Decision of 30 August 2003p. 282
D The Amendment of the TRIPS Agreementp. 286
5 Conclusionp. 286
IV Towards Solving the Conflictp. 287
1 Possible Solutionsp. 287
2 Challenges Ahead: FTAs and BITsp. 289
A Free Trade Agreementsp. 289
B Bilateral Investment Treatiesp. 291
C Conclusionp. 292
Annex 1 Summary of Argumentsp. 293
Annex 2 States and their Membership in Relevant Organizations and Agreementsp. 303
Annex 3 WTO Disputes on the TRIPS Agreementp. 308
Bibliographyp. 312
Indexp. 361