並行貿易：米国における処方薬輸入許可

Abstract

"Parallel Trade acts as an important driving force for market integration where there are important differences in price between member states"

- European Commission Communication on the single market in pharmaceuticals

Parallel trade is on the verge of breaking its confines of the EU and diffusing into other global markets. This global practice is far from simple, and the loopholes that have made it possible refuse to close. Whether you think parallel trade is a benefit or a cost, the reality is that it is affecting the whole pharma industry on a wide scale. It started out a North-South divide but even this is changing. The European Commission and other trade regulation bodies won' t protect the pharma companies pricing structures.

Although consumers may think that imported drugs into the US come from Canada, UK, or other Western European nations, it' s impossible to definitively verify an imported drug' s country of origin.

• Do developing countries see parallel trade as a benefit for cheap drugs and if so will it remain a benefit?
• This year how much will pharma companies' profits be threatened by parallel trade?
• With individual drugs already being bought in Canada and Mexico will large scale parallel trade become a reality in the US as there are no price controls in place?
• The US market is such an attractive market for parallel traders. How will the enlargement of the EU, to 27 affect parallel trade?

Patients, general practitioners, healthcare agencies and national governments are all benefiting from this gray market import. However, there are actual ‘real’ winners in this trade, parallel traders themselves. They gain the most benefit from such a trade, which is pure profit. On the other hand, pharma companies are blaming parallel trade, for huge losses in revenue, which in affect lowers innovation. Parallel trade is seen as a gateway for counterfeit drugs entering the supply chain.

"In the European Union, products pass freely from one member nation to another - through a system called ' parallel trade.' Consequently, drugs sold in England may actually have originated in a country with less rigorous safety standards, such as Cyprus or Latvia". Warwick News

The latest case of counterfeit drugs entering the UK supply chain was that of Eli Lilly' s antipsychotic drug, Zyprexa and Sanofi-Aventis and Bristol Myers Squibb' s Plavix. Three batches were recalled by the MHRA. Isn' t this enough evidence that parallel trade is having a negative affect on the pharma industry? Find out by buying this report.

Does parallel trade diminish the quality and safety of drugs? Isn' t repackaging a great issue when it comes to parallel trade? Isn' t the Internet is a great medium for a form of parallel trade? Many important questions that need answers.

Why You Must Buy This Report:

This 130+ paged report features key figures, including graphs and charts, important tables, news, insights, the latest developments in the parallel trade market with up-to-date analysis.

This report will give you the understanding you require to gain that competitive edge in the parallel trade market. This controversial practice is a hot topic in the pharma industry. Therefore, it is vital that the latest parallel trade report is brought without fail.

With in depth analysis of key markets, and the latest information on parallel trade, this report is vital to grasp an understanding of parallel trade.

Key questions that this report answers:

• Why aren' t regulatory bodies protecting pharma companies from parallel trade?
• What are the affects of parallel trade on each segment of the market?
• Is it possible for pharma companies to protect themselves legally from?
• What price link can pharma companies establish that will halt parallel trade without reducing profits further?
• What liability do pharma companies face through repackaging when aligned with parallel trade?
• How can big pharma use the internet to combat parallel trade?
• How does parallel trade (re-importation) affect the US and Canada?

Unique benefits to you when you order this report:

You can access your report whichever country you are in without using hard drive space Primary research throughout. You will not find this information anywhere else Report stored in your reading room for ever Full searchable report when you buy the company or corporate editions Copies can be printed off as many times as you want for offline reading Packed with charts, analysis, figures, graphs and tables

Table of Contents

Chapter 1. Executive Summary: Parallel Trade, Benefiting or Breaking the Pharma Industry?

Chapter 2. Parallel Trade in Global Pharmaceutical Industry

• 2.1 What is Parallel Trade?
• 2.2 Effects of Parallel Trade
  • 2.2.1 Innovation driving R&D
  • 2.2.2 Profitability
  • 2.2.3 Safety/Efficacy of Drugs
  • 2.2.4 Easier Access for Counterfeit Drugs
    • 2.2.4.1 Methods of Controlling Counterfeit Drugs

Chapter 3. Legal Aspects of Parallel Trade

• 3.1 Exhaustion of Rights
  • 3.1.1 National Exhaustion
  • 3.1.2 Regional Exhaustion
  • 3.1.3 International Exhaustion
    • 3.1.3.1 International Exhaustion and the Pharma Industry
• 3.2 Intellectual Property Rights
  • 3.2.1 TRIPS
    • 3.2.1.1 Controversy surrounding TRIPS
  • 3.2.2 Doha Development Round
  • 3.2.3 Pharmaceutical Patent Protection
• 3.3 Compulsory Licensing
  • 3.3.1 Pharma Companies and Compulsory Licensing

Chapter 4. Price is the Principal Driver of Parallel Trade

• 4.1 Pricing in Pharma
  • 4.1.1 Factors that Influence Pricing
• 4.2 Price Convergence
  • 4.2.1 Arbitrage
  • 4.2.2 The Impact of the Euro on Drug Prices
  • 4.2.3 Price Convergence - a weak argument
• 4.3 Price Differential
  • 4.3.1 Pricing is not the Only Factor in Determining the Parallel Trade Potential for a Drug
• 4.4 Pricing Control
  • 4.4.1 Governments Link to Price Control
  • 4.4.2 Parallel Trade is used as a Cost Containment Method
  • 4.4.3 Cost Containment Methods have had Limited Effects
  • 4.4.4 Price Controls May Affect Drug Launches
  • 4.4.5 Price Control affects Innovation
  • 4.4.5.1 Price Control Seen as Reason why Europe' s Drug Innovation Falls Behind
  • 4.4.6 Reference Pricing will Cause Drugs to be Priced Below the Market Line
  • 4.4.7 A Single European Price for Pharma Drugs is Unlikely
• 4.5 Price Limiting
  • 4.5.1 Price Sensitivity
    • 4.5.1.1 Inelastic Market
    • 4.5.1.2 Elastic Market
  • 4.5.2 Factors That Affect Price Sensitivity

Chapter 5. Parallel Trade in US and Canada

• 5.1 Regulations in the US and Canada
• 5.2 Medicare Act Reducing Reliance on Cheaper Drugs from Canada
• 5.3 Safe Drugs are Only Imported from Canada
• 5.4 FDA' s Approach to Personal Importation
• 5.5 The Future of Re-importation
  • 5.5.1 Bill Allowing Imported Drugs Clears Senate
  • 5.5.2 Effects of Allowing Reimportation in the US
• 5.6 Differences in Pricing between the US and Canada
• 5.7 Patented Drugs are Found to be Cheaper in Canada than in US
• 5.8 US Generic Drugs Cost Less than Canadian Drugs

Chapter 6. Parallel Trade in Europe

• 6.1 Parallel Trade Predominantly a European Activity
  • 6.1.1 Trade Activity in the EU
  • 6.1.2 EU Parallel Importation
• 6.2 Drug Prices in the EU
• 6.3 UK - One of the largest Importers of Parallel Trade
  • 6.3.1 The Method of Parallel Importing into the UK
  • 6.3.2 Regulation of UK Parallel Trade
  • 6.3.3 Does the NHS Really Benefit from Parallel Trade?
  • 6.3.4 UK Parallel Traders - Major Companies
• 6.4 Germany
  • 6.4.1 German Parallel Distributors
• 6.5 France
• 6.6 Spain
• 6.7 Sweden
  • 6.7.1 Parallel Distributors in Sweden
• 6.8 Norway
  • 6.8.1 Norwegian Parallel Importers
• 6.9 The Netherlands
• 6.10 Denmark
  • 6.10.1 Conditions for Parallel Import
• 6.11 Parallel Exporting Countries
• 6.12 GSK Wins Long Battle
• 6.13 EU Enlargement
• 6.14 Limitations to Growth

Chapter 7. The Role of the Internet in Parallel Trade

• 7.1 Internet Usage is Immense
• 7.2 Online Purchasing of Drugs
  • 7.2.1 The World Online Drugs Market will Increase steadily
  • 7.2.2 Benefits of Online Drug Sales
  • 7.2.3 Concerns of Online Drug Sales
  • 7.2.4 Consumers Point to Low Cost and Convenience as Reasons for Purchasing Drugs Online
  • 7.2.5 Online Pharmacies Differ in their Operations
• 7.3 Verified Internet Pharmacy Practice Sites (VIPPS)
  • 7.3.1 Certification of the VIPPS Programme
• 7.4 Regulations for International Sites
  • 7.4.1 US Regulations
  • 7.4.2 Australia
  • 7.4.3 Fiji
  • 7.4.4 India
  • 7.4.5 Israel
  • 7.4.6 New Zealand
  • 7.4.7 UK
• 7.5 Canadian Internet Pharmacies
  • 7.5.1 US Consumers Buying Less from Canadian Internet Pharmacies
• 7.6 Rogue Internet Pharmacies
  • 7.6.1 UN Issues Warning About Rogue Internet Pharmacies
  • 7.6.2 Continuing Challenges Faced in Counteracting Illegal Internet Pharmacies
• 7.7 Operation Cyber Chase - A Year Long Investigation
• 7.8 Online Pharmacies: Good or Bad?

Chapter 8. Counterfeiting is a Major Threat

• 8.1 An Immense Concern Due to Counterfeiting
• 8.2 Prevalence of Counterfeiting
  • 8.2.1 Counterfeiting Incidents in Europe
• 8.3 PSI - Will it help?
• 8.4 Global Reports of Counterfeit Medicines
• 8.5 Counterfeit Lipitor Dispersed through the UK Supply Chain

Chapter 9. The Issue of Repackaging

• 9.1 The Repackaging of Pharmaceuticals is an Important Aspect of Parallel Trade
• 9.2 Different Types of Packaging
• 9.3 What a Package Must Do
• 9.4 The EU Angle on Repackaging
• 9.5 FDA' s Approach to Repackaging
• 9.6 Legal Case of Repackaging
  • 9.6.1 Advocate General' s Opinion on EU Repackaging of Pharmaceutical Products
  • 9.6.2 Background to the Case
  • 9.6.3 Advocate General' s Main Conclusions
    • 9.6.3.1 Overstickering
    • 9.6.3.2 The Necessity Condition
    • 9.6.3.3 Damage
    • 9.6.3.4 Notice
    • 9.6.3.5 Burden of Proof
  • 9.6.4 Impact of Such a Legal Case
• 9.7 Repackaging Affects Quality

Chapter 10. Arguments for Parallel Trade

• 10.1 York Study Did Show Healthcare Costs to be Reduced by Small Amounts
• 10.2 Swedish Study Confirms Price Competitiveness in Parallel Trading of Drugs
• 10.3 University of Southern Denmark Agrees with York Methodology
• 10.4 EU Price Convergence Unlikely
• 10.5 The British Association of European Pharmaceutical Distributors Aim to Deliver Value

Chapter 11. Arguments Against Parallel Trade

• 11.1 Manufacturing Pharmaceutical companies Argument against Parallel Trade
  • 11.1.1 Loss of Profits
  • 11.1.2 Counterfeit Drugs
    • 11.1.2.1 Batches of Two Blockbuster Drugs being Recalled After Counterfeits were Found
• 11.2 The Right to Maximise Returns
• 11.3 LSE Report Showed Negligible Savings

Chapter 12. Parallel Trade: Double Edged Sword

• 12.1 Benefits of Parallel Trade
• 12.2 The Costs of Parallel Trade
• 12.3 Global Growth of Parallel Trade
• 12.4 The Future

List of Tables

• Table 2.1 R&D Expenditure in the UK ($m)
• Table 4.1 Comparative Drug Prices in Selected Developed Countries
• Table 4.2 All Factors that Influence Drug Prices
• Table 4.3 Pricing Differentials for Leading Drugs (30 day supply)
• Table 4.4 Another Example of Differential Pricing (price per pill)
• Table 4.5 Advantages and Disadvantages of Single European Price
• Table 5.1 Difference in Pricing of Selected Drugs
• Table 5.2 U.S./Canadian Price Comparisons
• Table 5.3 Price Per Standard Unit in the US Compared to Canada
• Table 5.4 Price Per Standard Unit of Lipitor in the US and Canada
• Table 5.5 Price Difference in Selected Generics
• Table 6.1 Key Financials for the EU Pharmaceutical Industry ($m), 1990-2005
• Table 6.2 EU Pharmaceutical Trade Balances ($m)
• Table 6.3 Price Per Standard Unit in EU States
• Table 6.4 Price Per Standard Unit of Lipitor in EU States
• Table 6.5 NHS Saving Compared to Parallel Importers' Profit
• Table 6.6 UK Parallel Distributors
• Table 6.7 German Parallel Importers
• Table 6.8 Swedish Parallel Traders
• Table 6.9 Norwegian Parallel Importers
• Table 7.1 Internet Usage World Wide
• Table 7.2 Top 20 Countries in Regards to Internet Usage
• Table 7.3 World Online Drug Market
• Table 7.4 US Agencies and their Authorities
• Table 7.5 Differences between Rogue and Quality Sites
• Table 8.1 Top Ranked Countries where Counterfeits were Seized/Discovered
• Table 10.1 Estimated Total Direct Savings from Parallel Trade in 2002
• Table 10.2 Estimated Direct Savings in 2004

List of Graphs

• Graph 1.1 Global R&D Expenditure and NME output
• Graph 4.1 Incidents in Europe
• Graph 5.1 World Internet Usage
• Graph 5.2 Top 20 Internet Usage Countries
• Graph 5.3 World Online Drug Market ($bn)
• Graph 7.1 European Parallel Trade
• Graph 7.2 EU Pharma Trade Balances
• Graph 7.3 Share of Parallel Imports in Pharmacy Market Sales (%)
• Graph 7.4 Estimated Share of Parallel Imports in Pharmacy Market Sales (%), 2007

List of Figures

• Figure 1.1 Parallel Trading
• Figure 3.1 Cost of Production
• Figure 3.2 Inelastic Market
• Figure 3.3 Elastic Market

Organisations Listed

• Abacist Pharma
• Abit Express
• ACA Mueller
• Acadic
• Ace Pharma
• Actipart
• Alpha Med
• Apothekamed
• Arzneim Pharm
• Beragena
• Bestphago
• Boehringer Ingelheim
• Bios
• Bristol Myers Squibb
• Cancernova
• Cocept Pharma
• Diaprax
• Doc Pharm
• Ecowest
• Eli Lilly
• Farlic
• Gerke Pharma
• Gpp Pharma
• Gruenwald
• GSK
• Holmsland
• Isopharm
• IPM
• Kern
• Kurz
• Logimed
• Lexon UK
• Maximed
• Maxi Pharma
• Medartuum
• Medi Spezial
• Merck
• Mevita
• Naturprod
• Novartis
• Necessity Supplies
• Omna Laek
• Opti Arzeni
• Parallel PH
• Pfizer
• Pharmel
• Pharmpole
• Pharm Dett
• Qdoxx
• Rehaforum
• Sanofi Aventis
• Servo Pharma
• Sigma
• Swingward and Doewlhurst
• Trans Euro Med
• Waymade
• Werner
• Western Pharma