AntiCounterfeiting Strategies Combating Fake Pharmaceuticals

CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Chapter summary 4
Key findings 5
CHAPTER 2 COUNTERFEITING - THE SCALE OF THE PROBLEM 9
Pharmaceutical counterfeiting - a growing global problem 10
What is a counterfeit medicine? 10
Counterfeit medicines are on the increase 12
Counterfeits with no API's predominate 13
What type of drugs are counterfeited - lifestyle versus lifesaving? 13
Counterfeit pharmaceuticals - a problem for both rich and poor nations 15
The cost of counterfeit medicines 16
The economic cost of counterfeiting 16
The health cost of counterfeiting 17
The governmental cost of counterfeiting 18
Sources of counterfeit medicines 19
Factors enabling and driving the production and distribution of counterfeit medicines 21
How counterfeit medicines reach the market 23
Parallel trade provides a point of entry for counterfeit medicines 24
The role of the internet in counterfeiting 27
CHAPTER 3 ANTI-COUNTERFEITING STRATEGIES 31
Anti-counterfeiting strategies 32
Internal anti-counterfeiting business units and policies 33
Secured supply chains 35
Simplifying the supply chain 36
FDA's prescription drug pedigree requirements 38
The emergence of e-pedigrees 41
Use of cutting edge anti-counterfeiting technologies 43
Preventative technologies 45
Unit-of-use packaging 46
Tamper-evident packaging 46
Authentication technologies 47
Overt technologies 50
Covert technologies 54
Forensic technologies 56
Diagnostic anti-counterfeiting strategies 58
Serialization and track & trace technologies 60
RFID 62
2D-barcodes are favored by EFPIA 69
Which to adopt, RFID or 2D-barcodes? 73
Improving legislation, regulation and law enforcement 78
Inadequate regulation, legislation and enforcement promotes counterfeiting 79
What will be the impact of IMPACT? 82
Summary of national and international anti-counterfeiting initiatives 87
Enhancing law enforcement 88
Education of consumers 93
National and international education initiatives 94
Industry-supported patient education 96
CHAPTER 4 BIBLIOGRAPHY 98
Datamonitor reports 98
Websites 98
Publications, online articles and meetings 109
Glossary of terms 111
List of Tables
Table 1: Countries with IP concerns to the US - Priority watch list, 2007 20
Table 2: Examples of tamper evident solutions 47
Table 3: Benefits of using different authentication measures throughout the pharmaceutical supply chain 49
Table 4: Overt anti-counterfeiting technologies 51
Table 5: Covert anti-counterfeiting technologies 55
Table 6: Forensic anti-counterfeiting technologies 56
Table 7: Readability of covert/forensic anti-counterfeit technologies 57
Table 8: Serialization/track & trace anti-counterfeiting technologies 61
Table 9: Comparison of RFID and 2D-barcode technologies 74
Table 10: Pros and cons of 2D-barcode, RFID and hybrid strategies 77
Table 11: California Express Solutions Team - project roles and responsibilities to harmonize e-pedigree, serialization and authentication 78
List of Figures
Figure 1: Defining counterfeit, substandard, diverted and genuine medicines 11
Figure 2: Counterfeit medicines are on the rise 12
Figure 3: Different types of counterfeit drugs that have been reported, 2000-01 13
Figure 4: Global incidence of counterfeiting, diversion and pharmaceutical theft, 2004-05 14
Figure 5: Number of incidents and seizures of counterfeit medicines by country, 2005 20
Figure 6: Factors enabling and driving the production and distribution of counterfeit medicines 21
Figure 7: Routes of entry for counterfeit medicines in the supply chain 24
Figure 8: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines 32
Figure 9: AstraZeneca's anti-counterfeiting efforts in the US 34
Figure 10: Distributor Licensing and Pedigree Requirements by State, October 2007 40
Figure 11: SupplyScape's timeline for meeting the 2009 California deadline 42
Figure 12: Types of anti-counterfeiting strategies 44
Figure 13: The use of bar coding was the most popular anti-counterfeit strategy employed by surveyed pharmaceutical manufacturers, 2005 45
Figure 14: How EPC and RFID work 63
Figure 15: Pfizer's risk-based approach to track & trace, authentication and pedigree technologies 76
Figure 16: The Declaration of Rome - February 2006 82
Figure 17: Survey findings for the most suitable methods of preventing counterfeit medicines, 2007 85
Figure 18: Anti-counterfeiting strategies that should be employed throughout the manufacturing and distribution of medicines 93
Figure 19: Pfizer educates patients on the threat of counterfeit medicines 96