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Generic Pharmaceuticals 2009

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Generic Pharmaceuticals 2009 Generic Pharmaceuticals 2009 The OECD Competition Committee held a roundtable discussion on Generic Pharmaceuticals in October 2009. This document includes an executive summary and the documents from the meeting: an analytical note by the staff of the United States Federal Trade Commission, written submissions from Canada, the Czech Republic, the European Commission, India, Indonesia, Ireland, Italy, Japan, Korea, Norway, the Russian Federation, South Africa, Spain, Sweden, the United Kingdom, the United States, and BIAC, as well as an aide-memoire. Practices that may harm competition in the pharmaceutical sector have emerged as important and controversial issues in recent years. The Committee examined the nature of competition between generic and branded products in the pharmaceutical sector, as well as the effects on competition of agreements to delay the entry of generics on the market. The discussion showed that the pharmaceutical sector is highly regulated, driven by R&D, and very dependent on patent protection. It also revealed that regulation of pharmaceutical prices and other factors has mixed effects, solving or mitigating some problems while creating or worsening others. One lesson was that competition authorities should be involved not only in competition enforcement settings but also in the regulatory regimes that cover this sector (both the branded and generic components). Competition, Patents and Innovation II (2009) Competition, Patents and Innovation (2006) Intellectual Property Rights (2004) Competition in the Pharmaceutical Industry (2001) Unclassified DAF/COMP(2009)39 Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 05-Oct-2010 ___________________________________________________________________________________________ _____________ English, French DIRECTORATE FOR FINANCIAL AND ENTERPRISE AFFAIRS COMPETITION COMMITTEE Unclassified DAF/COMP(2009)39 Cancels & replaces the same document of 27 September 2010 ROUNDTABLE ON GENERIC PHARMACEUTICALS English, French JT03289500 Document complet disponible sur OLIS dans son format d'origine Complete document available on OLIS in its original format DAF/COMP(2009)39 FOREWORD This document comprises proceedings in the original languages of a roundtable on Generic Pharmaceuticals, held by the Competition Committee in October 2009. It is published under the responsibility of the Secretary General of the OECD to bring information on this topic to the attention of a wider audience. This compilation is one of a series of publications entitled "Competition Policy Roundtables". PRÉFACE Ce document rassemble la documentation dans la langue d'origine dans laquelle elle a été soumise, relative à une table ronde sur les médicaments génériques dans les marchés publics qui s'est tenue en octobre 2009 dans le cadre du comité de la concurrence. Il est publié sous la responsabilité du Secrétaire général de l'OCDE, afin de porter à la connaissance d'un large public les éléments d'information qui ont été réunis à cette occasion. Cette compilation fait partie de la série intitulée "Les tables rondes sur la politique de la concurrence". Visit our Internet Site -- Consultez notre site Internet http://www.oecd.org/competition 2 DAF/COMP(2009)39 OTHER TITLES SERIES ROUNDTABLES ON COMPETITION POLICY 1. Competition Policy and Environment OCDE/GD(96)22 2. Failing Firm Defence OCDE/GD(96)23 3. Competition Policy and Film Distribution OCDE/GD(96)60 4. Competition Policy and Efficiency Claims in Horizontal Agreements OCDE/GD(96)65 5. The Essential Facilities Concept OCDE/GD(96)113 6. Competition in Telecommunications OCDE/GD(96)114 7. The Reform of International Satellite Organisations OCDE/GD(96)123 8. Abuse of Dominance and Monopolisation OCDE/GD(96)131 9. Application of Competition Policy to High Tech Markets OCDE/GD(97)44 10. General Cartel Bans: Criteria for Exemption for Small and Medium-sized Enterprises OCDE/GD(97)53 11. Competition Issues related to Sports OCDE/GD(97)128 12. Application of Competition Policy to the Electricity Sector OCDE/GD(97)132 13. Judicial Enforcement of Competition Law OCDE/GD(97)200 14. Resale Price Maintenance OCDE/GD(97)229 15. Railways: Structure, Regulation and Competition Policy DAFFE/CLP(98)1 16. Competition Policy and International Airport Services DAFFE/CLP(98)3 17. Enhancing the Role of Competition in the Regulation of Banks DAFFE/CLP(98)16 18. Competition Policy and Intellectual Property Rights DAFFE/CLP(98)18 19. Competition and Related Regulation Issues in the Insurance Industry DAFFE/CLP(98)20 20. Competition Policy and Procurement Markets DAFFE/CLP(99)3 21. Regulation and Competition Issues in Broadcasting in the light of Convergence DAFFE/CLP(99)1 22. Relationship between Regulators and Competition Authorities DAFFE/CLP(99)8 23. Buying Power of Multiproduct Retailers DAFFE/CLP(99)21 24. Promoting Competition in Postal Services DAFFE/CLP(99)22 25. Oligopoly DAFFE/CLP(99)25 26. Airline Mergers and Alliances DAFFE/CLP(2000)1 27. Competition in Professional Services DAFFE/CLP(2000)2 28. Competition in Local Services DAFFE/CLP(2000)13 29. Mergers in Financial Services DAFFE/CLP(2000)17 30. Promoting Competition in the Natural Gas Industry DAFFE/CLP(2000)18 31. Competition Issues in Electronic Commerce DAFFE/CLP(2000)32 32. Competition and Regulation Issues in the Pharmaceutical Industry DAFFE/CLP(2000)29 33. Competition Issues in Joint Ventures DAFFE/CLP(2000)33 34. Competition Issues in Road Transport DAFFE/CLP(2001)10 3 DAF/COMP(2009)39 35. Price Transparency DAFFE/CLP(2001)22 36. Competition Policy in Subsidies and State Aid DAFFE/CLP(2001)24 37. Portfolio Effects in Conglomerate Mergers DAFFE/COMP(2002)5 38. Competition and Regulation Issues in Telecommunications DAFFE/COMP(2002)6 39. Merger Review in Emerging High Innovation Markets DAFFE/COMP(2002)20 40. Loyalty and Fidelity Discounts and Rebates DAFFE/COMP(2002)21 41. Communication by Competition Authorities DAFFE/COMP(2003)4 42. Substantive Criteria used for the Assessment of Mergers DAFFE/COMP(2003)5 43. Competition Issues in the Electricity Sector DAFFE/COMP(2003)14 44. Media Mergers DAFFE/COMP(2003)16 45. Universal Service Obligations DAF/COMP(2010)13 46. Competition and Regulation in the Water Sector DAFFE/COMP(2004)20 47. Regulating Market Activities by Public Sector DAF/COMP(2004)36 48. Merger Remedies DAF/COMP(2004)21 49. Cartels: Sanctions against Individuals DAF/COMP(2004)39 50. Intellectual Property Rights DAF/COMP(2004)24 51. Predatory Foreclosure DAF/COMP(2005)14 52. Competition and Regulation in Agriculture: Monopsony Buying and Joint Selling DAF/COMP(2005)44 53. Enhancing Beneficial Competition in the Health Professions DAF/COMP(2005)45 54. Evaluation of the Actions and Resources of Competition Authorities DAF/COMP(2005)30 55. Structural Reform in the Rail Industry DAF/COMP(2005)46 56. Competition on the Merits DAF/COMP(2005)27 57. Resale Below Cost Laws and Regulations DAF/COMP(2005)43 58. Barriers to Entry DAF/COMP(2005)42 59. Prosecuting Cartels without Direct Evidence of Agreement DAF/COMP/GF(2006)7 60. The Impact of Substitute Services on Regulation DAF/COMP(2006)18 61. Competition in the Provision of Hospital Services DAF/COMP(2006)20 62. Access to key Transport Facilities DAF/COMP(2006)29 63. Environmental Regulation and Competition DAF/COMP(2006)30 64. Concessions DAF/COMP/GF(2006)6 65. Remedies and Sanctions DAF/COMP(2006)19 66. Competition in Bidding Markets DAF/COMP(2006)31 67. Competition and Efficient Usage of Payment cards DAF/COMP(2006)32 68. Vertical mergers DAF/COMP(2007)21 69. Competition and Regulation in Retail Banking DAF/COMP(2006)33 70. Improving Competition in Real Estate Transactions DAF/COMP(2007)36 71. Public Procurement – The Role of Competition Authorities in Promoting Competition DAF/COMP(2007)34 72. Competition, Patents and Innovation DAF/COMP(2007)40 73. Private Remedies DAF/COMP(2006)34 4 DAF/COMP(2009)39 74. Energy Security and Competition Policy DAF/COMP(2007)35 75. Plea Bargaining Settlement of Cartel Cases DAF/COMP(2007)38 76. Competitive Restrictions in Legal Professions DAF/COMP(2007)39 77. Dynamic Efficiencies in Merger Analysis DAF/COMP(2007)41 78. Guidance to Business on Monopolisation and Abuse of Dominance DAF/COMP(2007)43 79. The Interface between Competition and Consumer Policies DAF/COMP/GF(2008)10 80. Facilitating Practices in Oligopolies DAF/COMP(2008)24 81. Taxi Services Regulation and Competition DAF/COMP(2007)42 82. Techniques and Evidentiary Issues in Proving Dominance/ Monopoly Power DAF/COMP(2006)35 83. Managing Complex Merger Cases DAF/COMP(2007)44 84. Potential Pro-Competitive and Anti-Competitive Aspects of Trade/Business Associations DAF/COMP(2007)45 85. Market Studies DAF/COMP(2008)34 86. Land Use Restrictions as Barriers to Entry DAF/COMP(2008)25 87. Construction Industry DAF/COMP(2008)36 88. Antitrust Issues Involving Minority Shareholding and DAF/COMP(2008)30 Interlocking Directorates 89. Bundled and Loyalty Discounts and Rebates DAF/COMP(2008)29 90. Techniques for Presenting Complex Economic Theories to Judges DAF/COMP(2008)31 91. Competition Policy for Vertical Relations in Gasoline Retailing DAF/COMP(2008)35 92. Competition and Financial Markets DAF/COMP(2009)11 93. Refusals to Deal DAF/COMP(2007)46 94. Resale Price Maintenance DAF/COMP(2008)37 95. Experience with Direct Settlements in Cartel Cases DAF/COMP(2008)32 96. Competition Policy, Industrial Policy and National Champions DAF/COMP/GF(2009)9 97. Two-Sided Markets DAF/COMP(2009)20 98. Monopsony and Buyer Power DAF/COMP(2008)38 99. Competition and Regulation in Auditing and Related Professions DAF/COMP(2009)19 100. Roundtable on competition policy and the informal economy DAF/COMP/GF(2009)10 101. Competition, Patents and Innovation II DAF/COMP(2009)22 102. The Standard for Merger Review, with a Particular Emphasis on Country Experience with the change of Merger Review Standard from the Dominance Test to the SLC/SIEC Test DAF/COMP(2009)21 103.
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