SPI Infoamtion

Table of Contents

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 cross-border 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 supply-distribution 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 Fronti?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