Hardback
EU Law of Competition and Trade in the Pharmaceutical Sector
This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector.
Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry.
The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry.
The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
More Information
Critical Acclaim
Contributors
Contents
More Information
This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry.
Key features include:
• Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level
• Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers
• In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements
• Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter.
This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.
Key features include:
• Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level
• Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers
• In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements
• Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter.
This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.
Critical Acclaim
‘The topics are very interesting, the contributions are well researched and practical in their approach and are very readable in style. A must-have book for academics and practitioners involved in the pharmaceutical sector.’
–Riccardo Sciaudone, The Competition Law Observatory
‘Impressive and comprehensive. Any practitioner, policy maker or corporate counsel with an interest in the pharmaceutical industry will find in this book a full overview of the competition and trade issues facing the sector, both from a legal and economic perspective, and covering all the major economies in the world.’
– Gunnar Niels, Oxera Consulting LLP, UK
–Riccardo Sciaudone, The Competition Law Observatory
‘Impressive and comprehensive. Any practitioner, policy maker or corporate counsel with an interest in the pharmaceutical industry will find in this book a full overview of the competition and trade issues facing the sector, both from a legal and economic perspective, and covering all the major economies in the world.’
– Gunnar Niels, Oxera Consulting LLP, UK
Contributors
Contributors: R. Amils, N. Blalock, H. Brokelmann, C. Caballero, P. Callol, N. Carbonnelle, P. Caro de Sousa, M.A. Carrier, B. Durand, P. Figueroa, A. Foster, M. Ganino, O. Gannon, A. Guerrero, G.A. Hay, P. Hecker, J. Heithecker, F. Hernández, M. Ioannidou, I. Kokkoris, L. Luchianov, F. Maier-Rigaud, M. Martens, A. Minho López, P. Moullet, E. Navarro Varona, P. Riedel, S.B. Thomas, T. Weck
Contents
Contents:
1. Competition Law and Pharma: An Economic Perspective
Benoît Durand
2. Reverse Payments: an EU and U.S. Perspective
Frank Maier-Rigaud, Nathan Blalock and Oliver Gannon
3. Article 101 TFEU: Horizontal Cooperation Agreements in the Pharmaceutical Sector
Soledad Blanco Thomas, Lilia Luchianov and Thomas Weck
4. The Competitive Assessment of IP Licensing Agreements in the Pharmaceutical Sector
Pierre Moullet
5. Article 102 TFEU: Patent filings as an abuse of dominant position after “AstraZeneca”: the patent / antitrust interface under a new perspective
Francisco Hernández
6. Mergers in the Pharmaceutical Sector
Pablo Figueroa and Alejandro Guerrero
7. Mergers in the Medical Devices Sector
Jan Heithecker
8. Antitrust Practices in Pharmaceutical Public Procurement
Antonio Minho López
9. EU Trade Law and Pharmaceuticals
Pascale Hecker
10. The Pharmaceutical Sector and Parallel Trade
Edurne Navarro Varona and Cristina Caballero
11. Free Movement and Competition in the European Market for Pharmaceuticals
Pedro Caro de Sousa
12. IP Law and Pharmaceuticals: Patents and Supplementary Protection Certificates in the Pharmaceutical Sector
Rais Amils
13. The EU Regulatory Framework for Medical Products for Human Use
Marc Martens and Nicolas Carbonnelle
14. Antitrust and the Pharmaceutical Industry in the United States
George A. Hay
15. UK Competition and Trade in the Pharma Sector
Paula Riedel
16. Competition law and Pharma: China
Andrew Foster
17. Competition Law and Pharma: Spain
Helmut Brokelmann and Mariarosaria Ganino
18. The Application of Competition Law in the Pharmaceutical Sector: Challenges for BRICS
Maria Ioannidou and Ioannis Kokkoris
19. Product Hopping: The U.S. Approach
Michael A. Carrier
20. Marketing data in the Pharmaceutical Sector: a competition law consideration
Pedro Callol
Index
1. Competition Law and Pharma: An Economic Perspective
Benoît Durand
2. Reverse Payments: an EU and U.S. Perspective
Frank Maier-Rigaud, Nathan Blalock and Oliver Gannon
3. Article 101 TFEU: Horizontal Cooperation Agreements in the Pharmaceutical Sector
Soledad Blanco Thomas, Lilia Luchianov and Thomas Weck
4. The Competitive Assessment of IP Licensing Agreements in the Pharmaceutical Sector
Pierre Moullet
5. Article 102 TFEU: Patent filings as an abuse of dominant position after “AstraZeneca”: the patent / antitrust interface under a new perspective
Francisco Hernández
6. Mergers in the Pharmaceutical Sector
Pablo Figueroa and Alejandro Guerrero
7. Mergers in the Medical Devices Sector
Jan Heithecker
8. Antitrust Practices in Pharmaceutical Public Procurement
Antonio Minho López
9. EU Trade Law and Pharmaceuticals
Pascale Hecker
10. The Pharmaceutical Sector and Parallel Trade
Edurne Navarro Varona and Cristina Caballero
11. Free Movement and Competition in the European Market for Pharmaceuticals
Pedro Caro de Sousa
12. IP Law and Pharmaceuticals: Patents and Supplementary Protection Certificates in the Pharmaceutical Sector
Rais Amils
13. The EU Regulatory Framework for Medical Products for Human Use
Marc Martens and Nicolas Carbonnelle
14. Antitrust and the Pharmaceutical Industry in the United States
George A. Hay
15. UK Competition and Trade in the Pharma Sector
Paula Riedel
16. Competition law and Pharma: China
Andrew Foster
17. Competition Law and Pharma: Spain
Helmut Brokelmann and Mariarosaria Ganino
18. The Application of Competition Law in the Pharmaceutical Sector: Challenges for BRICS
Maria Ioannidou and Ioannis Kokkoris
19. Product Hopping: The U.S. Approach
Michael A. Carrier
20. Marketing data in the Pharmaceutical Sector: a competition law consideration
Pedro Callol
Index
