Competition and innovation in the EU regulation of pharmaceuticals: the case of parallel trade
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
Cambridge, Mass. [u.a.]
Intersentia
2011
|
| Schriftenreihe: | European studies in law and economics
4 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVII, 340 S. graph. Darst. |
| ISBN: | 9789400001473 |
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IMAGE 1
COMPETITION AND
INNOVATION IN THE EU REGULATION OF PHARMACEUTICALS
THE CASE OF PARALLEL TRADE
CLAUDIA DESOGUS
INTERSENTIA
CAMBRIDGE - ANTWERP - PORTLAND
IMAGE 2
CONTENTS
ACKNOWLEDGMENTS .* V
LIST OF ABBREVIATIONS XIII
TABLE OF EQUIVALENCE XV
LIST OF TABLES AND GRAPHS XVII
INTRODUCTION 1
1. BACKGROUND 1
2. PARALLEL TRADE: PAST SOLUTIONS AND NEW CHALLENGES 2
3. GENERAL SCOPE 4
4. PRODUCT AND GEOGRAPHIC SCOPE 5
5. METHODOLOGY 5
6. THEORETICAL BASELINE 6
7. STRUCTURE OF THE BOOK 6
CHAPTER I. THE EUROPEAN PHARMACEUTICAL MARKET 11
INTRODUCTION 11
1. THE ECONOMICS OF THE PHARMACEUTICALS 12
1.1. FEATURES OF THE SUPPLY-SIDE OF THE MARKET 15
1.2. FEATURES OF THE DEMAND-SIDE OF THE MARKET 20
1.2.1. WHO CHOOSES DRUGS: THE ROLE OF PHYSICIANS 20
1.2.2. WHO PAYS FOR DRUGS: THE ROLE OF GOVERNMENTS 21
1.2.3. THE COST-CONTAINMENT MEASURES APPLIED BY NATIONAL GOVERNMENTS 23
1.2.4. ADMINISTERING DRUGS: THE ROLE OF PHARMACISTS 27
2. THE EUROPEAN PHARMACEUTICAL MARKET 27
3. A SINGLE MARKET FOR PHARMACEUTICALS 32
3.1. THE HARMONISATION OF MARKETING AUTHORISATION FOR DRUGS 32 3.2. THE
HARMONISATION OF PRICE CONTROL MEASURES 36
4. PRICE CONTROLS AND FREE MOVEMENT OF GOODS 40
5. WHAT IS PARALLEL TRADE? 45
5.1. THE REGULATORY ENVIRONMENT 51
INTERSENTIA VII
IMAGE 3
COMPETITION AND INNOVATION IN THE EU REGULATION OF PHARMACEUTICALS
6. DEFINING THE RELEVANT MARKET IN THE PHARMACEUTICAL SECTOR 53
6.1. THE RELEVANT MARKET 54
6.1.1. THE PRODUCT MARKET 56
6.1.2. THE GEOGRAPHIC MARKET 58
6.2. THE PRODUCT MARKET DEFINITION FOR PHARMACEUTICALS 60
6.2.1. THE LIMITS OF THE SSNIP TEST 60
6.2.2. THE ATC CLASSIFICATION 62
6.2.3. THE LIMITS OF THE ATC FOR ARTICLE 102 TFEU CASES ' 64 6.2.4. WHEN
PHARMACEUTICAL PRODUCT MARKETS ARE NARROW 66 6.2.5. THE PRODUCT MARKET
DEFINITION IN PARALLEL TRADE CASES 72 6.4. THE GEOGRAPHIC MARKET
DEFINITION FOR PHARMACEUTICALS 77 7. CONCLUSIONS 78
CHAPTER II. THE INTERSECTION BETWEEN INTELLECTUAL PROPERTY RIGHTS AND
COMPETITION POLICY GOALS IN THE PHARMACEUTICAL SECTOR 79
INTRODUCTION 79
1. THE STRUCTURE AND THE FUNCTION OF INTELLECTUAL PROPERTY RIGHTS 81
1.1. THE TRADE OFF IN THE PHARMACEUTICAL SECTOR 84
1.2. STRIKING THE BALANCE: THE ITALIAN CASE 86
1.3. 'LAW IN BOOK' V. 'LAW IN ACTION' 88
2. THE RELATIONSHIP BETWEEN INTELLECTUAL PROPERTY RIGHTS AND COMPETITION
LAW UNDER THE EU TREATY 90
2.1. IN SEARCH OF A COMPROMISE (I): EXISTENCE V. EXERCISE OF AN IPR 91
2.2. IN SEARCH OF A COMPROMISE (II): THE 'SPECIFIC SUBJECT MATTER' 95 3.
THE PRINCIPLE OF 'REGIONAL EXHAUSTION 98
3.1. THE EXHAUSTION OF TRADEMARKS 100
3.2. THE EXHAUSTION OF PATENTS 104
3.3. THE EXHAUSTION OF INTELLECTUAL PROPERTY RIGHTS COVERING PRODUCTS
COMING FROM THIRD COUNTRIES 109
4. THE BALANCE BETWEEN INTELLECTUAL PROPERTY RIGHTS AND EU COMPETITION
LAW RULES 113
4.1. THE EXERCISE OF IPRS UNDER ARTICLE 101 TFEU 114
4.2. THE EXERCISE OF IPRS UNDER ARTICLE 102 TFEU 116
4.2.1. THE REFUSAL TO LICENCE IPRS 119
5. THE EARLY CASE LAW ON PARALLEL TRADE 125
5.1. EXPORT BANS AND OTHER AGREEMENTS THAT RESTRICT PARALLEL TRADE 125
5.1.1. THE COMMISSION PRACTICE 127
5.1.2. THE CASE LAW .". 129
5.2. UNILATERAL CONDUCTS THAT RESTRICT PARALLEL TRADE 131
5.2.1. REFUSAL TO SUPPLY CASES 131
5.2.2. PRICE DISCRIMINATION CASES 134
VIII INTERSENTIA
IMAGE 4
CONTENTS
6. NEW CASES ON PARALLEL TRADE OF PHARMACEUTICALS: A REVIREMENT 7 . 137
6.1. NEW CASES UNDER ARTICLE 102 TFEU: THE SYFAIT SAGA 137
6.2. NEW CASES UNDER ARTICLE 101 TFEU: THE GLAXO CASE 140
7. CONCLUSIONS 141
CHAPTER III. COMPETITION AND REGULATION IN THE PHARMACEUTICAL MARKET:
THE CASE OF PARALLEL TRADE 143
INTRODUCTION 143
1. REGULATION ON PRICES: IS THE PHARMACEUTICAL SECTOR 'SPECIFIC'? 148
1.1. AN OVERVIEW OF NATIONAL PHARMACEUTICAL POLICIES 150
1.1.1. THE PHARMACEUTICAL REGULATIONS IN THE IMPORTING COUNTRIES . 150
1.1.2. THE PHARMACEUTICAL REGULATIONS IN THE EXPORTING COUNTRIES . 154
1.1.3. NATIONAL POLICIES ON PARALLEL TRADE 156
1.1.4. THE NEGOTIATION OF PRICES FOR PHARMACEUTICALS 157 1.2. THE ROLE
OF PARALLEL TRADE IN PRICE NEGOTIATIONS 160
2. SAVINGS FROM PARALLEL TRADE OF PHARMACEUTICALS: DO THEY EXIST? 162
2.1. OPTIMAL STRATEGIES IN A WORLD WITHOUT PARALLEL TRADE: PRICE
DISCRIMINATION 162
2.2. OPTIMAL STRATEGIES IN A WORLD WITH PARALLEL TRADE 164
2.3. THE IMPACT OF PARALLEL TRADE OF PHARMACEUTICALS ON PRICE LEVELS IN
IMPORTING COUNTRIES 166
2.4. THE IMPACT OF PARALLEL TRADE OF PHARMACEUTICALS ON PRICE LEVELS IN
EXPORTING COUNTRIES 170
3. . AND HOW LARGE ARE THEY? COMPETITION AND REGULATION IN THE
PHARMACEUTICAL SECTOR 176
3.1. MEASURING THE MAGNITUDE OF SAVINGS FROM PARALLEL TRADE OF
PHARMACEUTICALS 176
3.1.1. COMPETITION AND REGULATION IN PHARMACEUTICALS 180 4. THE PRICE
HARMONISING FUNCTION OF PARALLEL TRADE OF PHARMACEUTICALS 182 4.1. THE
'CONSTITUTIONAL' ISSUE 186
4.2. 'NEGATIVE HARMONISATION' V. 'POSITIVE HARMONISATION' IN THE
PHARMACEUTICAL MARKET 189
5. ANTICOMPETITIVENESS 'BY OBJECT' OR 'BY EFFECT'? 194
5.1. THE MODERNISED APPROACH TO ARTICLE 101 TFEU AND THE GLAXO CASE .
195 5.1.1. AN EFFECT-BASED APPROACH? 196
5.1.2. . OR AN AD HOC EXCEPTION FOR THE PHARMACEUTICAL SECTOR?. 199
6. CONCLUSIONS 202
INTERSENTIA IX
IMAGE 5
COMPETITION AND INNOVATION IN THE EU REGULATION OF PHARMACEUTICALS
CHAPTER IV.
PARALLEL TRADE AND PHARMACEUTICAL INNOVATION: THE EMERGENCE OF THE
'EFFICIENCY DEFENCE' IN EUROPEAN COMPETITION LAW 205
INTRODUCTION 205
1. THE 'EFFICIENCY DEFENCE' IN EUROPEAN COMPETITION LAW 210
1.1. THE FOUR-PARTITE TEST UNDER ARTICLE 101(3) TFEU 210
1.1.1. THE TWO POSITIVE REQUIREMENTS 211
1.1.2. THE TWO NEGATIVE REQUIREMENTS 213
1.2. THE OBJECTIVE JUSTIFICATION TO ABUSIVE CONDUCTS BY DOMINANT
COMPANIES 215
2. INNOVATION IN THE PHARMACEUTICAL MARKET 219
2.1. THE ECONOMICS OF INNOVATION 219
2.2. MARKET STRUCTURE AS A DETERMINANT OF INNOVATION 221
2.2.1. MARKET POWER AS A DRIVER OF INNOVATION 222
2.2.2. COMPETITION AS A DRIVER OF INNOVATION 224
2.2.3. INTERIM CONCLUSIONS 227
2.3. MARKET STRUCTURE AND PHARMACEUTICAL INNOVATION 228
2.4. R&D PATTERNS IN THE PHARMACEUTICAL SECTOR 232
3. PATENTS, PROFITS AND INCENTIVE TO INNOVATE IN THE PHARMACEUTICAL
SECTOR . 236 3.1. THE IMPACT OF PARALLEL TRADE ON PROFITS 237
3.1.1. WHEN PARALLEL TRADE INCREASES MANUFACTURERS' PROFITS 239 3.2.
DOES MORE MONEY ALWAYS BRING MORE INNOVATION? 242
3.3. INTERIM CONCLUSIONS 245
4. A TEST FOR EFFICIENCIES UNDER ARTICLE 102 TFEU 246
4.1. THE 'LEGIMATE BUSINESS CONDUCT A LA SYFAIT V 247
4.2. THE 'LEGITIMATE BUSINESS CONDUCT A LA SYFAIT IF 249
4.3. THE 'STRICT APPROACH' 250
4.4. THE 'EFFICIENCY DEFENCE' 252
5. CONCLUSIONS 255
CHAPTER V. THE WELFARE EFFECT OF PARALLEL TRADE: A WORKABLE RULE OF
REASON 259
INTRODUCTION 259
1. THE RULE OF REASON 263
1.1. IS THERE A 'EUROPEAN RULE OF REASON'? 265
1.1.1. THE RULE OF REASON UNDER ARTICLE 101 TFEU: THE OLD DOCTRINAL
DEBATE 267
1.1.2. THE RULE OF REASON UNDER ARTICLE 101 TFEU: THE CASE LAW 270
1.1.3. RECENT CONTRIBUTIONS TO THE ACADEMIC DEBATE 274
1.1.4. THE RULE OF REASON UNDER ARTICLE 102 TFEU 276
INTERSENTIA
IMAGE 6
CONTENTS
2. THE IMPACT OF PARALLEL TRADE ON CONSUMER WELFARE 279
2.1. BALANCING THE ANTI- AND PRO-COMPETITIVE EFFECTS OF AN ABUSIVE
CONDUCT 280
2.2. THE WORKABILITY OF THE RULE OF REASON 282
3. SHARING THE BURDEN TO LIGHTEN IT: THE LAW OF EVIDENCE AND THE RULE OF
REASON 285
3.1. THE LEGAL BURDEN OF PROOF AND THE EVIDENTIAL BURDEN OF PROOF 285
3.2. THE PROOF OF RESTRICTION OF COMPETITION 288
3.2.1. THE BURDEN OF PROOF UNDER ARTICLE 101(1) TFEU IN PARALLEL TRADE
CASES 288
3.3. THE PROOF OF EFFICIENCIES 292
3.3.1. WHO HAS TO PROVE EFFICIENCIES UNDER ARTICLE 102 TFEU? 292 3.3.2.
THE STANDARD OF PROOF FOR EFFICIENCIES IN PARALLEL TRADE CASES . 298 4.
CONCLUSIONS 303
CONCLUSIONS AND FUTURE RESEARCH 307
LIST OF REFERENCES 311
INTERSENTIA XI |
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| series | European studies in law and economics |
| series2 | European studies in law and economics |
| spelling | Desogus, Claudia Verfasser (DE-588)1022205331 aut Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade Claudia Desogus Cambridge, Mass. [u.a.] Intersentia 2011 XVII, 340 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier European studies in law and economics 4 Zugl.: Rotterdam, Erasmus Univ., Diss., 2010 Europäische Union (DE-588)5098525-5 gnd rswk-swf Arzneimittelmarkt (DE-588)4003131-7 gnd rswk-swf Arzneimittelhandel (DE-588)4143178-9 gnd rswk-swf Wettbewerbspolitik (DE-588)4065839-9 gnd rswk-swf Wettbewerbsregeln (DE-588)4189757-2 gnd rswk-swf Wettbewerbsrecht (DE-588)4121924-7 gnd rswk-swf Regulierung (DE-588)4201190-5 gnd rswk-swf Binnenmarkt (DE-588)4145576-9 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Europäische Union (DE-588)5098525-5 b Binnenmarkt (DE-588)4145576-9 s Arzneimittelhandel (DE-588)4143178-9 s Regulierung (DE-588)4201190-5 s Wettbewerbsrecht (DE-588)4121924-7 s DE-604 Arzneimittelmarkt (DE-588)4003131-7 s Wettbewerbsregeln (DE-588)4189757-2 s Wettbewerbspolitik (DE-588)4065839-9 s European studies in law and economics 4 (DE-604)BV037184720 4 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=021099274&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Desogus, Claudia Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade European studies in law and economics Europäische Union (DE-588)5098525-5 gnd Arzneimittelmarkt (DE-588)4003131-7 gnd Arzneimittelhandel (DE-588)4143178-9 gnd Wettbewerbspolitik (DE-588)4065839-9 gnd Wettbewerbsregeln (DE-588)4189757-2 gnd Wettbewerbsrecht (DE-588)4121924-7 gnd Regulierung (DE-588)4201190-5 gnd Binnenmarkt (DE-588)4145576-9 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4003131-7 (DE-588)4143178-9 (DE-588)4065839-9 (DE-588)4189757-2 (DE-588)4121924-7 (DE-588)4201190-5 (DE-588)4145576-9 (DE-588)4113937-9 |
| title | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade |
| title_auth | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade |
| title_exact_search | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade |
| title_full | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade Claudia Desogus |
| title_fullStr | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade Claudia Desogus |
| title_full_unstemmed | Competition and innovation in the EU regulation of pharmaceuticals the case of parallel trade Claudia Desogus |
| title_short | Competition and innovation in the EU regulation of pharmaceuticals |
| title_sort | competition and innovation in the eu regulation of pharmaceuticals the case of parallel trade |
| title_sub | the case of parallel trade |
| topic | Europäische Union (DE-588)5098525-5 gnd Arzneimittelmarkt (DE-588)4003131-7 gnd Arzneimittelhandel (DE-588)4143178-9 gnd Wettbewerbspolitik (DE-588)4065839-9 gnd Wettbewerbsregeln (DE-588)4189757-2 gnd Wettbewerbsrecht (DE-588)4121924-7 gnd Regulierung (DE-588)4201190-5 gnd Binnenmarkt (DE-588)4145576-9 gnd |
| topic_facet | Europäische Union Arzneimittelmarkt Arzneimittelhandel Wettbewerbspolitik Wettbewerbsregeln Wettbewerbsrecht Regulierung Binnenmarkt Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=021099274&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV037184720 |
| work_keys_str_mv | AT desogusclaudia competitionandinnovationintheeuregulationofpharmaceuticalsthecaseofparalleltrade |