Market Report Source

Overview

Introduction

Counterfeit medicines are a global problem costing patient’s their health and the pharmaceutical industry and governmental organizations millions of dollars per year. Although there is no one preventative strategy, there are several measures that can be employed simultaneously to reduce the risk of fake medicines entering the pharmaceutical supply chain.

Scope

Overview of the prevalence and drivers of counterfeit medicines, examining the economic and health cost of fake medicines Analysis of how counterfeit medicines enter the market, and strategies taken to tighten up supply chain security Assessment of key anti-counterfeiting technologies employed by pharmaceutical manufacturers, supported by case study analysis Examination of governmental and NGO based initiatives to improve regulation, legislation and enforcement of anti-counterfeiting protocols

Highlights

Incidents of counterfeit medicines are on the increase. However, reported figures only represent the tip of the iceberg, particularly in developing countries due to the insufficient anti-counterfeiting resources available Parallel importation and online pharmacies are increasingly becoming the route of choice for counterfeiters to distribute fake medicines to patients on a global scale. Find out why, and what is being done to address these matters Currently, 2D-barcodes and radio frequency identification tagging (RFID) are the two most prominent track & trace technologies. However, with the FDA having no preference, which technologies will pharmaceutical companies opt for?

Reasons to Purchase

Identify the cause, prevalence and drivers of counterfeiting in the world today Evaluate which anti-counterfeiting strategies are available, and which ones to adopt Understand what anti-counterfeiting regulations and legislations will likely affect the pharmaceutical industry in the near future.

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY
Scope of the report
Chapter summary
Key findings

CHAPTER 2 COUNTERFEITING – THE SCALE OF THE PROBLEM
Pharmaceutical counterfeiting – a growing global problem
What is a counterfeit medicine?
Counterfeit medicines are on the increase
Counterfeits with no API’s predominate
What type of drugs are counterfeited – lifestyle versus lifesaving?
Counterfeit pharmaceuticals – a problem for both rich and poor nations
The cost of counterfeit medicines
The economic cost of counterfeiting
The health cost of counterfeiting
The governmental cost of counterfeiting
Sources of counterfeit medicines
Factors enabling and driving the production and distribution of counterfeit medicines
How counterfeit medicines reach the market
Parallel trade provides a point of entry for counterfeit medicines
The role of the internet in counterfeiting

CHAPTER 3 ANTI-COUNTERFEITING STRATEGIES
Anti-counterfeiting strategies
Internal anti-counterfeiting business units and policies
Secured supply chains
Simplifying the supply chain
FDA’s prescription drug pedigree requirements
The emergence of e-pedigrees
Use of cutting edge anti-counterfeiting technologies
Preventative technologies
Unit-of-use packaging
Tamper-evident packaging
Authentication technologies
Overt technologies
Covert technologies
Forensic technologies
Diagnostic anti-counterfeiting strategies
Serialization and track & trace technologies
RFID
2D-barcodes are favored by EFPIA
Which to adopt, RFID or 2D-barcodes?
Improving legislation, regulation and law enforcement
Inadequate regulation, legislation and enforcement promotes counterfeiting
What will be the impact of IMPACT?
Summary of national and international anti-counterfeiting initiatives
Enhancing law enforcement
Education of consumers
National and international education initiatives
Industry-supported patient education

CHAPTER 4 BIBLIOGRAPHY
Datamonitor reports
Websites
Publications, online articles and meetings
Glossary of terms

List of Tables
Table 1: Countries with IP concerns to the US – Priority watch list, 2007
Table 2: Examples of tamper evident solutions
Table 3: Benefits of using different authentication measures throughout the pharmaceutical supply chain
Table 4: Overt anti-counterfeiting technologies
Table 5: Covert anti-counterfeiting technologies
Table 6: Forensic anti-counterfeiting technologies
Table 7: Readability of covert/forensic anti-counterfeit technologies
Table 8: Serialization/track & trace anti-counterfeiting technologies
Table 9: Comparison of RFID and 2D-barcode technologies
Table 10: Pros and cons of 2D-barcode, RFID and hybrid strategies
Table 11: California Express Solutions Team – project roles and responsibilities to harmonize e-pedigree, serialization and authentication

List of Figures
Figure 1: Defining counterfeit, substandard, diverted and genuine medicines
Figure 2: Counterfeit medicines are on the rise
Figure 3: Different types of counterfeit drugs that have been reported, 2000-01
Figure 4: Global incidence of counterfeiting, diversion and pharmaceutical theft, 2004-05
Figure 5: Number of incidents and seizures of counterfeit medicines by country, 2005
Figure 6: Factors enabling and driving the production and distribution of counterfeit medicines
Figure 7: Routes of entry for counterfeit medicines in the supply chain
Figure 8: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines
Figure 9: AstraZeneca’s anti-counterfeiting efforts in the US
Figure 10: Distributor Licensing and Pedigree Requirements by State, October 2007
Figure 11: SupplyScape’s timeline for meeting the 2009 California deadline
Figure 12: Types of anti-counterfeiting strategies
Figure 13: The use of bar coding was the most popular anti-counterfeit strategy employed by surveyed pharmaceutical manufacturers, 2005
Figure 14: How EPC and RFID work
Figure 15: Pfizer’s risk-based approach to track & trace, authentication and pedigree technologies
Figure 16: The Declaration of Rome – February 2006
Figure 17: Survey findings for the most suitable methods of preventing counterfeit medicines, 2007
Figure 18: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines
Figure 19: Pfizer educates patients on the threat of counterfeit medicines