Compulsory licensing for expensive medicines [printed text] / Esther Van Zimmeren, Author ; Timo Minssen, Author ; Liesbet Paemen, Author ; Walter Van Dyck, Author ; Jeroen Luyten, Author ; Rosanne Janssens, Author ; Liese Barbier, Author ; Simoens, Steven, Author ; Céline Pouppez, Author ; Irina Cleemput  , Author ; Imgard Vinck , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2022 . - p.1-119; P1-64; P1-4 : ill., ; A4. - ( KCE Reports. Health Services Research (HSR); 356) . ISSN : D/2022/10.273/35 : € 0,00 Languages : English ( eng)
| Descriptors: |
Indexation
2020-50 ; Intellectual Property[MeSH Terms] Property, such as patents, trademarks, and copyright, that results from creative effort. The Patent and Copyright Clause (Art. 1, Sec. 8, cl. 8) of the United States Constitution provides for promoting the progress of science and useful arts by securing for limited times to authors and inventors, the exclusive right to their respective writings and discoveries. (From Black's Law Dictionary, 5th ed, p1014)
Year introduced: 1996 ; Legislation, Drug ; Legislation, Pharmacy [MeSH Terms] Laws and regulations, pertaining to the field of pharmacy, proposed for enactment or enacted by a legislative body.
Year introduced: 1968 ; Patent[MeSH Terms] Work consisting of documents granted by a government giving exclusive rights to an inventor or assignee to manufacture, use, or sell an invention for a certain number of years.
Year introduced: 2008(1999) ; Pharmaceutical Preparations ; R356
Classification
WA 32 Legislation
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| Contents note: |
Part 1 – Legal study
1 INTRODUCTION 9 -- 2 THE PHARMACEUTICAL SECTOR: TRENDS, PRACTICES AND CHARACTERISTICS OF THE LEGAL AND GOVERNANCE FRAMEWORK 12 -- 2.1 INTRODUCTION .12 -- 2.2 KEY STAKEHOLDERS & INNOVATION TRENDS IN THE PHARMACEUTICAL SECTOR 12 -- 2.3 CHARACTERISTICS RELEVANT LEGAL FRAMEWORK PHARMACEUTICAL SECTOR 14 -- 2.4 COSTS OF R&D, BUSINESS AND IP STRATEGIES .15 -- 3 KEY PATENT LAW PRINCIPLES AND THE PHARMACEUTICAL SECTOR .19 -- 3.1 INTRODUCTION .19 -- 3.2 THE NATURE OF PATENT RIGHTS AND THE PATENT RATIONALE 19 -- 3.3 PATENT APPLICATION PROCEDURES 21 -- 3.4 KEY PATENTABILITY CRITERIA AND PATENTING PRACTICES IN THE PHARMACEUTICAL SECTOR 23 -- 3.5 EXCEPTIONS TO PATENT RIGHTS RELEVANT FOR THE PHARMACEUTICAL SECTOR 28 -- 3.6 INTERIM CONCLUSION .31 -- 4 LEGAL AND GOVERNANCE FRAMEWORK FOR REGULATORY EXCLUSIVITIES AND TRANSPARENCY OF CLINICAL TRIALS DATA 33 -- 4.1 INTRODUCTION .33 -- 4.2 THE INTERNATIONAL AND EUROPEAN LEGAL AND GOVERNANCE FRAMEWORK RELATED TO REGULATORY EXCLUSIVITIES 34 -- 4.2.1 The International Legal Framework for Regulatory Exclusivities: TRIPs Agreement 34 -- 4.2.2 The European Legal Framework for Regulatory Exclusivities 34 -- 4.2.3 Trends, Business and Legal Practices regarding Regulatory Exclusivities 40 -- 4.3 LEGAL AND GOVERNANCE FRAMEWORK RELATED TO CTD TRANSPARENCY 43 -- 4.3.1 Introduction .43 -- 4.3.2 European Legal Framework for Clinical Trial Data Transparency 44 -- 4.3.3 Trends, Business and Legal Practices regarding Clinical Trials Transparency 45 -- 4.4 INTERIM CONCLUSION .48 -- 5 COMPULSORY LICENSING 49 -- 5.1 INTRODUCTION .49 -- 5.2 THE INTERNATIONAL AND EUROPEAN LEGAL AND POLICY FRAMEWORK FOR COMPULSORY LICENSING 50 -- 5.2.1 CLs & the International Legal Framework: Paris Convention and TRIPs Agreement 50 -- 5.2.2 CLs & the European Legal and Policy Framework: The EU Biotechnology Directive and the Unitary Patent Package, the EC Action Plan and Competition Law 59 -- 5.3 THE BELGIAN LEGAL FRAMEWORK FOR CLS .71 -- 5.3.1 Current Belgian Legal Framework for CLs .71 -- 5.3.2 CLs and Import to Belgium .74 -- 5.3.3 Legislative Proposal CLs .75 -- 5.3.4 Recommendations regarding the CL Mechanism for Public Health in Belgium and the Legislative Proposal for Excessive Pricing .78 -- 5.4 CLS FOR PUBLIC HEALTH & EXCESSIVELY PRICED MEDICINES IN OTHER COUNTRIES .80 -- 5.4.1 Key CL Mechanisms 81 -- 5.5 CLS FOR PUBLIC HEALTH & EXCESSIVELY PRICED MEDICINES IN THE NETHERLANDS .85 -- 5.6 IMPLICATIONS DATA & MARKET EXCLUSIVITIES FOR COMPULSORY LICENSING 88 -- 5.7 INTERIM CONCLUSION .91 -- 6 COMPLEMENTARY MECHANISMS WITHIN AND BEYOND THE PATENT LAW CONTEXT 92 -- 6.1 CONSIDER SOCIALLY RESPONSIBLE LICENSING CONDITIONS FOR ACADEMIA 92 -- 6.2 STIMULATE VOLUNTARY LICENSING: PATENT POOLS AND CLEARINGHOUSES 93 -- 6.3 INCREASE COLLABORATION & COORDINATION WITH NATIONAL AND EUROPEAN COMPETITION AUTHORITIES IN THE PHARMACEUTICAL SECTOR AND IN PARTICULAR FOR EXCESSIVE PRICING .94 -- 6.4 INCREASE TRANSPARENCY ON DATA AND R&D COSTS 95 -- 6.5 IMPOSE CONDITIONS ON ACCESS & PRICING IN CASE OF PUBLIC FUNDING .95 -- 6.6 INCREASE COORDINATION ON PRICING & REIMBURSEMENT 95 -- 7 CONCLUSIONS 96 -- SUPPLEMENT .99 -- APPENDIX 1. COMPETITION CASES EXCESSIVE PRICING .99 -- APPENDIX 2. TABLE COMPARATIVE ANALYSIS CLS IN OTHER COUNTRIES 109 -- APPENDIX 3. INFORMATIVE CL CASES .111 -- APPENDIX 4. SUMMARY OF THE LEGAL FRAMEWORK FOR PHARMACY PREPARATIONS IN BELGIUM .112 -- APPENDIX 4.1. EUROPEAN AND BELGIAN LEGISLATION ON NON-INDUSTRIAL PREPARATIONS 113 -- APPENDIX 4.2. QUALITY RULES PREPARATIONS BY PHARMACIES IN BELGIUM 115 -- APPENDIX 4.3. DIFFERENT PRACTICES IN THE EUROPEAN UNION .116 -- APPENDIX 5. BRIEF OVERVIEW OF THE DRUGS PRICING CRITERIA IN BELGIUM 118
Part 2 – Economic study
LIST OF ABBREVIATIONS 3 -- 1 PROBLEM DESCRIPTION 4 -- 2 OBJECTIVES 5 -- 3 LITERATURE REVIEW METHODS 5 -- 3.1 UNDERSTANDING THE CONSEQUENCES OF COMPULSORY LICENSING 5 -- 3.2 COMBINING THEORY WITH PRACTICE 5 -- 3.3 APPLYING A FLEXIBLE AND PURPOSIVE SEARCH STRATEGY 6 -- 3.4 EXTRACTING AND SYNTHESISING DATA 6 -- 3.5 INTERACTING WITH THE STUDY COMMISSIONER 6 -- 4 LITERATURE REVIEW RESULTS 7 -- 4.1 SEARCH FLOW DIAGRAM . 7 -- 4.2 DATA EXTRACTION 8 -- 4.2.2 Empirical studies 19 -- 4.2.3 Remuneration .31 -- 5 EXAMINING THE ECONOMIC IMPACT OF CL FOR MEDICINES 33 -- 5.1 INDUSTRIAL CONSEQUENCES 34 -- 5.1.1 Development of a domestic pharmaceutical industry 34 -- 5.1.2 Reduced investment by originator pharmaceutical companies 37 -- 5.1.3 Reduced investment from other industries vulnerable to IP protection 39 -- 5.1.4 State retaliation .39 -- 5.2 HEALTH CONSEQUENCES .40 -- 5.2.1 Increased access for patients to expensive, innovative drugs .40 -- 5.2.2 Freeing of resources that can be invested elsewhere 41 -- 5.2.3 Reduced access to innovative drugs through fewer drug launches or fewer trials 41 -- 5.2.4 Reduced supply of innovative medicines due to lower investment in R&D 41 -- 5.3 ADEQUATE REMUNERATION FOR COMPULSORY LICENSES 42 -- 5.3.1 Adequate remuneration of CL in developing economies .43 -- 5.3.2 Adequate remuneration of CL in developed economies 44 -- 6 CONCLUSION .48 -- APPENDIX 1. SEARCH STRATEGY 58 -- APPENDIX 1.1. SEARCH STRATEGY IN GENERAL 58 -- APPENDIX 1.2. SEARCH STRATEGY FOR PEER-REVIEWED LITERATURE 59 -- APPENDIX 1.3. SEARCH STRATEGY FOR GREY LITERATURE .64
Part 3 – Overall conclusions
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| Link for e-copy: |
https://doi.org/10.57598/R356C |
| Format of e-copy: |
PDF (2,29 MB) |
| Record link: |
https://kce.docressources.info/index.php?lvl=notice_display&id=4841 |
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Budget impact analysis of orphan drugs in Belgium in Journal of Medical Economics, 13(2010)02 ([05/01/2010])
