Library Catalogue
Socio-Economic Impact of Data Exclusivity on Access to Medicine in India (Record no. 111207)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 10278nam a2200193Ia 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251125121612.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 210518s2012 xx 000 0 und d |
| 040 ## - CATALOGING SOURCE | |
| Transcribing agency | NLS |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Navneet Singh Tewatia |
| 245 ## - TITLE STATEMENT | |
| Title | Socio-Economic Impact of Data Exclusivity on Access to Medicine in India |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Bangalore |
| Name of publisher, distributor, etc. | NLSIU |
| Date of publication, distribution, etc. | 2012 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 216p |
| 505 ## - FORMATTED CONTENTS NOTE | |
| Formatted contents note | CONTENTS<br/>Acknowledgements;<br/>Contents;<br/>Table of cases;<br/>Table of statutes;<br/>Table of treaties;<br/>List of abbreviations;<br/>Bibliography;<br/>Chapter 1: Introduction;<br/>1 INTRODUCTION;<br/>2 METHODOLOGY;<br/>3 SCOPE AND LIMITATIONS;<br/>4 RESEARCH QUESTIONS;<br/>5 CHAPTERISATION;<br/>5.1 CHAPTER 1 & 2;<br/>5.2 CHAPTER 3;<br/>5.3 CHAPTER 4;<br/>5.4 CHAPTER 5 & 6;<br/>Chapter 2: Significance of Right to Health to ensure Access to Medicine<br/>1 INTRODUCTION;<br/>2 DEFINITION OF HEALTH;<br/>3 DETERMINANTS OF HEALTH;<br/>4 RIGHT TO HEALTH IN INTERNATIONAL CONVENTIONS;<br/>4.1 INTERNATIONAL COVENANT ON ECONOMICS, SOCIAL AND CULTURAL RIGHTS (ICESCR);<br/>4.2 UNIVERSAL DECLARATION OF HUMAN RIGHTS;<br/>4.3 ALMAATA DECLARATION ON HEALTH FOR ALL BY 2000;<br/>4.4 WHO CONSTITUTION;<br/>4.5 CONVENTION ON THE ELIMINATION OF ALL FORMS OF DISCRIMINATION AGAINST WOMEN;<br/>4.6 CONVENTION ON THE ELIMINATION OF ALL FORMS OF RACIAL DISCRIMINATION;<br/>4.7 CONVENTION ON THE RIGHTS OF THE CHILD;<br/>4.8 CAIRO PROGRAMME OF ACTION;<br/>4.9 COPENHAGEN DECLARATION;<br/>4.10 BEIJING DECLARATION;<br/>4.11 BEIJING PLATFORM FOR ACTION;<br/>4.12 HABITATAGENDA;<br/>5 INDIA'S OBLIGATION TO SECURE RIGHT TO HEALTH UNDER INTERNATIONAL<br/>TREATIES;<br/>6 POSITION OF RIGHT TO HEALTH IN INDIA;<br/>6.1.1 Paschim Baga Khet Mazoor Samiti Vs State of West Bengal;<br/>6.1.2 Vincent Panikurlangara v Union of India;<br/>6.1.3 Consumer Education and Resource Centre Vs Union of India;<br/>6.1.4 Francis Coloria Mullin v. Administrator, Union Territory of Delhi;<br/>6.1.5 State of Punjab and Others v. Mohinder Singh;<br/>6.1.6 State of Punjab v. Ram Lubhaya Bagga (1998);<br/>7 RIGHT TO HEALTH AND ACCESS TO MEDICINE;<br/>7.1 AIDAN AND ORS VS UNION OF INDIA;<br/>7.2 SAHARA HOUSE V. UOI;<br/>8 DIRECTIVE PRINCIPLES OF STATE POLICY ARTICLE 39 (B) AND (C) AND ACCESS<br/>TO MEDICINE;<br/>8.1.1 Interpretation of definitions in Article 39 (b) & (c);<br/>9 CONCLUSION;<br/>10 ABOUT THE NEXT CHAPTER;<br/>Chapter 3: Introduction to TRIPS Article 39.3 and Position of Data Exclusivity Law in India;<br/>1 INTRODUCTION;<br/>1.1 CLINICAL DEVELOPMENT PROCESS - ORIGINATION OF DATA;<br/>1.2 CONCEPT OF DATA EXCLUSIVITY;<br/>1.3 DIFFERENCE BETWEEN DATA EXCLUSIVITY, DATA PROTECTION AND PATENTS;<br/>2 PROTECTION OF TEST DATA UNDER TRIPS ARTICLE 39.3;<br/>2.1 TRIPS ARTICLE 39.3;<br/>2.2 POSSIBLE INTERPRETATIONS OF TRIPS ARTICLE 39.3; <br/>2.3 FORMS OF PROTECTION OF DATA SUBMITIED FOR MARKETING APPROVAL;<br/>2.4 CONDITIONS FOR PROTECTION OF DATA SUBMITIED FOR MARKETING APPROVAL;<br/>3 PROTECTION OF TEST DATA BEFORE TRIPS AGREEMENT;<br/>4 NEGOTIATING HISTORY OF ARTICLE 39 OF TRIPS AGREEMENT;<br/>4.1 EARLY NATIONAL PROPOSALS;<br/>5 ANALYSIS OF DATA EXCLUSIVITY LAWS IN DIFFERENT COUNTRIES;<br/>5.1 DATA EXCLUSIVITY PERIOD FOR BIO-SIMILARS;<br/>6 REASONS FOR COUNTRIES TO ADOPT DATA EXCLUSIVITY AS TRIPS PLUS<br/>MEASURE;<br/>6.1 ADOPTING DATA EXCLUSIVITY FORWTO ACCESSION;<br/>6.2 SIGNING FREE TRADE AGREEMENTS AND OTHER BILATERAL TRADE AGREEMENTS WITH DEVELOPED COUNTRIES CONSISTING TRIPS PLUS CLAUSE;<br/>7 POSITION OF DATA EXCLUSIVITY LAW IN INDIA;<br/>7.1 ENFORCEMENT OF THE DRUGS AND COSMETICS ACT IN INDIA;<br/>7.2 REQUIREMENT OF DATA FOR IMPORT OR MANUFACTURE OF NEW DRUG IN INDIA;<br/>7.3 ADOPTION OF COMMON TECHNICAL DOCUMENT FORMAT BY INDIA;<br/>8 WHY INDIAN GOVERNMENT IS CONSIDERING ADOPTING DATA EXCLUSIVITY?.;<br/>8.1 PRESSURES FROM INTERNATIONAL COMMUNITY ON INDIA FOR ADOPTION OF DATA EXCLUSIVITY PROVISIONS;<br/>8. 1. 1 Push from United States of America;<br/>8.1.2 Push from European Union;<br/>9 VIEWS OF STAKEHOLDERS IN INDIA ON ISSUE OF DATA EXCLUSIVITY;<br/>9.1 PHARMACEUTICAL INDUSTRY IN INDIA ON DATA EXCLUSIVITY;<br/>9.1.1 Government of India;<br/>9.1.2 United Nations' Agencies;’<br/>9.1.3 Civil Society Organizations;<br/>10 INDIA'S OBLIGATION FOR ARTICLE 39.3 UNDER TRIPS AGREEMENT;<br/>11 CONCLUSION;<br/>12 ABOUT THE NEXT CHAPTER;<br/>Chapter 4: Access to Medicine - Introduction Determinants and Situation in India;<br/>1 INTRODUCTION;<br/>2 PUBLIC HEALTH PROFILE OF INDIA;<br/>2.1 INDIA'S EXPENDITURE ON HEALTHCARE;<br/>3 ACCESS TO MEDICINE;<br/>3.1 GLOBAL SITUATION OF ACCESS TO MEDICINE;<br/>3.2 ACCESS TO MEDICINES AND MILLENNIUM DEVELOPMENT GOALS;<br/>4 ACCESS TO MEDICINE SITUATION IN INDIA;5 FACTORS AFFECTING ACCESS TO MEDICINE;<br/>6 FACTORS AFFECTING ACCESS TO MEDICINE SPECIFIC TO INDIA;<br/>6.1 RATIONALE USE OF DRUGS;<br/>6.1.1 National List of Essential Medicines;<br/>6.1.2 Prescription behavior of physicians and dispensing practices in India;<br/>6.1.3 Generic drug substitution;<br/>6.2 AFFORDABLE PRICES;<br/>6.2.1 Medicine price and its impact on access to medicine;<br/>6.2.2 Drug price control in India;<br/>6.2.3 Trend of Medicine prices in India;<br/>6.2.4 The reasons for rise in the prices of medicines;<br/>6.3 SUSTAINABLE FINANCING;<br/>6.3.1 Health insurance;<br/>6.3. 1. 1 Case Study showing importance of drug pricing in absence of health insurance;<br/>6.4 RELIABLE HEALTH & SUPPLY SYSTEMS;<br/>6.4.1 National drug policy;<br/>6.4.2 Intellectual Property Protection;<br/>6.4.3 Free trade agreements;<br/>6.4.3.1 Injection provisions;<br/>6.4.3.2 Border measures as per foreign trade laws;<br/>6.4.3.3 Third party Liability;<br/>6.4.3.4 Patent Term Extension;<br/>6.4.4 Medicine Supply systems;<br/>6.4.5 Indigenous production of medicine;<br/>6.4.6 Mergers and acquisitions and FDI policies;<br/>6.4.7 Drug regulatory environment;<br/>6.4.8 Product lag period between global launch and Indian launch;<br/>6.4.9 Lack of research & development and product improvement;<br/>7 IMPROVING ACCESS OF MEDICINES IN INDIA;<br/>7.1 GOVERNMENT'S INITIATIVES TO IMPROVE ACCESS TO MEDICINE;<br/>7.1.1 Increasing healthcare insurance for public health;<br/>7.1.2 National Rural Health Mission (NRHM);<br/>7. 1.3 Supply of medicines under Common minimal Programme;<br/>7.1.4 Using TRIPS flexibilities;<br/>7.1.4.1 Amendment of Indian Patent Act while considering the public health safeguards and<br/>access to medicines;<br/>7.1.4.2 Compulsory License provision;<br/>7.1.5 Grants for opening generic drug stores;<br/>7.1.6 Price control of medicines;<br/>7. 1.7 Drug regulatory reforms;<br/>7. 1.8 Providing fiscal benefits to industry;<br/>7 .2 MULTILATERAL AGENCIES' CONTRIBUTION IN IMPROVING ACCESS;<br/>7.3 ROLE OF CIVIL SOCIETY AND NGOs;<br/>7.3.1 Stimulating pharmaceutical companies for improving Access to Medicine;<br/>7.4.1. PHARMACEUTICAL COMPANIES' CONTRIBUTION TO IMPROVE ACCESS OF MEDICINES;<br/>7.4.1.1 Increasing the affordability of medicines;<br/>7.4.1.2 Investing in country specific R&D;<br/>7.4.1.3 Innovative licensing strategies;<br/>8 CONCLUSIONS;<br/>9 ABOUT THE NEXT CHAPTER;<br/>Chapter 5: Implications of Data Exclusivity in India;<br/>1 INTRODUCTION;<br/>1.1 INTER-MINISTERIAL COMMITTEE CONSTITUTED BY THE GOVERNMENT;<br/>1. 1. 1 Need to Strengthen Legal Provisions on Data Protection – <br/>1.1.2 Different Data Protection Measures to be adopted for Agro-chemicals Pharmaceuticals. and Traditional Medicines;<br/>1.1.3 A Calibrated Approach to be adopted in case of Pharmaceuticals;<br/>1. 1.4 Safeguards suggested;<br/>1. 1.5 Step-by-step analysis of Satwant Reddy Committee proposal;<br/>2 EVIDENCES INDICATING THAT DATA EXCLUSIVITY CAN HAVE SERIOUS IMPACT ON AFFORDABILITY & ACCESSIBILITY TO CHEAPER GENERIC VARIANTS – ANALOGY FROM OTHER COUNTRIES;<br/>2.1 DATA EXCLUSIVITY IN JORDAN;<br/>2.1.1 Impact of data exclusivity on access to medicine and public health in Jordan since<br/>2001;<br/>2.1.2 Economic impact of data exclusivity on FDI in Jordan;<br/>2.1.3 Impact of US-Jordan FTA's data exclusivity clause on Indian exports to Jordan;<br/>2.2 GUATEMALA; <br/>2.3 ANALOGY FROM BRAZIL;<br/>3 REJECTION OF DATA EXCLUSIVITY BY WTO MEMBER COUNTRIES;<br/>4 ANALYSIS OF IMPACT DATA EXCLUSIVITY ON ACCESS TO MEDICINES IN INDIA;<br/>4.1 ASSUMPTIONS MADE FOR A POSSIBLE DATA EXCLUSIVITY MODEL IN INDIA;<br/>4.2 How DOES DATA EXCLUSIVITY WORK;<br/>4.3 IMPACT ON FUTURE AVAILABILITY OF GENERIC DRUGS - HYPOTHETICAL SCENARIOS;<br/>4.3.1 Scenario 1. Drug patented in India;<br/>4.3.2 Scenario 2. Drug not patented in India;<br/>4.3.3 Scenario 3. Patent application rejected by the Patent Office or rejected due to Pre-<br/>Grant or Post - Grant Opposition, withdrawal of patent application;<br/>5 ECONOMIC IMPLICATIONS OF DATA EXCLUSIVITY;<br/>5.1 IMPACT ON THE EXPORT OF PHARMACEUTICALS ;<br/>5.2 COST INVOLVED IN REGENERATING THE TEST DATA;<br/>5.3 ADDITIONAL EXPENDITURE INCURRED IN BUYING EXPENSIVE DRUGS;<br/>5.4 REVENUE GENERATED BY MNCs FROM SALES OF NEW DRUGS;<br/>5.5 IMPACT ON FOREIGN DIRECT INVESTMENTS;<br/>6 DATA EXCLUSIVITY LEADS TO ETHICAL AND SOCIAL IMPLICATIONS BY EXPOSING CLINICAL STUDY SUBJECTS TO DRUGS & PLACEBO;<br/>7 VIOLATION OF COMPETITION LAWS;<br/>8 UNDERMINING THE USE OF FLEXIBILITIES GIVEN UNDER TRIPS AGREEMENT;<br/>8.1 COMPULSORY LICENSES DURING PUBLIC HEALTH CRISES;<br/>8.1.1 Case of Avian Flu and Data Exclusivity in Europe;<br/>8.2 DATA EXCLUSIVITY UNDERMINES THE SECTION 3 (D);<br/>9 IMPACT OF DATA EXCLUSIVITY ON ACCESS TO MEDICINE AND RIGHT TO HEALTH;<br/>9.1 DRUG PRICES & GENERIC COMPETITION;<br/>9.2 IMPACT ON THE LAUNCH OF NEW DRUGS IN INDIA FOR ACCESS TO FUTURE DRUGS;<br/>10 CONCLUSION;<br/>Chapter 6: Summary of Conclusions and Suggestions;<br/>SUMMARY OF CONCLUSIONS;<br/>CONCLUSIONS FROM CHAPTER 2 - SIGNIFICANCE OF RIGHT TO HEALTH TO ENSURE ACCESS TO MEDICINE;<br/>CONCLUSIONS FROM CHAPTER 3 -INTRODUCTION TO TRIPS ARTICLE 39.3 AND POSITION OF DATA<br/>EXCLUSIVITY LAW IN INDIA;<br/>CONCLUSIONS FROM CHAPTER 4 - ACCESS TO MEDICINE -INTRODUCTION, DETERMINANTS AND SITUATION IN INDIA;<br/>CONCLUSIONS FROM CHAPTER 5 -IMPLICATIONS OF DATA EXCLUSIVITY IN INDIA;<br/>SUGGESTIONS;<br/>IMPROVEMENT IN THE SUPPLY CHAIN MANAGEMENT POLICY FOR MEDICINES;<br/>REGULAR & PERIODIC UPDATION OF NATIONAL LIST OF ESSENTIAL MEDICINES;<br/>BALANCE APPROACH FOR PRICE CONTROL OF MEDICINE;<br/>AMENDMENTS IN DRUGS & COSMETICS ACT AND RULE TO MEET THE OBLIGATIONS UNDER TRIPS;<br/>ARTICLE 39(3) USING TRIPS FLEXIBILITY;<br/>LEGAL PROVISIONS FOR SECURING AFFORDABILITY AND ACCESSIBILITY OF MEDICINES TO SECURE RIGHT TO HEALTH;<br/>ANNEXURE;<br/> |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Data Exclusivity Law in India |
| -- | Right to Health - Access to Medicine - India |
| -- | TRIPS - Data Exclusivity Law - India |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Dr. T Ramakrishna - Guide |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://dans.nls.ac.in/handle/123456789/513">https://dans.nls.ac.in/handle/123456789/513</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Thesis |
| Withdrawn status | Lost status | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | 21.05.2018 | PhD041 | 21.05.2018 | 21.05.2018 | Thesis |