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How to React to Parallel Trade

Informa Healthcare
September 1, 2007
146 Pages - SKU: IFHC1693935

Abstract Table of Contents Search inside this report Related Reports

Countries covered: Europe

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.

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; 2.2 Parallel distribution of centrally-approved medicines; 2.3 Specific mechanism; 2.4 Repackaging/re-labelling
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; 3.6 Diversion of compassionate relief supplies
CHAPTER 4 MARKET PROFILES: 4.1 Major countries of destination; 4.2 Major source countries
CHAPTER 5 STRATEGIC RESPONSES AND THEIR POTENTIAL CONSEQUENCES: 5.1 Main manufacturer counter-strategies to PT; 5.2 Risks
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; 6.6 Free pricing with rebates
CHAPTER 7 SUPPLY MANAGEMENT: 7.1 Export prohibition; 7.2 Stock allocation; 7.3 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; 9.2 Switzerland; 9.3 Israel; 9.4 Philippines
CHAPTER 10 FUTURE PROSPECTS: 10.1 No single European price; 10.2 Waning EU support; 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; 10.9 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

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