Report: Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity TOC

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

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

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

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

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 Frontieres
- 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

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

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

Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity