CONTENTS
Acknowledgements;
Contents;
Table of cases;
Table of statutes;
Table of treaties;
List of abbreviations;
Bibliography;
Chapter 1: Introduction;
1 INTRODUCTION;
2 METHODOLOGY;
3 SCOPE AND LIMITATIONS;
4 RESEARCH QUESTIONS;
5 CHAPTERISATION;
5.1 CHAPTER 1 & 2;
5.2 CHAPTER 3;
5.3 CHAPTER 4;
5.4 CHAPTER 5 & 6;
Chapter 2: Significance of Right to Health to ensure Access to Medicine
1 INTRODUCTION;
2 DEFINITION OF HEALTH;
3 DETERMINANTS OF HEALTH;
4 RIGHT TO HEALTH IN INTERNATIONAL CONVENTIONS;
4.1 INTERNATIONAL COVENANT ON ECONOMICS, SOCIAL AND CULTURAL RIGHTS (ICESCR);
4.2 UNIVERSAL DECLARATION OF HUMAN RIGHTS;
4.3 ALMAATA DECLARATION ON HEALTH FOR ALL BY 2000;
4.4 WHO CONSTITUTION;
4.5 CONVENTION ON THE ELIMINATION OF ALL FORMS OF DISCRIMINATION AGAINST WOMEN;
4.6 CONVENTION ON THE ELIMINATION OF ALL FORMS OF RACIAL DISCRIMINATION;
4.7 CONVENTION ON THE RIGHTS OF THE CHILD;
4.8 CAIRO PROGRAMME OF ACTION;
4.9 COPENHAGEN DECLARATION;
4.10 BEIJING DECLARATION;
4.11 BEIJING PLATFORM FOR ACTION;
4.12 HABITATAGENDA;
5 INDIA'S OBLIGATION TO SECURE RIGHT TO HEALTH UNDER INTERNATIONAL
TREATIES;
6 POSITION OF RIGHT TO HEALTH IN INDIA;
6.1.1 Paschim Baga Khet Mazoor Samiti Vs State of West Bengal;
6.1.2 Vincent Panikurlangara v Union of India;
6.1.3 Consumer Education and Resource Centre Vs Union of India;
6.1.4 Francis Coloria Mullin v. Administrator, Union Territory of Delhi;
6.1.5 State of Punjab and Others v. Mohinder Singh;
6.1.6 State of Punjab v. Ram Lubhaya Bagga (1998);
7 RIGHT TO HEALTH AND ACCESS TO MEDICINE;
7.1 AIDAN AND ORS VS UNION OF INDIA;
7.2 SAHARA HOUSE V. UOI;
8 DIRECTIVE PRINCIPLES OF STATE POLICY ARTICLE 39 (B) AND (C) AND ACCESS
TO MEDICINE;
8.1.1 Interpretation of definitions in Article 39 (b) & (c);
9 CONCLUSION;
10 ABOUT THE NEXT CHAPTER;
Chapter 3: Introduction to TRIPS Article 39.3 and Position of Data Exclusivity Law in India;
1 INTRODUCTION;
1.1 CLINICAL DEVELOPMENT PROCESS - ORIGINATION OF DATA;
1.2 CONCEPT OF DATA EXCLUSIVITY;
1.3 DIFFERENCE BETWEEN DATA EXCLUSIVITY, DATA PROTECTION AND PATENTS;
2 PROTECTION OF TEST DATA UNDER TRIPS ARTICLE 39.3;
2.1 TRIPS ARTICLE 39.3;
2.2 POSSIBLE INTERPRETATIONS OF TRIPS ARTICLE 39.3;
2.3 FORMS OF PROTECTION OF DATA SUBMITIED FOR MARKETING APPROVAL;
2.4 CONDITIONS FOR PROTECTION OF DATA SUBMITIED FOR MARKETING APPROVAL;
3 PROTECTION OF TEST DATA BEFORE TRIPS AGREEMENT;
4 NEGOTIATING HISTORY OF ARTICLE 39 OF TRIPS AGREEMENT;
4.1 EARLY NATIONAL PROPOSALS;
5 ANALYSIS OF DATA EXCLUSIVITY LAWS IN DIFFERENT COUNTRIES;
5.1 DATA EXCLUSIVITY PERIOD FOR BIO-SIMILARS;
6 REASONS FOR COUNTRIES TO ADOPT DATA EXCLUSIVITY AS TRIPS PLUS
MEASURE;
6.1 ADOPTING DATA EXCLUSIVITY FORWTO ACCESSION;
6.2 SIGNING FREE TRADE AGREEMENTS AND OTHER BILATERAL TRADE AGREEMENTS WITH DEVELOPED COUNTRIES CONSISTING TRIPS PLUS CLAUSE;
7 POSITION OF DATA EXCLUSIVITY LAW IN INDIA;
7.1 ENFORCEMENT OF THE DRUGS AND COSMETICS ACT IN INDIA;
7.2 REQUIREMENT OF DATA FOR IMPORT OR MANUFACTURE OF NEW DRUG IN INDIA;
7.3 ADOPTION OF COMMON TECHNICAL DOCUMENT FORMAT BY INDIA;
8 WHY INDIAN GOVERNMENT IS CONSIDERING ADOPTING DATA EXCLUSIVITY?.;
8.1 PRESSURES FROM INTERNATIONAL COMMUNITY ON INDIA FOR ADOPTION OF DATA EXCLUSIVITY PROVISIONS;
8. 1. 1 Push from United States of America;
8.1.2 Push from European Union;
9 VIEWS OF STAKEHOLDERS IN INDIA ON ISSUE OF DATA EXCLUSIVITY;
9.1 PHARMACEUTICAL INDUSTRY IN INDIA ON DATA EXCLUSIVITY;
9.1.1 Government of India;
9.1.2 United Nations' Agencies;’
9.1.3 Civil Society Organizations;
10 INDIA'S OBLIGATION FOR ARTICLE 39.3 UNDER TRIPS AGREEMENT;
11 CONCLUSION;
12 ABOUT THE NEXT CHAPTER;
Chapter 4: Access to Medicine - Introduction Determinants and Situation in India;
1 INTRODUCTION;
2 PUBLIC HEALTH PROFILE OF INDIA;
2.1 INDIA'S EXPENDITURE ON HEALTHCARE;
3 ACCESS TO MEDICINE;
3.1 GLOBAL SITUATION OF ACCESS TO MEDICINE;
3.2 ACCESS TO MEDICINES AND MILLENNIUM DEVELOPMENT GOALS;
4 ACCESS TO MEDICINE SITUATION IN INDIA;5 FACTORS AFFECTING ACCESS TO MEDICINE;
6 FACTORS AFFECTING ACCESS TO MEDICINE SPECIFIC TO INDIA;
6.1 RATIONALE USE OF DRUGS;
6.1.1 National List of Essential Medicines;
6.1.2 Prescription behavior of physicians and dispensing practices in India;
6.1.3 Generic drug substitution;
6.2 AFFORDABLE PRICES;
6.2.1 Medicine price and its impact on access to medicine;
6.2.2 Drug price control in India;
6.2.3 Trend of Medicine prices in India;
6.2.4 The reasons for rise in the prices of medicines;
6.3 SUSTAINABLE FINANCING;
6.3.1 Health insurance;
6.3. 1. 1 Case Study showing importance of drug pricing in absence of health insurance;
6.4 RELIABLE HEALTH & SUPPLY SYSTEMS;
6.4.1 National drug policy;
6.4.2 Intellectual Property Protection;
6.4.3 Free trade agreements;
6.4.3.1 Injection provisions;
6.4.3.2 Border measures as per foreign trade laws;
6.4.3.3 Third party Liability;
6.4.3.4 Patent Term Extension;
6.4.4 Medicine Supply systems;
6.4.5 Indigenous production of medicine;
6.4.6 Mergers and acquisitions and FDI policies;
6.4.7 Drug regulatory environment;
6.4.8 Product lag period between global launch and Indian launch;
6.4.9 Lack of research & development and product improvement;
7 IMPROVING ACCESS OF MEDICINES IN INDIA;
7.1 GOVERNMENT'S INITIATIVES TO IMPROVE ACCESS TO MEDICINE;
7.1.1 Increasing healthcare insurance for public health;
7.1.2 National Rural Health Mission (NRHM);
7. 1.3 Supply of medicines under Common minimal Programme;
7.1.4 Using TRIPS flexibilities;
7.1.4.1 Amendment of Indian Patent Act while considering the public health safeguards and
access to medicines;
7.1.4.2 Compulsory License provision;
7.1.5 Grants for opening generic drug stores;
7.1.6 Price control of medicines;
7. 1.7 Drug regulatory reforms;
7. 1.8 Providing fiscal benefits to industry;
7 .2 MULTILATERAL AGENCIES' CONTRIBUTION IN IMPROVING ACCESS;
7.3 ROLE OF CIVIL SOCIETY AND NGOs;
7.3.1 Stimulating pharmaceutical companies for improving Access to Medicine;
7.4.1. PHARMACEUTICAL COMPANIES' CONTRIBUTION TO IMPROVE ACCESS OF MEDICINES;
7.4.1.1 Increasing the affordability of medicines;
7.4.1.2 Investing in country specific R&D;
7.4.1.3 Innovative licensing strategies;
8 CONCLUSIONS;
9 ABOUT THE NEXT CHAPTER;
Chapter 5: Implications of Data Exclusivity in India;
1 INTRODUCTION;
1.1 INTER-MINISTERIAL COMMITTEE CONSTITUTED BY THE GOVERNMENT;
1. 1. 1 Need to Strengthen Legal Provisions on Data Protection –
1.1.2 Different Data Protection Measures to be adopted for Agro-chemicals Pharmaceuticals. and Traditional Medicines;
1.1.3 A Calibrated Approach to be adopted in case of Pharmaceuticals;
1. 1.4 Safeguards suggested;
1. 1.5 Step-by-step analysis of Satwant Reddy Committee proposal;
2 EVIDENCES INDICATING THAT DATA EXCLUSIVITY CAN HAVE SERIOUS IMPACT ON AFFORDABILITY & ACCESSIBILITY TO CHEAPER GENERIC VARIANTS – ANALOGY FROM OTHER COUNTRIES;
2.1 DATA EXCLUSIVITY IN JORDAN;
2.1.1 Impact of data exclusivity on access to medicine and public health in Jordan since
2001;
2.1.2 Economic impact of data exclusivity on FDI in Jordan;
2.1.3 Impact of US-Jordan FTA's data exclusivity clause on Indian exports to Jordan;
2.2 GUATEMALA;
2.3 ANALOGY FROM BRAZIL;
3 REJECTION OF DATA EXCLUSIVITY BY WTO MEMBER COUNTRIES;
4 ANALYSIS OF IMPACT DATA EXCLUSIVITY ON ACCESS TO MEDICINES IN INDIA;
4.1 ASSUMPTIONS MADE FOR A POSSIBLE DATA EXCLUSIVITY MODEL IN INDIA;
4.2 How DOES DATA EXCLUSIVITY WORK;
4.3 IMPACT ON FUTURE AVAILABILITY OF GENERIC DRUGS - HYPOTHETICAL SCENARIOS;
4.3.1 Scenario 1. Drug patented in India;
4.3.2 Scenario 2. Drug not patented in India;
4.3.3 Scenario 3. Patent application rejected by the Patent Office or rejected due to Pre-
Grant or Post - Grant Opposition, withdrawal of patent application;
5 ECONOMIC IMPLICATIONS OF DATA EXCLUSIVITY;
5.1 IMPACT ON THE EXPORT OF PHARMACEUTICALS ;
5.2 COST INVOLVED IN REGENERATING THE TEST DATA;
5.3 ADDITIONAL EXPENDITURE INCURRED IN BUYING EXPENSIVE DRUGS;
5.4 REVENUE GENERATED BY MNCs FROM SALES OF NEW DRUGS;
5.5 IMPACT ON FOREIGN DIRECT INVESTMENTS;
6 DATA EXCLUSIVITY LEADS TO ETHICAL AND SOCIAL IMPLICATIONS BY EXPOSING CLINICAL STUDY SUBJECTS TO DRUGS & PLACEBO;
7 VIOLATION OF COMPETITION LAWS;
8 UNDERMINING THE USE OF FLEXIBILITIES GIVEN UNDER TRIPS AGREEMENT;
8.1 COMPULSORY LICENSES DURING PUBLIC HEALTH CRISES;
8.1.1 Case of Avian Flu and Data Exclusivity in Europe;
8.2 DATA EXCLUSIVITY UNDERMINES THE SECTION 3 (D);
9 IMPACT OF DATA EXCLUSIVITY ON ACCESS TO MEDICINE AND RIGHT TO HEALTH;
9.1 DRUG PRICES & GENERIC COMPETITION;
9.2 IMPACT ON THE LAUNCH OF NEW DRUGS IN INDIA FOR ACCESS TO FUTURE DRUGS;
10 CONCLUSION;
Chapter 6: Summary of Conclusions and Suggestions;
SUMMARY OF CONCLUSIONS;
CONCLUSIONS FROM CHAPTER 2 - SIGNIFICANCE OF RIGHT TO HEALTH TO ENSURE ACCESS TO MEDICINE;
CONCLUSIONS FROM CHAPTER 3 -INTRODUCTION TO TRIPS ARTICLE 39.3 AND POSITION OF DATA
EXCLUSIVITY LAW IN INDIA;
CONCLUSIONS FROM CHAPTER 4 - ACCESS TO MEDICINE -INTRODUCTION, DETERMINANTS AND SITUATION IN INDIA;
CONCLUSIONS FROM CHAPTER 5 -IMPLICATIONS OF DATA EXCLUSIVITY IN INDIA;
SUGGESTIONS;
IMPROVEMENT IN THE SUPPLY CHAIN MANAGEMENT POLICY FOR MEDICINES;
REGULAR & PERIODIC UPDATION OF NATIONAL LIST OF ESSENTIAL MEDICINES;
BALANCE APPROACH FOR PRICE CONTROL OF MEDICINE;
AMENDMENTS IN DRUGS & COSMETICS ACT AND RULE TO MEET THE OBLIGATIONS UNDER TRIPS;
ARTICLE 39(3) USING TRIPS FLEXIBILITY;
LEGAL PROVISIONS FOR SECURING AFFORDABILITY AND ACCESSIBILITY OF MEDICINES TO SECURE RIGHT TO HEALTH;
ANNEXURE;

Data Exclusivity Law in India Right to Health - Access to Medicine - India TRIPS - Data Exclusivity Law - India