Access to Medicine in the Context of Patent Monopoly

Contents
List of Abbreviations v;
List of Illustrations vi;
List of Tables vi;
Acknowledgement vii;
1. Introduction 1;
2. Literature Review 5;
2.1 Understanding Patent System 5;
2.2 The question of accessibility 10;
3. Research Methodology 16;
3.1 Research Problem 16;
3.2 Rationale Of The Study 16;
3.3 Objective of The Study 16;
3.4 Research Questions 17;
3.5 Research Methodology 17;
3.6 Data Analysis 19;
4. Flexibilities under TRIPS Agreement 20;
4.1. Parallel imports 20;
4.2 Analysis and Findings 23;
4.3 Policy Recommendations for Parallel Imports 26;
4.4 Compulsory Licensing 26;
4.5 India’s Tryst with Compulsory Licensing 28;
4.6 Case Study 32;
4.7 Offensive & Defensive Strategies Of The Pharmaceutical Companies 34;
4.8 Policy Recommendations for Compulsory Licensing 37;
5. The Role of Pharmacovigilance in Drug Safety 39;
5.1 Reporting System in US vs India 43;
5.2 Legal Framework 48;
5.3 Regulatory Framework 50;
5.2 Conclusion 56;
5.3 Policy Recommendations 57;
6. Pricing of the patented drugs 60;
6.1 Understanding the Supply-Demand 61;
6.2 Types of Pharmaceutical Pricing Models 63;
6.3 National Pricing Systems: A cross-Country Analysis of Mexico vs India 66;
6.4 Conclusion for Pricing of Patented Drugs 70;
6.5 Policy Recommendations 71;
7. Conclusion 75;
Appendix viii;
i. Questionnaire viii;
ii. Stakeholder Analysis xii;
References 78.