Competition law and policy in the Japanese pharmaceutical sector:
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| Schriftenreihe: | Kobe University Monograph Series in Social Science Research
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| Beschreibung: | xxi, 245 Seiten Illustrationen 24 cm |
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| 245 | 1 | 0 | |a Competition law and policy in the Japanese pharmaceutical sector |c Akira Negishi, Masako Wakui, Naoko Mariyama, editors |
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Contents Part I Healthcare and Pharmaceuticals: Innovation and Regulation in Japan 1 Regulation and Competition in the Pharmaceutical Industry in Japan. 3 Akira Negishi 1.1 Introduction . 1.2 Entry Restrictions for Manufacturing and Sales in the Pharmaceutical Sector . 1.2.1 Licences for the Manufacturing and Sales of Pharmaceutical Products . 1.2.2 Licence for Opening a Pharmacy. 1.2.3 Licence for Drug Sales Business . 1.3 Elimination of Distance Restrictions on Establishing Pharmacies and Lifting of Bans on Online Sales of Over-The-Counter Drugs. 6 1.3.1 Freedom to Choose an Occupation and Distance Restrictions on the Opening of Pharmacies . 1.3.2 Constitution and Prohibition of Online Sales of Over-The-Counter Drugs . 1.4 Approval for Manufacturing and Marketing of Pharmaceutical Products . 1.5 Price Regulation and Competition for Medical Drugs . 1.5.1 Price Regulation of Medical Drugs . 1.5.2 Price Competition for Pharmaceutical Products . 1.5.3 Price Regulation of Medical Drugs and Promotion of Innovation to Develop New
Drugs . 1.6 Distribution Regulations for Medical Drugs: AMA and MHLW Distribution Improvement Guidelines . 1.7 The Relationship Between the Approval of Generic Drugs and Patents on Original Drugs. 13 3 4 4 5 5 6 7 8 9 9 9 10 11 ix
X Contents 1.7.1 Approval of Generic Drugs. 1.7.2 Japanese-Style Patent Linkage System . 1.7.3 Competition Between Original and Generic Drugs. 1.8 Conclusions . References . 2 3 Competition and Cooperation: Building a Sustainable Healthcare Delivery System in a Society with a Declining Population. Goro Sato 2.1 Introduction . 2.2 Laws Relating to the Healthcare Delivery System: From the Perspective of Competition Policy . 20 2.2.1 The Basic Legal Structure of the Healthcare Delivery System . 2.2.2 Medical Services and the Antimonopoly Act. 2.2.3 Recent Healthcare Reform: From Competition to Cooperation . 23 2.3 Challenges Facing the Healthcare Delivery System. 2.3.1 Recent Healthcare Reform: From Competition to Cooperation . 26 2.3.2 Methods of Delivering Healthcare Services . 2.3.3 Securing Physicians and Efficient Use of Medical Equipment. 2.3.4 Planning
Administration Implementation Methods and Ensuring Effectiveness. 2.4 Building a Sustainable Healthcare Delivery System and Competition Policy . 30 2.4.1 Re-examination of the Nature of the Competition Policy. 30 2.4.2 Competition and Sustainability in Healthcare Delivery Systems . 31 2.4.3 The Necessity of Securing Service Users’ Interests . 2.4.4 Population Decline and Competition Policy as Impediments to Sustainability . 2.5 Conclusions . References . Drug Regulation in Japan. Yutaka Tejima 3.1 Introduction . 3.2 Necessity and Methods of Medical Research Regulation . 3.3 Laws and Regulations Related to Medical Research . 3.3.1 Outline of the Clinical Trials Act. 3.3.2 Next Generation Medical Infrastructure Act . 3.4 Legal Regulations for Pharmaceutical Products . 13 13 15 15 16 19 19 20 22 26 28 29 29 31 32 32 33 35 35 36 37 38 39 39
Contents xi Introduction. . . The Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices . 40 3.4.3 Act on the Safety of Regenerative Medicine . Relief for Accidents Caused by Medicines . 3.5.1 Introduction. 3.5.2 Responsibility of the National Government . 3.5.3 Product Liability of Pharmaceutical Manufacturers . 3.5.4 The Pharmaceutical and Medical Devices Agency and the Health Hazard Relief System . 46 3.4.1 3.4.2 3.5 4 5 Collaboration Between the Patent System and Pharmaceutical Regulations for Drug-Discovery Innovation in Japan . Takeshi Maeda 4.1 Introduction . 4.2 Incentives for Drug Discovery. 4.2.1 Competition in Pharmaceutical R D . 4.2.2 Monopoly Through Patent Rights . 4.2.3 Monopoly Under Re-Examination (‘data Protection’) . 4.2.4 Summary . 4.3 Monopoly Achieved Through Cooperation Between the Patent System and Pharmaceutical Law . 55 4.3.1 The Relationship Between the Patent System and
Pharmaceutical Regulations . 4.3.2 Impact of Pharmaceutical Regulations on Patent Rights. 58 4.3.3 Patent Linkage: The Impact of Patent Rights on PharmaceuticalRegulations . 60 4.4 NHI Drug Price Standard. 4.4.1 How to Calculatethe NHI Price. 4.4.2 Interaction Between the NHI Drug Price System and Patent Law . 66 4.5 Conclusion . References . Corruption and Conflicts of Interest in the Pharmaceutical Market: Regulation of Pharmaceutical Companies’ Gift-Giving Practices . Masako Wakui 5.1 Introduction . 5.2 The Impact of Gifts and Payments to Doctors . 5.2.1 Medication Choice. 5.2.2 Pharmaceutical Company Gift-Giving 71 and Payments to Doctors. 39 44 45 45 45 45 49 49 50 50 51 52 55 55 63 64 66 67 69 69 70 70
Contents xii Potential Adverse Effects of Gifts and Payments . The Relationship Between Doctors and Pharmaceutical Companies in Japan . 5.3 Japanese Laws and Regulations Regarding the Relationship Between Doctors and Pharmaceutical Companies . 74 5.3.1 Current State. 5.3.2 The Need to Strengthen Regulations . 5.4 Redesigning Regulations . 5.4.1 Pharmaceutical Companies. 5.4.2 Doctors and Hospitals . 5.4.3 Regulatory Bodies and Policy Makers . 5.5 Conclusions . References . 5.2.3 5.2.4 Part II 6 71 72 74 79 81 82 82 83 84 84 The Japanese Antimonopoly Act and Its Relation to the Pharmaceutical Industry Antimonopoly Act and Its Application to the Pharmaceutical Industry in Japan . Akira Negishi 6.1 Introduction . 6.2 Regulation Under the AMA. 6.3 Private Monopolisation Cases Relating to Pharmaceutical Products
. 6.3.1 Private Monopolisation . 6.3.2 Nordion, an Exclusion-Type Private Monopolisation Case. 6.3.3 Nihon Medi-Physics, a Private Monopolisation Commitment Case . 96 6.4 Unreasonable Restraint of Trade (Cartel) Cases Related to Pharmaceutical Products . 97 6.4.1 Unreasonable Restraint of Trade . 6.4.2 National Health Insurance (NHI) Drug Price List and Revisions . 6.4.3 Generic Lanthanum Carbonate OD Tablets Price Cartel . 6.4.4 Original Drug Calvin Tablets Price Fixing Cartel . 6.5 Unfair Trade Practices Related to Pharmaceutical Products . 6.5.1 Unfair Trade Practices (UTP). 6.5.2 Cooper Vision Japan Contact Lenses and Suspected UTPs . 100 6.5.3 Regulation of ASBP and Violations of the Subcontract Act Relating to Pharmaceutical Business. 101 91 91 92 94 94 95 97 97 98 99 100 100
Contents Two Business Combination Cases from the Pharmaceutical Sector . 103 6.6.1 Business Combination Regulation. 6.6.2 Takeda’s Acquisition of Shire. 6.6.3 M3’s Acquisition of Nihon Ultmark . 6.7 Pharmaceutical Product Price Regulation Under the AMA . References . xiii 6.6 7 8 Horizontal Cooperation and Alliances Amongst Pharmaceutical Companies and the Japanese Antimonopoly Act . Shingo Seryo 7.1 Introduction . 7.2 AMA Provisions Regarding Business Alliances. 7.3 Sample Cases Involving Pharmaceuticals . 7.3.1 Recent JFTC Horizontal Cartel Cases. 7.3.2 JFTC Consultation Cases . 7.3.3 Co-Promotion and Co-Marketing . 7.4 General Analytical Framework of the AMA in Business Alliances. 120 7.4.1 Horizontal Production Alliances . 7.4.2 Horizontal Sales Alliances . 7.4.3 Horizontal Purchase Alliances
. 7.4.4 Horizontal R D Alliances . 7.5 JFTC Enforcement Policies Regarding Horizontal Cooperation . 122 References . Merger Regulations in the Japanese Pharmaceutical Industry . Kuninobu Takeda 8.1 Introduction . 8.2 Cases in the Pharmaceutical Manufacturing Industry . 8.2.1 Published Cases . 8.2.2 Kyowa Kirin Case (FY 2008 Case 1) . 8.2.3 Novartis and GlaxoSmithKline Case (FY2014 Case 4). 131 8.3 Cases in the Pharmaceutical Wholesale and Retail Industry. 8.3.1 Cases . 8.3.2 Alfresa Holdings and Tamper Nakata Case (FY2010 Case 9) . 134 8.3.3 Medipal Holdings and JCR Pharma Case (FY2017 Case1). 135 8.4 Remedies . 8.5 Conclusion . References .
103 104 105 106 107 109 109 110 Ill 112 114 117 120 120 121 121 125 127 127 128 128 129 134 134 136 137 138
xiv Contents 9 Pay-For-Delay Agreements in Japan . 139 Naoko Mariyama 9.1 Introduction . 139 9.2 Pay-For-Delay AgreementsOutside Japan . 140 9.2.1 Pay-For-DelayAgreements. 140 9.2.2 Pay-For-Delay Agreements in the United States . 141 9.2.3 Pay-For-Delay Agreements in the European Union . 143 9.2.4 Similarities Between Approaches in the European Union and the United States . 146 9.3 The Japanese Approach to Pay-For-Delay Agreements. 147 9.3.1 Pay-For-Delay in Japan . 147 9.3.2 Pharmaceutical Regulation in Japan . 148 9.3.3 Patent Infringement Lawsuits and Settlements in Japan . '. 150 9.4 Pay-For-Delay Under the AMA . 151 9.4.1 Scope of the Patent Test Under the AMA. 151 9.4.2 Private Monopolisation and Pay-For-Delay Agreements . 152 9.4.3 Unreasonable Restraint of Trade and Pay-For-Delay Agreements . 153 9.4.4 Unfair Trade Practice and Pay-For-Delay Agreements . 155 9.5 Conclusions
. 156 References . 156 10 No Challenge Clauses in the Pharmaceutical Industry in Japan . Thomas K. Cheng 10.1 Introduction . 10.2 No Challenge Clauses. 10.2.1 Overview . 10.2.2 No Challenge Clauses in Japan . 10.2.3 No Challenge Clauses in Other Jurisdictions . 10.3 Licensing in the Pharmaceutical Industry . 10.3.1 Overview. 10.3.2 The Pharmaceutical Industry in Japan. 10.3.3 Licensing in the Pharmaceutical Industryin Japan . 10.4 Some Theoretical Issues. 10.4.1 The Role of Market Power . 10.4.2 The Role of Patent Validity. 10.4.3 The Relevance of the Number of Patents Being Licensed . 177 10.5 Conclusion . References
. 159 159 160 160 160 164 167 167 168 170 172 173 175 178 178
Contents 11 Will Authorised Biologies Deter Biosimilars?—Utilising JFTC’s Expertise in Drug Pricing. Takanori Abe 11.1 Issue: Report of the Japan Biosimilar Association . 11.2 The US . 11.3 Europe. 11.4 Japan . 11.5 Implications for Japan . 11.5.1 Differences Between the US, Europe, and Japan. 11.5.2 Utilising the JFTC’s Expertise in Drug Pricing . 11.5.3 Emphasis on Patient Choice and Quality of Healthcare in Drug Pricing. References . XV 181 182 184 186 188 192 192 194 198 199 Part III An Economic Analysis of the Pharmaceutical Industry and Trade Practices in Japan 12 The Pharmaceutical Industry in Japan: A History of Its Development. 203 Kenta Nakamura 12.1 Introduction . 203 12.2 The History of the Pharmaceutical Industry in Japan: An Overview
. 204 12.2.1 The Era of Foreign Technology Introduction: Post-World War II Through the 1950s. 205 12.2.2 The Era of Rapid Growth: The 1960s . 205 12.2.3 The Era of Independent Development of New Drugs: The 1970s to the Mid-1980s . 206 12.2.4 The Era of Innovative Drug Development: From the Mid-1980s Onward . 207 12.3 Lessons from the Development of Innovative New Drugs in Japan. 208 12.3.1 Drug Discovery and Science. 210 12.3.2 Researcher-Initiated Drug Discovery . 211 12.3.3 Developing Researcher and Human Network Capabilities . 211 12.3.4 Global Clinical Development and Sales Capabilities . 212 12.3.5 Patent Protection . 213 12.3.6 Three Types of Competition in the Pharmaceutical Industry . 214 12.3.7 ‘Me-Too’ or‘Follow-On’ Drugs . 215 12.4 Conclusion . 216 References
. 216
xvi 13 Contents Trade Practices in the Japanese Pharmaceutical Market: A Simulation Analysis of Improvement Policies . Konosuke Noto 13.1 Introduction . 13.2 Pharmaceutical Distribution Market and Trade Practices . 13.2.1 The NHI Drug Pricing System. 13.2.2 Trade Practices in the Pharmaceutical Market . 13.2.3 Response to Trade Practices . 13.3 Drug Price Revision Rules and Trade Practices . 13.3.1 Market Under Drug Price Revision Rules . 13.3.2 Rebate, Allowance and Adjustment Rate . 13.3.3 NHI Price Margin and Adjustment Rate. 13.3.4 Lump-Sum Bulk Purchase as Price Negotiation . 13.3.5 Unsettled Provisional Delivery as Price Negotiation . 13.3.6 Transaction Model with Trade Practices. 13.4 PolicySimulation . 13.4.1 Hypothetical Drug . 13.4.2 Simulation Setup . 13.4.3 Simulation Results . 13.5 Conclusion
. References . Index. 219 219 220 220 221 222 224 224 225 227 228 229 230 232 232 232 234 236 237 239 |
| adam_txt |
Contents Part I Healthcare and Pharmaceuticals: Innovation and Regulation in Japan 1 Regulation and Competition in the Pharmaceutical Industry in Japan. 3 Akira Negishi 1.1 Introduction . 1.2 Entry Restrictions for Manufacturing and Sales in the Pharmaceutical Sector . 1.2.1 Licences for the Manufacturing and Sales of Pharmaceutical Products . 1.2.2 Licence for Opening a Pharmacy. 1.2.3 Licence for Drug Sales Business . 1.3 Elimination of Distance Restrictions on Establishing Pharmacies and Lifting of Bans on Online Sales of Over-The-Counter Drugs. 6 1.3.1 Freedom to Choose an Occupation and Distance Restrictions on the Opening of Pharmacies . 1.3.2 Constitution and Prohibition of Online Sales of Over-The-Counter Drugs . 1.4 Approval for Manufacturing and Marketing of Pharmaceutical Products . 1.5 Price Regulation and Competition for Medical Drugs . 1.5.1 Price Regulation of Medical Drugs . 1.5.2 Price Competition for Pharmaceutical Products . 1.5.3 Price Regulation of Medical Drugs and Promotion of Innovation to Develop New
Drugs . 1.6 Distribution Regulations for Medical Drugs: AMA and MHLW Distribution Improvement Guidelines . 1.7 The Relationship Between the Approval of Generic Drugs and Patents on Original Drugs. 13 3 4 4 5 5 6 7 8 9 9 9 10 11 ix
X Contents 1.7.1 Approval of Generic Drugs. 1.7.2 Japanese-Style Patent Linkage System . 1.7.3 Competition Between Original and Generic Drugs. 1.8 Conclusions . References . 2 3 Competition and Cooperation: Building a Sustainable Healthcare Delivery System in a Society with a Declining Population. Goro Sato 2.1 Introduction . 2.2 Laws Relating to the Healthcare Delivery System: From the Perspective of Competition Policy . 20 2.2.1 The Basic Legal Structure of the Healthcare Delivery System . 2.2.2 Medical Services and the Antimonopoly Act. 2.2.3 Recent Healthcare Reform: From Competition to Cooperation . 23 2.3 Challenges Facing the Healthcare Delivery System. 2.3.1 Recent Healthcare Reform: From Competition to Cooperation . 26 2.3.2 Methods of Delivering Healthcare Services . 2.3.3 Securing Physicians and Efficient Use of Medical Equipment. 2.3.4 Planning
Administration Implementation Methods and Ensuring Effectiveness. 2.4 Building a Sustainable Healthcare Delivery System and Competition Policy . 30 2.4.1 Re-examination of the Nature of the Competition Policy. 30 2.4.2 Competition and Sustainability in Healthcare Delivery Systems . 31 2.4.3 The Necessity of Securing Service Users’ Interests . 2.4.4 Population Decline and Competition Policy as Impediments to Sustainability . 2.5 Conclusions . References . Drug Regulation in Japan. Yutaka Tejima 3.1 Introduction . 3.2 Necessity and Methods of Medical Research Regulation . 3.3 Laws and Regulations Related to Medical Research . 3.3.1 Outline of the Clinical Trials Act. 3.3.2 Next Generation Medical Infrastructure Act . 3.4 Legal Regulations for Pharmaceutical Products . 13 13 15 15 16 19 19 20 22 26 28 29 29 31 32 32 33 35 35 36 37 38 39 39
Contents xi Introduction. . . The Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices . 40 3.4.3 Act on the Safety of Regenerative Medicine . Relief for Accidents Caused by Medicines . 3.5.1 Introduction. 3.5.2 Responsibility of the National Government . 3.5.3 Product Liability of Pharmaceutical Manufacturers . 3.5.4 The Pharmaceutical and Medical Devices Agency and the Health Hazard Relief System . 46 3.4.1 3.4.2 3.5 4 5 Collaboration Between the Patent System and Pharmaceutical Regulations for Drug-Discovery Innovation in Japan . Takeshi Maeda 4.1 Introduction . 4.2 Incentives for Drug Discovery. 4.2.1 Competition in Pharmaceutical R D . 4.2.2 Monopoly Through Patent Rights . 4.2.3 Monopoly Under Re-Examination (‘data Protection’) . 4.2.4 Summary . 4.3 Monopoly Achieved Through Cooperation Between the Patent System and Pharmaceutical Law . 55 4.3.1 The Relationship Between the Patent System and
Pharmaceutical Regulations . 4.3.2 Impact of Pharmaceutical Regulations on Patent Rights. 58 4.3.3 Patent Linkage: The Impact of Patent Rights on PharmaceuticalRegulations . 60 4.4 NHI Drug Price Standard. 4.4.1 How to Calculatethe NHI Price. 4.4.2 Interaction Between the NHI Drug Price System and Patent Law . 66 4.5 Conclusion . References . Corruption and Conflicts of Interest in the Pharmaceutical Market: Regulation of Pharmaceutical Companies’ Gift-Giving Practices . Masako Wakui 5.1 Introduction . 5.2 The Impact of Gifts and Payments to Doctors . 5.2.1 Medication Choice. 5.2.2 Pharmaceutical Company Gift-Giving 71 and Payments to Doctors. 39 44 45 45 45 45 49 49 50 50 51 52 55 55 63 64 66 67 69 69 70 70
Contents xii Potential Adverse Effects of Gifts and Payments . The Relationship Between Doctors and Pharmaceutical Companies in Japan . 5.3 Japanese Laws and Regulations Regarding the Relationship Between Doctors and Pharmaceutical Companies . 74 5.3.1 Current State. 5.3.2 The Need to Strengthen Regulations . 5.4 Redesigning Regulations . 5.4.1 Pharmaceutical Companies. 5.4.2 Doctors and Hospitals . 5.4.3 Regulatory Bodies and Policy Makers . 5.5 Conclusions . References . 5.2.3 5.2.4 Part II 6 71 72 74 79 81 82 82 83 84 84 The Japanese Antimonopoly Act and Its Relation to the Pharmaceutical Industry Antimonopoly Act and Its Application to the Pharmaceutical Industry in Japan . Akira Negishi 6.1 Introduction . 6.2 Regulation Under the AMA. 6.3 Private Monopolisation Cases Relating to Pharmaceutical Products
. 6.3.1 Private Monopolisation . 6.3.2 Nordion, an Exclusion-Type Private Monopolisation Case. 6.3.3 Nihon Medi-Physics, a Private Monopolisation Commitment Case . 96 6.4 Unreasonable Restraint of Trade (Cartel) Cases Related to Pharmaceutical Products . 97 6.4.1 Unreasonable Restraint of Trade . 6.4.2 National Health Insurance (NHI) Drug Price List and Revisions . 6.4.3 Generic Lanthanum Carbonate OD Tablets Price Cartel . 6.4.4 Original Drug Calvin Tablets Price Fixing Cartel . 6.5 Unfair Trade Practices Related to Pharmaceutical Products . 6.5.1 Unfair Trade Practices (UTP). 6.5.2 Cooper Vision Japan Contact Lenses and Suspected UTPs . 100 6.5.3 Regulation of ASBP and Violations of the Subcontract Act Relating to Pharmaceutical Business. 101 91 91 92 94 94 95 97 97 98 99 100 100
Contents Two Business Combination Cases from the Pharmaceutical Sector . 103 6.6.1 Business Combination Regulation. 6.6.2 Takeda’s Acquisition of Shire. 6.6.3 M3’s Acquisition of Nihon Ultmark . 6.7 Pharmaceutical Product Price Regulation Under the AMA . References . xiii 6.6 7 8 Horizontal Cooperation and Alliances Amongst Pharmaceutical Companies and the Japanese Antimonopoly Act . Shingo Seryo 7.1 Introduction . 7.2 AMA Provisions Regarding Business Alliances. 7.3 Sample Cases Involving Pharmaceuticals . 7.3.1 Recent JFTC Horizontal Cartel Cases. 7.3.2 JFTC Consultation Cases . 7.3.3 Co-Promotion and Co-Marketing . 7.4 General Analytical Framework of the AMA in Business Alliances. 120 7.4.1 Horizontal Production Alliances . 7.4.2 Horizontal Sales Alliances . 7.4.3 Horizontal Purchase Alliances
. 7.4.4 Horizontal R D Alliances . 7.5 JFTC Enforcement Policies Regarding Horizontal Cooperation . 122 References . Merger Regulations in the Japanese Pharmaceutical Industry . Kuninobu Takeda 8.1 Introduction . 8.2 Cases in the Pharmaceutical Manufacturing Industry . 8.2.1 Published Cases . 8.2.2 Kyowa Kirin Case (FY 2008 Case 1) . 8.2.3 Novartis and GlaxoSmithKline Case (FY2014 Case 4). 131 8.3 Cases in the Pharmaceutical Wholesale and Retail Industry. 8.3.1 Cases . 8.3.2 Alfresa Holdings and Tamper Nakata Case (FY2010 Case 9) . 134 8.3.3 Medipal Holdings and JCR Pharma Case (FY2017 Case1). 135 8.4 Remedies . 8.5 Conclusion . References .
103 104 105 106 107 109 109 110 Ill 112 114 117 120 120 121 121 125 127 127 128 128 129 134 134 136 137 138
xiv Contents 9 Pay-For-Delay Agreements in Japan . 139 Naoko Mariyama 9.1 Introduction . 139 9.2 Pay-For-Delay AgreementsOutside Japan . 140 9.2.1 Pay-For-DelayAgreements. 140 9.2.2 Pay-For-Delay Agreements in the United States . 141 9.2.3 Pay-For-Delay Agreements in the European Union . 143 9.2.4 Similarities Between Approaches in the European Union and the United States . 146 9.3 The Japanese Approach to Pay-For-Delay Agreements. 147 9.3.1 Pay-For-Delay in Japan . 147 9.3.2 Pharmaceutical Regulation in Japan . 148 9.3.3 Patent Infringement Lawsuits and Settlements in Japan . '. 150 9.4 Pay-For-Delay Under the AMA . 151 9.4.1 Scope of the Patent Test Under the AMA. 151 9.4.2 Private Monopolisation and Pay-For-Delay Agreements . 152 9.4.3 Unreasonable Restraint of Trade and Pay-For-Delay Agreements . 153 9.4.4 Unfair Trade Practice and Pay-For-Delay Agreements . 155 9.5 Conclusions
. 156 References . 156 10 No Challenge Clauses in the Pharmaceutical Industry in Japan . Thomas K. Cheng 10.1 Introduction . 10.2 No Challenge Clauses. 10.2.1 Overview . 10.2.2 No Challenge Clauses in Japan . 10.2.3 No Challenge Clauses in Other Jurisdictions . 10.3 Licensing in the Pharmaceutical Industry . 10.3.1 Overview. 10.3.2 The Pharmaceutical Industry in Japan. 10.3.3 Licensing in the Pharmaceutical Industryin Japan . 10.4 Some Theoretical Issues. 10.4.1 The Role of Market Power . 10.4.2 The Role of Patent Validity. 10.4.3 The Relevance of the Number of Patents Being Licensed . 177 10.5 Conclusion . References
. 159 159 160 160 160 164 167 167 168 170 172 173 175 178 178
Contents 11 Will Authorised Biologies Deter Biosimilars?—Utilising JFTC’s Expertise in Drug Pricing. Takanori Abe 11.1 Issue: Report of the Japan Biosimilar Association . 11.2 The US . 11.3 Europe. 11.4 Japan . 11.5 Implications for Japan . 11.5.1 Differences Between the US, Europe, and Japan. 11.5.2 Utilising the JFTC’s Expertise in Drug Pricing . 11.5.3 Emphasis on Patient Choice and Quality of Healthcare in Drug Pricing. References . XV 181 182 184 186 188 192 192 194 198 199 Part III An Economic Analysis of the Pharmaceutical Industry and Trade Practices in Japan 12 The Pharmaceutical Industry in Japan: A History of Its Development. 203 Kenta Nakamura 12.1 Introduction . 203 12.2 The History of the Pharmaceutical Industry in Japan: An Overview
. 204 12.2.1 The Era of Foreign Technology Introduction: Post-World War II Through the 1950s. 205 12.2.2 The Era of Rapid Growth: The 1960s . 205 12.2.3 The Era of Independent Development of New Drugs: The 1970s to the Mid-1980s . 206 12.2.4 The Era of Innovative Drug Development: From the Mid-1980s Onward . 207 12.3 Lessons from the Development of Innovative New Drugs in Japan. 208 12.3.1 Drug Discovery and Science. 210 12.3.2 Researcher-Initiated Drug Discovery . 211 12.3.3 Developing Researcher and Human Network Capabilities . 211 12.3.4 Global Clinical Development and Sales Capabilities . 212 12.3.5 Patent Protection . 213 12.3.6 Three Types of Competition in the Pharmaceutical Industry . 214 12.3.7 ‘Me-Too’ or‘Follow-On’ Drugs . 215 12.4 Conclusion . 216 References
. 216
xvi 13 Contents Trade Practices in the Japanese Pharmaceutical Market: A Simulation Analysis of Improvement Policies . Konosuke Noto 13.1 Introduction . 13.2 Pharmaceutical Distribution Market and Trade Practices . 13.2.1 The NHI Drug Pricing System. 13.2.2 Trade Practices in the Pharmaceutical Market . 13.2.3 Response to Trade Practices . 13.3 Drug Price Revision Rules and Trade Practices . 13.3.1 Market Under Drug Price Revision Rules . 13.3.2 Rebate, Allowance and Adjustment Rate . 13.3.3 NHI Price Margin and Adjustment Rate. 13.3.4 Lump-Sum Bulk Purchase as Price Negotiation . 13.3.5 Unsettled Provisional Delivery as Price Negotiation . 13.3.6 Transaction Model with Trade Practices. 13.4 PolicySimulation . 13.4.1 Hypothetical Drug . 13.4.2 Simulation Setup . 13.4.3 Simulation Results . 13.5 Conclusion
. References . Index. 219 219 220 220 221 222 224 224 225 227 228 229 230 232 232 232 234 236 237 239 |
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| geographic | Japan (DE-588)4028495-5 gnd |
| geographic_facet | Japan |
| id | DE-604.BV047944149 |
| illustrated | Illustrated |
| index_date | 2024-07-03T19:35:56Z |
| indexdate | 2024-07-20T04:08:12Z |
| institution | BVB |
| isbn | 9789811678134 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033325594 |
| oclc_num | 1424560074 |
| open_access_boolean | |
| owner | DE-M382 DE-739 |
| owner_facet | DE-M382 DE-739 |
| physical | xxi, 245 Seiten Illustrationen 24 cm |
| publishDate | 2022 |
| publishDateSearch | 2022 |
| publishDateSort | 2022 |
| publisher | Springer |
| record_format | marc |
| series2 | Kobe University Monograph Series in Social Science Research |
| spelling | Competition law and policy in the Japanese pharmaceutical sector Akira Negishi, Masako Wakui, Naoko Mariyama, editors Singapore Springer [2022] xxi, 245 Seiten Illustrationen 24 cm txt rdacontent n rdamedia nc rdacarrier Kobe University Monograph Series in Social Science Research Pharmazie (DE-588)4045705-9 gnd rswk-swf Wettbewerbsrecht (DE-588)4121924-7 gnd rswk-swf Japan (DE-588)4028495-5 gnd rswk-swf Japan (DE-588)4028495-5 g Pharmazie (DE-588)4045705-9 s Wettbewerbsrecht (DE-588)4121924-7 s DE-604 Negishi, Akira 1943- (DE-588)1023118408 edt Wakui, Masako 1969- (DE-588)1172820708 edt Mariyama, Naoko edt Erscheint auch als Online-Ausgabe 978-981-16-7814-1 Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033325594&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Competition law and policy in the Japanese pharmaceutical sector Pharmazie (DE-588)4045705-9 gnd Wettbewerbsrecht (DE-588)4121924-7 gnd |
| subject_GND | (DE-588)4045705-9 (DE-588)4121924-7 (DE-588)4028495-5 |
| title | Competition law and policy in the Japanese pharmaceutical sector |
| title_auth | Competition law and policy in the Japanese pharmaceutical sector |
| title_exact_search | Competition law and policy in the Japanese pharmaceutical sector |
| title_exact_search_txtP | Competition law and policy in the Japanese pharmaceutical sector |
| title_full | Competition law and policy in the Japanese pharmaceutical sector Akira Negishi, Masako Wakui, Naoko Mariyama, editors |
| title_fullStr | Competition law and policy in the Japanese pharmaceutical sector Akira Negishi, Masako Wakui, Naoko Mariyama, editors |
| title_full_unstemmed | Competition law and policy in the Japanese pharmaceutical sector Akira Negishi, Masako Wakui, Naoko Mariyama, editors |
| title_short | Competition law and policy in the Japanese pharmaceutical sector |
| title_sort | competition law and policy in the japanese pharmaceutical sector |
| topic | Pharmazie (DE-588)4045705-9 gnd Wettbewerbsrecht (DE-588)4121924-7 gnd |
| topic_facet | Pharmazie Wettbewerbsrecht Japan |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033325594&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT negishiakira competitionlawandpolicyinthejapanesepharmaceuticalsector AT wakuimasako competitionlawandpolicyinthejapanesepharmaceuticalsector AT mariyamanaoko competitionlawandpolicyinthejapanesepharmaceuticalsector |