Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution: Issues, initiatives and insights for supply chain integrity - 2009/10/01 - Business Insights

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

from Business Insights
148 page report published Oct 01, 2009

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IntroductionParallel 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.Key findings
- Parallel trade is an expanding global sector of industry now that reimportation is permitted in the USA. European parallel trade is set to grow based on accession countries providing new markets in which to trade multiple products in multiple markets.
- Counterfeiting is prevalent in higher priced drug markets of developed nations and also in lower priced markets of essential drugs in developing countries.
- The drug distribution routes are the market access points for counterfeits. Parallel traded and non-parallel traded routes are vulnerable to counterfeiting.
- Anti-counterfeiting technologies are being deployed in westernised countries but there are issues that need to be resolved before widespread implementation such as standardization of protocols, technology reliability and validity, and stakeholder funding. Key features of this report
-Analysis of parallel trade and counterfeiting in European Union, North America, Asia and Africa. Country-by-country analysis including France, Germany, UK, USA, Spain, Netherlands, USA, Canada, China, India, and other countries.
-Evaluation of the drivers behind parallel trade and counterfeiting in context of drug distribution.
-Coverage of recent regulatory and legislation changes relative to parallel trade and counterfeiting in Europe and North America.Use this report to
-Understand how the international markets are affected by parallel trade and counterfeiting.
-Information on the scope of parallel trade and counterfeiting in key European territories and how importation has affected pricing in North America.
-Evaluate the impact of importation on the US market and how counterfeits can penetrate the drug supply-distribution chain.
-Shows the routes of market access for counterfeits and why they are increasingly being produced. Discover
- What is the process of parallel trade in Europe and North America and why is it associated with counterfeiting?
- What is the extent of parallel trade and reimportation in Europe and North America?
- How has recent regulation and legislation changed the parallel trade sector?
- What is the impact of online pharmacies on parallel trade and counterfeiting?
- How are countries dealing with counterfeiting and what efforts have been implemented?

Source:

Business Insights

Document ID:

rbhc0240

Industry:

Health Care

Industry:

Pharmaceutical

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Title	Starting Page	Number of Pages
Sections
Table of Contents Impact of Counterfeits on Parallel Trade & Pharmaceutical Distribution Executive summary 10 PT in Europe: A legitimate mechanism for redistribution 10 PT in North America: A cross-border growth industry 11 Counterfeits and the global supp	0	1
Table of Contents	0	1
Impact of Counterfeits on Parallel Trade &	0	1
Pharmaceutical Distribution	0	1
Executive summary 10	0	1
PT in Europe: A legitimate mechanism for redistribution 10	0	1
PT in North America: A cross-border growth industry 11	0	1
Counterfeits and the global supply-distribution chain 12	0	1
Anti-counterfeiting strategies: current perspectives 13	0	1
Global initiatives to combat counterfeiting 14	0	1
Chapter 1 PT in Europe: A legitimate mechanism for redistribution 16	0	1
Summary 16	0	1
Introduction 17	0	1
The parallel trade process 18	0	1
Driving factors for profitable parallel trade 20	0	1
Drug price differential 20	0	1
Exchange rate fluctuations 21	0	1
Government price controls 22	0	1
Pharmacoeconomics as a price control measure 24	0	1
Multiple importation markets driving profit margins 24	0	1
Supportive legal and regulatory free trade framework 25	0	1
Selection criteria for parallel-traded drugs 26	0	1
Disease incidence and type 26	0	1
Drug formulation 26	0	1
Transport and distribution 27	0	1
Advantages and disadvantages of parallel trade 29	0	1
Key advantages of parallel trade 29	0	1
Key disadvantages of parallel trade 31	0	1
Quality and safety concerns: the risk of counterfeiting 32	0	1
Parallel traders: building bridges for portfolio services 34	0	1
Extent of parallel trade in European markets 35	0	1
Denmark 37	0	1
Germany 38	0	1
France 38	0	1
Netherlands 39	0	1
Norway 39	0	1
Spain 39	0	1
United Kingdom 41	0	1
Direct-to-pharmacy distribution 42	0	1
Pharmaceutical Price Regulation Scheme 2009 43	0	1
Recent legislation on parallel trade in Europe 44	0	1
Importance of stakeholder support 46	0	1
Chapter 2 PT in North America: A crossborder growth industry 48	0	1
Summary 48	0	1
Pharmaceutical importation in the US 49	0	1
The legal framework: past and present 49	0	1
2003 Medicare reform bill and Canadian imports 50	0	1
Recent legislature on importation 53	0	1
Scope of parallel importation in the US 54	0	1
Online pharmacies and parallel distribution 56	0	1
Unapproved imports in Canada 61	0	1
Chapter 3 Counterfeits and the global pharmaceutical supplydistribution chain 64	0	1
Summary 64	0	1
Introduction 65	0	1
The extent of counterfeiting â€“ a global analysis 66	0	1
Factors driving counterfeit trade 67	0	1
Counterfeits in developed countries: recent evidence 70	0	1
European Union 70	0	1
United Kingdom 71	0	1
France 72	0	1
Germany 73	0	1
Italy 73	0	1
Netherlands 73	0	1
Recent enforcement action in the EU 74	0	1
North America 76	0	1
USA 76	0	1
Canada 77	0	1
Counterfeits in developing countries 78	0	1
Counterfeiting in Africa, Asia, Middle East, and South America 79	0	1
Africa 81	0	1
Middle East 82	0	1
Asia 82	0	1
Types of drugs targeted by counterfeiters 83	0	1
Counterfeits and the pharmaceutical distribution chain 86	0	1
Access points for counterfeits 86	0	1
Repackaging, wholesaling, and counterfeiting: recent issues 89	0	1
Repackaging and counterfeiting 89	0	1
Wholesaling and counterfeiting 90	0	1
Online pharmacies 90	0	1
Unauthorized Internet pharmacies and counterfeits 91	0	1
Major producers of counterfeit drugs: China and India 94	0	1
China 95	0	1
Domestic counterfeiting: recent evidence 96	0	1
Contract manufacturing and the risk of counterfeiting 97	0	1
The counterfeit route: going West 99	0	1
India 99	0	1
Factors contributing to copycat & counterfeiting activities 100	0	1
The legitimate distribution pathway: problems going West 102	0	1
Chapter 4 Anti-counterfeiting strategies: current perspectives 104	0	1
Summary 104	0	1
Anti-counterfeiting strategies 105	0	1
Technical strategies 105	0	1
Non-technical strategies 105	0	1
Non-technical strategies and counterfeiting: current initiatives 106	0	1
Anti-counterfeiting technologies in developed countries 107	0	1
Current focus: track-and-trace technologies & mass serialization 109	0	1
European Union 109	0	1
United States 110	0	1
Mass serialization: main technology types 112	0	1
Barcodes 112	0	1
Radio frequency identification 112	0	1
Radio frequency identification in developed countries: recent activities 116	0	1
Chemical authentication technologies in developed countries: recent activities and initiatives 117	0	1
New packaging technologies 119	0	1
Anti-counterfeiting technologies in developing countries 120	0	1
Radio frequency identification in developing countries: recent activities 120	0	1
Chapter 5 Global initiatives to combat counterfeiting 122	0	1
Summary 122	0	1
International anti-counterfeiting initiatives 123	0	1
Government efforts 123	0	1
European Commission 123	0	1
United States Department of Health & Human Services 126	0	1
World Health Organization 127	0	1
INTERPOL 129	0	1
Non-government efforts 129	0	1
UNICEF 129	0	1
Medecins Sans FrontiÃ¨res 130	0	1
UNITAID 130	0	1
Anti-counterfeiting initiatives in Asia 131	0	1
India 131	0	1
China 132	0	1
Taiwan 134	0	1
Pharmaceutical trade and industry organizations 135	0	1
Pharmaceutical Security Institute (PSI) 136	0	1
International Federation of Pharmaceutical Manufacturers Associations	0	1
(IFPMA) 136	0	1
European Federation of Pharmaceutical Manufacturers Associations (EFPIA) 137	0	1
The European Alliance for Access to Safe Medicines (EAASM) 139	0	1
New initiative: Rx-360 139	0	1
Stockholm Network 140 Considerations for parallel trade and counterfeiting 140 Key points and recommendations 140 Chapter 6 Appendix 143 Primary research methodology 143 References 143 Websites 144 Glossary 145 Index 147 List of Figures Figure 1.1: General	0	1

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