Providing market research reports, industry analysis, company profiles and country reports for strategic planning, competitive intelligence, marketing and business research.
Search for Market Research Reports:    

How to React to Parallel Trade

Published by: Informa Healthcare

Published: Sep. 1, 2007 - 146 Pages


Table of Contents


CHAPTER 1 INTRODUCTION
1.1 Basics
1.2 How it works
1.3 How it began
1.4 How it developed
1.5 The scale of the issue
1.6 Arguments for and against
CHAPTER 2 BRINGING PARALLEL IMPORTS TO MARKET
2.1 National regulatory approval
2.1.1 Criteria employed
2.1.2 Application procedure
2.1.3 Assessment
2.1.4 Conditions
2.2 Parallel distribution of centrally-approved medicines
2.3 Specific mechanism
2.4 Repackaging/re-labelling
2.4.1 Trademarks
2.4.1.1 The BMS case
2.4.1.2 The Boehringer case
2.4.2 Copyright
2.4.3 Quality concerns
CHAPTER 3 MAJOR CONTROVERSIES
3.1 Impact on investment in R&D
3.2 Impact on launch decisions
3.3 Shortages created by parallel exporting
3.4 Savings from parallel trade
3.5 Counterfeits and parallel trade
3.5.1 Industry view
3.5.2 Other contributors
3.5.3 Traders’ response
3.5.3.1 UK
3.5.3.2 Germany
3.5.3.3 Denmark
3.5.4 Evidence
3.6 Diversion of compassionate relief supplies
CHAPTER 4 MARKET PROFILES
4.1 Major countries of destination
4.1.1 Denmark
4.1.2 Finland
4.1.3 Germany
4.1.4 Netherlands
4.1.5 Norway
4.1.6 Sweden
4.1.7 United Kingdom
4.1.7.1 PL(PI) scheme
4.1.7.2 Savings
4.1.7.3 PPRS
4.2 Major source countries
4.2.1 Greece
4.2.2 Spain
4.2.3 Other countries
4.2.3.1 Austria
4.2.3.2 Belgium
4.2.3.3 France
4.2.3.4 Portugal
4.2.3.5 Poland
CHAPTER 5 STRATEGIC RESPONSES AND THEIR POTENTIAL CONSEQUENCES
5.1 Main manufacturer counter-strategies to PT
5.2 Risks
5.2.1 Commercial risks
5.2.2 Legal risks
5.2.2.1 Treaty of Rome
5.2.2.2 Directive 2004/27/EC
5.2.3 Summary of legal processes
CHAPTER 6 PRICE MANAGEMENT
6.1 Price corridors
6.2 Euro-based pricing
6.3 Price reductions
6.4 Brand equalisation deals
6.5 Dual pricing
6.5.1 GW’s scheme
6.5.2 Pfizer’s scheme
6.5.2.1 Article 100
6.5.2.2 Pfizer makes changes
6.5.2.3 Royal decree
6.6 Free pricing with rebates
6.6.1 Pan-European opportunity
6.6.2 National opportunities
CHAPTER 7 SUPPLY MANAGEMENT
7.1 Export prohibition
7.2 Stock allocation
7.2.1 Article 81: The Adalat case
7.2.2 Article 82
7.2.2.1 Relevant product market
7.2.2.2 The Syfait case
7.2.2.3 France’s Competition Council
7.2.3 Where are we now?
7.3 Direct distribution
7.3.1 Involvement of wholesalers in PT
7.3.2 Examples of direct distribution
CHAPTER 8 RECOMMENDATIONS
8.1 Don’t rush to ‘do something’
8.2 Don’t forget to use your full rights
8.3 Don’t let lawyers drive the agenda (but do take early legal advice)
8.4 Supply management schemes can work (and stay within the law)
8.5 Responding to incoming PT with price cuts is generally not advisable
8.6 Dual pricing opportunities exist (but mainly in Spain)
8.7 Emphasise to payers that savings from PT are very limited
8.8 Emphasise that savings to patients are almost non existent
CHAPTER 9 OTHER COUNTRIES
9.1 United States
9.1.1 Personal importation
9.1.2 Legislative attempts
9.1.2.1 Bipartisan bill
9.1.2.2 Impact limited?
9.2 Switzerland
9.3 Israel
9.4 Philippines
CHAPTER 10 FUTURE PROSPECTS
10.1 No single European price
10.2 Waning EU support
10.2.1 European Commission
10.2.2 ECJ
10.2.3 European Parliament
10.2.4 EMEA
10.3 National drivers and restraints remain important
10.4 EU enlargement less of a threat
10.5 No product now immune
10.6 No country now immune
10.7 Manufacturers regaining control of distribution
10.8 Changes among parallel traders
10.8.1 Diversification
10.8.2 Exits
10.9 Prospects for US
REFERENCES
APPENDIX 1 ECJ JUDGMENTS ON PHARMACEUTICAL PARALLEL TRADE
APPENDIX 2 EUROPEAN ASSOCIATION OF EURO-PHARMACEUTICAL COMPANIES (EAEPC)
APPENDIX 3 EAEPC GOOD PARALLEL DISTRIBUTION PRACTICE GUIDELINES FOR MEDICINAL PRODUCTS
APPENDIX 4 PL(PI) LICENCE HOLDERS IN UK


Abstract

Parallel trade is now very much a part of the European pharmaceutical landscape. And as such you cannot avoid at some point being affected by it. It is essential, therefore, that you learn how to deal with it so you can begin implementing counter measures to minimise the risk it poses to your profitability.

This report tells you everything you need to know about parallel trade and provides expert advice on what you can do to tackle it.

This report provides:
  • a complete and independent overview of parallel trade, which explains the complex economic, legal and regulatory aspects involved, so you can assess the potential impact it may have on your profitability
  • a clear and comprehensive guide to the legal and regulatory issues that surround parallel trade, enabling you to get to grips with this complex area more quickly
  • key market profiles, detailing the regional variations that provide the perfect environment for parallel trade to thrive so you can understand, country to country, how this affects the industry
  • profiles of leading parallel importers
  • so you can build a thorough understanding of the companies involved and their activities
  • expert guidance on how to respond strategically to parallel trade
  • discover how you can combat parallel trade and cut the risk to your bottom line
  • an exploration of the future prospects for parallel trade
  • so you can prepare for the future and be ready to pre-empt the parallel traders' next steps.
About the author:
From 2001-2005, Donald Macarthur was Secretary General of the European Association of Euro-Pharmaceutical Companies (EAEPC), the pan-European grouping of national associations and individual firms involved in parallel trading of medicines with membership from 16 EEA countries.

During the preceding 16 years he was an independent consultant and analytical writer on global pharmaceutical business issues. He has produced 40+ reports and his consultancy clients have included the European Federation of Pharmaceutical Industries and Associations (he was the very first consultant ever used by EFPIA), PhRMA, the European grouping of national full-line pharmaceutical wholesaling associations (GIRP), government agencies, and several major multinational manufacturers and financial firms.

He spent 16 years in development, regulatory affairs and medical department functions in the pharmaceutical industry in the UK (Fisons, 1969-72; Parke-Davis, 1972-75; Roche, 1976-78; Serono, 1978-82; Lundbeck 1982-84) and is A Member of the Royal Pharmaceutical Society and Visiting Professor in European Pharmacy Practice & Policy at the School of Pharmacy (University of London). He is listed in Marquis' Who's Who in the World.



Get Full Details About This Report >>
US: 800.298.5699
Int'l: +1.240.747.3093
Buy this Report
Price and Delivery Options
Search Inside Report


 

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.

 

© MarketResearch.com 2008