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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 Abbreviations | p. xxvii |
Introduction | p. xxxiii |
1 Background of the Debate | p. 1 |
I Finding a Cure for a New Disease | p. 2 |
II BW's Decision on AZT Pricing Causes Outrage | p. 5 |
III The HIV/AIDS Pandemic Today | p. 6 |
IV The TRIPS Agreement and Access to Medicine: The South African Medicines Act | p. 11 |
V Beyond AIDS Drugs: Anthrax and Cipro | p. 15 |
2 Patent Law | p. 18 |
I A Short Primer on Patents | p. 19 |
II The History of Patent Law | p. 20 |
1 Patent Privileges | p. 21 |
2 The First Patent Acts | p. 22 |
3 The 19th Century | p. 27 |
4 The Patentability of Pharmaceutical Products | p. 28 |
III Rationales of Patent Law | p. 29 |
1 Natural Law Rationale | p. 29 |
2 Contract Rationale | p. 30 |
3 Reward Rationale | p. 31 |
4 Incentive Rationale | p. 31 |
5 Prospect Theory | p. 32 |
IV International Patent Law | p. 33 |
1 International Patent Law before the TRIPS Agreement | p. 34 |
2 Shortcomings of the Traditional System | p. 36 |
3 The North-South Divide: Arguments for and against Stronger Patent Protection | p. 37 |
4 Unilateral Pressure on Developing Countries | p. 39 |
5 The WTO/GATT setting | p. 41 |
A Background: The GATT | p. 41 |
B Intellectual Property in the GATT | p. 43 |
C The Uruguay Round | p. 44 |
D Validity of the TRIPS Agreement | p. 48 |
V Trips Agreement Patent Standards | p. 49 |
1 Interpretation in Light of the Object and Purpose of the TRIPS Agreement | p. 50 |
2 Basic Principles of the TRIPS Agreement | p. 51 |
3 Conditions of Patentability | p. 53 |
A Patentable Subject Matter | p. 53 |
a Inventions | p. 54 |
b All Fields of Technology, Exceptions, Non-Discrimination | p. 55 |
aa All Fields of Technology | p. 55 |
bb Exceptions for Pharmaceuticals? | p. 56 |
cc Non-Discrimination | p. 59 |
dd The Drug Approval Process: Patent Law Implications | p. 60 |
c Product and Process Patents | p. 64 |
B Novelty | p. 65 |
C Inventive Step | p. 66 |
D Capability of Industrial Application | p. 66 |
E Disclosure | p. 67 |
4 Rights Conferred | p. 67 |
5 Transitional Arrangements | p. 70 |
6 Conclusion on Patent Law | p. 75 |
3 Access to Medicine as a Human Right | p. 76 |
I Background | p. 79 |
1 International Human Rights | p. 79 |
2 Health and Human Rights | p. 83 |
3 Intellectual Property and Human Rights | p. 84 |
II The Interpretation of Human Rights Conventions | p. 85 |
III Justiciability | p. 86 |
1 Terminology | p. 87 |
2 Economic, Social, and Cultural Rights as Justiciable Rights | p. 89 |
IV Who is Bound by International Human Rights Law? | p. 94 |
1 Human Rights Obligations of Corporations | p. 94 |
2 Human Rights Obligations of International Organizations | p. 99 |
V Conventions | p. 102 |
1 Icescr | p. 102 |
A Access to Medicine as Part of the Right to Health | p. 102 |
a Content of the Right | p. 103 |
b Duties imposed on States Parties | p. 107 |
aa Obligation to Respect | p. 107 |
bb Obligation to Protect | p. 109 |
cc Obligation to Fulfil | p. 110 |
dd Justifying Non-Compliance with Lack of Financial Means | p. 110 |
B Enjoyment of the Benefits of Scientific Progress | p. 112 |
2 The WHO | p. 112 |
3 ICCPR | p. 115 |
A Content of the Right | p. 115 |
B Duties Imposed on States Parties | p. 118 |
4 Universal Declaration of Human Rights | p. 119 |
5 Other Agreements | p. 121 |
VI General International Law | p. 121 |
1 Customary International Law | p. 122 |
A Treaties and Customary International Law | p. 122 |
B State Practice | p. 123 |
C Opinio juris | p. 133 |
2 General Principles | p. 134 |
VII Conclusion on Human Rights | p. 136 |
4 Conflict between Patents and Access to Medicine | p. 137 |
I Interference of Patents with Access to Medicine due to Price Effects | p. 138 |
1 Microeconomic Theory | p. 138 |
A Competitive Market | p. 138 |
B Monopoly Pricing | p. 142 |
C Patents as Monopolies-other Pricing Factors | p. 144 |
D Pricing in Developing Countries | p. 146 |
2 Empirical Studies and Extrapolations | p. 148 |
3 Severity of the Access Impact | p. 150 |
II Justification of the Interference | p. 152 |
1 Protection of the Inventor's Material Interests | p. 153 |
A Author-Scope ratione personae | p. 154 |
B Interests of Inventors-Scope ratione materiae | p. 155 |
C Moral and Material Interests | p. 157 |
D The Right in the Conflict with Access to Medicine | p. 157 |
2 Justification as an Incentive for Future Research | p. 158 |
III Effects on Third Parties: Duty to Cooperate | p. 166 |
IV A Conflict between the Patent and the Human Rights Regime? | p. 169 |
1 Conflict of International Legal Regimes: Terminology | p. 170 |
A Fragmentation of International Law | p. 170 |
B International Legal Regimes | p. 172 |
C Conflict | p. 173 |
a Definition of Conflict | p. 174 |
b Typologies of Conflicts | p. 179 |
2 Conflict of International Legal Regimes: Towards Hierarchy? | p. 182 |
A Law of Coexistence and Reciprocity-A Law without Hierarchy | p. 182 |
B Law of Cooperation and Community Interests-Hierarchy in International Law | p. 185 |
a Erga Omnes Obligations-Integral Treaties | p. 187 |
b Jus cogens | p. 190 |
c Non-consenting States and Community Interests | p. 192 |
C Institutionalization, Factual Hierarchy | p. 193 |
D 'Soft-enforced' Human Rights Meet 'Hard-enforced' WTO | p. 197 |
a The WTO Regime | p. 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 Powerhouse | p. 199 |
cc The WTO and Regime Conflict | p. 200 |
b The Human Rights Regime | p. 203 |
aa Normative Hierarchy: Law of Values | p. 203 |
bb Factual Hierarchy: Soft Enforcement | p. 205 |
cc Human Rights and Regime Conflict | p. 205 |
c Perplexity | p. 206 |
5 Access to Medicine as a Human Right in the WTO Order | p. 207 |
I Access to Medicine as a Human Right within WTO Dispute Settlement | p. 208 |
1 Five Models for the Use of Non-WTO Law in WTO Dispute Settlement | p. 209 |
2 The WTO: A Self-contained Regime? | p. 210 |
3 Jurisdiction | p. 212 |
A Violation Complaints | p. 213 |
B Non-Violation Complaints | p. 213 |
C De Lege Ferenda | p. 214 |
4 Applicable Law | p. 215 |
A Examples of Provisions | p. 215 |
B Article 7 of the DSU | p. 216 |
C Article 11 of the DSU | p. 218 |
D Article 3.2 of the DSU | p. 218 |
a The Function of Article 3.2 of the DSU | p. 218 |
b The Approach Prescribed by the DSU: Use of International Law for Interpretation | p. 219 |
c Interpretation in Light of the Object and Purpose | p. 222 |
5 Jurisprudence on Non-WTO Law in WTO Dispute Settlement | p. 223 |
A Treaties | p. 223 |
B General International Law | p. 226 |
6 Access to Medicine as jus cogens within WTO Dispute Settlement? | p. 229 |
II TRIPS Agreement Flexibilities in the Light of Human Rights | p. 229 |
1 Parallel Imports | p. 230 |
A No International Exhaustion | p. 232 |
B Mandatory International Exhaustion | p. 232 |
C The Choice is Left to Members | p. 233 |
2 Limited Exceptions | p. 234 |
A Limited | p. 235 |
B Conflict with Normal Exploitation | p. 236 |
C Prejudice Legitimate Interests | p. 236 |
D Article 27 of the TRIPS Agreement and Its Scope | p. 237 |
E Examples of Measures under Article 30 of the TRIPS Agreement | p. 238 |
3 Compulsory Licences | p. 239 |
A Grounds for Granting Compulsory Licences | p. 241 |
a Local Working Requirements and Article 27 of the TRIPS Agreement | p. 242 |
b Commonly Suggested Grounds | p. 244 |
B Procedure of the Grant | p. 245 |
a Authorization on Individual Merits | p. 245 |
b Prior Negotiations | p. 245 |
aa The Requirement of Prior Negotiations | p. 246 |
bb Waiver of the Requirement | p. 246 |
c Adequate Remuneration | p. 247 |
d Review of the Decisions | p. 249 |
C Scope of the Rights under Compulsory Licences | p. 249 |
a Limited by the Purpose | p. 250 |
b Non-exclusive, Non-assignable | p. 250 |
c Territoriality | p. 250 |
aa Interpretation of the Provision | p. 251 |
bb Options for Members Lacking Pharmaceutical Manufacturing Capacity | p. 251 |
D Conclusion as to Compulsory Licences | p. 253 |
4 Revocation of Patents | p. 253 |
5 Conclusion | p. 255 |
III WTO Decisions to Remedy Insufficiencies | p. 255 |
1 The Doha Declaration | p. 256 |
A Negotiating History | p. 256 |
B Content of the Decision | p. 257 |
C Evaluation | p. 261 |
2 The Decision of 30 August 2003 | p. 261 |
A Negotiating History | p. 262 |
B Content of the Decision | p. 264 |
a Product Scope of the Decision | p. 265 |
b Country Scope | p. 265 |
c Waiver of Article 31(f) of the TRIPS Agreement | p. 266 |
aa Notification by Importing Member | p. 267 |
bb Conditions of Compulsory Licence Granted by Exporting Member | p. 267 |
cc Notification by Exporting Member | p. 268 |
d Waiver of Article 31(f) of the TRIPS Agreement within Regional Trade Agreements | p. 268 |
e Waiver of Article 31(h) of the TRIPS Agreement | p. 269 |
f Further Safeguards against Trade Diversion | p. 269 |
g Technicalities | p. 270 |
C Implementation | p. 270 |
D Evaluation | p. 271 |
3 Amendment of the TRIPS Agreement | p. 272 |
A Negotiating History | p. 272 |
B Content of the Decision | p. 274 |
C Evaluation | p. 275 |
4 The Legal Status of the Decisions: Flexibility in Decision-Making | p. 276 |
A Background: Decision-Making in the WTO | p. 276 |
B The Doha Declaration | p. 279 |
C The Decision of 30 August 2003 | p. 282 |
D The Amendment of the TRIPS Agreement | p. 286 |
5 Conclusion | p. 286 |
IV Towards Solving the Conflict | p. 287 |
1 Possible Solutions | p. 287 |
2 Challenges Ahead: FTAs and BITs | p. 289 |
A Free Trade Agreements | p. 289 |
B Bilateral Investment Treaties | p. 291 |
C Conclusion | p. 292 |
Annex 1 Summary of Arguments | p. 293 |
Annex 2 States and their Membership in Relevant Organizations and Agreements | p. 303 |
Annex 3 WTO Disputes on the TRIPS Agreement | p. 308 |
Bibliography | p. 312 |
Index | p. 361 |