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市場調査レポート
並行取引と医薬品流通における偽造医薬品の影響：課題と取組み、サプライチェーンインテグリティに対する見解
Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity
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Abstract
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.
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 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
- Counterfeits in developing countries
- Counterfeiting in Africa, Asia, Middle East, and South America
- 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 Frontieres
- UNITAID
- Anti-counterfeiting initiatives in Asia
- 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
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