Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution

Summary

Introduction

Parallel trade is a legitimate method of pharmaceutical import and export within the EU zone. Although previously recognized in North America as illegal, cross-border reimportation is now permitted following legislation allowing drugs to be imported into the US from Canada. However, counterfeit drugs have been shown to be increasingly introduced into the global supply chain, which threatens patient safety, ethical pharmaceutical sales, and undermines the integrity of the distribution channels. Parallel trade is regarded as a major contributor to counterfeiting and this is explored in the report.

Furthermore, the report provides a comprehensive account of the route of market access for counterfeits and shows how companies and governments in Europe and North America are tackling the problem strategically. It also updates the reader on the latest parallel trade and anti-counterfeiting initiatives adopted globally and whether current efforts to stem the practice have been successful or not. The report discusses further action plans and recommends which strategies are likely to best curtail the practice.

This report also evaluates the extent of parallel trade in Europe and counterfeiting globally with an analysis of major counterfeit-producing countries and the anti-counterfeiting efforts currently in place.

Key findings

• Parallel trade is an expanding global sector of industry now that reimportation is permitted in the USA. European parallel trade is set to grow based on accession countries providing new markets in which to trade multiple products in multiple markets.
• Counterfeiting is prevalent in higher priced drug markets of developed nations and also in lower priced markets of essential drugs in developing countries.
• The drug distribution routes are the market access points for counterfeits. Parallel traded and non-parallel traded routes are vulnerable to counterfeiting.
• Anti-counterfeiting technologies are being deployed in westernised countries but there are issues that need to be resolved before widespread implementation such as standardization of protocols, technology reliability and validity, and stakeholder funding.

Key features of this report

• Analysis of parallel trade and counterfeiting in European Union, North America, Asia and Africa. Country-by-country analysis including France, Germany, UK, USA, Spain, Netherlands, USA, Canada, China, India, and other countries.
• Evaluation of the drivers behind parallel trade and counterfeiting in context of drug distribution.
• Coverage of recent regulatory and legislation changes relative to parallel trade and counterfeiting in Europe and North America.

Use this report to

• Understand how the international markets are affected by parallel trade and counterfeiting.
• Information on the scope of parallel trade and counterfeiting in key European territories and how importation has affected pricing in North America.
• Evaluate the impact of importation on the US market and how counterfeits can penetrate the drug supply-distribution chain.
• Shows the routes of market access for counterfeits and why they are increasingly being produced.

Discover

• What is the process of parallel trade in Europe and North America and why is it associated with counterfeiting?
• What is the extent of parallel trade and reimportation in Europe and North America?
• How has recent regulation and legislation changed the parallel trade sector?
• What is the impact of online pharmacies on parallel trade and counterfeiting?
• How are countries dealing with counterfeiting and what efforts have been implemented?

Contents

• Impact Of Counterfeits On Parallel Trade & Pharmaceutical Distribution
• Executive Summary
  • Pt In Europe: A Legitimate Mechanism For Redistribution
  • Pt In North America: A Cross-Border Growth Industry
  • Counterfeits And The Global Supply-Distribution Chain
  • Anti-Counterfeiting Strategies: Current Perspectives
  • Global Initiatives To Combat Counterfeiting
• Chapter 1 Pt In Europe: A Legitimate Mechanism For Redistribution
  • Summary
  • Introduction
  • The Parallel Trade Process
  • Driving Factors For Profitable Parallel Trade
  • Drug Price Differential
  • Exchange Rate Fluctuations
  • Government Price Controls
  • Pharmacoeconomics As A Price Control Measure
  • Multiple Importation Markets Driving Profit Margins
  • Supportive Legal And Regulatory Free Trade Framework
  • Selection Criteria For Parallel-Traded Drugs
  • Disease Incidence And Type
  • Drug Formulation
  • Transport And Distribution
  • Advantages And Disadvantages Of Parallel Trade
  • Key Advantages Of Parallel Trade
  • Key Disadvantages Of Parallel Trade
  • Quality And Safety Concerns: The Risk Of Counterfeiting
  • Parallel Traders: Building Bridges For Portfolio Services
  • Extent Of Parallel Trade In European Markets
  • Denmark
  • Germany
  • France
  • Netherlands
  • Norway
  • Spain
  • United Kingdom
  • Direct-To-Pharmacy Distribution
  • Pharmaceutical Price Regulation Scheme 2009
  • Recent Legislation On Parallel Trade In Europe
  • Importance Of Stakeholder Support
• Chapter 2 Pt In North America: A Crossborder Growth Industry
  • Summary
  • Pharmaceutical Importation In The Us
  • The Legal Framework: Past And Present
  • 2003 Medicare Reform Bill And Canadian Imports
  • Recent Legislature On Importation
  • Scope Of Parallel Importation In The Us
  • Online Pharmacies And Parallel Distribution
  • Unapproved Imports In Canada
• Chapter 3 Counterfeits And The Global Pharmaceutical Supplydistribution Chain
  • Summary
  • Introduction
  • The Extent Of Counterfeiting - A Global Analysis
  • Factors Driving Counterfeit Trade
  • Counterfeits In Developed Countries: Recent Evidence
  • European Union
  • United Kingdom
  • France
  • Germany
  • Italy
  • Netherlands
  • Recent Enforcement Action In The Eu
  • North America
  • Usa
  • Canada
  • Counterfeits In Developing Countries
  • Counterfeiting In Africa, Asia, Middle East, And South America
  • Africa
  • Middle East
  • Asia
  • Types Of Drugs Targeted By Counterfeiters
  • Counterfeits And The Pharmaceutical Distribution Chain
  • Access Points For Counterfeits
  • Repackaging, Wholesaling, And Counterfeiting: Recent Issues
  • Repackaging And Counterfeiting
  • Wholesaling And Counterfeiting
  • Online Pharmacies
  • Unauthorized Internet Pharmacies And Counterfeits
  • Major Producers Of Counterfeit Drugs: China And India
  • China
  • Domestic Counterfeiting: Recent Evidence
  • Contract Manufacturing And The Risk Of Counterfeiting
  • The Counterfeit Route: Going West
  • India
  • Factors Contributing To Copycat & Counterfeiting Activities
  • The Legitimate Distribution Pathway: Problems Going West
• Chapter 4 Anti-Counterfeiting Strategies: Current Perspectives
  • Summary
  • Anti-Counterfeiting Strategies
  • Technical Strategies
  • Non-Technical Strategies
  • Non-Technical Strategies And Counterfeiting: Current Initiatives
  • Anti-Counterfeiting Technologies In Developed Countries
  • Current Focus: Track-And-Trace Technologies & Mass Serialization
  • European Union
  • United States
  • Mass Serialization: Main Technology Types
  • Barcodes
  • Radio Frequency Identification
  • Radio Frequency Identification In Developed Countries: Recent Activities
  • Chemical Authentication Technologies In Developed Countries: Recent Activities And Initiatives
  • New Packaging Technologies
  • Anti-Counterfeiting Technologies In Developing Countries
  • Radio Frequency Identification In Developing Countries: Recent Activities
• Chapter 5 Global Initiatives To Combat Counterfeiting
  • Summary
  • International Anti-Counterfeiting Initiatives
  • Government Efforts
  • European Commission
  • United States Department Of Health & Human Services
  • World Health Organization
  • Interpol
  • Non-Government Efforts
  • Unicef
  • Medecins Sans Frontiè res
  • Unitaid
  • Anti-Counterfeiting Initiatives In Asia
  • India
  • China
  • Taiwan
  • Pharmaceutical Trade And Industry Organizations
  • Pharmaceutical Security Institute (Psi)
  • International Federation Of Pharmaceutical Manufacturers Associations
  • (Ifpma)
  • European Federation Of Pharmaceutical Manufacturers Associations (Efpia)
  • The European Alliance For Access To Safe Medicines (Eaasm)
  • New Initiative: Rx-360
  • Stockholm Network
  • Considerations For Parallel Trade And Counterfeiting
  • Key Points And Recommendations
• Chapter 6 Appendix
  • Primary Research Methodology
  • References
  • Websites
  • Glossary
  • Index
• List Of Figures
  • Figure 1.1: Generalized Parallel Trade Process For Pharmaceuticals In Europe
  • Figure 1.2: Major Factors Contributing To Parallel Trade In The Eu
  • Figure 1.3: Advantages & Disadvantages Of Parallel Trade
  • Figure 1.4: Estimated Market Penetration Of Parallel Imports By Value In Key European Destinations (%), 2001 & 2009
  • Figure 2.5: Key Opposing Issues On Parallel Importation From Canada
  • Figure 2.6: Prescription Drugs Typically Imported Into The Us
  • Figure 2.7: Typical Savings Offered By A Canadian Online Pharmacy, 2009
  • Figure 2.8: Lowest Price Guarantee Offered By Canadian Online Pharmacy, 2009
  • Figure 3.9: Therapy Areas With Largest Increase In Incidents Y-O-Y (%), 2008
  • Figure 3.10: Key Factors Driving Counterfeiting In Pharmaceuticals
  • Figure 3.11: Increasing Trend Of Counterfeiting, Illegal Diversion And Theft Of Pharmaceuticals, 2002- 2008
  • Figure 3.12: Counterfeit Access Points In The Drug Distribution Chain
  • Figure 4.13: Non-Technical And Technical Anti-Counterfeiting Strategies Used In The Drug Supply And Distribution Chain
  • Figure 4.14: Advantages & Disadvantages Of Rfid & Epc Anti-Counterfeiting Technologies
• List Of Tables
  • Table 1.1: Common Pharmaceutical Pricing Controls
  • Table 1.2: European Stakeholder Support Initiatives
  • Table 2.3: Key Provisions Of The H.R.1 [108th] Medicare Prescription Drug,
  • Table 2.4: Key Provisions Of The H.R.1 [108th] Medicare Prescription Drug,
  • Table 2.5: Popular Online Pharmacy Brands, 2009
  • Table 2.6: Popular Full Service Online Pharmacies In The Us
  • Table 2.7: Drug Price Savings Offered By Canadian Pharmacies In 2009
  • Table 3.8: Results Of Impact-Interpol Anti-Counterfeit Initiatives In Developing Countries
  • Table 3.9: Lifestyle Drugs Potentially Targeted By Counterfeiters
  • Table 3.10: Products Susceptible To Counterfeits In The Us, 2004
  • Table 3.11: Authorized Online Pharmacies In The Us
  • Table 4.12: Anti-Counterfeiting Technology Types
  • Table 5.13: Key European Commission Anti-Counterfeiting Proposals, 2008
  • Table 5.14: World Health Organization Guidelines To Combat Drug Counterfeiting
  • Table 5.15: Efpia Policy Initiatives On Parallel Trade To Maintain Supply Integrity